Patent Law
Patent Docs 
Focuses on recent developments in biotechnology and pharmaceutical patent law, offering updates regarding changes in Patent Office rules and procedures that affect biotech/pharma patent prosecution, providing summaries of recent court decisions that impact biotech/pharma patent litigation and prosecution, and monitoring newly filed biotech/pharma patent litigation. In addition, Patent Docs highlights recently issued biotech/pharma patents, and reports on biotech/pharma news.
Post Frequency: 3.2/day Last Entry: November 21, 2009 at 01:39:24 Recent Entries: 1022
By Donald Zuhn, Kevin Noonan, Chris Singer, Sherri Oslick, and Jason Derry
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LEI National CLE Conference
Posted on November 21, 2009Law Education Institute, Inc. (LEI) will be holding the 27th Annual National CLE Conference on January 6-10, 2010 in Vail, Colorado. The Intellectual Property program of the conference, which will be held at the Vail Marriott Resort & Spa, will offer presentations on a number of topics, including: ? Federal Circuit and legislative update; ? Continued importance of opinions of counsel post-Seagate and Broadcom; ? Recent developments in licensing case law; ? Unglamorous but deadly -- Invalidity under Section 112; ? Effective litigation strategies using the ITC, district courts and re-examination ? Patent corporate counsel panel: What keeps corporate counsel...
Amicus Briefs in Ariad v. Eli Lilly: Professor Christopher Holman
Posted on November 20, 2009By Kevin E. Noonan -- Christopher M. Holman, Associate Professor of Law at the University of Missouri-Kansas City (and proprietor of Holman's Biotech IP Blog), has filed an amicus brief in support of neither party in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co...
Chisum on Patent Law Themes and Inequitable Conduct
Posted on November 19, 2009By Donald Zuhn -- Earlier this month, Donald Chisum (at right), who for the past 31 years has authored the patent treatise Chisum on Patents, was in Chicago to give a luncheon presentation on recent patent law developments to a group of local practitioners...
Patent Term Adjustment: 37 C.F.R. § 1.704(b)'s Three-Month Provision
Posted on November 18, 2009By Sydney Kokjohn -- Patent practitioners concerned about patent term adjustment should pay careful attention to 37 C.F.R. § 1.704(b) concerning applicant delay, especially regarding the date of issue fee payments. This section provides that "an applicant shall be deemed to have failed to engage in reasonable efforts to conclude processing or examination of an application for the cumulative total of any periods of time in excess of three months that are taken to reply to any notice or action by the Office making any rejection, objection, argument, or other request...
Lilly Files Principal Brief for Ariad v. Lilly Rehearing En Banc
Posted on November 17, 2009By Donald Zuhn -- Last week, Defendant-Appellant Eli Lilly & Co. filed its principal brief for the rehearing en banc of Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., which is scheduled for December 7th. (Patent Docs provided a summary of Ariad's principal brief, which was filed on October 5th, last Tuesday; see "Next Up: Ariad v...
Court Report
Posted on November 16, 2009By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Monsanto Co. et al. v. Germann 4:09-cv-01848; filed November 11, 2009 in the Eastern District of Missouri ? Plaintiffs: Monsanto Co...
Conference & CLE Calendar
Posted on November 16, 2009November 16-17, 2009 - Patent Litigation 2009 (Practising Law Institute) - New York, NY November 17-18, 2009 - Structuring, Negotiating, and Managing Pharma/Biotech Collaborative Agreements (American Conference Institute) - New York, NY November 18, 2009 - Patentable Subject Matter After the Bilski Oral Argument (American University Washington College of Law and the Federal Circuit Bar Association) - 4:30-6:30 pm (EST) December 7, 2009 - 20th Annual Conference on U...
Panel to Focus on Bilski Oral Argument
Posted on November 16, 2009On Thursday, November 18, 2009, the American University Washington College of Law Program on Information Justice and Intellectual Property and the Federal Circuit Bar Association (FCBA) will be offering a panel discussion entitled "Patentable Subject Matter After the Bilski Oral Argument...
Director Kappos Joins Blogger Ranks
Posted on November 13, 2009By Donald Zuhn -- On Tuesday, the U.S. Patent and Trademark Office announced that USPTO Director David Kappos (at right) has launched a new blog "to foster a direct dialogue with the USPTO's stakeholders and the general public." The blog, running under the heading "Director's Forum: David Kappos' Public Blog," can be reached through a link on the USPTO homepage or at www...
USPTO Proposes Patents Ombudsman Pilot Program
Posted on November 13, 2009By Christopher P. Singer -- On October 27, 2009, the U.S. Patent and Trademark Office published a notice in the Federal Register (74 Fed. Reg. 55212) outlining a new "Patents Ombudsman Pilot Program." The program is intended to provide patent applicants and practitioners with an additional resource for application specific prosecution issues, particularly when prosecution of the application has stalled...
If It Ain't Over 'Til It's Over, Today It's Over
Posted on November 13, 2009By Kevin E. Noonan -- Chief Judge Paul Michel, writing for most of the en banc Court of Appeals for the Federal Circuit (Judge Lourie took no part in the decision), today granted the joint motion of all parties to dismiss the appeal of Tafas v. Kappos...
USPTO News: Public and Private PAIR Maintenance & Form Usage
Posted on November 13, 2009By Christopher P. Singer -- PAIR Maintenance The USPTO posted a message on the front page of PAIR announcing that both Public and Private PAIR will be down for maintenance for part of this weekend. The maintenance is expected to begin at 10:00 pm EST on Saturday, November 14th and last until about 11:00 am EST on Sunday, November 15th...
Biotech/Pharma Docket
Posted on November 12, 2009By Suresh Pillai -- Infosint Seeks Increased Damages Award in Citalopram Suit Following a decision by the U.S. District Court for the Southern District of New York in October finding Forest Laboratories and Lundbeck A/S liable for infringement of Infosint's patent covering the antidepressant citalopram, Infosint has now returned to the District Court seeking an increase in its damages award...
Next Up: Ariad v. Lilly Rehearing En Banc
Posted on November 11, 2009By Donald Zuhn -- With oral argument before the Supreme Court in In re Bilski now concluded, patent practitioners can begin to turn their attention toward the next big patent case awaiting oral argument: the Federal Circuit's en banc rehearing of Ariad Pharmaceuticals, Inc...
Supreme Court Bilski Argument
Posted on November 10, 2009By Kevin E. Noonan -- The highest form of tea leaf-reading is guessing how the Supreme Court will rule based on oral argument. Yet occasionally the Court's questioning suggests general trends and tendencies, and today's argument in Bilski v. Kappos may be one of those times...
Reminder: RCE Docketing Change Effective November 15, 2009
Posted on November 10, 2009By Christopher P. Singer -- As reported a few weeks ago, the U.S. Patent and Trademark Office issued a pre-OG Notice regarding the way it will docket requests for continued examination (RCE) beginning on November 15, 2009. For any RCE that is filed on or after that date, the Office will place that RCE on an examiner's "Special New" application docket, which also includes divisional and continuation applications as well as applications that have been granted petitions to make special under 37 C...
Court Report
Posted on November 09, 2009By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Novartis AG et al. v. Apotex Inc. et al. 1:09-cv-06950; filed November 4, 2009 in the Northern District of Illinois ? Plaintiffs: Novartis AG; Novartis Pharmaceuticals Corp...
Conference & CLE Calendar
Posted on November 09, 2009November 9-10, 2009 - Patent Litigation 2009 (Practising Law Institute) - Atlanta, GA November 9-11, 2009 - Developing IP Strategies for Crystalline Forms*** (International Quality & Productivity Center) - London, England November 10, 2009 - The Patent Cooperation Treaty (PCT): Important Tool for Small and Medium-Sized Enterprises (SMEs) and Independent Inventors (World Intellectual Property Organization) - Baltimore, MD November 10, 2009 - The 'Day After' Show: Analyzing the Bilski Oral Arguments at the U...
Bilski CLE Options
Posted on November 07, 2009On Monday, November 9, 2009, the Supreme Court will hear oral argument in In re Bilski, and two CLE providers plan to offer same day or next day coverage of the proceedings. Practising Law Institute (PLI) will be offering same day coverage on its Patent Practice Center blog...
CLE on Avoiding Inequitable Conduct Claims
Posted on November 07, 2009Managing IP and Lexis Nexis will be offering a free web seminar entitled: "Avoid Patent Unenforceability Claims Due to Inequitable Conduct" on November 12, 2009 from 12:00-1:30 PM (EST). J. Timothy Meigs of BD Technologies, Lawrence Sung of Dewey & LeBoeuf LLP, and Jeffrey Lindeman of Nixon Peabody LLP will provide tips for conducting the business and legal affairs associated with research and development to minimize the risks that an inequitable conduct defense will be lodged in litigation...
Follow-on Biologics News Briefs - No. 9
Posted on November 06, 2009By Donald Zuhn -- Patient Groups Back Senate and House Committee FOB Legislation In September, twenty-seven patients' groups sent a letter to Sen. Harry Reid (D-NV), Sen. Mitch McConnell (R-KY), Speaker of the House Nancy Pelosi (D-CA), and Rep. John Boehner (R-OH), expressing their "strong support for the inclusion of a regulatory pathway for biosimilars in the America's Affordable Health Choices Act of 2009...
Biotech/Pharma Docket
Posted on November 05, 2009By Suresh Pillai -- Mayo Seeks Supreme Court Review in Prometheus Labs Case Following the U.S. Court of Appeals for the Federal Circuit's ruling that Prometheus Laboratories' method patents were valid under In re Bilski, the Mayo Clinic has petitioned the U...
House Health Care Bill Includes Biosimilar Licensure Pathway
Posted on November 04, 2009By Donald Zuhn -- Last Thursday, Rep. John Dingell (D-MI) introduced the Affordable Health Care for America Act (H.R. 3962) in the House of Representatives. The 1,990-page bill, which was co-sponsored by Rep. Robert Andrews (D-NJ), George Miller (D-CA), Frank Pallone, Jr...
12 Senators Write in Support of 12-Year Data Exclusivity Period
Posted on November 04, 2009By Donald Zuhn -- On October 23, twelve Senators sent a letter to Sen. Harry Reid (D-NV), asking the Senate majority leader to "support the establishment of a responsible pathway for the approval of follow-on biologic treatments, or 'biosimilars,' that ensures patient safety and includes 12 years of data exclusivity...
BRCA Patent Suit to Continue in Southern District of New York
Posted on November 03, 2009By Kevin E. Noonan -- Judge Robert W. Sweet of the Southern District of New York ruled against the defendant's motions to dismiss in Association for Molecular Pathology v. U.S. Patent and Trademark Office (see Opinion). The defendants brought these motions under Federal Rules of Civil Procedure 12(b)(1) (for lack of subject matter jurisdiction), (b)(2) (for lack of personal jurisdiction), and (b)(6) (for failure to state a claim)...
Follow-on Biologics Data Exclusivity Debate Scorecard - Part III
Posted on November 02, 2009By Donald Zuhn -- Over the past twelve months, Patent Docs has reported on a number of papers, letters, and statements that outline positions taken by various players in the follow-on biologics (FOB) data exclusivity debate. In view of the recent Time magazine article "How Drug-Industry Lobbyists Got Their Way on Health Care," which mentions that Duke University Prof...
Modeling a Zombie Infection Outbreak
Posted on October 31, 2009By Andrew Williams -- As many children and partygoers prepare to dress up as the undead for trick-or-treating fun or Halloween-themed parties, the scientific community is taking the potential of a Zombie attack more seriously. A group of mathematicians at the University of Ottawa and Carleton University (also in Ottawa) have prepared a paper for the up-coming book "Infectious Disease Modelling Research Progress," in which they have not only introduced and refined a basic model for zombie infections, they derive conditions under which Zombie eradication can occur...
Follow-on Biologics Data Exclusivity Debate Scorecard - Part II
Posted on October 30, 2009By Donald Zuhn -- Over the past twelve months, Patent Docs has reported on a number of papers, letters, and statements that outline positions taken by various players in the follow-on biologics data exclusivity debate. In view of last week's Time magazine article "How Drug-Industry Lobbyists Got Their Way on Health Care," which mentions that Duke University Prof...
Follow-on Biologics Data Exclusivity Debate Scorecard - Part I
Posted on October 29, 2009By Donald Zuhn -- Over the past twelve months, Patent Docs has reported on a number of papers, letters, and statements that outline positions taken by various players in the follow-on biologics data exclusivity debate. In view of last week's Time magazine article "How Drug-Industry Lobbyists Got Their Way on Health Care," which mentions that Duke University Prof...
Patent "Reform" May Happen This Year, After All
Posted on October 28, 2009By Kevin E. Noonan -- Just when you thought . . . it was safe to ignore patent reform, and fresh off a concerted push from the new Commerce Secretary, the new Patent and Trademark Office Director, and the new Deputy Director for patent reform that includes fee setting and substantive rulemaking authority, a Senate insider told a group of assembled patent attorneys and their clients that there is an 70-80% chance that the Senate will pass a bill this year (early next year at the latest)...
Time Magazine on Data Exclusivity Debate
Posted on October 28, 2009By Donald Zuhn ?- A report in last week's Time magazine focuses on the ongoing debate over "an obscure but crucial health-care provision": follow-on biologics data exclusivity -- the period of time that generic biologic manufacturers would have to wait before they are allowed to use an innovator's data to secure FDA approval for their generic biologics, or biosimilars, under a follow-on biologics regulatory pathway...
Biotech/Pharma Docket
Posted on October 27, 2009By Suresh Pillai -- Teva Loses Bid For Dismissal of Famciclovir Infringement Suit Last week, the U.S. District Court for the District of New Jersey denied Teva Pharmaceutical's bid to have Novartis Pharmaceuticals' patent infringement suit dismissed for lack of plaintiff standing...
Court Report
Posted on October 26, 2009By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Wyeth v. Intervet Inc. et al. 1:09-cv-00780; filed October 20, 2009 in the District Court of Delaware ? Plaintiff: Wyeth ? Defendants: Intervet Inc...
Conference & CLE Calendar
Posted on October 26, 2009October 26-28, 2009 - Intellectual Property Counsels' Committee (IPCC) Fall Conference & Meeting (Biotechnology Industry Organization) - Washington, DCNovember 9-10, 2009 - Patent Litigation 2009 (Practising Law Institute) - Atlanta, GA November 9-11, 2009 - Developing IP Strategies for Crystalline Forms*** (International Quality & Productivity Center) - London, England November 10, 2009 - The Patent Cooperation Treaty (PCT): Important Tool for Small and Medium-Sized Enterprises (SMEs) and Independent Inventors (World Intellectual Property Organization) - Baltimore, MD November 12-13, 2009 - Paragraph IV on Trial*** (American Conference Institute) - New York, NY November 13, 2009 - The Patent Cooperation Treaty (PCT):...
NVCA Study Shows Increase in Third Quarter Venture Funding
Posted on October 24, 2009By Donald Zuhn ?- On Tuesday, the National Venture Capital Association (NVCA), a trade association representing the U.S. venture capital industry, released the results of its latest venture funding study. The study, conducted with PriceWaterhouseCoopers and Thomson Reuters, indicates that venture capitalists invested $4...
Empirical Research Fails to Support Gene Patenting Ban
Posted on October 23, 2009By Kevin E. Noonan -- Bans on gene patenting and the possibility of having a court, Congress, or czar declare them banned are all the rage recently, spurred in part by the lawsuit against Myriad Genetics and the University of Utah (among other defendants) in the Federal District Court for the Southern District of New York (see "Association for Molecular Pathology v...
USPTO Schedules Roundtable Discussion on Worksharing
Posted on October 23, 2009By Donald Zuhn -- In a Federal Register notice published on Wednesday (74 Fed. Reg. 54028), the U.S. Patent and Trademark Office announced that it plans to hold a roundtable discussion to "obtain input from diverse sources in the patent community and/or the public sector to evaluate views on work sharing...
Biotech/Pharma Docket
Posted on October 22, 2009By Suresh Pillai -- Infosint Awarded $15 Million Verdict in Lexapro® Suit A federal jury in the U.S. District Court for the Southern District of New York has awarded Infosint $15 million as a reasonable royalty in Infosint's patent dispute with Lundbeck A/S and Forest Laboratories, Inc...
Dr. Tafas Files Reply to USPTO/GSK Motion to Dismiss Appeal and Vacate District Court Judgment
Posted on October 21, 2009By Donald Zuhn ?- On Monday, Counsel for Dr. Triantafyllos Tafas filed a reply to the joint motion to dismiss the appeal in Tafas v. Kappos and for a vacatur of the District Court's injunction and judgment filed by the U.S. Patent and Trademark Office and Appellee GlaxoSmithKline on October 9, 2009...
Senate Judiciary Committee Acts on Reverse Payments
Posted on October 21, 2009By Kevin E. Noonan -- With fresh life being breathed into its patent "reform" bill by the new Commerce Secretary and PTO management, the Senate Judiciary Committee on Thursday acted on another "reform" measure, voting in favor of sending to the floor of the Senate a bill prohibiting "reverse payments...
Four Senators Write in Support of 12-Year Data Exclusivity Period
Posted on October 20, 2009By Donald Zuhn ?- Earlier this month, four Senators sent a letter to Senate majority leader Harry Reid (D-NV) expressing their "strong support" for including an approval pathway for biosimilars in any health care reform package brought to the Senate floor for a vote...
PhRMA Supports Follow-on Biologics Regulatory Pathway Providing 12-Years of Data Exclusivity
Posted on October 20, 2009By Donald Zuhn ?- In a statement issued by the Pharmaceutical Research and Manufacturers of America (PhRMA) earlier today, the advocacy group representing pharmaceutical and biotechnology research companies indicated that it "supports the development of a responsible, abbreviated approval pathway for biosimilars that includes a fair period of data protection that is critical for the future of medical progress...
Myriad Sticks to Its Business Model
Posted on October 20, 2009By Kevin E. Noonan -- Myriad Genetics, one of the preeminent gene-based diagnostics companies, has been targeted by the American Civil Liberties Union, Dan Ravicher?s PUBPAT Organization, a raft of medical researchers and their associations, and individual patients in a lawsuit filed in the Southern District of New York; the avowed aim of the plaintiffs is to get the issue of "gene patenting" before the U...
Maybe Hatch-Waxman Data Exclusivity Isn't So Good For Traditional Drugs After All
Posted on October 19, 2009By Kevin E. Noonan -- The principal debate involving follow-on biologics legislation has revolved around the length of the data exclusivity term granted to innovators. The bill voted out of committee in the Senate Health, Education, Labor and Pensions (HELP) Committee has a 12-year data exclusivity term, which is shorter than the term supported by industry groups such as the Biotechnology Industry Organization (BIO) and also shorter than the term supported by the only peer-reviewed economic analysis of record...
Court Report
Posted on October 19, 2009By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Shelbyzyme LLC v. Genzyme Corp. 1:09-cv-00768; filed October 14, 2009 in the District Court of Delaware Infringement of U...
Conference & CLE Calendar
Posted on October 19, 2009October 20, 2009 - What the Federal Circuit Can Learn from the Supreme Court -- and Vice Versa (American University Washington College of Law) - 6:00 pm (EST) October 20-21, 2009 - 17th Forum on Biotech Patenting (C5) - London, United Kingdom October 22-23, 2009 - Pharmaceutical Congress on Paragraph IV Disputes*** (Center for Business Intelligence) - Philadelphia, PA October 26-28, 2009 - Intellectual Property Counsels' Committee (IPCC) Fall Conference & Meeting (Biotechnology Industry Organization) - Washington, DCNovember 9-10, 2009 - Patent Litigation 2009 (Practising Law Institute) - Atlanta, GA November 9-11, 2009 - Developing IP Strategies for Crystalline Forms***...
IPO PTO Day
Posted on October 17, 2009The Intellectual Property Owners Association (IPO) and U.S. Patent and Trademark Office will be co-sponsoring the 20th Annual Conference on U.S. Patent and Trademark Office Law and Practice (PTO Day) on December 7, 2009 in Washington, D.C. The PTO Day program includes patent general sessions on the following topics: ? Quality Initiatives and Measurement Compact Prosecution ? Hidden Problems In PCT Cases ? Discussion of Bilski post Supreme Court Argument ? Discussion of 101 Examination Instructions And breakout sessions on the following topics: ? Chemical/Biotech Patent Examining Practice (including Q&A) ? Interferences & Board Update ? Reexamination (Inter Parte/Ex Parte)...
American University Lecture to Focus on CAFC
Posted on October 17, 2009On Tuesday, October 20, 2009, the American University Washington College of Law Program on Information Justice and Intellectual Property will be offering the Fifth Annual Finnegan Distinguished Lecture on Intellectual Property. The lecture, entitled: "What the Federal Circuit Can Learn from the Supreme Court -- and Vice Versa," will feature Prof...
NEJM Authors Say Five Years of Data Exclusivity Would Be Sufficient
Posted on October 16, 2009By Donald Zuhn -- In an online paper published by the New England Journal of Medicine on Wednesday, a New York patent attorney and two Harvard professors contend that follow-on biologics (FOB) legislation being proposed in the House and Senate, which provides 12 years of data exclusivity, would "upset[] the delicate balance between the interests of consumers and those of innovators...
Recent Fee Increases for Foreign Patent Offices Acting as ISA for the PCT
Posted on October 16, 2009By Christopher P. Singer -- Within the last month, a number of foreign patent offices that act as International Searching Authorities (ISA) for the PCT announced fee increases to their search fees. IP Australia and the Korean Intellectual Property Office both enacted search fee increases that have been effective since September 15, 2009...
Thailand Becomes PCT Member State
Posted on October 16, 2009By Christopher P. Singer -- Back on September 24, 2009, WIPO announced that Thailand deposited its instrument of accession to the Patent Cooperation Treaty (PCT), becoming the 142nd contracting state of the treaty. The current list of contracting states can be viewed here...
Commerce Department Brass Weighs in on Patent Reform
Posted on October 15, 2009By Kevin E. Noonan -- Tuesday was Sharon Barner's first day as Deputy Director of the U.S. Patent and Trademark Office, and she spent part of it addressing members of the patent bar in Chicago. In a 90-minute roundtable meeting, Ms. Barner and Commerce Department General Counsel Cameron Kerry discussed patent reform and the Administration's support for S...
Biotech/Pharma Docket
Posted on October 15, 2009By Suresh Pillai -- Teva Files Counterclaims in Gilead Suit In answer to a complaint filed in the U.S. District Court for the Southern District of New York by Gilead Sciences Inc. over alleged patent infringement, Teva Pharmaceuticals has filed an amended answer and counterclaim alleging that the patents-in-suit are invalid...
Biogen Idec Receives Method-of-Use Patent on Human ß-Interferon
Posted on October 01, 2009Implications for Patent Protection for Avonex® Anti-Multiple Sclerosis Drug By Kevin E. Noonan -- There is a tendency to blame the process when an undesired outcome occurs. That is happening in the wake of regulatory filings with the Securities and Exchange Commission regarding U...
In re '318 Patent Infringement Litigation (Fed. Cir. 2009)
Posted on September 30, 2009By Donald Zuhn -- Last week, a divided panel of the Federal Circuit affirmed a determination by the District Court for the District of Delaware that the claims of U.S. Patent No. 4,663,318 were invalid for lack of enablement. The '318 patent, which issued on May 5, 1987 from U...
AstraZeneca Pharmaceuticals LP v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2009)
Posted on September 29, 2009Sometimes, Sins of Omission Are Not Inequitable Conduct By Kevin E. Noonan -- St. Thomas Aquinas recognized two types of sin: those of omission and those of commission. In patent law, inequitable conduct comes closest to this concept of sin, where frequently the accused behavior is the failure to submit to a patent examiner during prosecution information that is material to patentability...
Obviousness-type Double Patenting after Amgen v. F. Hoffmann-La Roche
Posted on September 28, 2009By Kevin E. Noonan -- Although Amgen's erythropoietin franchise has weathered its most recent challenge by F. Hoffmann-La Roche's pegylated EPO analog, Mircera® (see Amgen Inc. v. F. Hoffman-La Roche Ltd. (Fed. Cir. 2009)), the victory was not absolute...
Court Report
Posted on September 28, 2009By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Eurand Inc. et al. v. Anchen Pharmaceuticals Inc. et al. 1:09-cv-00715; filed September 23, 2009 in the District Court of Delaware ? Plaintiffs: Eurand Inc...
Conference & CLE Calendar
Posted on September 28, 2009September 30-October 1, 2009 - Biotech Patents*** (American Conference Institute) - Boston, MA October 5-6, 2009 - Patent Litigation 2009 (Practising Law Institute) - McLean, VA October 7-8, 2009 - Maximizing Pharmaceutical Patent Lifecycles*** (American Conference Institute) - New York, NY October 14, 2009 - Developments in Pharmaceutical and Biotech Patent Law (Practising Law Institute) - San Francisco, CA October 15-16, 2009 - Patent Litigation 2009 (Practising Law Institute) - Chicago, IL October 20-21, 2009 - 17th Forum on Biotech Patenting (C5) - London, United Kingdom October 22-23, 2009 - Pharmaceutical Congress on Paragraph IV Disputes*** (Center for Business Intelligence)...
USPTO and ARIPO Sign Bilateral Cooperation Agreement
Posted on September 26, 2009By Donald Zuhn -- The U.S. Patent and Trademark Office announced today that it had signed a Workplan for Bilateral Cooperation on intellectual property issues with the African Regional Intellectual Property Organization (ARIPO). The Workplan, which will serve to promote the development of effective intellectual property systems in ARIPO member countries, was signed by Under Secretary of Commerce for Intellectual Property David Kappos and Director General of ARIPO Dr...
USPTO Seeks Comments Regarding Sequence Listing Rules
Posted on September 25, 2009By Donald Zuhn -- The U.S. Patent and Trademark Office recently published a notice in the Federal Register inviting public comment regarding the Requirements for Patent Applications Containing Nucleotide Sequence and/or Amino Acid Sequence Disclosures (74 Fed...
Biotech/Pharma Docket
Posted on September 24, 2009By Suresh Pillai -- Cook and W. L. Gore Prevail in Suit over Endovascular Grafts The Court of Appeals for the Federal Circuit has affirmed a lower court ruling that neither Cook Inc. nor W. L. Gore & Associates infringed Edwards Lifesciences LLC's patents covering endovascular grafts used to treat aneurysms without open vessel surgery...
USPTO and EPO Announce Extension of Trial Period for PPH Program
Posted on September 24, 2009By Christopher P. Singer -- In a notice dated September 23, 2009, the U.S. Patent and Trademark Office announced that it will extend for one year the trial period for its patent prosecution highway (PPH) program with the European Patent Office. The extended trial period will expire on September 30, 2010...
ACI Patent Opinion Writing Boot Camp
Posted on September 24, 2009American Conference Institute (ACI) will be holding its Patent Opinion Writing Boot Camp on October 28-29, 2009 in Philadelphia, PA. The conference will allow attendees to: ? Identify how Seagate has altered opinion practice and the new standard for willful infringement; ? Clarify business objectives to determine the ultimate purpose of the opinion and the anticipated audiences; ? Formulate a pre-drafting strategy which accounts for the preparation, timing, and scope of the opinion; ? Understand how the opinion letter fits into the overall IP strategy; ? Incorporate new invalidity opinion strategies from evolving legal standards concerning written description and enablement;...
AsymmetRx, Inc. v. Biocare Medical, LLC (Fed. Cir. 2009)
Posted on September 23, 2009By Donald Zuhn -- Last week, the Federal Circuit determined that Plaintiff-Appellant AsymmetRx, Inc. did not have standing to bring an action for infringement of the patents-at-suit absent the participation of the President and Fellows of Harvard College...
WIPO Releases Report on Worldwide IP Rights
Posted on September 22, 2009By Donald Zuhn -- Last week, the World Intellectual Property Organization (WIPO) released a report on intellectual property trends showing that the number of filed patent, trademark, and industrial design applications increased in 2007 ("World Intellectual Property Indicators 2009")...
Patent Profile: Advaxis Granted New U.S. Patent in Protein Adjuvant Technology Portfolio
Posted on September 22, 2009By Sherri Oslick -- Last week, Advaxis, Inc., a biotechnology corporation focused on using a bioengineered bacterium, Listeria monocytogenes (Lm), to activate the immune system to treat cancer, infectious disease, or allergic syndromes, was issued U.S...
Roll Call Authors Unite against Current Follow Biologics Legislation
Posted on September 21, 2009By Donald Zuhn -- Earlier this month, James Love and James Glassman, writing in the Congressional newspaper Roll Call, expressed "alarm" regarding recent Congressional action concerning the establishment of a follow-in biologics (FOB) regulatory pathway ("Don't Kill Competition for High-Tech Drugs")...
Conference & CLE Calendar
Posted on September 21, 2009September 21-22, 2009 - 2009 World Stem Cell Summit*** - Baltimore, MD September 21-22, 2009 - Patent Litigation 2009 (Practising Law Institute) - San Francisco, CA September 23-25, 2009 - 10th Annual Generic Drugs Summit on the Business of Biosimilars (Institute for International Research) - Boston, MA September 30-October 1, 2009 - Biotech Patents*** (American Conference Institute) - Boston, MA October 5-6, 2009 - Patent Litigation 2009 (Practising Law Institute) - McLean, VA October 7-8, 2009 - Maximizing Pharmaceutical Patent Lifecycles*** (American Conference Institute) - New York, NY October 14, 2009 - Developments in Pharmaceutical and Biotech Patent Law (Practising...
ACI Foreign Patent Law & Regulation Conference
Posted on September 19, 2009American Conference Institute (ACI) will be holding a conference on Foreign Patent Law & Regulation for the U.S. Life Sciences Patent Practitioner from December 7-8, 2009 in New York, NY. The conference will allow attendees to: ? Develop a strategic plan for deciding when and where to file life sciences patents abroad; ? Prosecute and file life sciences and pharmaceutical patents in emerging Asian markets; ? Navigate unique issues that arise in the context of seeking supplementary protection certificates (SPCs) and method of use/treatment claims in life sciences patents; ? Address cultural idiosyncrasies and technical requirements in various jurisdictions when...
Tech Companies Send Letter on Patent Reform to Secretary Locke
Posted on September 18, 2009By Donald Zuhn -- On Monday, a group of 56 companies sent a letter to Secretary of Commerce Gary Locke (below) urging the Secretary "to push for improvements" to the post-grant and inter partes examination provisions of patent reform legislation currently before Congress...
Prometheus Laboratories, Inc. v. Mayo Collaborative Services (Fed. Cir. 2009)
Posted on September 17, 2009Medical Diagnostics Claims Are Patentable Subject Matter By Kevin E. Noonan -- Over the past few years, Federal Circuit decisions in In re Bilski and Classen Immunotherapeutics, Inc. v. Biogen Idec, combined with Justice Breyer's dissent in Laboratory Corp...
Interactive Graphic Illustrates How U.S. Patent System Has Driven American Economy
Posted on September 17, 2009By Donald Zuhn -- Last month, the Milwaukee Journal Sentinel published two articles documenting the current state of the U.S. patent system (see "The Milwaukee Journal Sentinel Gets It Right about Patents"). The authors of those pieces, John Schmid and Ben Poston, have now compiled an interactive graphic that shows how the U...
Amgen Inc. v. F. Hoffman-La Roche Ltd. (Fed. Cir. 2009)
Posted on September 16, 2009Something for Everyone, but the Injunction Stands By Kevin E. Noonan -- Amgen has several times successfully defended its erythropoietin (EPO) franchise, the company's first commercial success and in many ways the crown jewel of its (or anyone's) biologics drug pipeline...
Biotech/Pharma Docket
Posted on September 16, 2009By Suresh Pillai -- Purdue Files Appeal in Ultram® Suit against Par Purdue Pharma Products Inc. has filed an appeal with the U.S. Court of Appeals for the Federal Circuit seeking to overturn an earlier federal court decision that invalidated Purdue's patents (U...
ChemBridge Makes Chemical Libraries Available Via Public Access Database
Posted on September 15, 2009By Donald Zuhn -- Last month, ChemBridge Corp. announced that it would make ten of its most popular chemical screening libraries available to researchers via the Collaborative Drug Discovery (CDD) Public Access database. The CDD Public Access database, a collection of public data from leading vendors, researchers, scientific literature, and patent resources, is hosted by Collaborative Drug Discovery, Inc...
Court Report
Posted on September 14, 2009By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Warner Chilcott C. LLC v. Lupin Limited et al. 1:09-cv-00673; filed September 9, 2009 in the District Court of Delaware ? Plaintiff: Warner Chilcott Co...
Conference & CLE Calendar
Posted on September 14, 2009September 13-15, 2009 - 2009 Annual Meeting (Intellectual Property Owners Association) - Chicago, IL September 14-15, 2009 - 3rd Summit on Biosimilars and Follow-on Biologics*** (Center for Business Intelligence) - National Harbor, MD September 15-16, 2009 - FDA Boot Camp*** (American Conference Institute) - Boston, MA September 17, 2009 - Developments in Pharmaceutical and Biotech Patent Law (Practising Law Institute) - New York, NY September 21-22, 2009 - 2009 World Stem Cell Summit*** - Baltimore, MD September 21-22, 2009 - Patent Litigation 2009 (Practising Law Institute) - San Francisco, CA September 23-25, 2009 - 10th Annual Generic Drugs Summit on...
Analyst Lists Five Biotech Companies to Watch
Posted on September 12, 2009By Donald Zuhn -- Last week, Dr. Simos Simeonidis, a Senior Biotechnology Analyst for Rodman & Renshaw, LLC, provided FierceBiotech with a list of five biotech companies to watch in the coming months ("Five Biotech Companies to Watch"). On Dr. Simeonidis' list were Poniard Pharmaceuticals, GTx, OncoGenex, MannKind Corp...
WIPO to Offer Seminars on PCT
Posted on September 12, 2009The World Intellectual Property Organization (WIPO) will hold a one-day seminar on the Patent Cooperation Treaty (PCT) for small and medium-sized enterprises and independent inventors on November 10, 2009 in Baltimore, MD and on November 13, 2009 in Las Vegas, NV...
Sanofi-Aventis U.S. LLC v. Sandoz, Inc. (Fed. Cir. 2009)
Posted on September 11, 2009More Claim Construction Confusion from the Federal Circuit By Kevin E. Noonan -- The Federal Circuit demonstrated once again the quagmire that can exist when lower courts attempt to apply the CAFC's rather quixotic jurisprudence on claim construction...
BIO Top Brass Meet the Press
Posted on September 10, 2009By Kevin E. Noonan -- The Biotechnology Industry Organization (BIO) held a media briefing on Federal policy issues today, with most of BIO's executive staff assembling at BIO headquarters in Washington, D.C. In addition to the media present on site, BIO hosted several more members of the press by teleconference...
Patent Profile: OncoGenex Announces Issuance of Patent for Antisense Cancer Therapeutic
Posted on September 09, 2009By Donald Zuhn -- Last month, OncoGenex Pharmaceuticals, Inc. announced that the U.S. Patent and Trademark Office had issued U.S. Patent No. 7,569,551. The '551 patent is directed to a method of enhancing cancer cell chemo- or radiation-sensitivity using an antisense oligodeoxynucleotide targeted against the testosterone-repressed prostate message-2 (TRPM-2) gene...
Changes in USPTO Senior Management
Posted on September 09, 2009By Christopher P. Singer -- In a press release issued last week, the U.S. Patent and Trademark Office announced that current Commissioner for Patents, John Doll, has indicated that he plans to retire from the agency on October 2, 2009. USPTO Director David Kappos has nominated Robert Stoll (at right), a current USPTO executive, to take over Mr...
USPTO Says Some Requests for PTA Reconsideration Are Premature
Posted on September 08, 2009By Sydney Kokjohn -- We recently received a dismissal of a Request for Reconsideration of Patent Term Adjustment Determination under 37 C.F.R. § 1.705(b). The Request was filed solely on the basis that the Patent Office had taken more than three years to issue the patent...
Court Report
Posted on September 08, 2009By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. King Pharmaceuticals Inc. et al. v. Sandoz Inc. 2:09-cv-04513; filed September 1, 2009 in the District Court of New Jersey ? Plaintiffs: King Pharmaceuticals Inc...
Conference & CLE Calendar
Posted on September 08, 2009September 13-15, 2009 - 2009 Annual Meeting (Intellectual Property Owners Association) - Chicago, IL September 14-15, 2009 - 3rd Summit on Biosimilars and Follow-on Biologics*** (Center for Business Intelligence) - National Harbor, MD September 15-16, 2009 - FDA Boot Camp*** (American Conference Institute) - Boston, MA September 17, 2009 - Developments in Pharmaceutical and Biotech Patent Law (Practising Law Institute) - New York, NY September 21-22, 2009 - 2009 World Stem Cell Summit*** - Baltimore, MD September 21-22, 2009 - Patent Litigation 2009 (Practising Law Institute) - San Francisco, CA September 23-25, 2009 - 10th Annual Generic Drugs Summit on...
VC CEO Believes Biotech Is Entering Golden Era
Posted on September 07, 2009By Donald Zuhn -- In the August issue of Life Science Leader Magazine, Randal Kirk, Chairman and CEO of the venture capital firm Third Security, LLC, writes that while some 600 to 800 life science companies are expected to go out of business or be absorbed by other companies within the next two years, biotech is at the edge of "a golden era of valuable discoveries that forever will revolutionize its foundation" ("At the Outset of the Golden Era of Biotech")...
Developing IP Strategies for Crystalline Forms Conference
Posted on September 05, 2009International Quality & Productivity Center (IQPC) will be holding its 5th Annual Developing IP Strategies for Crystalline Forms conference from November 9-11, 2009 in London, England. The conference will provide: ? An international case law update for the EU, U...
ACI Pharma/Biotech Collaborative Agreements Conference
Posted on September 05, 2009American Conference Institute (ACI) will be holding its 13th Advanced Forum on Structuring, Negotiating, and Managing Pharma/Biotech Collaborative Agreements from November 17-18, 2009 in New York, NY. The conference will allow attendees to: ? Integrate emerging trends in investment capital and current deal structuring into product strategies; ? Establish a strong presence in new and emerging markets; ? Strengthen market power by ensuring effective due diligence; ? Maximize profitability through skillful negotiations of critical performance terms; ? Develop strategies to determine the impact of M&A activity and best position a company for an acquisition; ? Gain greater control by drafting...
Paper Declares that with Respect to Drug Innovation, "Europe Is Ahead"
Posted on September 04, 2009By Donald Zuhn -- A paper published in the latest issue of the policy journal Health Affairs disputes the widely held notion that the United States has eclipsed Europe in terms of pharmaceutical research productivity. In the article, entitled "Global Drug Discovery: Europe Is Ahead," Dr...
Cancer Drug Development in The New York Times
Posted on September 03, 2009By Kevin E. Noonan -- The fastest-growing part of the biotech/pharma industry is anticancer drugs, according to an article in The New York Times today ("For Profit, Industry Seeks Cancer Drugs"). Written by Andrew Pollack, one of the paper's senior business and technology writers, the article highlights the interplay between scientific interest and business opportunity driving this phenomenon...
Biotech/Pharma Docket
Posted on September 02, 2009By Suresh Pillai -- Capricorn Keeps Zicam® IP Suit Active, But Loses Bid for Inventorship Change The U.S. District Court for the District of Delaware has ruled that Capricorn Pharma, Inc. can proceed with its suit against Matrixx Initiatives Inc. for allegedly infringing Capricorn's patent covering Zicam®, a cold medication...
BioWorld Reports on the Top 25 Biotech Drugs
Posted on September 02, 2009By Kevin E. Noonan -- BioWorld Today posted an article last week about the top 25 biotech drugs currently on the market. Written by Michael Harris, Executive Editor, the piece represents a précis of a longer report by BioWorld, entitled "Market-Leading Biotechnology Drugs 2009: Blockbuster Dynamics in an Ailing Economy...
Biotech/Pharma Financing Improving, R&D Spending Up
Posted on September 01, 2009By Donald Zuhn -- A recent article in Signals Magazine reports that biotech and specialty pharma companies raised 41% more revenue in the first six months of 2009 ($8.3 billion) than they did in the same period in 2008 ($5.9 billion) ("Biotech Financing Gathers Steam")...
Leg Length Variation in Dogs and its Relevance to Human Mutations
Posted on September 01, 2009By Kevin E. Noonan -- One of the benefits of the exponential increase in genetic information consequent to the determination of the genomic DNA sequence of numerous species (the various "genome projects" that include the Human Genome Project) is that it permits sequence comparisons between related species...
Court Report
Posted on August 31, 2009By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Aventis Pharma S.A. et al. v. Sun Pharmaceutical Industries Ltd...
The Genetic Basis of Coat Variation in Dogs
Posted on August 31, 2009By Kevin E. Noonan -- The genetic age, characterized by numerous genome projects (not the least of which is the Human Genome Project) has focused the public's attention on the influence of our genes on our characteristics. This has led to questions about whether there is a "gene" for risk-taking, or homosexuality, or aggressiveness...
Conference & CLE Calendar
Posted on August 31, 2009September 1, 2009 - Prior Art & Obviousness 2009: The PTO & CAFC Perspective on Patent Law Sections 102 & 103 (Practising Law Institute) - San Francisco, CA September 2, 2009 - Biotechnology/Chemical/Pharmaceutical Customer Partnership Meeting (U.S. Patent and Trademark Office) - 10:00 am - 4:45 pm (EDT) September 13-15, 2009 - 2009 Annual Meeting (Intellectual Property Owners Association) - Chicago, IL September 14-15, 2009 - 3rd Summit on Biosimilars and Follow-on Biologics*** (Center for Business Intelligence) - National Harbor, MD September 15-16, 2009 - FDA Boot Camp*** (American Conference Institute) - Boston, MA September 17, 2009 - Developments in...
IIR 10th Annual Generic Drugs Summit
Posted on August 29, 2009The Institute for International Research (IIR) will be holding its 10th Annual Generic Drugs Summit entitled "Business of Biosimilars: Innovative Tools and Strategies to Compete in the Evolving Biosimilars Market" on September 23-25, 2009 in Boston, MA...
C5 Biotech Patenting Conference
Posted on August 29, 2009C5 (UK) will be holding its 17th Forum on Biotech Patenting on October 20-21, 2009 in London, United Kingdom. The conference will allow attendees to collect up-to-date information and insights on: ? Recent changes in policy and patentability criteria: Hear directly from the EPO; ? The latest EPO decisions impacting key aspects of biotech patenting such as methods of surgery and new standards on double patenting and prior art; ? Major U...
Deloitte White Paper Addresses Unintended Consequences of Follow-on Biologic Regulatory Pathway
Posted on August 28, 2009By Donald Zuhn -- Last spring, Patent Docs discussed pending follow-on biologics legislation with California Healthcare Institute (CHI) president and CEO Dr. David Gollaher (see "CHI CEO on Patent Reform and Follow-on Biologics Legislation"). During the discussion, Dr...
Ortho-McNeil Pharmaceutical, Inc. v. Teva Pharmaceuticals Industries, Ltd. (Fed. Cir. 2009)
Posted on August 27, 2009By Donald Zuhn -- The Federal Circuit today vacated-in-part and affirmed-in-part an order by the District Court for the District of New Jersey granting summary judgment of invalidity of U.S. Reissued Patent No. 39,221 based on anticipation and obviousness...
The Tragedy of a Bad Idea
Posted on August 26, 2009By Kevin E. Noonan -- Some (bad) ideas are a long time a-dyin'. One of the most persistent in biotechnology patent law is the concept of the "tragedy of the anticommons." An intriguing idea when first proposed by Heller and Eisenberg in 1998, it was also frightfully naïve about the "anticommons" effects of circumstances much more germane to most academic molecular biologists (like priority and career advancement)...
Professor Grabowski's Economic Analysis of Data Exclusivity for Follow-on Biologic Drugs
Posted on August 25, 2009By Kevin E. Noonan -- Professor Henry Grabowski has been cited often in the data exclusivity debate, on the economic justification for a twelve-year data exclusivity period for biologic drugs. Dr. Grabowski (at right), a Professor at The Fuqua School of Business at Duke University, has some credibility (in addition to his academic credentials) for having the only peer-reviewed analysis of the topic (his paper, "Follow-on biologics: data exclusivity and the balance between innovation and competition," was published online in Nature Reviews Drug Discovery on May 12, 2008)...
Court Report
Posted on August 23, 2009By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. A.F. of L. - A.G.C. Building Trades Plan v. Merck & Co. et al. 3:09-cv-04202; filed August 14, 2009 in the District Court of New Jersey ? Plaintiff: A...
Agenda for Next BCP Customer Partnership Meeting Announced
Posted on August 23, 2009The next biotechnology/chemical/pharmaceutical (BCP) customer partnership meeting will be held on September 2, 2009. The proposed agenda for that meeting is as follows: Morning Session ? Greetings and Overview (10:00 - 10:15 am EDT): John LeGuyader, Remy Yucel, and Michael Wityshyn, Directors, Technology Center 1600 ? Interview Practice (10:15 - 11:00 am): Tim Callahan, Director, TC 2400 ? Break (11:00 - 11:15 am) ? Reissue Overview (11:15 am - 12:00 pm): Laufer Pinchus, Office of Patent Legal Administration, and Jean Vollano, QAS, TC 1600 ? Inappropriate Restricting (12:00 - 12:45 pm): Julie Burke, QAS, TC 1600 ? Lunch (12:45 ?...
Conference & CLE Calendar
Posted on August 23, 2009September 1, 2009 - Prior Art & Obviousness 2009: The PTO & CAFC Perspective on Patent Law Sections 102 & 103 (Practising Law Institute) - San Francisco, CA September 2, 2009 - Biotechnology/Chemical/Pharmaceutical Customer Partnership Meeting (U.S. Patent and Trademark Office) - 10:00 am - 4:45 pm (EDT) September 13-15, 2009 - 2009 Annual Meeting (Intellectual Property Owners Association) - Chicago, IL September 14-15, 2009 - 3rd Summit on Biosimilars and Follow-on Biologics*** (Center for Business Intelligence) - National Harbor, MD September 15-16, 2009 - FDA Boot Camp*** (American Conference Institute) - Boston, MA September 17, 2009 - Developments in...
Keeping $118 in Your Pocket
Posted on August 22, 2009By Christopher P. Singer -- "In these economic times" it seems that new USPTO Director David Kappos understands that people appreciate an opportunity to save money. Patent Docs is happy to report that the Patent Office has announced on its website (interestingly, "buried" underneath a story about the Director's swearing in) that it will not require registered practitioners to pay the $118 annual practitioner maintenance fee for FY 2009...
AEI Presents Follow-on Biologic "Reality"
Posted on August 21, 2009By Donald Zuhn -- In a report originally published by the American Enterprise Institute for Public Policy Research (AEI) late last year, the nonpartisan public policy group advocated for a 12 to 14-year exclusivity period, concluding that "the social losses from providing for fairly long exclusivity periods (twelve to fourteen years) would be small compared to what are likely to be substantial social gains from exclusivity...
Federal Circuit Grants En Banc Review in Ariad v. Lilly
Posted on August 21, 2009By Donald Zuhn -- The Court of Appeals for the Federal Circuit today decided that the appeal in Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. warrants en banc consideration. In June, Ariad filed a petition for rehearing of the decision issued by the Federal Circuit on April 3 (see "Ariad Files Petition for Rehearing in Ariad v...
Federal Circuit Grants Stay in Tafas v. Kappos
Posted on August 21, 2009By Donald Zuhn -- On July 24, the Department of Justice (DOJ) filed a joint motion with Plaintiffs-Appellees Dr. Triantafyllos Tafas and GlaxoSmithKline seeking to stay briefing and oral argument in Tafas v. Kappos (previously Tafas v. Doll) until 60 days after the U...
ACI Paragraph IV on Trial Conference
Posted on August 21, 2009American Conference Institute (ACI) will be holding its 2nd Annual Paragraph IV on Trial conference on November 12-13, 2009 in New York, NY. At this conference, Hatch-Waxman litigators experienced in representing both generic and innovator drug manufacturers will immerse attendees in a live, two-day, interactive mock trial of a Paragraph IV case based on a real-life fact pattern derived from an ANDA filing...
The Milwaukee Journal Sentinel Gets It Right about Patents
Posted on August 20, 2009By Kevin E. Noonan -- Published articles in the popular press rarely report accurately about patents and the patent system. That's why it is unexpected, remarkable, and incredibly timely that the Milwaukee Journal Sentinel published not one but two in-depth articles about patents and the U...
Follow-on Biologics News Briefs - No. 8
Posted on August 20, 2009By Donald Zuhn -- President Obama Wants to Speed Up Introduction of Generic Drugs In a health care town hall meeting held in Portsmouth, NH last week, President Obama told attendees that he wanted to speed up the introduction of generic drugs into the marketplace...
By Suresh Pillai -- Settlement
Posted on August 19, 2009By Suresh Pillai -- Settlement Announced in University of Iowa Dispute with Amgen The University of Iowa Research Foundation (UIRF) has announced a settlement in its dispute with Amgen Inc. over alleged patent infringement of two UIRF patents covering a cytomegalovirus promoter used in the design and manufacture of a number of marketed vaccines and therapeutics...
Investors Saw Biotech Rebound Coming
Posted on August 18, 2009By Donald Zuhn -- Last week, the Biotechnology Industry Organization (BIO) and Thomson Reuters released the results of an investor perception study conducted earlier this year that correctly forecast a rebound for the biotech industry. A 37-page report outlining the result of the study can be obtained here...
BIO CEO Makes Case for 12-Year Data Exclusivity Period
Posted on August 17, 2009By Donald Zuhn -- Last week, CNBC anchor Joe Kernen challenged Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood over the wisdom of implementing a follow-on biologics (FOB) regulatory pathway that provides innovator biologics manufacturers with 12 years of exclusivity...
Court Report
Posted on August 17, 2009By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Astrazeneca LP et al. v. Breath Ltd. 1:09-cv-04115; filed August 12, 2009 in the District Court of New Jersey ? Plaintiffs: Astrazeneca LP; Astrazeneca AB ? Defendant: Breath Ltd...
Conference & CLE Calendar
Posted on August 17, 2009August 17-18, 2009 - Advanced Patent Prosecution Workshop 2009: Claim Drafting & Amendment Writing (Practising Law Institute) - San Francisco, CA September 1, 2009 - Prior Art & Obviousness 2009: The PTO & CAFC Perspective on Patent Law Sections 102 & 103 (Practising Law Institute) - San Francisco, CA September 13-15, 2009 - 2009 Annual Meeting (Intellectual Property Owners Association) - Chicago, IL September 14-15, 2009 - 3rd Summit on Biosimilars and Follow-on Biologics*** (Center for Business Intelligence) - National Harbor, MD September 15-16, 2009 - FDA Boot Camp*** (American Conference Institute) - Boston, MA September 17, 2009 - Developments...
CBI Pharmaceutical Congress on Paragraph IV Disputes and Settlements
Posted on August 15, 2009The Center for Business Intelligence (CBI) will be holding its 2nd Annual Pharmaceutical Congress on Paragraph IV Disputes and Settlements on October 22-23, 2009 in Philadelphia, PA. The conference will cover issues relevant to both brand and generic companies during two days of presentations and panel discussions on litigation strategies, statutory guidelines, current cases, and their landmark decisions...
BIO IPCC Fall Conference
Posted on August 15, 2009The Biotechnology Industry Organization (BIO) will be holding its Intellectual Property Counsels' Committee (IPCC) Fall Conference & Meeting on October 26-28, 2009 in Washington, DC. The semi-annual IPCC conference will once again be open to the public...
PLI Patent Litigation 2009
Posted on August 15, 2009Practising Law Institute (PLI) will be holding five sessions of its Patent Litigation 2009 seminar this fall in San Francisco (September 21-22), McLean, VA (October 5-6), Chicago (October 15-16), Atlanta (November 9-10), and New York (November 16-17)...
BIO Files Amicus Brief in Bilski
Posted on August 14, 2009By Kevin E. Noonan -- The Biotechnology Industry Organization (BIO) filed an amicus brief with the Supreme Court last week in Bilski v. Doll, the appeal from the Federal Circuit's en banc decision establishing the "machine or transformation" test as the exclusive test for patent eligibility of process claims...
New Director to Be Sworn in on Thursday
Posted on August 13, 2009By Donald Zuhn -- The U.S. Patent and Trademark Office has announced that on Thursday at 12:30 pm (EST), U.S. Secretary of Commerce Gary Locke will administer the oath of office to David Kappos (at right), the new Under Secretary of Commerce for Intellectual Property and Director of the USPTO...
Is Biotech/Pharma Beginning to Bounce Back?
Posted on August 13, 2009By Donald Zuhn -- It has not been a great year for the biotech/pharma industry. In February, BIO President and CEO Jim Greenwood noted that almost a third of BIO's membership had less than six months of cash on hand, 45% had less than one year of cash remaining, and only 10% of the 370 publicly-traded biotechnology companies reported a positive income (see "BIO Meets the Press")...
Biotech/Pharma Docket
Posted on August 12, 2009By Suresh Pillai -- Jury Finds AGA Guilty of Infringement in Medtronic Dispute A jury in the U.S. District Court for the Northern District of California has ruled that AGA Medical Corp. infringed Medtronic Inc.'s patents for blood vessel occlusion devices, and has ordered AGA to pay Medtronic $57 million...
Patent Profile: Cytori Receives Notice of Allowance for Use of Adipose-Derived Stem Cells in Bone Disorders
Posted on August 12, 2009By Mark Chael -- Recently, Cytori Therapeutics, Inc. announced that the U.S. Patent and Trademark Office had issued a Notice of Allowance for claims directed to prosthetic devices seeded with adipose-derived stem cells. According to the press release, these claims are related to the use of Cytori's Celution® System for the treatment of bone diseases...
Alnylam to Donate RNAi Patents to Patent Pool
Posted on August 11, 2009By Donald Zuhn -- Last month, Alnylam Pharmaceuticals announced that it would contribute more than 1,500 of its RNA interference (RNAi) patents to the patent pool established by GlaxoSmithKline earlier this year. Alnylam is known for the development of therapeutics based on RNAi for the treatment of respiratory syncytial virus (RSV) infection, liver cancer, hypercholesterolemia, Huntington's disease, and TTR amyloidosis...
USPTO Office of PCT Legal Administration Mailing List
Posted on August 11, 2009By Mark Chael -- For the benefit of our readers, we would like to remind you that the Office of PCT Legal Administration at the U.S. Patent and Trademark Office maintains a mailing list "to notify PCT customers, via e-mail, of updates to the forms and other information on [its] pages...
Bayer Schering Pharma AG v. Barr Laboratories, Inc. (Fed. Cir. 2009)
Posted on August 10, 2009Common Sense, Perhaps, But Whose? By Kevin E. Noonan -- The Supreme Court in KSR International Co. v. Teleflex Inc. established a standard (such as it is) of "common sense" in evaluating whether an invention is obvious. If the Court had been careful to follow the statute, it might have stressed more carefully that the answer to the question "whose common sense" must be the person of ordinary skill in the art...
Court Report
Posted on August 09, 2009By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Sandoz Inc. v. Boehringer Ingelheim Pharma GmbH & Co. KG et al. 1:09-cv-01444; filed July 31, 2009 in the District Court of the District of Columbia ? Plaintiff: Sandoz Inc...
Conference & CLE Calendar
Posted on August 09, 2009August 17-18, 2009 - Advanced Patent Prosecution Workshop 2009: Claim Drafting & Amendment Writing (Practising Law Institute) - San Francisco, CA September 1, 2009 - Prior Art & Obviousness 2009: The PTO & CAFC Perspective on Patent Law Sections 102 & 103 (Practising Law Institute) - San Francisco, CA September 13-15, 2009 - 2009 Annual Meeting (Intellectual Property Owners Association) - Chicago, IL September 14-15, 2009 - 3rd Summit on Biosimilars and Follow-on Biologics*** (Center for Business Intelligence) - National Harbor, MD September 15-16, 2009 - FDA Boot Camp*** (American Conference Institute) - Boston, MA September 17, 2009 - Developments...
ACI Patent Opinion Writing Boot Camp
Posted on August 08, 2009American Conference Institute (ACI) will be holding its Patent Opinion Writing Boot Camp on October 28-29, 2009 in Philadelphia, PA. The conference will allow attendees to: ? Identify how Seagate has altered opinion practice and the new standard for willful infringement; ? Clarify business objectives to determine the ultimate purpose of the opinion and the anticipated audiences; ? Formulate a pre-drafting strategy which accounts for the preparation, timing, and scope of the opinion; ? Understand how the opinion letter fits into the overall IP strategy; ? Incorporate new invalidity opinion strategies from evolving legal standards concerning written description and enablement;...
Exergen Corp. v. Wal-Mart Stores, Inc. (Fed. Cir. 2009)
Posted on August 07, 2009Has Inequitable Conduct Met Its Match? By Kevin E. Noonan -- There have been clear indications for some time that certain members of the Federal Circuit believe that the Court's inequitable conduct jurisprudence has gone astray from the "a high bar" Judge Rader (at right) believes the Court's earlier case law requires for establishing this affirmative defense...
Follow-on Biologics News Briefs - No. 7
Posted on August 06, 2009By Donald Zuhn -- California Healthcare Institute Applauds Eshoo-Inslee-Barton Amendment Last Friday, the House Committee on Energy and Commerce passed a health care reform bill by a close 31-28 vote (see "House Committee Approves Health Care Reform Bill Calling for 12-Year Exclusivity Period")...
Gene Patenting Debate Continues - Round Two
Posted on August 05, 2009By Donald Zuhn -- Gene patenting. It's a topic that Public Radio just can't seem to get enough of this summer. In June, Dr. Hans Sauer, the Associate General Counsel for Intellectual Property for the Biotechnology Industry Organization (BIO); Joshua Sarnoff, Professor of the Practice of Law at American University's Washington College of Law; and Shobita Parthasarathy, Co-Director of the Science, Technology and Public Policy Program at the Ford School of Public Policy at the University of Michigan discussed the topic on WAMU, Washington, DC's leading public radio station (see "Gene Patenting Debate Continues")...
Biotech/Pharma Docket
Posted on August 04, 2009By Suresh Pillai -- Settlement Announced in Ethyol® Infringement Suit Sun Pharmaceutical Industries, Ltd. and Medimmune LLC have announced a settlement of their patent dispute regarding Sun's manufacture and marketing of a generic version of the Medimmune drug Ethyol®, a cancer therapy drug...
Efficient Delivery of siRNA
Posted on August 04, 2009By Kevin E. Noonan -- A research paper in the June 2009 edition of Nature Biotechnology (Eguchi et al., 2009, "Efficient siRNA delivery into primary cells by a peptide transduction domain?dsRNA binding domain fusion protein," Nature Biotechnology 27: 567-71) describes a new system for introducing short interfering RNAs (siRNAs) into mammalian cells that may help this technology become practicable for therapeutic uses...
Patents and Data Exclusivity: It Ain't Necessarily So
Posted on August 03, 2009By Kevin E. Noonan -- The most troublesome point of contention in the follow-in biologics (FOBs) debate has undoubtedly revolved around the term for data exclusivity. In a subject so complex, it may be understandable that there are differing views about the importance of data exclusivity, and whether this is "much ado about nothing" or a vitally-important part of any follow-on biologics regime...
Court Report
Posted on August 03, 2009By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Juridical Foundation The Chemo-Sero-Therapeutic Research Institute v...
Conference & CLE Calendar
Posted on August 03, 2009August 4, 2009 - Venue in Patent Litigation: New Strategies after Genetech and TS Tech USA (Strafford) - 1:00-2:30 PM (EST) August 17-18, 2009 - Advanced Patent Prosecution Workshop 2009: Claim Drafting & Amendment Writing (Practising Law Institute) - San Francisco, CA September 1, 2009 - Prior Art & Obviousness 2009: The PTO & CAFC Perspective on Patent Law Sections 102 & 103 (Practising Law Institute) - San Francisco, CA September 13-15, 2009 - 2009 Annual Meeting (Intellectual Property Owners Association) - Chicago, IL September 14-15, 2009 - 3rd Summit on Biosimilars and Follow-on Biologics*** (Center for Business Intelligence) -...
House Committee Approves Health Care Reform Bill Calling for 12-Year Exclusivity Period
Posted on August 01, 2009By Donald Zuhn -- On Friday, the House Committee on Energy and Commerce approved a health care reform bill by a narrow three-vote margin (31-28). The bill (H.R. 3200), entitled "America's Affordable Health Choices Act," was originally introduced in the House on July 14, 2009 by Rep...
ACI Maximizing Pharmaceutical Patent Lifecycles Conference
Posted on August 01, 2009American Conference Institute (ACI) will be holding its 10th Maximizing Pharmaceutical Patent Lifecycles on October 7-8, 2009 in New York, NY. The conference will allow attendees to: ? See how a new global legal paradigm for pharmaceutical patent life cycles is being shaped by forces in the U...
Ex parte Competitive Technologies, Inc. (B.P.A.I. 2009)
Posted on July 31, 2009Board Finds Metabolite Claim to be Patentable By Kevin E. Noonan -- The most significant non-decision from the Supreme Court in recent memory is Justice Breyer's dissent over the Court's decision to dismiss its granted certiorari petition (as improvidently granted) in the Laboratory Corp...
Fish & Richardson Catches Error in Patent Office's PTA Calculation
Posted on July 31, 2009By Sydney Kokjohn -- Fish & Richardson and its pharmaceutical client Japan Tobacco Inc. recently discovered another error in the U.S. Patent and Trademark Office's method of calculating patent term adjustment ("PTA"). On January 8, 2009, Fish & Richardson filed an Application for Patent Term Adjustment under 37 C...
Senate Judiciary Committee to Consider Kappos Nomination on Wednesday
Posted on July 29, 2009By Donald Zuhn -- On Wednesday, the Senate Judiciary Committee will hold a hearing on several nominations, including that of David Kappos for Under Secretary of Commerce for Intellectual Property and Director of the U.S. Patent and Trademark Office. The Committee, which is scheduled to begin the hearing at 10:00 am (EST), will also be considering nominees for the Eleventh Circuit and the South Dakota District Court...
Follow-on Biologics News Briefs - No. 6
Posted on July 29, 2009By Donald Zuhn -- BIO CEO Cites Letters from Patient Groups Supporting Longer Exclusivity Period Last week, BIO President and CEO Jim Greenwood (at right) noted that a number of patient groups had joined BIO in seeking passage of a follow-on biologics bill providing a minimum of 12 years of data exclusivity...
Senate Judiciary Committee Hears from Director Nominee
Posted on July 29, 2009By Donald Zuhn -- Today, the Senate Judiciary Committee heard testimony from David Kappos (at right), the Obama Administration's nominee for Under Secretary of Commerce for Intellectual Property and Director of the U.S. Patent and Trademark Office. While the hearing was mostly uneventful, Senator Arlen Specter (D-PA) provided an interesting line of questioning when he asked Mr...
University of Pittsburgh v. Hedrick (Fed. Cir. 2009)
Posted on July 28, 2009For Stem Cells, It Seems That Conception Is Enough By Kevin E. Noonan -- On Thursday, the Federal Circuit affirmed a District Court determination that the University of Pittsburgh had established, by clear and convincing evidence, that four inventors had been improperly named in U...
Could the "New Rules" Nightmare Finally Be Over?
Posted on July 27, 2009By Kevin E. Noonan -- Hal Wegner has shared with Patent Docs papers filed by the Department of Justice (DOJ) on Friday, asking the Federal Circuit to defer proceedings on its en banc review of the panel decision in Tafas v. Doll. The basis for this request is to give Under Secretary-designate David Kappos the opportunity to consider what action should be taken in the case...
Court Report
Posted on July 26, 2009By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. King Pharmaceuticals Inc. et al. v. Sandoz Inc. 2:09-cv-03587; filed July 21, 2009 in the District Court of New Jersey ? Plaintiffs: King Pharmaceuticals Inc...
Conference & CLE Calendar
Posted on July 26, 2009July 29, 2009 - Pharmaceutical Antitrust Initiatives and Developments in the U.S. and Abroad*** (American Conference Institute) - 1:00-2:30 PM (EST) July 30 - August 4, 2009 - 2009 Annual Meeting (American Bar Association) - Chicago, IL August 4, 2009 - Venue in Patent Litigation: New Strategies after Genetech and TS Tech USA (Strafford) - 1:00-2:30 PM (EST) August 17-18, 2009 - Advanced Patent Prosecution Workshop 2009: Claim Drafting & Amendment Writing (Practising Law Institute) - San Francisco, CA September 1, 2009 - Prior Art & Obviousness 2009: The PTO & CAFC Perspective on Patent Law Sections 102 & 103...
ACI Biotech Patents Conference
Posted on July 25, 2009American Conference Institute (ACI) will be holding its 11th Advanced Forum on Biotech Patents on September 30 to October 1, 2009 in Boston, MA. The conference will allow attendees to: ? Adopt a practical approach to incorporating follow-on biologics into your current patent strategies; ? Implement best practices for avoiding § 112 and § 103 rejections in light of Kubin, Ariad, and KSR for patenting biotech inventions including gene sequences; ? Establish effective strategies to overcome charges of inequitable conduct; ? Uncover ways to overcome increasing rejections related to diagnostic and treatment claims and integrate Bilski and related precedents into...
Venue in Patent Litigation CLE
Posted on July 25, 2009Strafford will be offering a CLE seminar entitled: "Venue in Patent Litigation: New Strategies after Genentech and TS Tech USA" on August 4, 2009 from 1:00-2:30 PM (EST). The CLE will examine the latest case law developments on patent venue, discuss the evolving venue standards in patent litigation, and offer strategies for pursuing and defending motions to transfer venue...
Bristol-Myers Squibb to Acquire Medarex
Posted on July 24, 2009By Sherri Oslick -- On Wednesday Bristol-Myers Squibb and Medarex, Inc. announced that they have entered into a definitive merger agreement by which Bristol-Myers Squibb will acquire Medarex for $2.4 billion. With Medarex holding approximately $300 million in net cash and marketable securities, the purchase prices is effectively about $2...
USPTO e-Office Action Program Launches
Posted on July 23, 2009By Christopher P. Singer -- The U.S. Patent and Trademark Office issued a press release on July 21, announcing the start of the e-Office Action program following a successful pilot version of the program. The e-Office Action program allows participating patent applicants to receive e-mail notifications of office communications, rather than receiving the usual paper notifications by regular mail...
USPTO Announces A "No Decision" Regarding Annual Practitioner Fee
Posted on July 23, 2009By Christopher P. Singer -- After much speculation and rumor regarding the practitioner maintenance fee (see "Annual Fee for Registered Practitioners May Be Delayed"), the U.S. Patent and Trademark Office posted an announcement clarifying that, "[t]he Final Rules adopted in November 2008 do not specify the date by which the annual fee, if collected, must be paid...
Biotech/Pharma Docket
Posted on July 22, 2009By Suresh Pillai -- Judge Denies Attorneys Fees to Sandoz in Dispute with Sanofi-Aventis The U.S. District Court for the Central District of California denied Sandoz Inc.'s motion seeking attorneys' fees and costs in its patent infringement suit with Sanofi-Aventis...
Ironically, It Seems Big Pharma Is Preferred by Venezuelan People
Posted on July 21, 2009By Kevin E. Noonan -- Venezuelan President Hugo Chavez (at right) made headlines last month, and caused not a small amount of consternation, with the pronouncement that his government would act to prevent foreign (read: Western or U.S.) drug companies from enforcing patents to maintain high drug prices in his country...
Annual Fee for Registered Practitioners May Be Delayed
Posted on July 21, 2009By Christopher P. Singer -- As previously reported on Patent Docs, the U.S. Patent and Trademark Office (USPTO) had planned to institute an annual fee for all registered practitioners (73 Fed. Reg. 67750). The fee was intended to be required for practitioners to maintain active status to practice before the Office, and was thought to be due in fiscal year 2009 (i...
Follow-on Biologics News Briefs - No. 5
Posted on July 20, 2009By Donald Zuhn -- Virginia Governor: Time Has Come to Move Forward Virginia Governor Timothy Kaine, once a candidate to be President Obama's running mate, sent a letter to the Virginia Congressional delegation at the end of June, stating that he was "encouraged by efforts in Congress to strengthen the approval process for biogeneric and biosimilar products," and "strongly encourag[ed the delegation] to move forward with legislation this year...
Conference & CLE Calendar
Posted on July 20, 2009July 20, 2009 - Buying, Selling and Licensing Patents: Strategies for Turning Your Patent Portfolios into Revenue Streams (Law Seminars International) - Washington, DC July 21-22, 2009 - FDA Boot Camp*** (American Conference Institute) - Chicago, IL July 23-24, 2009 - Advanced Patent Prosecution Workshop 2009: Claim Drafting & Amendment Writing (Practising Law Institute) - New York, NY July 29, 2009 - Pharmaceutical Antitrust Initiatives and Developments in the U...
2009 World Stem Cell Summit
Posted on July 18, 2009The 2009 World Stem Cell Summit will be taking place on September 21-22 in Baltimore, MD. The 2009 Summit, which is being organized in part by the Genetics Policy Institute, will bring together researchers, clinicians, business pathfinders, key policy-makers, regulators, advocates, and experts in law and ethics to give presentations, share information, and chart the future of regenerative medicine...
IPO 2009 Annual Meeting
Posted on July 18, 2009The Intellectual Property Owners Association (IPO) will be holding its 2009 Annual Meeting on September 13-15, 2009 in Chicago, IL. Among the presentations being offered at the annual meeting are: ? Building, protecting and getting the most out of your IP portfolio in today's economic climate: A New quality-and-cost paradigm; ? Remedies: Damages and injunctive relief from various perspectives; ? IPO corporate IP management benchmarking survey; ? Local Model Patent Rules; ? Consequences to indemnification in view of Quanta Computer v...
PLI Developments in Pharmaceutical and Biotech Patent Law Seminar
Posted on July 18, 2009Practising Law Institute (PLI) will be holding a seminar on Developments in Pharmaceutical and Biotech Patent Law on September 17, 2009 in New York, NY and on October 14, 2009 in San Francisco, CA. Groupcasts of the New York session will also be held in Boston, MA; Philadelphia, PA; Pittsburgh, PA; and New Brunswick, NJ...
Former House Economist Testifies at Follow-on Biologics Hearing
Posted on July 17, 2009By Donald Zuhn -- In a hearing on follow-on biologics held earlier this week, the House Subcommittee on the Courts and Competition Policy heard testimony from seven witnesses including Rep. Anna Eshoo (D-CA), economist Alex Brill, Momenta Pharmaceuticals General Counsel Bruce Leicher, and representatives from the National Venture Capital Association (NVCA), Biotechnology Industry Organization (BIO), U...
The Risk of Biogenerics
Posted on July 16, 2009By Kevin E. Noonan -- Follow-on biologic drugs, or biosimilars as they are called in Europe, are once again the subject of attempts by Congress to provide a regulatory pathway for approval. Currently, these drugs are not regulated by the Food, Drug and Cosmetic Act and hence not subject to the provisions of the Hatch-Waxman Act that promote generic versions of small molecule drugs...
House Subcommittee Holds Hearing on Follow-on Biologics
Posted on July 15, 2009By Donald Zuhn -- This afternoon, the House Subcommittee on the Courts and Competition Policy held a hearing on follow-on biologics entitled "Biologics and Biosimilars: Balancing Incentives for Innovation." Among the witnesses appearing before the Subcommittee were Rep...
Biotech/Pharma Docket
Posted on July 15, 2009By Suresh Pillai -- Settlement Announced in Eloxatin® Suit The U.S. District Court for the District of New Jersey has issued an order announcing a settlement of all outstanding litigation between Sanofi-Aventis and Ebewe Pharma over Eloxatin®, a colon cancer drug marketed and distributed by Sanofi...
NVCA Study Supports 12-Year Data Exclusivity Period
Posted on July 14, 2009By Donald Zuhn -- On Friday, the National Venture Capital Association (NVCA) released the results of a study suggesting that "a data exclusivity period of at least 12 years for innovator products is a critical fulcrum in the effort to balance cost with the preservation of biotech innovation...
Senators Hatch and Enzi Champion 12-Year Data Exclusivity in Senate
Posted on July 14, 2009By Kevin E. Noonan -- As reported today in The Wall Street Journal, the innovator biotechnology industry scored a major victory in the Senate on Monday, when that chamber's Health, Education, Labor and Pensions Committee approved an amendment providing a 12-year data exclusivity period for biologic drug makers...
Court Report
Posted on July 13, 2009By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Max-Planck-Gesellschaft zur Frderung der Wissenschaften e.V. v. Wolf Greenfield & Sacks, P...
Conference & CLE Calendar
Posted on July 13, 2009July 14-15, 2009 - Pharma/Biotech Collaborative Agreements (American Conference Institute) - San Francisco, CA July 15, 2009 - Cost-Effective Patent Strategies (Law Seminars International) - Seattle, WA July 15, 2009 - Corporate Intellectual Property Conference (Law Bulletin Publishing Company) - Chicago, IL July 18-21, 2009 - National Association of Patent Practitioners (NAPP) 2009 Annual Meeting - San Diego, CA July 20, 2009 - Buying, Selling and Licensing Patents: Strategies for Turning Your Patent Portfolios into Revenue Streams (Law Seminars International) - Washington, DC July 21-22, 2009 - FDA Boot Camp*** (American Conference Institute) - Chicago, IL July 23-24, 2009 -...
FDA Boot Camp Conference
Posted on July 11, 2009American Conference Institute (ACI) will be holding its fall session of the FDA Boot Camp conference on September 15-16, 2009 in Boston, MA. The conference will provide information on: ? The organization, jurisdiction, functions, and operations of the FDA; ? The essentials of the approval process for drugs, biologics, and devices, including: NDAs, 505b2s, INDs, 510 K submissions, BLAs, MPA process, and ANDA applications; ? Clinical trials for drugs and biologics and the clearance process for devices; ? The classification of devices and the concept of "risk-based" classification; ? The role of the Hatch-Waxman Act in the patenting of drugs...
Summit on Biosimilars and Follow-on Biologics
Posted on July 11, 2009The Center for Business Intelligence (CBI) will be holding its 3rd Summit on Biosimilars and Follow-on Biologics on September 14-15, 2009 in National Harbor, MD. The conference will address the multiple competing follow-on biologics bills that have been introduced in the current Congress and the impact of this legislation on the life sciences industry...
CLE on Pharmaceutical Antitrust Initiatives and Developments
Posted on July 11, 2009American Conference Institute (ACI) will be offering a webinar entitled: "Pharmaceutical Antitrust Initiatives and Developments in the U.S. and Abroad" on July 29, 2009 from 1:00-2:30 PM (EST). Seth Silber of Wilson Sonsini Goodrich & Rosati and Jeffrey Brennan of Dechert LLP, both of whom were senior-level attorneys with the Federal Trade Commission, will provide insights into what the U...
NCHC Sends Letter on Biosimilars to Senate Health Committee
Posted on July 10, 2009By Donald Zuhn -- On the same day that BIO CEO Jim Greenwood was briefing the media regarding follow-on biologics legislation in the current Congress, the National Coalition on Health Care (NCHC) was making its position on the legislation known in a letter sent to Senate Committee on Health, Education, Labor, and Pensions (HELP) Chairman Senator Ted Kennedy and the Committee's ranking member, Senator Michael Enzi (R-WY)...
Senator Kennedy Weighs in on Biosimilar Data Exclusivity Period
Posted on July 10, 2009By Kevin E. Noonan -- Yesterday, Senator Ted Kennedy (D-MA) proposed that innovator biologic drugmakers should be given up to 13.5 years of data exclusivity in any follow-on biologics legislation to be considered by Congress this session. As reported by Catherine Larkin at Bloomberg...
BIO CEO Provides Update on Follow-on Biologics Legislation
Posted on July 09, 2009By Donald Zuhn -- During a Wednesday afternoon teleconference, Jim Greenwood, the President and CEO of the Biotechnology Industry Organization (BIO), discussed a recent "flurry of activity" surrounding follow-on biologics legislation currently being debated in Congress...
WIPO Becomes Priority Document Exchange Participant Office
Posted on July 09, 2009By Christopher P. Singer -- On June 30, 2009, the U.S. Patent and Trademark Office sent out an e-Commerce e-Alert announcing that the World Intellectual Property Organization (WIPO) is now participating in the Priority Document Exchange (PDX) program...
Biotech/Pharma Docket
Posted on July 08, 2009By Suresh Pillai -- Stanford Graduate Student Adds Claims to Suit against Mentor and Professor over Patent Inventorship Christopher Sclimenti, a former graduate student in the laboratory of Stanford University faculty member Michele Calos, has amended his suit against both Stanford and his former mentor, claiming that Dr...
NIH Releases New Stem Cell Rules
Posted on July 08, 2009By Kevin E. Noonan -- Yesterday, the National Institutes of Health released guidelines governing requirements (and limitations) for federal funding of research on human embryonic stem cells. These rules supersede rules promulgated during the Bush administration that so severely constrained the number of funding-eligible human stem cell lines as to effectively prohibit use of federal funds for this research...
Secretary Locke Appoints Godici to Assess USPTO Challenges
Posted on July 08, 2009By Donald Zuhn -- The U.S. Patent and Trademark Office announced today that Secretary of Commerce Gary Locke (at right) has appointed Nicholas Godici "to look at ways to strengthen the management structure of the USPTO and provide an up-to-date assessment of the challenges the office faces...
Federal Circuit Grants En Banc Review in Tafas v. Doll
Posted on July 07, 2009By Kevin E. Noonan -- The Federal Circuit today ordered en banc review of Tafas v. Doll, vacating the panel decision of March 20, 2009. The Court's decision was reported per curiam and Judge Lourie did not participate in the decision to rehear the appeal en banc...
Court Report
Posted on July 06, 2009By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Daiichi Sankyo Co., Ltd. et al. v. Apotex, Inc. et al. 1:09-cv-03997; filed July 2, 2009 in the Northern District of Illinois Daiichi Sankyo Co...
Conference & CLE Calendar
Posted on July 06, 2009July 6, 2009 - Prior Art & Obviousness 2009: The PTO & CAFC Perspective on Patent Law Sections 102 & 103 (Practising Law Institute) - New York, NY July 8, 2009 - Markman Hearings and Claim Construction in Patent Litigation (Practising Law Institute) - New York, NY July 10, 2009 - Questions of Venue after TS Tech and Genentech (Law Seminars International) - 1:00-2:00 pm (EST) July 14-15, 2009 - Pharma/Biotech Collaborative Agreements (American Conference Institute) - San Francisco, CA July 15, 2009 - Cost-Effective Patent Strategies (Law Seminars International) - Seattle, WA July 15, 2009 - Corporate Intellectual Property...
CLE on Venue
Posted on July 06, 2009Law Seminars International (LSI) will be offering a one-hour telebriefing entitled: "Questions of Venue after TS Tech and Genentech" on July 10, 2009 from 1:00-2:00 PM (EST). Robert McFarlane, a partner at Townsend and Townsend and Crew LLP, and Chester Chuang, Senior Corporate Counsel at Electronics For Imaging, Inc...
In re Fallaux (Fed. Cir. 2009)
Posted on July 03, 2009By Donald Zuhn -- Appellants Frits Jacobus Fallaux, Robert Cornelis Hoeben, Alex Jan Van Der Eb, Abraham Bout, and Domenico Valerio are the named inventors on U.S. Application No. 10/618,526 (U.S. Patent Publication No. 2005/0260596), which is directed to an isolated adenovirus packaging cell comprising nucleic acid sequences encoding the adenovirus E1A and E1B gene products but lacking a nucleic acid sequence encoding adenovirus pIX...
Revision of Procedures Relating to Amending PCT Applications
Posted on July 02, 2009By Christopher P. Singer -- In a notice published in the Federal Register on Wednesday, July 1, 2009 (74 Fed. Reg. 31372), the U.S. Patent and Trademark Office published rule changes relating to amendment practice in PCT applications, which took effect on July 1, 2009...
Biotech/Pharma Docket
Posted on July 01, 2009By Suresh Pillai -- Beckman Asks for Dismissal in Patent Dispute with Sequenom Following the completion of a Markman hearing in a dispute with Sequenom Inc. concerning patents covering genotyping methods, Beckman Coulter has asked the District Court to dismiss its complaint...
FierceBiotech Announces "Fierce 15" for 2009
Posted on July 01, 2009By Christopher P. Singer -- FierceBiotech published its annual "Fierce 15" list of what it considers to be among the most promising of the up-and-coming companies in the biotechnology industry. FierceBiotech, a daily biotech industry news and article provider, has been publishing the Fierce 15 since 2003...
Follow-on Biologics in the News - No. 4
Posted on June 30, 2009By Donald Zuhn -- IPO Continues to Support 14-Year Exclusivity Period The Intellectual Property Owners Association (IPO), reporting on last week's announcement that the White House believes a 7-year data exclusivity period "strikes the appropriate balance between innovation and competition," reminded its members today that the IPO Board adopted a resolution in September 2008 supporting legislation that "promotes continued innovation by providing at least 14 years of data exclusivity for an innovator?s biological product with additional periods of exclusivity available for new indications and/or for approval for use in the pediatric population" (see "Follow-on Biologics in the News - No...
USPTO Initiates Patent Prosecution Highway Pilot Program with Finland Patent Office
Posted on June 30, 2009By Christopher P. Singer -- In June 29, 2009 press release, the U.S. Patent and Trademark Office announced that it has agreed with the National Board of Patents and Registration of Finland (NBPR) to establish a Patent Prosecution Highway (PPH) program...
Court Report
Posted on June 28, 2009By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Dey, L.P. et al. v. Teva Parenteral Medicines, Inc. et al. 1:09-cv-00087; filed June 23, 2009 in the Northern District of West Virginia ? Plaintiffs: Dey, L...
Conference & CLE Calendar
Posted on June 28, 2009June 29-30 - Product and Pipeline Enhancement for Generics (Marcus Evans) - Washington, DC July 6, 2009 - Prior Art & Obviousness 2009: The PTO & CAFC Perspective on Patent Law Sections 102 & 103 (Practising Law Institute) - New York, NY July 8, 2009 - Markman Hearings and Claim Construction in Patent Litigation (Practising Law Institute) - New York, NY July 14-15, 2009 - Pharma/Biotech Collaborative Agreements (American Conference Institute) - San Francisco, CA July 15, 2009 - Cost-Effective Patent Strategies (Law Seminars International) - Seattle, WA July 15, 2009 - Corporate Intellectual Property Conference (Law Bulletin Publishing Company)...
Is Venezuela the new Thailand?
Posted on June 26, 2009By Kevin E. Noonan -- A great deal has been written over the past week about Venezuela's new patented drug policy. Last Saturday, President Hugo Chavez (at right) announced that his government would "shake up" Venezuela's intellectual property laws, particularly with respect to patents on medicines...
White House Recommends 7-Year Data Exclusivity Period for Follow-on Biologics
Posted on June 26, 2009By Donald Zuhn -- Reuters reports that the White House sent a letter to Rep. Henry Waxman (D-CA), the Chairman of the House Energy and Commerce Committee, on Thursday stating that a follow-on biologics regulatory pathway providing a 7-year data exclusivity period would "strike[] the appropriate balance between innovation and competition...
Autogenomics, Inc. v. Oxford Gene Technology Ltd. (Fed. Cir. 2009)
Posted on June 25, 2009By Donald Zuhn -- Last month, the Federal Circuit affirmed the judgment of the District Court for the Central District of California granting Defendant-Appellee Oxford Gene Technology's motion to dismiss for lack of personal jurisdiction. Oxford filed the motion to dismiss after Plaintiff-Appellant Autogenomics filed suit against Oxford seeking a declaratory judgment of invalidity, unenforceability, and non-infringement with respect to U...
Biotech/Pharma Docket
Posted on June 24, 2009By Suresh Pillai -- Caraco Motion for Summary Judgment in Prandin® Case Denied The U.S. District Court for the Eastern District of Michigan has denied a motion for summary judgment brought by Caraco Pharmaceutical Laboratories Ltd. and Sun Pharmaceutical Industries Ltd...
Kappos Nomination Supported by Industry and Patent Groups
Posted on June 24, 2009By Donald Zuhn -- Last Thursday, the White House announced that President Obama had selected David Kappos (at right), the Vice President and Assistant General Counsel of Intellectual Property Law at IBM, to head up the U.S. Patent and Trademark Office...
Biotech Director at EPO Discusses European Patent Practice - Part II
Posted on June 24, 2009By Bradley Crawford -- In the first post in this series, background information from Mr. Enrique Molina Galan's presentation at BIO 2009 was reported. The focus of this post is on the second part of his talk, where Mr. Molina Galan described the European Patent Office's role in fostering innovation...
Committee Publishes National Model Patent Jury Instructions
Posted on June 24, 2009By Sherri Oslick -- Assembled by Chief Judge Paul R. Michel (at right) of the United States Court of Appeals for the Federal Circuit, a committee comprising litigators and judges from across the nation has prepared and published model jury instructions for patent infringement cases based on the experience of those both on the bench and in the bar...
The Genetics of Complex Behaviors: It Really Isn't That Simple
Posted on June 23, 2009By Kevin E. Noonan -- Early last week, the Journal of the American Medical Association published a study ("Interaction Between the Serotonin Transporter Gene (5-HTTLPR), Stressful Life Events, and Risk of Depression") by Neil Risch at the University of California, San Francisco and colleagues at the National Institutes of Mental Health, Johns Hopkins University, Yale University School of Medicine, the Rockefeller University, the University of Pittsburgh School of Medicine, and Virginia Commonwealth University that showed no statistically-significant link between depression and the short HTT allele...
Court Report
Posted on June 23, 2009By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Sepracor Inc. et al. v. Synthon Pharmaceuticals, Inc. et al. 5:09-cv-00264; filed June 17, 2009 in the Eastern District of North Carolina Infringement of U...
Future Drug Sales Predictions Highlight Importance of Follow-on Biologics Legislation
Posted on June 22, 2009By Kevin E. Noonan -- As reported last week by FierceBiotech, EvaluatePharma, a market forecasting firm specializing in the life sciences sector, released its prediction on the future of the pharmaceutical industry. According to EvaluatePharma, six of the top ten selling drugs by 2014 will be biologics...
Utility under Canadian Patent Law and the Doctrine of Sound Prediction
Posted on June 22, 2009By Claire Palmer -- In Canada, for subject matter to be patentable, it must be novel, inventive, and have utility. A patent will fail for lack of utility if it can be shown that "the invention will not work, either in the sense that it will not operate at all or, more broadly, that it will not do what the specification promises that it will do" (Consolboard Inc...
Conference & CLE Calendar
Posted on June 22, 2009June 21-23, 2009 - IP Business Congress (Intellectual Asset Management magazine) - Chicago, IL June 22-27, 2009 - Innovation Week 2009 (U.S. Patent and Trademark Office) - Arlington, VA June 29-30 - Product and Pipeline Enhancement for Generics (Marcus Evans) - Washington, DC July 6, 2009 - Prior Art & Obviousness 2009: The PTO & CAFC Perspective on Patent Law Sections 102 & 103 (Practising Law Institute) - New York, NY July 8, 2009 - Markman Hearings and Claim Construction in Patent Litigation (Practising Law Institute) - New York, NY July 14-15, 2009 - Pharma/Biotech Collaborative Agreements (American Conference Institute)...
Corporate Intellectual Property Conference
Posted on June 20, 2009The Law Bulletin Publishing Company will be holding its 4th Annual Corporate Intellectual Property Conference on July 15, 2009 in Chicago, IL. The conference will address the following topics: ? Protecting and leveraging IP assets in a down economy; ? Update on major case law affecting IP; ? Licensing IP assets: Strategies for success; ? Damages: Valuation and presentation; and ? Copyright and trademark issues...
Generic Pharmaceuticals Conference
Posted on June 20, 2009Marcus Evans has announced its 2nd Annual Product and Pipeline Enhancement for Generics conference on "Formulating a Concrete Plan for Sustainability in the Rapidly Changing Global Generic Pharmaceutical Market." The conference, to be held on June 29-30, 2009 in Washington, DC, will offer presentations on the following topics: ? Ensuring the sustainability of the generics industry; ? Devising a risk-balanced patent strategy to mitigate potential lawsuits; ? Recent developments in the law impacting Hatch-Waxman litigation; ? Integrating your patent and regulatory strategies; ? Comprehending the factors involved in a profitable IP strategy; ? Best practices for navigating the global biogenerics...
AEI Believes Advantages of Longer Data Exclusivity Period Outweigh Disadvantages
Posted on June 19, 2009By Donald Zuhn -- In a follow-on biologics report that has received widespread media attention, the Federal Trade Commission concluded last week that a 12-14 year data exclusivity period was not needed to promote innovation by pioneer biologics companies (see "No One Seems Happy with Follow-on Biologics According to the FTC")...
The Uncertain Future of Genetic Diagnosis of Human Behavior
Posted on June 19, 2009By Kevin E. Noonan -- Sickle cell anemia was the first known human disease associated with a genetic polymorphism (an A?T single nucleotide polymorphism, or SNP), resulting in the substitution of a valine residue (encoded by a GTG codon) for a glutamic acid residue (encoded by a GAG codon) in the beta chain of human hemoglobin...
Patent Office Extends Comment Period Regarding Deferred Examination
Posted on June 19, 2009By Christopher P. Singer -- In a Notice published in the Federal Register (74 Fed. Reg. 28473) on Tuesday, June 16, 2009, the U.S. Patent and Trademark Office announced an additional public comment period relating to a potential deferred patent examination pathway...
Biotech/Pharma Docket
Posted on June 18, 2009By Suresh Pillai -- Settlement Announced in Oxycontin® Litigation KV Pharmaceutical Co. announced a settlement in its litigation with Purdue Pharma LP over the painkiller Oxycontin® (see "Court Report," June 11, 2007). The settlement resolves three lawsuits filed by Purdue in the U...
USPTO NEWS: Patent Public Advisory Committee to Meet Thursday
Posted on June 18, 2009By Christopher P. Singer -- The U.S. Patent and Trademark Office posted a notice on its website today announcing that the next meeting of the Patent Public Advisory Committee (PPAC) will be held on June 18, 2009. The meeting will be held on the USPTO campus, Madison North Auditorium, Concourse Level, 600 Dulany Street, Alexandria, VA...
President Obama to Nominate David Kappos as USPTO Director
Posted on June 18, 2009By Donald Zuhn -- Senate Judiciary Chairman Patrick Leahy (D-VT) released a statement today indicating that President Obama intends to nominate David Kappos (at right) to be the Undersecretary of Commerce for Intellectual Property and Director of the U...
The Unwanted Consequences of Banning Gene Patenting
Posted on June 17, 2009By Kevin E. Noonan -- Academics are useful people -- they provoke us to think and rethink our assumptions and the consequences of our institutions and practices, and can expand them in unexpected and frequently useful ways. But they also tend to live in a world constructed within the boundaries of their own skulls, and rarely have the kind of practical experience that comes from building a business or making a product...
USPTO News: E-Commerce Alert
Posted on June 17, 2009By Christopher P. Singer -- Earlier this month, the U.S. Patent and Trademark Office sent out by e-mail its latest e-Commerce e-Alert, this one entitled "Tips to Improve Your e-Filing Effectiveness." Included in the e-Alert were four general procedures that help to streamline electronic prosecution through the use of EFS-Web and Private PAIR...
Falsehoods, Distortions and Outright Lies in the Gene Patenting Debate
Posted on June 16, 2009By Kevin E. Noonan -- The zeitgeist has turned harshly on patenting in the U.S., perhaps nowhere as starkly as in gene patenting. Originally the subject of op-ed rants by famous authors (see "Science Fiction in The New York Times") and quixotic bills introduced by undistinguished members of Congress (see "The Continuing Threat to Gene Patenting"), the filing by the American Civil Liberties Union of a complaint against Myriad Genetics several weeks ago seems to have opened the floodgates of opposition to these patents...
USPTO Issues Beta Release of New Website
Posted on June 16, 2009By Christopher P. Singer -- The U.S. Patent and Trademark Office recently unveiled a beta test release of its new website. According to the USPTO, the new site has been designed to improve the overall look and feel, as well as to enhance the user experience with improved navigation...
No One Seems Happy with Follow-on Biologics According to the FTC
Posted on June 15, 2009By Kevin E. Noonan -- Last week, the Federal Trade Commission issued a report on follow-on biologics ("Emerging Health Care Issues: Follow-on Biologic Drug Competition"). As many patent practitioners did a few years ago when the FTC issued a report on patent reform, many in the biotech and pharma community, generics companies, and Congress are asking "What is the FTC camel's nose doing in our tent?" The report is extensive, covering the likely market impact of follow-on biologics (FOB) competition, the effects of patent protection and market incentives in the face of FOB introduction, the potential impact of a Hatch-Waxman-like...
By Sherri Oslick -- About Court
Posted on June 15, 2009By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Medicis Pharmaceutical Corp. v. Ranbaxy Inc. et al. 1:09-cv-00435; filed June 11, 2009 in the District Court of Delaware Infringement of U...
Conference & CLE Calendar
Posted on June 15, 2009June 16-17, 2009 - Biotech Patenting (C5) - Munich, Germany June 17, 2009 - The Future of Reverse Payment Settlements: Insider's Guide to Imminent Antitrust Policy Changes (American Conference Institute) - 1:00-2:30 PM (EST) June 19, 2009 - Patent Enforcement & Early Stage Litigation (Law Seminars International) - San Francisco, CA June 22-27, 2009 - Innovation Week 2009 (U...
Biotech/Pharma Lobbying Scoreboard - 1st Quarter '09
Posted on June 13, 2009By Donald Zuhn -- While the recession has certainly had an effect on biotech/pharma patent filings, the recession appears to have had little impact on lobbying expenditures in the biotech/pharma industry. With the reporting period for first quarter lobbying now passed, many biotech/pharma companies and organizations not only kept pace with, but handily surpassed, their first quarter spending from a year ago: ? The Pharmaceutical Research and Manufacturers of America (PhRMA), the pharmaceutical industry's primary trade group, spent $6...
FDA Boot Camp Conference
Posted on June 13, 2009As we noted last month, American Conference Institute (ACI) will be holding the next installment of its FDA Boot Camp conference on July 21-22, 2009 in Chicago, IL. Designed to provide patent attorneys with a comprehensive overview of the basics of Fodd and Drug Administration law, this conference will help attendees gain a better understanding of the underlying regulatory processes with which drugmakers must comply...
USPTO Posts Comments on Deferred Examination
Posted on June 12, 2009By Donald Zuhn -- Last February, the U.S. Patent and Trademark Office hosted a roundtable discussion on deferred examination. The roundtable, which lasted about four hours, brought together two dozen participants, representing a variety of industries and organizations (as well as positions on the issue), to discuss the advantages and disadvantages of implementing a deferred examination system in the U...
Ortho-McNeil Pharmaceutical, Inc. v. Mylan Laboratories Inc. (Fed. Cir. 2009)
Posted on June 11, 2009By Donald Zuhn -- The Federal Circuit today affirmed-in-part and vacated-in-part an order by the District Court for the Northern District of West Virginia awarding $1,011,712 in costs to Plaintiff-Appellee Daiichi Pharmaceutical Co., and remanded to the District Court for an apportionment determination of the awarded costs...
Gene Patenting Debate Continues
Posted on June 10, 2009By Donald Zuhn -- Last Thursday, authorities on patent law and public policy were brought together to discuss the intersection of cutting-edge genetic research and intellectual property. The discussion, prompted by the recent ACLU v. USPTO case, took place on The Kojo Nnamdi Show on WAMU, Washington, DC's leading public radio station, and those interested in listening to the full 52-minute program can do so here...
Uncertain Future for Waxman Follow-on Biologics Bill
Posted on June 10, 2009By Kevin E. Noonan -- If behavior can inform belief, it may be getting less and less likely that H.R. 1427, the "Promoting Innovation and Access to Life-Saving Medicine Act," has any reasonable chance of passing in this Congress. The bill, introduced on March 11, 2009 by House Committee on Energy and Commerce Chairman Henry Waxman (D-CA; at right), has as one of its key provisions a data exclusivity period of only 5 years (see "Waxman Introduces Follow-on Biologics Bill"), a term most in the biotechnology community believe is too short to support innovation in the sector...
Biotech/Pharma Docket
Posted on June 09, 2009By Suresh Pillai -- Par Files Amended Complaint in Nascobal® Suit Par Pharmaceuticals filed an amended complaint against Fleming & Co. Pharmaceuticals, alleging patent and trademark infringement and unfair competition over Par's prescription nasal spray, Nascobal®...
Court Report
Posted on June 08, 2009By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Takeda Pharmaceutical Co. et al. v. Sandoz, Inc. 1:09-cv-05210; filed June 3, 2009 in the Southern District of New York Infringement of U...
Conference & CLE Calendar
Posted on June 08, 2009June 16-17, 2009 - Biotech Patenting (C5) - Munich, Germany June 17, 2009 - The Future of Reverse Payment Settlements: Insider's Guide to Imminent Antitrust Policy Changes (American Conference Institute) - 1:00-2:30 PM (EST) June 19, 2009 - Patent Enforcement & Early Stage Litigation (Law Seminars International) - San Francisco, CA June 22-27, 2009 - Innovation Week 2009 (U...
PLI Advanced Patent Prosecution Workshop
Posted on June 06, 2009Practising Law Institute (PLI) will be holding a two-day seminar entitled: "Advanced Patent Prosecution Workshop 2009: Claim Drafting & Amendment Writing" on July 23-24, 2009 in New York, NY and on August 17-18, 2009 in San Francisco, CA. At the New York seminar, PLI's faculty will offer presentations on the following topics: ? Ethics in the PTO; ? Concurrent Sessions I: Advanced Specification Drafting Issues -- all concurrent sessions will provide lectures specific to four different technologies including biotechnology and chemical/pharmaceutical; ? Concurrent Sessions II: Advanced Claim Drafting Issues; ? Concurrent Workshops I: Advanced Claim Drafting; ? In re Bilski...
CLE on Reverse Payment Settlements
Posted on June 06, 2009American Conference Institute (ACI) will be offering a webinar entitled: "The Future of Reverse Payment Settlements: Insider's Guide to Imminent Antitrust Policy Changes" on June 17, 2009 from 1:00-2:30 PM (EST). Thomas Barnett, former Assistant Attorney General in charge of the Justice Department's Antitrust Division and co-chair of Covington & Burling's Antitrust & Consumer Law Practice Group; Meredyth Smith Andrus, Federal Trade Commission, Bureau of Competition; and Robert Rhoad, Co-Leader of Crowell & Moring's Health Care Litigation Team, will provide an overview of the present status of the law on patent settlements, including an analysis of the key issues in...
GSK Files Petition for Rehearing in Tafas v. Doll
Posted on June 05, 2009By Donald Zuhn -- Plaintiff-appellee Dr. Triantafyllos Tafas was not alone yesterday in filing a petition for a panel rehearing or rehearing en banc of the March 20 decision in Tafas v. Doll (see Patent Docs report). Also seeking a rehearing of the Federal Circuit's decision in Tafas were plaintiffs-appellees SmithKline Beecham Corp...
Agilent Technologies, Inc. v. Affymetrix, Inc. (Fed. Cir. 2009)
Posted on June 05, 2009By Kevin E. Noonan -- The Federal Circuit clarified the role of the written description requirement in interference practice today in an opinion by Judge Rader, one of the Court's most severe critics of its written description jurisprudence. Unlike the situation where the written description requirement is used to invalidate patents (which is the subject of a petition for en banc review in Ariad v...
Tafas Files Petition for Rehearing in Tafas v. Doll
Posted on June 04, 2009By Donald Zuhn -- Earlier today, counsel for Dr. Triantafyllos Tafas filed a petition for a panel rehearing or rehearing en banc of the decision issued by the Federal Circuit in Tafas v. Doll. In that decision, issued on March 20, a split panel determined that Rules 75, 78, 114, and 265 are procedural, but that Rule 78 is inconsistent with 35 U...
Ariad Files Petition for Rehearing in Ariad v. Lilly
Posted on June 04, 2009By Donald Zuhn -- Yesterday, Ariad Pharmaceuticals filed a petition for a panel rehearing of the decision issued by the Federal Circuit in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co. In that decision, issued on April 3, the Federal Circuit reversed the District Court's denial of Lilly's motion for JMOL in view of a jury verdict of infringement and validity of the asserted claims, and affirmed the District Court's ruling that Lilly failed to establish the affirmative defense of inequitable conduct (see Patent Docs report)...
A Response to Mr. Brill, and a Modest Proposal Regarding Inequitable Conduct
Posted on June 04, 2009By Kevin E. Noonan -- As reported today in a Patent Docs post, Economist Alex Brill (at right) has proposed that Congress include in patent reform legislation provisions "putting some teeth" into the penalties available for inequitable conduct, presumably as a way to discourage it...
USPTO Launches On-Line Interface for Practitioner Changes of Address
Posted on June 04, 2009By Christopher P. Singer -- In a notice posted on June 3, 2009, the U.S. Patent and Trademark Office announced the launch of an on-line system that will allow registered practitioners to update their official address of record with the Office of Enrollment and Discipline (OED) electronically, without the need to submit paper forms...
Docs at BIO: Biotech Director at EPO Discusses European Patent Practice
Posted on June 03, 2009By Bradley Crawford -- On May 19, 2009, Mr. Enrique Molina Galan, one of nine Directors of Biotechnology at the European Patent Office, discussed biotech patent practice before the European Patent Office at BIO 2009. In a presentation entitled "How Is the European Patent Office Supporting Innovation in Europe?" Mr...
Former House Economist Sets Sights on Inequitable Conduct "Reform"
Posted on June 03, 2009By Donald Zuhn -- Economist Alex Brill, who last fall released a report on follow-on biologics, is back, this time focusing on proposals for "reforming" the U.S. patent system instead of suggestions for creating a follow-on biologics regulatory pathway...
Amgen, Inc. v. Ariad Pharmaceuticals, Inc. (Fed. Cir. 2009)
Posted on June 02, 2009By Andrew Williams -- On Monday, the Federal Circuit issued its decision in Amgen, Inc. v. Ariad Pharmaceuticals, Inc., dealing another blow to Ariad Pharmaceuticals and U.S. Patent No. 6,410,516, directed to certain aspects of the NF-?B transcription factor pathway...
The Supreme Court, In re Bilski and the Lingering Question of Labcorp v. Metabolite
Posted on June 02, 2009By Kevin E. Noonan -- The Supreme Court today granted certiorari to the patent applicants in the In re Bilski case, an en banc decision from the Federal Circuit last fall. In doing so, the Court continued its recent history of more direct supervision of the Federal Circuit, a decision made more notable by the Federal Circuit's express reliance on its interpretation of Supreme Court precedent in crafting a legal test for patentability of method claims...
Court Report
Posted on June 01, 2009By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Stiefel Laboratories Inc. v. KV Pharmaceutical Co. 1:09-cv-00376; filed May 28, 2009 in the District Court of Delaware Infringement of U...
Conference & CLE Calendar
Posted on June 01, 2009June 16-17, 2009 - Biotech Patenting (C5) - Munich, Germany June 19, 2009 - Patent Enforcement & Early Stage Litigation (Law Seminars International) - San Francisco, CA June 22-27, 2009 - Innovation Week 2009 (U.S. Patent and Trademark Office) - Arlington, VA June 21-23, 2009 - IP Business Congress (Intellectual Asset Management magazine) - Chicago, IL July 6, 2009 - Prior Art & Obviousness 2009: The PTO & CAFC Perspective on Patent Law Sections 102 & 103 (Practising Law Institute) - New York, NY July 8, 2009 - Markman Hearings and Claim Construction in Patent Litigation (Practising Law Institute) -...
PLI Seminar on Prior Art & Obviousness
Posted on May 30, 2009Practising Law Institute (PLI) will be holding a seminar entitled: "Prior Art & Obviousness 2009: The PTO & CAFC Perspective on Patent Law Sections 102 & 103" on July 6, 2009 in New York, NY and on September 1, 2009 in San Francisco, CA. The seminar will provide information on the following topics: ? When is a patent a "patent" under the statute? ? Public accessibility -- on the web, on the shelf, in the mail, "routine" practices; ? Four steps to the abyss of 102(d); ? Ex parte 102(g); abandon, suppress, conceal; ? Actual vs...
PLI Seminar on Markman Hearings and Claim Construction
Posted on May 30, 2009Practising Law Institute (PLI) will be holding a seminar entitled: "Markman Hearings and Claim Construction in Patent Litigation" on July 8, 2009 in New York, NY. Groupcasts of the New York session will also be held in New Brunswick, NJ; Philadelphia, PA; and Pittsburgh, PA...
Docs at BIO: "Perfect Storm" Super Session
Posted on May 29, 2009By Kevin E. Noonan -- Last week, Biogen Idec sponsored a "Super Session" at the BIO 2009 International Conference entitled "Weathering the Perfect Storm of Financial Distress and Political Pressure." The session was moderated by Stephen Sands, Lazard Freres & Co...
Docs at BIO: Panel Addresses Narrowing Scope of Biotech Patents
Posted on May 28, 2009By Donald Zuhn -- In a Breakout Session entitled "The Narrowing Scope of Biotech Patent Claims: What Does It Mean for the Industry?" at last week's BIO International Convention, a panel consisting of Anne Dollard, the Deputy General Counsel and Chief Patent Counsel for Takeda San Francisco; Thomas Kim, Senior Director of Intellectual Property for VGX Pharmaceuticals, Inc...
Court Report
Posted on May 28, 2009By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Teva Pharmaceutical Industries Ltd. et al. v. Amgen Inc. 2:09-cv-02256; filed May 20, 2009 in the Eastern District of Pennsylvania Infringement of U...
USPTO News: EFS-Web Maintenance Scheduled for Sunday, May 31, 2009
Posted on May 28, 2009By Christopher P. Singer -- The U.S. Patent and Trademark Office has posted on the top page of the EFS-Web portal site an advisory that the system will be unavailable because of system maintenance. According to the advisory, the maintenance is scheduled to begin at midnight and end at 4 a...
Docs at Bio: Patent Reform Super Session
Posted on May 27, 2009By Kevin E. Noonan -- Last week, Eli Lilly & Co. sponsored a "Super Session" at the BIO 2009 International Conference entitled "Biotechnology Intellectual Property at the Crossroads." The session was moderated by John Lechleiter, President and Chief Executive Officer at Lilly, for a panel consisting of Robert Armitage, Lilly's General Counsel; Gregory Glover of the Pharmaceutical Law Group; and H...
Docs at BIO: Panel Addresses Follow-on Biologics Policy
Posted on May 26, 2009By Sherri Oslick -- In a Breakout Session held last Wednesday at BIO 2009, a panel consisting of David Bassett, a Partner at WilmerHale; Genia Long, Managing Principal at Analysis Group; David Ridley, Assistant Professor of Business Administration at the Fuqua School of Business at Duke University; David Korn, Sr...
Buying, Selling and Licensing Patents Seminar
Posted on May 25, 2009Law Seminars International (LSI) will be holding a one-day seminar entitled "Buying, Selling and Licensing Patents: Strategies for Turning Your Patent Portfolios into Revenue Streams" on July 20, 2009 in Washington, DC. During the seminar, LSI's faculty will offer presentations on the following topics: ? Patent marketplace 2009 and beyond; ? Patent sales case studies; ? Patent reform and patent valuation; ? Creating and implementing decision rules for patent portfolio mining and management (hold, sell, license or abandon?); ? Designing a patent purchasing program; and ? Licensing vs...
ABA 2009 Annual Meeting
Posted on May 25, 2009The American Bar Association (ABA) will be holding its 2009 Annual Meeting from July 30 to August 4, 2009 in Chicago, IL. During the Annual Meeting, various ABA sections and divisions will be offering more than 250 CLE programs, including the following programs that will be offered by the Intellectual Property Law section: ? Patent Reform Act 2009: A Fresh Look? (Friday, July 31, 10:30 - 11:30 am) ? Helping Companies in a Down Economy: Strategic Planning for Identifying and Valuing Your IP (Friday, July 31, 2:00 - 3:30 pm) ? In re Bilski: Are Method Claims a Thing of...
Biotech/Pharma Docket
Posted on May 22, 2009By Suresh Pillai -- Bavarian Nordic Suit over TroVax® Survives Motion to Dismiss Last week, the U.S. District Court for the Southern District of California refused to dismiss an amended complaint filed by Bavarian Nordic A/S alleging that Oxford Biomedica infringes Bavarian Nordic's U...
GSK's Sherry Knowles Responds to Post on BIO Session
Posted on May 22, 2009By Donald Zuhn -- On Wednesday, we posted a report on a BIO Super Session entitled "A Model Patent Office for the Future -- Promoting and Protecting Investments in Innovation" (see "Docs at BIO: Panel Offers Suggestions for Fixing the USPTO"). At that session, a panel consisting of Sherry Knowles (at right), Vice President of Corporate Intellectual Property at GlaxoSmithKline Biopharmaceuticals, Inc...
Docs at BIO: Panel Offers Suggestions for Fixing the USPTO
Posted on May 21, 2009By Donald Zuhn -- In a Wednesday Super Session entitled "A Model Patent Office for the Future -- Promoting and Protecting Investments in Innovation," a panel consisting of Sherry Knowles, Vice President of Corporate Intellectual Property at GlaxoSmithKline Biopharmaceuticals, Inc...
Docs at BIO: Steve Burrill's State of the Biotechnology Industry Report 2009
Posted on May 20, 2009By Kevin E. Noonan -- What a difference a year makes. Steven Burrill (at right), President and CEO of Burrill & Co., unveiled his company's "State of the Biotechnology Industry" report on Tuesday at BIO 2009 in Atlanta. Mr. Burrill described what he termed "a sea change" that has occurred over the past several months, changes that have altered his rather optimistic proscriptions for the future set out in last year's report...
Docs at BIO: Lilly Counsel Discusses Patent Issues Regarding Personalized Medicine
Posted on May 20, 2009By Donald Zuhn -- In a Breakout Session entitled "The Emerging Promise of Personalized Medicine," a panel consisting of Cindy Collins, Group Vice President at Beckman Coulter, Inc.; Brian Barrett, Associate General Patent Counsel at Eli Lilly & Company; Dr...
Docs at BIO: Ernst & Young Hosts Super Session Addressing Financial Performance of Biotech Industry
Posted on May 20, 2009By Sherri Oslick -- In a Super Session held Tuesday morning at the BIO 2009 conference, Ernst & Young hosted "Beyond Borders -- Ernst & Young's Global Biotechnology Report 2009," a presentation that summarized the financial performance of the biotechnology industry in 2008 and addressed related issues and trends...
Abbott Laboratories v. Sandoz, Inc. (Fed. Cir. 2009)
Posted on May 19, 2009By Kevin E. Noonan -- In an otherwise unremarkable decision affirming the district court's claim construction and summary judgment of noninfringement in Abbott Laboratories v. Sandoz, the Court of Appeals for the Federal Circuit took the opportunity to reconcile a long-standing conflict in its precedent...
Meet the Docs at BIO 2009
Posted on May 19, 2009The Biotechnology Industry Organization (BIO) is holding its annual BIO International Convention this week at the Georgia World Congress Center in Atlanta. Founded in 1993, BIO is a nonprofit association seeking supportive biotechnology policies on behalf of more than 1,200 biotechnology companies, state and international affiliates, and related organizations, as well as providing business development services for many emerging biotech companies...
Altana Pharma AG v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2009)
Posted on May 18, 2009By Andrew Williams -- Last Thursday, the Federal Circuit affirmed the decision of the District Court for the District of New Jersey denying a request by Altana Pharma and Wyeth (collectively "Altana") for a preliminary injunction to prevent Teva Pharmaceuticals ("Teva") from marketing a generic version of the antiulcer drug Protonix®...
Association for Molecular Pathology v. U.S. Patent and Trademark Office
Posted on May 18, 2009By Kevin E. Noonan -- The lawsuit filed by plaintiffs and represented by lawyers from the American Civil Liberties Union and the Public Patent Foundation (PUBPAT) is easy to decry in the biotechnology patent community. Patent Docs will provide a detailed explication of the complaint, including a discussion of its many falsehoods, misstatements and half-truths in a coming post...
Court Report
Posted on May 18, 2009By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Genzyme Corp. v. Lupin Ltd. et al. 1:09-cv-01258; filed May 14, 2009 in the District Court of Maryland Infringement of U...
Conference & CLE Calendar
Posted on May 18, 2009May 18-21, 2009 - BIO International Convention (Biotechnology Industry Organization) - Atlanta, GA May 20, 2009 - Tafas v. Doll -- Dissecting the Decision and Preparing for Resurgence of USPTO Rules Limiting Patent Claims*** (American Conference Institute) - 1:00-2:30 PM (EST) May 27, 2009 - Follow-on Biologics Patent Litigation: Using Additional Patents and REMS to Protect Market Share (FDA News) - 11:00 am to 12:30 pm (EST) June 16-17, 2009 - Biotech Patenting (C5) - Munich, Germany June 19, 2009 - Patent Enforcement & Early Stage Litigation (Law Seminars International) - San Francisco, CA June 22-27, 2009 - Innovation Week...
Follow-on Biologics Webinar
Posted on May 16, 2009FDA News will be offering a webinar entitled: "Follow-on Biologics Patent Litigation: Using Additional Patents and REMS to Protect Market Share" on May 27, 2009 from 11:00 am to 12:30 pm (EST). Chad Landmon and Matt Becker of Axinn, Veltrop & Harkrider LLP will provide a comparison of competing follow-on biologics legislation and demonstrate the major differences between the bills, discuss the potential impact of this legislation on innovator biologics manufacturers, describe how patent challenges to biologics will be different from small molecule drugs, offer practical strategies for building the strongest possible patent portfolios, and provide information on structuring a...
NAPP Annual Meeting
Posted on May 16, 2009The National Association of Patent Practitioners (NAPP) will be holding its 2009 Annual Meeting on July 18-21, 2009 in San Diego, CA. An optional short-course entitled: "The Nuts & Bolts of Patent Prosecution Practice" will be offered on July 18. Topics to be covered during the short course include: ? Inventorship ? Prior Art Searching ? Basic Claim Drafting ? Written Specification ? Patent Drawings ? Responding to Office Actions ? Examiner Interviews ? Allowance & Issue ? Practitioner Knowledge Tools ? Building a Successful Solo Practice Following the organization's annual meeting on July 19, a two-day conference entitled: "2009...
IPO Releases List of Top 300 Patent Holders for 2008
Posted on May 15, 2009"Biotech/Pharma" Top 43 By Donald Zuhn -- The Intellectual Property Owners Association (IPO) released its 26th annual list of the top 300 organizations receiving U.S. patents. Patent Docs Readers may recall that the U.S. Patent & Trademark Office stopped releasing its annual list of top patent recipients in 2006 in order to "discourag[e] any perception that we believe more is better...
Procter & Gamble Co. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2009)
Posted on May 14, 2009By Donald Zuhn -- The Federal Circuit today affirmed a determination by the District Court for the District of Delaware that U.S. Patent No. 5,583,122 was not invalid as obvious nor invalid for obviousness-type double patenting. The '122 patent, which is owned by Plaintiff-Appellee Procter & Gamble Co...
More on House Patent Reform Hearing
Posted on May 13, 2009By Donald Zuhn -- On April 30th, the House Committee on the Judiciary heard testimony from seven witnesses (and accepted written testimony from other interested parties) regarding the House patent reform bill (H.R. 1260) (see "House Judiciary Committee Holds Hearing on Patent Reform")...
Patent Profile: Immunomedics Announces Patent for Dock-and-Lock Antibody Assemblies
Posted on May 13, 2009By Mark Chael -- On May 5th, Immunomedics, Inc. announced that its majority-owned subsidiary, IBC Pharmaceuticals, Inc., was granted U.S. Patent No. 7,527,787, entitled "Multivalent Immunoglobulin-based Bioreactive Assemblies." Claim 1 from the patent reads: 1...
Court Report: Special Edition
Posted on May 13, 2009By Kevin E. Noonan -- Association for Molecular Pathology et al. v. U.S. Patent and Trademark Office, Myriad Genetics et al. 09-cv-04515-RWS; filed May 12, 2009 in the District Court for the Southern District of New York Earlier today, a group of patients, physicians, academic researchers and medical societies filed suit in the Southern District of New York against the U...
BIO IP Policy Briefing
Posted on May 12, 2009By Kevin E. Noonan -- Last Friday, the Biotechnology Industry Organization (BIO) presented its members-only 2009 Spring IP Policy Briefing to member companies, particularly directed to member law firms. The presentation was moderated by Lila Feisee, BIO's Managing Director, Intellectual Property...
Court Report
Posted on May 11, 2009By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Yeda Research and Development Co., Ltd., v. Doll 1:09-cv-00820; filed May 4, 2009 in the District Court of the District of Columbia Review and correction of the patent term adjustment calculation made by the U...
Conference & CLE Calendar
Posted on May 11, 2009May 18-21, 2009 - BIO International Convention (Biotechnology Industry Organization) - Atlanta, GA May 20, 2009 - Tafas v. Doll -- Dissecting the Decision and Preparing for Resurgence of USPTO Rules Limiting Patent Claims*** (American Conference Institute) - 1:00-2:30 PM (EST) June 16-17, 2009 - Biotech Patenting (C5) - Munich, Germany June 19, 2009 - Patent Enforcement & Early Stage Litigation (Law Seminars International) - San Francisco, CA June 22-27, 2009 - Innovation Week 2009 (U...
FDA Boot Camp Conference
Posted on May 09, 2009American Conference Institute (ACI) will be holding the next session of its FDA Boot Camp conference on July 21-22, 2009 in Chicago, IL. The conference will allow attendees to: ? Master the basics of the approval processes for drugs, biologics, and devices, including in-depth discussion of the application, pre-approval, and post-approval requirements; ? Comprehend the structure of the FDA and the roles of the three major agency centers: CDER, CBER, and CDHR; ? Develop a practical working knowledge of clinical trials for drugs and biologics and the clearance process for devices; ? Learn how devices are classified, monitored, and regulated;...
USPTO Begins Pilot Program with the German Patent Office
Posted on May 08, 2009By Christopher P. Singer -- As we previously reported by Patent Docs, the U.S. Patent and Trademark Office began a Patent Prosecution Highway (PPH) Pilot Program with the German Patent and Trademark Office (DPMA) on April 27, 2009 which will last for two years...
Patent Profile: ImmunoCellular Therapeutics Announces Issuance of Patent for Method of Monitoring Myeloma or Ovarian Cancer Therapy
Posted on May 08, 2009By Mark Chael -- On April 29, 2009, ImmunoCellular Therapeutics, Ltd. announced that the U.S. Patent and Trademark Office issued Patent No. 7,498,129, which relates to the company's monoclonal antibody platform. The '129 patent is entitled "Myeloma Cell and Ovarian Cancer Cell Surface Glycoproteins, Antibodies Thereto, and Uses Thereof," and according to ImmunoCellular, is directed to the use of the company's antibodies to measure the effectiveness of proposed treatments for multiple myeloma and ovarian cancer...
New Administration, Same Result: U.S. Trade Representative's Section 301 Report
Posted on May 07, 2009By Kevin E. Noonan -- U.S. Trade Representative Ron Kirk issued a "Special 301 Report" on April 30. This report, on the state of intellectual property rights worldwide, identifies twelve countries on a "priority watch list" and another 33 on a "watch list," all relating to deficiencies in intellectual property protection in these countries...
Patent Profile: Raptor Pharmaceuticals Secures Allowances for Brain Drug Delivery Methods
Posted on May 07, 2009By Mark Chael -- On April 29, 2009, Raptor Pharmaceuticals Corp. announced that the U.S. Patent and Trademark Office recently issued Notices of Allowance for two of its pending patent applications related to methods of delivering drugs to the brain. The Notices were issues for U...
Biotech/Pharma Docket
Posted on May 06, 2009By Suresh Pillai -- Novartis Denied Jury Trial in Famvir® Suit Last week, the U.S. District Court for the District of New Jersey denied Novartis Pharmaceutical Corp.'s request for a jury trial in its suit against Roxane Laboratories Inc. In the lawsuit, filed in July 2008 (see "Court Report," May 18, 2008), Norvartis alleges that Roxane infringed Novartis patents covering Famvir®, a treatment for genital and oral herpes...
Amgen Inc. v. International Trade Commission (Fed. Cir. 2009)
Posted on May 05, 2009By Andrew Williams -- Last year, a panel of the Federal Circuit affirmed the International Trade Commission's (ITC's) grant of summary judgment against Amgen in its attempts to block importation of Roche's Micera® peglylated erythropoietin product. At the time, Patent Docs provided a detailed report of the decision and its implications...
By Sherri Oslick -- About Court
Posted on May 04, 2009By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Warner Chilcott Co. et al. v. Midlothian Laboratories L.L.C. 2:09-cv-02026; filed April 30, 2009 in the District Court of New Jersey Warner Chilcott Co...
Conference & CLE Calendar
Posted on May 04, 2009May 18-21, 2009 - BIO International Convention (Biotechnology Industry Organization) - Atlanta, GA May 20, 2009 - Tafas v. Doll -- Dissecting the Decision and Preparing for Resurgence of USPTO Rules Limiting Patent Claims*** (American Conference Institute) - 1:00-2:30 PM (EST) June 16-17, 2009 - Biotech Patenting (C5) - Munich, Germany June 19, 2009 - Patent Enforcement & Early Stage Litigation (Law Seminars International) - San Francisco, CA June 22-27, 2009 - Innovation Week 2009 (U...
Pharma/Biotech Collaborative Agreements Conference
Posted on May 02, 2009American Conference Institute (ACI) will be holding a Pharma/Biotech Collaborative Agreements conference from July 14-15, 2009 in San Francisco, CA. The conference will allow attendees to: ? Capitalize on shifting trends in the venture capital investment landscape; ? Draft critical termination terms; ? Forge and protect lucrative relationships with investors; ? Negotiate partnerships with start-up innovators and government programs; ? Contend with increased pressure from anxious investor's seeking an immediate healthy return on their investment; ? Redefine alliance management priorities; ? Position an IP portfolio to increase market power; ? Negotiate milestones into the compensation structure; and ? Convert a...
Cost-Effective Patent Strategies Workshop
Posted on May 02, 2009Law Seminars International (LSI) will be holding a one-day workshop on Using Cost-Effective Patent Strategies on July 15, 2009 in Seattle, WA. During the workshop, LSI's faculty will offer presentations on the following topics: ? Value of patents under recent law: Planning procurement in light of a changing landscape; ? If not filing patents: Using trade secret protection as a cost-saving measure; ? Managing costs of patent procurement and enforcement defense; ? Building a more profitable portfolio: Tips for more effective and efficient patent procurement; ? Managing legal costs in patent transactions; ? Enforcing patents efficiently: Getting the money without...
House Judiciary Committee Holds Hearing on Patent Reform
Posted on May 01, 2009By Donald Zuhn -- Earlier today, the House Committee on the Judiciary heard testimony from seven witnesses (and accepted written testimony from other interested parties) regarding the House patent reform bill (H.R. 1260). Although the hearing was not made available for online viewing, written testimony from the witnesses who testified at the hearing can be downloaded at the Committee's website...
House Judiciary Committee (Finally) Releases Witness List for Patent Reform Hearing
Posted on April 30, 2009By Donald Zuhn -- On Monday, the House Committee on the Judiciary announced that it would be holding on hearing on its patent reform bill (H.R. 1260) on April 30, 2009 at 10:00 AM (Eastern). Although the Committee posted a notice regarding the hearing on its website, it did not release a witness list until today...
CHI CEO on Patent Reform and Follow-on Biologics Legislation
Posted on April 29, 2009By Donald Zuhn -- Earlier today, California Healthcare Institute president and CEO Dr. David Gollaher provided Patent Docs with an update regarding the status of patent reform and follow-on biologics legislation in the 111th Congress. The California Healthcare Institute (CHI) is an independent organization comprising more than 250 biomedical companies and academic and research institutions involved in researching and advocating policy to forward the interests of California's biomedical community...
Follow-on Biologics in the News - No. 3
Posted on April 28, 2009By Donald Zuhn -- Johnson & Johnson: 5-Year Exclusivity Period Would Kill Incentives to Innovate Last month, Amgen Inc. Vice President Stuart Watt asserted that any follow-on biologics regulatory pathway established by Congress would have to specify an exclusivity period of at least 12 years in order to provide incentives to innovator drug companies to continue developing new biologic drugs (see "Amgen VP Makes Case for Longer Exclusivity Period in Follow-on Biologics Legislation")...
Is Everything Obvious?
Posted on April 26, 2009By Kevin E. Noonan -- Two pronouncements, one from the Supreme Court and the other from the Federal Circuit, portend the parlous state that could await American innovation should judges come to believe that that their judgment is as sound as that of actual innovators...
Court Report
Posted on April 26, 2009By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Bone Care International LLC et al. v. Eagle Pharmaceuticals Inc...
Conference & CLE Calendar
Posted on April 26, 2009April 27-28, 2009 - 3rd Annual Paragraph IV Disputes Conference*** (American Conference Institute) - New York, NY April 29-30, 2009 - Corporate IP Counsel Summit (World Research Group) - New York, NY May 18-21, 2009 - BIO International Convention (Biotechnology Industry Organization) - Atlanta, GA May 20, 2009 - Tafas v...
CLE on Tafas v. Doll
Posted on April 25, 2009American Conference Institute (ACI) will be offering a webinar entitled: "Tafas v. Doll -- Dissecting the Decision and Preparing for Resurgence of USPTO Rules Limiting Patent Claims" on May 20, 2009 from 1:00-2:30 PM (EST). Michele Cimbala, Ph.D.; Elizabeth Haanes, Ph...
First Quarter Venture Capital Funding at 12-Year Low
Posted on April 24, 2009By Donald Zuhn -- Late last week, PricewaterhouseCoopers and the National Venture Capital Association (NVCA), a trade association representing the U.S. venture capital industry, announced the release of their quarterly MoneyTree Report (based on data from Thomson Reuters), which showed that venture capitalists had invested $3...
Amgen VP Makes Case for Longer Exclusivity Period in Follow-on Biologics Legislation
Posted on April 23, 2009By Donald Zuhn -- For the past two years, much of the debate surrounding the various follow-on biologics bills that have been introduced in Congress has centered on the exclusivity periods provided by each bill. So far, three follow-on biologics bills have been introduced in the 111th Congress: H...
Biotech/Pharma Docket
Posted on April 22, 2009By Suresh Pillai -- AstraZeneca Secures Temporary Restraining Order in PULMICORT® Case Last week, the U.S. District Court for the District of New Jersey barred Apotex from launching a generic version of PULMICORT® by granting AstraZeneca's requested temporary restraining order (see "Biotech/Pharma Docket," April 15, 2009)...
Takeda Pharmaceutical Co. v. Doll (Fed. Cir. 2009)
Posted on April 21, 2009Another "Bright-Line" Rule from the Federal Circuit By Kevin E. Noonan -- The Supreme Court has had the occasion to overrule the Federal Circuit with prolixity over the past ten years. And in many of those cases (including KSR Int?l Co. v. Teleflex Inc...
Court Report
Posted on April 19, 2009By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Par Pharmaceutical, Inc. v. Novartis Pharmaceuticals Corp. et al...
Conference & CLE Calendar
Posted on April 19, 2009April 20-21, 2009 - 5th International Judges Conference on Intellectual Property Law (Intellectual Property Owners Association) - Washington, DC April 20-21, 2009 - 6th Annual Freedom to Operate Forum (C5 (UK)) - London, England April 22, 2009 - "How Recent Patent Developments May Be Creating a 'Perfect Storm' for Biotechnology" (Association of Patent Law Firms) - 12:30-1:30 PM (EST) April 24, 2009 - Patent Claim Construction (Law Seminars International) - College Park, GA April 27-28, 2009 - 3rd Annual Paragraph IV Disputes Conference*** (American Conference Institute) - New York, NY April 29-30, 2009 - Corporate IP Counsel Summit (World Research...
CLE on Biotech Patenting "Perfect Storm"
Posted on April 18, 2009The Association of Patent Law Firms (APLF) will be offering a dial in presentation entitled: "How Recent Patent Developments May Be Creating a 'Perfect Storm' for Biotechnology" on April 22, 2009 from 12:30-1:30 PM (EST). Kevin Noonan, Andrew Williams, and Donald Zuhn of McDonnell Boehnen Hulbert and Berghoff LLP will discuss recent decisions on obviousness (In re Kubin), written description (Ariad v...
IP Business Congress
Posted on April 18, 2009Intellectual Asset Management (IAM) magazine will be hosting the second IP Business Congress on June 21-23, 2009 in Chicago, IL. The IP Business Congress is designed to meet the needs of senior business executives responsible for the creation and management of IP value inside corporations, as well as those who advise them...
Patent Enforcement & Early Stage Litigation Workshop
Posted on April 18, 2009Law Seminars International (LSI) will be holding a one-day workshop on Patent Enforcement & Early Stage Litigation on June 19, 2009 in San Francisco, CA. During the workshop, LSI's faculty will offer presentations on the following topics: ? Recent decisions impacting patent viability, value, and enforceability; ? A fresh look at the plaintiff's decision to sue or license; ? Updating the defendant's approach to developing a defense strategy; ? Effective procedural practice for plaintiffs and defendants; ? Special judicial panel: Patent litigation under the new case law; ? Conveying complex technology; ? Working through the legal, economic, and business decisions...
Dickinson and Figg on Patent Reform
Posted on April 17, 2009By Donald Zuhn -- At last month's Biotechnology Industry Organization (BIO) Intellectual Property Counsels' Committee (IPCC) conference, Q. Todd Dickinson, Executive Director of the American Intellectual Property Law Association (AIPLA), and E. Anthony Figg of Rothwell, Figg, Ernst & Manbeck, P...
USPTO Extends Patent Prosecution Highway Pilot Program with IP Australia; Begins Pilot Program with German Patent Office
Posted on April 16, 2009By Christopher P. Singer -- In a Notice, dated April 13, 2009, the U.S. Patent and Trademark Office announced that it will continue the existing Patent Prosecution Highway (PPH) Pilot Program with the Intellectual Property Office of Australia (IP Australia) for an unspecified period of time in order to gather more information and assess the feasibility of the program prior to making the PPH program permanent...
Biotech/Pharma Docket
Posted on April 16, 2009By Suresh Pillai -- Resolution Announced in Johnson & Johnson Razadyne® ER Patent Litigation Johnson & Johnson units Janssen LP, Janssen Pharmaceutica NV, and Ortho-McNeil Neurologics have stipulated to a dismissal with prejudice of all claims of patent infringement against KV Pharmaceutical Co...
Ariad Decision Voids Attempt to Use Broad Claiming to Avoid the Written Description Requirement
Posted on April 15, 2009By Kevin E. Noonan -- Beginning with Regents of the University of California v. Eli Lilly and Company, the Federal Circuit has applied the written description requirement stringently in many art areas as a requirement of 35 U.S.C. § 112, first paragraph, that is separate from the enablement requirement...
The Non-obviousness of DNA
Posted on April 14, 2009By Kevin E. Noonan -- The recent discussion of the Federal Circuit's decision in the In re Kubin case suggests there may be some misunderstanding of the science behind the legal question of obviousness. Because obviousness is a question of law based heavily on underlying issues of fact, it is important for commentators as well as judges to have some understanding of the underlying science...
Patent Profile: Ryogen Announces Issuance of Two Genomics Patents
Posted on April 14, 2009By Donald Zuhn -- Ryogen LLC recently announced that the U.S. Patent and Trademark Office had issued U.S. Patent Nos. 7,468,266 and 7,470,522. The '266 patent is directed to an isolated genomic polynucleotide encoding human lipoprotein-associated phospholipase A2, as well as vectors and host cells comprising such polynucleotides, antisense oligonucleotides to such polynucleotides, and methods for modulating human lipoprotein-associated phospholipase A2 levels in a subject using such polynucleotides...
Gene Patenting and the Wisdom of Judge Lourie
Posted on April 13, 2009By Kevin E. Noonan -- Biotechnology patent law faces the consequences of two decisions handed down last week by the Federal Circuit: In re Kubin and Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. The first of these illustrates the folly of ignoring the wisdom of the In re Deuel decision, in applying established principles of chemical patent practice to avoid the philosophical error of finding a chemical compound obvious because methods for making an unpredictable compound were well known...
Court Report
Posted on April 13, 2009By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Wyeth v. Cadila Healthcare Ltd. et al. 1:09-cv-00239; filed April 9, 2009 in the District Court of Delaware Infringement of U...
Conference & CLE Calendar
Posted on April 13, 2009April 13, 2009 - New PTO Rules and Patent Reform in the 111th Congress (Practising Law Institute) - 1:00-3:00 PM (EST) April 16, 2009 - Biologue Chicago (Biotech Committee of the Intellectual Property Law Association of Chicago) - Chicago, IL April 20-21, 2009 - 5th International Judges Conference on Intellectual Property Law (Intellectual Property Owners Association) - Washington, DC April 20-21, 2009 - 6th Annual Freedom to Operate Forum (C5 (UK)) - London, England April 24, 2009 - Patent Claim Construction (Law Seminars International) - College Park, GA April 27-28, 2009 - 3rd Annual Paragraph IV Disputes Conference*** (American Conference...
CLE on Tafas v. Doll and Patent Reform
Posted on April 11, 2009Practising Law Institute (PLI) will be offering an audio webcast entitled: "New PTO Rules and Patent Reform in the 111th Congress" on April 13, 2009 from 1:00-3:00 PM (EST). Robert Spar, former Director of the Office of Patent Legal Administration for the U...
C5 Biotech Patenting Conference
Posted on April 11, 2009C5 (UK) will be holding its annual Biotech Patenting conference on June 16-17, 2009 in Munich, Germany. The conference will allow attendees to: ? Identify the principles followed by the courts and patent offices when determining inventorship and entitlement disputes; ? Capitalize on gene patenting and stem cell related inventions; ? Understand the practical impact of recent case law and other legal developments; ? Broaden your knowledge of effective claim construction to avoid patent challenges and defend the validity of their claims; ? Formulate strategies and tactics to conduct successful cross-jurisdictional litigation; ? Tackle the latest scientific and legal developments...
Biotech/Pharma Docket
Posted on April 10, 2009By Suresh Pillai -- Delaware District Court Invalidates Concerta® Patent The U.S. District Court for the District of Delaware has ruled that Watson Pharmaceuticals, Inc.'s generic version of Concerta® (methylphenidate hydrochloride extended-release tablets) does not infringe ALZA Corporation's and McNeill-PPC's patent covering the drug...
Digene Corp. v. Third Wave Technologies, Inc. (Fed. Cir. 2009)
Posted on April 09, 2009By Donald Zuhn -- On April 1st, the Federal Circuit affirmed the judgment of the District Court for the Western District of Wisconsin that Defendant-Cross Appellant Third Wave Technologies, Inc. did not infringe U.S. Patent No. 5,643,715, owned by Plaintiff-Appellant Digene Corp...
More Changes Coming in Europe
Posted on April 09, 2009By Christopher P. Singer -- About two weeks ago, we were advised of by one of our European associates about changes to the rules relating to divisional practice in the European Patent Office (see "Changes Coming to Divisional Application Practice in Europe")...
Not Everyone Thinks "Patent Reform" is a Great Idea
Posted on April 08, 2009By Kevin E. Noonan -- The Senate Judiciary Committee, particularly the triumvirate of Chairman Patrick Leahy (D-VT), Ranking Member Arlen Specter (R-PA), and Senator Diane Feinstein (D-CA), are pretty proud of themselves these days, having rammed their "compromise" patent "reform" bill through the Committee and headed to the Senate floor...
In re Kubin (Fed. Cir. 2009)
Posted on April 06, 2009By Kevin E. Noonan -- The sky isn't falling. But it's becoming increasingly clear that when the Supreme Court sneezes, the Federal Circuit gets a cold (if not pneumonia). And the questions continue about whether the Federal Circuit as currently constituted has the institutional fortitude to exercise its Congressional mandate to harmonize patent law in this country...
Conference & CLE Calendar
Posted on April 06, 2009April 16, 2009 - Biologue Chicago (Biotech Committee of the Intellectual Property Law Association of Chicago) - Chicago, IL April 20-21, 2009 - 5th International Judges Conference on Intellectual Property Law (Intellectual Property Owners Association) - Washington, DC April 20-21, 2009 - 6th Annual Freedom to Operate Forum (C5 (UK)) - London, England April 24, 2009 - Patent Claim Construction (Law Seminars International) - College Park, GA April 27-28, 2009 - 3rd Annual Paragraph IV Disputes Conference*** (American Conference Institute) - New York, NY April 29-30, 2009 - Corporate IP Counsel Summit (World Research Group) - New York, NY May...
Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. (Fed. Cir. 2009)
Posted on April 06, 2009By Andrew Williams -- On Friday, the Federal Circuit issued its decision in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., reversing the U.S. District Court for the District of Massachusetts's denial of Lilly's motion for JMOL in view of a jury verdict of infringement and validity of the asserted claims, and affirming the District Court's ruling that Lilly failed to establish the affirmative defense of inequitable conduct...
Court Report
Posted on April 06, 2009By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Genzyme Corp. v. Impax Laboratories, Inc. 1:09-cv-00846; filed April 3, 2009 in the District Court of Maryland Infringement of U...
Senate "Patent Reform" Bill (S. 515) Voted out of Judiciary Committee
Posted on April 03, 2009By Kevin E. Noonan -- The "tyranny of the majority" has been the bane (or at least the peril) of representational democracy at least since Alexis de Tocqueville coined the term in 1835; more recently, Lani Guinier lost the nomination to be President Clinton's Assistant Attorney General for Civil Rights for her scholarly writings about proportional democracy as a remedy for that particular ill...
Anti-Reverse Payment Legislation Introduced in the House
Posted on April 03, 2009By Donald Zuhn -- Last week, Rep. Bobby Rush (D-IL) (at right) introduced the Protecting Consumer Access to Generic Drugs Act of 2009 (H.R. 1706) in the House. The bill, which was co-sponsored by Rep. Diana DeGette (D-CO), John Dingell (D-MI), Michael Doyle (D-PA), Edward Markey (D-MA), Janice Schakowsky (D-IL), Bart Stupak (D-MI), and Henry Waxman (D-CA), is similar to a bill (S...
Federal Circuit Issues Significant Biotech Decisions
Posted on April 03, 2009By Donald Zuhn -- This morning, the Federal Circuit issued decisions in both In re Kubin and Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. In Kubin, the Federal Circuit, with Circuit Judge Rader writing for Circuit Judges Friedman and Linn, affirmed the Board's decision that Kubin's claims were obvious...
EFS & PAIR News
Posted on April 03, 2009By Christopher P. Singer -- This past week, the Electronic Business Center (EBC) posted two notices on its PAIR and EFS-Web systems. In the notice posted on the opening page of EFS-Web, the Patent Office announced that it is making a minor change to the document description identification of a letter submitted with an information disclosure statement (IDS)...
Some (But Not All) Amendments Introduced in "Patent Reform" Bill
Posted on April 02, 2009By Kevin E. Noonan -- Senator Leahy (D-VT) (at right), chairman of the Senate Judiciary Committee, has circulated several amendments to be proposed to reflect the "compromise" he hopes to have reached with Senators Specter (R-PA) and Feinstein (D-CA) over S...
Third Follow-on Biologics Bill Introduced in 111th Congress
Posted on April 02, 2009By Donald Zuhn -- Last Thursday, Senator Charles Schumer (D-NY) (at right) introduced the Promoting Innovation and Access to Life-Saving Medicine Act (S. 726), the first follow-on biologics bill to be introduced in the Senate and third follow-on biologics bill to be introduced in the 111th Congress...
"Progress" on Senate "Patent Reform" Bill
Posted on April 01, 2009By Kevin E. Noonan -- Today, the Senate Judiciary Executive Committee continued its Executive Business Meeting from last week and announced that "significant" progress had been made in reaching a compromise on S. 515 supported by Committee Chairman Senator Patrick Leahy (D-VT), ranking member Senator Arlen Spector (R-PA), and Senator Diane Feinstein (D-CA) (a webcast of today's meeting is available here)...
In re Gleave (Fed. Cir. 2009)
Posted on March 30, 2009By Kevin E. Noonan -- The duality of nucleic acids has long posed a challenge to patent law. A gene is, in one way of looking at it, "but a chemical compound, albeit a complex one," and this view of the gene's nature has informed the emphasis on "structure, structure, structure" taken by the Federal Circuit from Amgen Inc...
Court Report
Posted on March 29, 2009By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Monsanto Co. et al. v. Dart et al. 4:09-cv-00474; filed March 25, 2009 in the Eastern District of Missouri Infringement of U...
Conference & CLE Calendar
Posted on March 29, 2009March 30-31, 2009 - Pharmaceutical and Biotech Patent Claim Drafting*** (American Conference Institute) - New York, NY March 30-31, 2009 - FDA Boot Camp*** (American Conference Institute) - New York, NY April 1-4, 2009 - 24th Annual Intellectual Property Law Conference (American Bar Association Section of Intellectual Property Law) - Arlington, VA April 16, 2009 - Biologue Chicago (Biotech Committee of the Intellectual Property Law Association of Chicago) - Chicago, IL April 20-21, 2009 - 5th International Judges Conference on Intellectual Property Law (Intellectual Property Owners Association) - Washington, DC April 20-21, 2009 - 6th Annual Freedom to Operate Forum...
BIO International Convention
Posted on March 29, 2009The Biotechnology Industry Organization (BIO) will be holding its annual BIO International Convention on May 18-21, 2009 in Atlanta, GA. Founded in 1993, BIO is a nonprofit association seeking supportive biotechnology policies on behalf of more than 1,200 biotechnology companies, state and international affiliates, and related organizations, as well as providing business development services for many emerging biotech companies...
Senate Judiciary Committee Discusses S. 515 at Executive Business Meeting; Adopts "Technical" Amendment GRA09350
Posted on March 27, 2009By Christopher P. Singer -- The Senate Judiciary Committee held an Executive Business Meeting today to discuss, among other topics, the pending Patent Reform Bill, S. 515. The recorded meeting can be viewed here. [Note: the portion relating to S. 515 begins just after the 11 minute mark]...
Author of Nature Article Provides Rebuttal; Patent Docs Provides Surrebuttal
Posted on March 27, 2009On Wednesday, we reported on an article, entitled "The dangers of diagnostic monopolies," that appeared in the March 26th edition of Nature (see "Genetic Diagnostic Testing: The 'Anti-Commons' Revisited?"). Today, we received an e-mail from one of the authors of the article, Robert Cook-Deegan (at right), providing some additional comments regarding the article: This is a very thoughtful take on our article...
IPO Board Opposes USTPO Fee Increases and Willful Infringement Provision of Reform Bill
Posted on March 27, 2009By Christopher P. Singer -- The Intellectual Property Owners Association (IPO) today announced that its Board of Directors has adopted two resolutions, one against any legislation concerning willful patent infringement, and the other against any significant U...
Changes Coming to Divisional Application Practice in Europe
Posted on March 27, 2009By Christopher P. Singer -- One of our European associates, Forresters, alerted us today about change to Rule 36 EPC that was enacted on March 26, 2009 by the EPO Administrative Council. The rule change is expected to limit the opportunities for divisional application filings in Europe, relative to the current rule, in an effort to curtail the current "abusive" practice of divisional application filing in Europe...
Biologue Chicago
Posted on March 27, 2009The Biotech Committee of the Intellectual Property Law Association of Chicago (IPLAC) will be hosting its next Biologue Chicago event on April 16, 2009 from 5:30-7:30 pm at the Metropolitan Club in the Sears Tower (now known to some as the Willis Tower)...
Gary Locke Confirmed as New Secretary of Commerce
Posted on March 26, 2009By Christopher P. Singer -- On March 24, 2009, the Senate unanimously confirmed Gary Locke (at right) as the 36th Secretary of Commerce. While Secretary Locke obviously has a number of critical economic issues that require his immediate attention, the Department of Commerce also oversees the expansion of the country's broadband infrastructure (including the digital TV transition), the Census (to be taken in 2010), the National Oceanic and Atmospheric Administration (NOAA), and the National Institute of Standards and Technology (NIST), in addition to the U...
Genetic Diagnostic Testing: The "Anti-Commons" Revisited?
Posted on March 25, 2009By Kevin E. Noonan -- "Monopoly" is a loaded buzzword when it comes to patents. It is imprecise, indeed incorrect, but it can be effective in appealing to prejudices that emphasize a negative view of patent rights. It also effectively telegraphs the writer's own prejudices, so that when it is used in the title of a putatively academic article it can be particularly jarring...
USPTO Will Not Enforce New Claims and Continuation Rules . . . For Now
Posted on March 25, 2009By Christopher P. Singer -- In the wake of the Federal Circuit's decision in Tafas v. Doll (see "Tafas v. Doll (Fed. Cir. 2009)"; "Federal Circuit Issues Decision in Tafas v. Doll"; and "Anyone Remember What These 'New Rules' Are All About?"), the U.S...
ABA IP Section Seeks Inequitable Conduct Reform
Posted on March 24, 2009By Donald Zuhn -- The Federal Circuit's recent decision in Tafas v. Doll, in which the CAFC found that new Rule 265 -- which creates the dreaded Examination Support Document (ESD) -- was both procedural and not inconsistent with the Patent Act (see "Tafas v...
Biotech/Pharma Docket
Posted on March 24, 2009By Suresh Pillai -- Settlement Announced in SOLODYN® Patent Dispute Last week, Teva Pharmaceutical Industries Ltd. and Medicis Pharmaceutical Corp. entered into a settlement agreement that effectively ends a dispute between the two companies over the patent family covering SOLODYN® (minocycline HCL, used to treat acne) Extended Release Tablets...
Tafas v. Doll (Fed. Cir. 2009)
Posted on March 23, 2009By Donald Zuhn -- On Friday, the Federal Circuit issued its decision in Tafas v. Doll (formerly Tafas v. Dudas). The Tafas appeal concerns the validity of four rules in the continuation and claims rules package promulgated by the U.S. Patent and Trademark Office on August 21, 2007...
Anyone Remember What These "New Rules" Are All About?
Posted on March 23, 2009By Kevin E. Noonan -- It has been quite some time since most in the patent community have given much thought to the ill-advised "claims and continuation" rules promulgated by the Patent and Trademark Office on August 21, 2007 that were preliminarily enjoined on Halloween, 2007 (one day before they were to go into effect) and permanently enjoyed on April Fool's Day, 2008...
Court Report
Posted on March 22, 2009By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Warner Chilcott Laboratories Ireland Ltd. et al. v. Impax Laboratories, Inc...
Conference & CLE Calendar
Posted on March 22, 2009March 23-24, 2009 - 3rd Annual Patent Law Institute (Practising Law Institute) - San Francisco, CA March 24, 2009 - 5th Annual Document Management, E-Discovery, and Litigation Readiness for Life Sciences (American Conference Institute) - New York, NY March 25-27, 2009 - Intellectual Property Counsels' Committee Spring Conference & Meeting (Biotechnology Industry Organization) - Phoenix, AZ March 30-31, 2009 - Pharmaceutical and Biotech Patent Claim Drafting*** (American Conference Institute) - New York, NY March 30-31, 2009 - FDA Boot Camp*** (American Conference Institute) - New York, NY April 1-4, 2009 - 24th Annual Intellectual Property Law Conference (American Bar Association...
Senator Kyl Introduces Alternative to Leahy Patent Reform Bill
Posted on March 20, 2009By Donald Zuhn -- Another day, another bill. The 111th Congress has been on the job for a little more than ten weeks, but despite this short time span, legislators have already introduced seven bills that could significantly impact the life sciences sector if enacted...
Tafas v. Doll (Fed. Cir. 2009)
Posted on March 20, 2009By Donald Zuhn -- In a 55-page opinion issued earlier today, the Federal Circuit determined that the four rules at issue in Tafas v. Dudas are procedural, but that Rule 78 is inconsistent with 35 U.S.C. § 120 (i.e., that portion of the rule which limits the number of continuation applications), and therefore, affirmed-in-part, vacated-in-part, and remanded...
Second Follow-on Biologics Bill Is Introduced in House
Posted on March 19, 2009By Donald Zuhn -- Yesterday, Rep. Anna Eshoo (D-CA) (at right) provided an alternative to Rep. Henry Waxman's (D-CA) follow-on biologics bill, when she introduced the Pathway for Biosimilars Act (H.R. 1548). Rep. Waxman had introduced his own bill (H...
MAPP Economist Advises Congress on Damages Provision
Posted on March 18, 2009By Donald Zuhn -- Back in January, the Manufacturing Alliance on Patent Policy (MAPP) released a report indicating that the apportionment of damages provisions H.R. 1908 -- the patent reform bill passed by the House in September 2007 -- would have severe economic effects (see "Manufacturing Alliance on Patent Policy: Apportionment of Damages Provision Will Have Adverse Effects")...
Senate and House Introduce Bills Prohibiting Authorized Generics
Posted on March 16, 2009By Donald Zuhn -- Recently, a number of bills that would significantly impact the biotech and pharma industry have been introduced in Congress. These bills include the Preserve Access to Affordable Generics Act (S. 369), which would prohibit brand name drug companies from compensating generic drug companies for delaying the entry of generic drugs into the market; the Promoting Innovation and Access to Life-Saving Medicine Act (H...
Senate Judiciary Committee Places Patent Reform Bill on Agenda
Posted on March 16, 2009By Donald Zuhn -- The Senate Judiciary Committee has placed the Senate patent reform bill (S. 515) on the agenda for the Committee's March 19th Executive Business Meeting. The meeting, which begins at 10:00 am (Eastern), will be webcast. The meeting agenda and a webcast link can be found at the Committee's website...
By Suresh Pillai -- Sepracor Settles
Posted on March 16, 2009By Suresh Pillai -- Sepracor Settles Xopenex Suit With Barr Last week, Sepracor Inc. and Barr Pharmaceuticals, Inc. (a Teva Pharmaceuticals subsidiary) entered into a settlement agreement that effectively ends a dispute between the two companies over the patent family covering Xopenex®, an inhaled asthma treatment...
USPTO News: Competency of ISAs -- Potential Delays for Applications filed with the RO/US
Posted on March 16, 2009By Christopher P. Singer -- In a pre-OG Notice dated March 13, 2009, the U.S. Patent and Trademark Office addressed some issues relating to the competency of certain foreign patent offices to act as an International Searching Authority (ISA) under the PCT...
Court Report
Posted on March 15, 2009By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Sanofi-Aventis U.S. LLC et al. v. Ebewe Pharma Ges.M.B.H. NFG.KG 3:09-cv-01116; filed March 11, 2009 in the District Court of New Jersey Infringement of U...
Conference & CLE Calendar
Posted on March 15, 2009March 23-24, 2009 - 3rd Annual Patent Law Institute (Practising Law Institute) - San Francisco, CA March 24, 2009 - 5th Annual Document Management, E-Discovery, and Litigation Readiness for Life Sciences (American Conference Institute) - New York, NY March 25-27, 2009 - Intellectual Property Counsels' Committee Spring Conference & Meeting (Biotechnology Industry Organization) - Phoenix, AZ March 30-31, 2009 - Pharmaceutical and Biotech Patent Claim Drafting*** (American Conference Institute) - New York, NY March 30-31, 2009 - FDA Boot Camp*** (American Conference Institute) - New York, NY April 1-4, 2009 - 24th Annual Intellectual Property Law Conference (American Bar Association...
More Response to New Patent Reform Legislation
Posted on March 13, 2009By Donald Zuhn -- BIO Seeks Improvements to Patent Reform Legislation Following Tuesday's hearing on patent reform, the Biotechnology Industry Organization (BIO) issued a press release urging the Senate Judiciary Committee to make improvements to its new patent reform bill (S...
Roche and Genetech Agree on Terms of Merger
Posted on March 13, 2009By Christopher P. Singer -- In a March 12, 2009 press release, Roche and Genentech announced that the two companies had agreed on terms of a merger agreement. According to the report, the terms of the agreement include Roche's cash acquisition of all outstanding publicly held shares of Genentech stock at $95 per share, which will total about $46...
Waxman Introduces Follow-on Biologics Bill
Posted on March 12, 2009By Donald Zuhn -- It appears that Representative Henry Waxman (D-CA) (at right) will be the first to introduce a follow-on biologics bill in the 111th Congress. According to a Reuters report, Rep. Waxman has initiated a bipartisan effort to create a follow-on biologics regulatory pathway in the United States...
President Obama Reaffirms Faith in Science
Posted on March 12, 2009By Kevin E. Noonan -- In all the understandable excitement surrounding President Obama's lifting of the Bush Administration's ban on federal funding for embryonic stem cell research, his broader message may have gotten lost. Overturning the stem cell ban is just a part of a return to the tradition, the guiding principle in Western societies since the end of the Dark Ages, to use the scientific method and its results to understand the world and make rational decisions on policy based on science instead of ideology...
Senate Judiciary Committee Holds Hearing on Patent Reform
Posted on March 11, 2009By Donald Zuhn -- For almost two hours this morning, the Senate Judiciary Committee heard testimony regarding its efforts to reform U.S. patent law. Not surprisingly, much of the discussion at the hearing focused on Section 4 of the Senate patent reform bill (S...
Biotech/Pharma Docket
Posted on March 11, 2009By Suresh Pillai --Final Judgment Granted to Applera in Dispute with Enzo On March 5, the U.S. District Court for the District of Connecticut, upon the order of the Court of Appeals for the Federal Circuit (see "Biotech/Pharma Docket," March 2, 2009), reopened the patent litigation suit between Applera (based in Foster City, CA) and Enzo Biochem (based in New York, NY) and issued final judgment in favor of Applera (now Life Technologies, following Applera's merger with Invitrogen)...
USPTO News: Patent Office Extends Deferred Examination Comment Period
Posted on March 10, 2009By Christopher P. Singer -- In a Federal Register Notice (74 Fed. Reg. 10036) published on Monday, March 9, the U.S. Patent and Trademark Office announced that it is extending the deadline for submitting written comments regarding issues raised at last month's roundtable discussion on deferred examination, or any issue relating to deferral of examination, to May 23...
What Good is the Federal Circuit?
Posted on March 10, 2009By Kevin E. Noonan -- The Court of Appeals for the Federal Circuit occupies a unique place in the Federal appellate system. Like the D.C. Circuit and unlike the other circuits, it is not regional and its jurisdiction is not limited to Federal District Courts in a particular geographical area...
Merck and Schering-Plough to Merge
Posted on March 10, 2009By Donald Zuhn -- The new year has witnessed yet another blockbuster biotech/pharma deal. On the heels of Pfizer's $68 billion acquisition of Wyeth (see "Pfizer Expected to Announce Wyeth Acquisition on Monday") in January, Merck & Co., Inc. and Schering-Plough Corp...
President Obama to Lift Stem Cell Limits on Monday
Posted on March 09, 2009By Donald Zuhn -- The New York Times reported late last week that President Obama will satisfy one of his campaign pledges on Monday when he reverses limits imposed by the Bush administration on embryonic stem cell research. In August of 2001, the Bush administration ordered that federal research be limited to lines of cells that were already in existence at the time...
Court Report
Posted on March 08, 2009By Sherri Oslick --About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.Genzyme Corp. v. Lupin Ltd. et al.1:09-cv-00147; filed March 5, 2009 in the District Court of DelawareInfringement of U...
Conference & CLE Calendar
Posted on March 08, 2009March 13, 2009 - Current Strategies for Patent Claim Construction: Key Updates on Patent Prosecution and Litigation (Law Seminars International) - San Francisco, CAMarch 23-24, 2009 - 3rd Annual Patent Law Institute (Practising Law Institute) - San Francisco, CAMarch 24, 2009 - 5th Annual Document Management, E-Discovery, and Litigation Readiness for Life Sciences (American Conference Institute) - New York, NYMarch 25-27, 2009 - Intellectual Property Counsels' Committee Spring Conference & Meeting (Biotechnology Industry Organization) - Phoenix, AZMarch 30-31, 2009 - Pharmaceutical and Biotech Patent Claim Drafting*** (American Conference Institute) - New York, NYMarch 30-31, 2009 - FDA Boot Camp*** (American...
Senator Specter Seeks Resolution of Issues before Vote on Patent Reform Bill
Posted on March 06, 2009By Donald Zuhn -- On Tuesday, Senator Arlen Spector (R-PA) (at right), the ranking member of the Senate Judiciary Committee, sent a letter to Committee Chairman Patrick Leahy (D-VT), requesting that the Senate patent reform bill (S. 515) "not be placed on the Executive Business Agenda until late May, after the Court of Appeals for the Federal Circuit has the opportunity to hear argument in Lucent Technologies, Inc...
White House Seeks Comments on Rulemaking and Rule Enforcement Policy
Posted on March 06, 2009By David Boundy --A notice and comment period of great importance to the patent community opened last week, and this period is scheduled to remain open only until March 16th. This period arises as a result of a "Memorandum for the Heads of Executive Departments and Agencies" (74 Fed...
Chile Now PCT Contracting State . . . Peru to Follow
Posted on March 06, 2009By Sherri Oslick -- On March 2, 2009, Chile deposited its instrument of accession to the Patent Cooperation Treaty (PCT) with the World Intellectual Property Office (WIPO), becoming the 140th PCT Contracting State. The PCT will enter into force in Chile on June 2, 2009...
Patent Claim Construction Seminar
Posted on March 06, 2009Law Seminars International (LSI) will be holding a one-day seminar on Patent Claim Construction on April 24, 2009 at the Georgia International Convention Center in College Park, GA. The seminar will address:? Current Federal Circuit cases on claim interpretation;? Creating more valuable patents and making them easier to defend;? Overall litigation strategies from plaintiff and defendant perspectives;? Evidentiary hearings;? The use of special masters;? Successful summary judgment motions;? Trying the case for appeal;? Effective discovery; and? Using demonstrative evidence to help win claim construction disputes...
Patent Profile: Thrasos Therapeutics Announces Issuance of U.S. Patent No. 7,482,329
Posted on March 05, 2009Congressman Waxman Tells GPhA Meeting that Hatch-Waxman Model Will Work for Follow-on Biologics
Posted on February 26, 2009By Donald Zuhn -- Congressman Henry Waxman (D-CA), the Chairman of the House Committee on Energy and Commerce, addressed the Generic Pharmaceutical Association (GPhA) yesterday, telling attendees of the trade group's annual meeting in Naples, FL that "a workable scientific regulatory and legal pathway for biogenerics and biosimilar pharmaceuticals will ensure more affordable medications for Americans and we believe it will spur innovation in the bio tech markets" (see GPhA press release)...
Patent Reform Bill to Be Introduced on Monday . . . Maybe
Posted on February 26, 2009By Donald Zuhn -- Earlier today, the Manufacturing Alliance on Patent Policy (MAPP) let us know, through its media relations firm, that "well sourced rumors" have pegged Monday, March 2nd as the day on which the first of perhaps three patent reform bills will be introduced in the 111th Congress...
Eli Lilly & Co. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2009)
Posted on February 25, 2009By Donald Zuhn -- The Federal Circuit today affirmed a decision by the District Court for the Southern District of Indiana to extend the statutory 30-month stay under 21 U.S.C. § 355(j)(5)(B)(iii), thereby preventing the U.S. Food and Drug Administration from approving the Abbreviated New Drug Application (ANDA) filed by Defendant-Appellant Teva Pharmaceuticals USA, Inc...
Biotech/Pharma Docket
Posted on February 24, 2009By Suresh Pillai --King Pharmaceuticals' Patents on SKELAXIN® Invalidated By District Court In the case of King Pharmaceuticals, Inc. v. Eon Labs, Inc., the U.S. District Court for the Eastern District of New York invalidated two of the King patents at issue in the case, U...
Comments on Deferred Examination Due by February 26th
Posted on February 24, 2009By Donald Zuhn -- It's been more than a week since the U.S. Patent and Trademark Office hosted a roundtable discussion on deferred examination. The roundtable brought together two dozen participants, representing a variety of industries and organizations, to discuss whether a deferred examination system should be implemented in the U...
The New York Times Gets One Right
Posted on February 23, 2009By Kevin E. Noonan -- Like a broken clock that nonetheless tells the right time twice a day, it was inevitable that The New York Times would eventually run a story where they got it right on patenting (see "Crop Scientists Say Biotechnology Seed Companies Are Thwarting Research")...
Court Report
Posted on February 22, 2009By Sherri Oslick --About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.Millennium Pharmaceuticals Inc. et al. v. Teva Parenteral Medicines Inc...
Conference & CLE Calendar
Posted on February 22, 2009February 23-24, 2009 - Pharmaceutical and Biotech Patent Claim Drafting*** (American Conference Institute) - Palo Alto, CAFebruary 25-26, 2009 - Optimizing Patent Strategies at Patent Forum 2009 (World Research Group) - San Francisco, CAMarch 2-3, 2009 - 3rd Annual Patent Law Institute (Practising Law Institute) - New York, NYMarch 3, 2009 - Biotechnology, Chemical, and Pharmaceuticals (BCP) Technology Groups Customer Partnership Meeting (U...
Biotech/Pharma Business Briefs
Posted on February 21, 2009By Jason Derry* and Donald Zuhn --GPC Biotech and Agennix to Merge GPC Biotech AG and Agennix Inc. have announced a plan to merge. Both companies are focused on discovering and developing treatments for cancer. A new company will be formed with the help of cash from the investment company dievini Hopp Biotech...
Paragraph IV Disputes Conference
Posted on February 21, 2009American Conference Institute (ACI) will be holding its 3rd Annual Paragraph IV Disputes conference on April 27-28, 2009 in New York, NY. The conference will allow attendees to:? Strategically evaluate patent strength, Orange Book listing, and assertion strategies;? Interpret and apply the MMA statutory scheme as it applies to declaratory judgments;? Litigate with multiple ANDA filers in various jurisdictions;? Implement effective and cost-saving e-discovery and document management processes during Paragraph IV litigation;? Master the interplay between 180-day exclusivity, forfeiture provisions, and citizens petitions;? Minimize downstream risk and calculating damages associated with preliminary injunctions and at risk launches; and? Factor recent...
International Judges Conference on Intellectual Property Law
Posted on February 21, 2009The Intellectual Property Owners Association (IPO) will be holding its 5th International Judges Conference on Intellectual Property Law on April 20-21, 2009 in Washington, DC. The conference will provide discussions on the following topics: ? Litigation Issues: A panel discussion regarding current and possible future judicial collaboration in addressing discovery and settlement issues in cross-border IP disputes;? Developing Judicial Issues: A panel discussion regarding the use of precedents and principles from other countries, the enforcement of trade secret protection, and specialization and training for judges handling IP matters;? Transnational Enforcement: A panel discussion regarding a hypothetical fact pattern, in which...
Patent Profile: Vermillion Announces Allowance of Ovarian Cancer Biomarker Application
Posted on February 20, 2009By Donald Zuhn -- Last week, Vermillion, Inc. announced that the U.S. Patent and Trademark Office had issued a Notice of Allowance for its application directed to diagnostic methods using hepcidin as a biomarker for ovarian cancer. The patent that eventually issues from the allowed application will be the Fremont, CA-based molecular diagnostics company's third U...
Will GSK Break the Doha Impasse in the Global Drug Pricing Crisis?
Posted on February 20, 2009By Kevin E. Noonan --As we have noted in the past, the World Trade Organization (WTO) and Trade-related Aspects of Intellectual Property Rights (TRIPS) portion of the General Agreements on Tariffs and Trade (GATT) have not resulted in the general reverence for intellectual property protection intended by Western countries in the developing world, particularly with regard to pharmaceuticals (see "Not Getting It about Patented Drug Prices at The Wall Street Journal")...
New EPO Fee Schedule Effective April 1, 2009
Posted on February 19, 2009By Christopher P. Singer -- Recently, the European Patent Office (EPO) published a notice on its website announcing a new fee schedule that will become effective on April 1, 2009. A complete description of the revised fees can be found here. This schedule will be applicable for all EP applications, including divisional and new applications, that are filed on or after April 1, 2009...
Follow-on Biologics in the News
Posted on February 19, 2009By Donald Zuhn --Innovators Looking for Help from Follow-on Biologics Last week, Merck announced that it had acquired Insmed's portfolio of follow-on biologic therapeutic candidates as well as its biologics manufacturing facilities in Boulder, CO (see "Biotech/Pharma Business Briefs")...
The Future of Biotechnology
Posted on February 18, 2009By Kevin E. Noonan -- Congress has the power, under Article I of the U.S. Constitution, to grant patents "to promote the progress of Science and the Useful Arts." The value of patenting to the public is disclosure ?- the raw material that drives progress is full disclosure of an invention in a patent specification that satisfies 35 U...
NVCA Study Shows Decline in 2008 Investment; BIO Study Predicts Biotech Rebound in 2009
Posted on February 17, 2009By Donald Zuhn -- In December, the National Venture Capital Association (NVCA), a trade association representing the U.S. venture capital industry, issued its forecast for venture investment in the coming year, predicting that most sectors would see a continued slowdown in investment in 2009 (see "NVCA Predicts Another Slow Year for Venture-backed Businesses in 2009")...
Court Report
Posted on February 16, 2009By Sherri Oslick --About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.Monsanto Co. et al. v. Schroeder et al.2:09-cv-10460; filed February 6, 2009 in the Eastern District of MichiganInfringement of U...
Conference & CLE Calendar
Posted on February 16, 2009February 17-18, 2009 - Pharma/Biotech Patent Litigation (C5) - Amsterdam, NetherlandsFebruary 23-24, 2009 - Pharmaceutical and Biotech Patent Claim Drafting*** (American Conference Institute) - Palo Alto, CAFebruary 25-26, 2009 - Optimizing Patent Strategies at Patent Forum 2009 (World Research Group) - San Francisco, CAMarch 2-3, 2009 - 3rd Annual Patent Law Institute (Practising Law Institute) - New York, NYMarch 3, 2009 - Biotechnology, Chemical, and Pharmaceuticals (BCP) Technology Groups Customer Partnership Meeting (U...
Patent Office Hosts Roundtable on Deferred Examination: The Proponents
Posted on February 16, 2009By Donald Zuhn -- Last week, the U.S. Patent and Trademark Office hosted a roundtable discussion on deferred examination. The roundtable, which lasted about four hours, brought together two dozen participants, representing a variety of industries and organizations (as well as positions on the issue), to discuss the advantages and disadvantages of implementing a deferred examination system in the U...
Biotech/Pharma Business Briefs
Posted on February 14, 2009By Jason Derry --Merck to Buy Biologics Division from Insmed Insmed Inc. and Merck have announced a deal in which Merck will purchase Insmed's research and production division and facility for developing follow-on biologics for $130 million (see Insmed press release)...
24th Annual Intellectual Property Law Conference
Posted on February 14, 2009The American Bar Association (ABA) Section of Intellectual Property Law will be holding the 24th Annual Intellectual Property Law Conference on April 1-4, 2009 in Arlington, VA. Among the topics that will be covered at the conference are:? The Patent Reform Movement ? Where Is It Going and Will It Get There?? From Drafting to Appeal ? The Changing U...
PLI Patent Law Institute
Posted on February 14, 2009Practising Law Institute (PLI) will be holding its 3rd Annual Patent Law Institute on March 2-3, 2009 in New York, NY and on March 23-24, 2009 in San Francisco, CA. A live webcast of the New York session will also be available. The two-day conference consists of six one-hour plenary sessions of broad interest to patent lawyers and a separate breakout track consisting of six one-hour sessions focusing on one of three patent practice sub-groups: patent prosecution; patent litigation; and patent transactions...
C5 Freedom to Operate Forum
Posted on February 14, 2009C5 (UK) will be holding its 6th Annual Freedom to Operate Forum on April 20-21, 2009 in London, England. The conference will provide practical knowledge and strategic advice on:? Effective FTO landscaping, searching, and competitor analysis;? The latest EPO, U...
Patent Office Hosts Roundtable on Deferred Examination: The Opposition
Posted on February 13, 2009By Donald Zuhn -- This morning, the U.S. Patent and Trademark Office hosted a roundtable discussion on deferred examination. The roundtable, which lasted about four hours, brought together two dozen participants, representing a variety of industries and organizations (as well as positions on the issue), to discuss the advantages and disadvantages of implementing a deferred examination system in the U...
Center for American Progress Report a Mixed Bag of Recommendations to Obama Administration
Posted on February 12, 2009By Kevin E. Noonan -- Rick Weiss gets it when it comes to the value of patents. "Patents assure an inventor a period of time, generally 20 years, to exclude others from using the invention, in return for a full explication of that invention by the patent holder," he says...
Manufacturing Alliance Sends Letter on Patent Reform to President Obama
Posted on February 11, 2009By Donald Zuhn --Last month, the Manufacturing Alliance on Patent Policy (MAPP) released a report that indicates that the apportionment of damages provisions found in prior Senate (S. 1145) and House (H.R. 1908) patent reform bills would have adverse effects on the U...
USPTO News: Optional e-Office Action Program to Begin in March
Posted on February 11, 2009By Christopher P. Singer -- The U.S. Patent and Trademark Office sent out a series of e-Commerce Alerts on February 10, 2009, announcing that the existing pilot e-Office Action program will be made permanent and available as an option to all applicants beginning this March...
Foley Attorney Releases Treatise on Inter Partes Reexamination
Posted on February 11, 2009By Donald Zuhn -- Recently, we were contacted by Matthew Smith (at right), an associate in Foley & Lardner's Washington, DC office and an adjunct professor at the George Washington University Law School, who wanted to let us know about a treatise on inter partes reexamination that he had just completed...
Biotech/Pharma Docket
Posted on February 10, 2009By Suresh Pillai --GeoPharma and Dr. Reddy's Resolve Patent Litigation Related to Claritin® Patents On January 20, 2009, GeoPharma, based in Largo, FL, announced the settlement of its Clarinex® (Desloratadine) ANDA patent litigation with Schering-Plough (based in Kenilworth, NJ) and Sepracor (based in Marlborough, MA) (see "Court Report," February 24, 2008)...
Patent Office Announces Agenda and Participants for Deferred Examination Roundtable
Posted on February 10, 2009By Donald Zuhn -- Last month, in a notice published in the Federal Register, the U.S. Patent and Trademark Office announced that it would be holding a roundtable discussion regarding deferred examination on February 12th (see "USPTO Schedules Roundtable Discussion on Deferred Examination")...
More § 154(b)(4)(A) Actions Filed against Director
Posted on February 09, 2009By Donald Zuhn --Shortly before leaving the U.S. Patent and Trademark Office, former Director Jon Dudas was served with three last complaints from patentees seeking additional Patent Term Adjustment (PTA) for their patents. The three complaints bring the number of 35 U...
Court Report
Posted on February 08, 2009By Sherri Oslick --About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.Boehringer Ingelheim Vetmedica Inc. v. Merial Ltd. et al.3:09-cv-00212; filed February 4, 2009 in the District Court of ConnecticutDeclaratory judgment of license to practice, non-infringement and invalidity of U...
Conference & CLE Calendar
Posted on February 08, 2009February 12, 2009 - Patent Portfolio Strategies in the Post-KSR Environment (FX Conferences) - 11:30 AM to 12:30 PM (EST)February 12, 2009 - Stanford IP Litigation Clearinghouse: A Pioneering Database with "Life and Death" Statistics for Patent Litigators (Practising Law Institute) - 1:00-2:00 PM (EST)February 13, 2009 - Fourth Annual Workshop on Patent Claim Construction (Law Seminars International) - Chicago, ILFebruary 14, 2009 - Compulsory Licensing and Other IP Controls (American Bar Association) - 7:30-9:00 AM (CST)February 17-18, 2009 - Pharma/Biotech Patent Litigation (C5) - Amsterdam, NetherlandsFebruary 23-24, 2009 - Pharmaceutical and Biotech Patent Claim Drafting*** (American Conference Institute) -...
USPTO News: Agenda for Next BCP Meeting
Posted on February 07, 2009The biotechnology, chemical, and pharmaceuticals (BCP) technology groups at the U.S. Patent and Trademark Office will hold their next quarterly customer partnership meeting on March 3, 2009 at the USPTO's Madison Auditorium, 600 Dulany Street, Alexandria, VA...
BIO IPCC Spring Conference
Posted on February 07, 2009The Biotechnology Industry Organization (BIO) will be holding its Intellectual Property Counsels' Committee (IPCC) Spring Conference & Meeting on March 25-27, 2009 in Phoenix, AZ. The semi-annual IPCC conference will be open to the public for the first time ever...
Document Management, E-Discovery, and Litigation Readiness for Life Sciences Conference
Posted on February 07, 2009American Conference Institute (ACI) will be holding its 5th Annual Document Management, E-Discovery, and Litigation Readiness for Life Sciences conference from March 24, 2009 in New York, NY. The conference will provide information on:? Implementing an effective litigation hold on ESI -- and auditing compliance;? Gathering and monitoring e-data stored on multiple databases in decentralized locations;? Reviewing and producing proprietary and highly sensitive product and company information during discovery;? Cost-effectively managing outside counsel and vendor relationships during litigation; and? Responding to extensive production requests during government investigation...
Patent Claim Construction Workshop
Posted on February 07, 2009Law Seminars International (LSI) will be holding a one-day workshop on Current Strategies for Patent Claim Construction: Key Updates on Patent Prosecution and Litigation on March 13, 2009 in San Francisco, CA. The workshop will address:? The latest on managing patent drafting;? Case law overview on patent claim interpretation;? Judicial perspective on patent claim construction;? Electronic discovery and ethics;? Advantages and disadvantages of evidentiary hearings;? Successful summary judgment hearings;? The nuts and bolts of case management; and? Handling claim construction on appeal...
Bill to Prohibit Reverse Payments Introduced in the Senate
Posted on February 05, 2009By Donald Zuhn -- Yesterday, Senator Herb Kohl (D-WI) (at right) introduced the Preserve Access to Affordable Generics Act (S. 369) in the Senate. The bill, which is co-sponsored by Senators Sherrod Brown (D-OH), Richard Durbin (D-IL), Russell Feingold (D-WI), and Chuck Grassley (R-IA), is designed to prohibit brand name drug companies from compensating generic drug companies for delaying the entry of generic drugs into the market...
Patent Profile: EXACT Sciences Announces Issuance of Colorectal Cancer Screening Patent
Posted on February 05, 2009By Sherri Oslick -- EXACT Sciences Corp. announced today the issuance of U.S. Patent No. 7,485,420, entitled "Methods and Compositions for Detecting Colon Cancers," which is directed toward the use of differentially methylated vimentin as a marker of colorectal cancer...
Applying In re Bilski to Diagnostic Method Claims
Posted on February 05, 2009By Kevin E. Noonan -- An astute reader has asked, regarding our post concerning EXACT Sciences' announcement of the issuance of U.S. Patent No. 7,485,420, whether the claims of the '420 patent would be invalid under the Federal Circuit's In re Bilski standard for patentable subject matter...
The Effects of Intellectual Property Protection on Agricultural Research: Patents Are Not The Problem
Posted on February 04, 2009By Kevin E. Noonan -- Perhaps the most beautiful sentence in scientific literature is this one:It has not escaped our notice that the specific pairing we have postulated immediately suggests a possible copying mechanism for the genetic material.James Watson & Francis Crick, "Molecular Structure of Nucleic Acids; A Structure for Deoxyribose Nucleic Acid," Nature 171: 737-38 (April 25, 1953)It is beautiful because of its elegance, its understatement, and because it provokes in the reader recognition that one of the fundamental mysteries of life on this planet has been answered, with the tantalizing promise that the first two human beings who...
USPTO News: Patent Office Calls Continuing Education Pilot Program a Success
Posted on February 04, 2009By Donald Zuhn -- Last fall, the U.S. Patent and Trademark Office announced that it was seeking up to a thousand registered practitioners to help with a pilot test of the Office's new online Continuing Education for Practitioners (CEP) system (see "Patent Office Seeking Volunteers to Test Continuing Education System")...
Biotech/Pharma Docket
Posted on February 03, 2009By Suresh Pillai --Oxford Gene Technology Settles Legal Action with Bioarray Solutions On January 21, 2009, Oxford, UK-based Oxford Gene Technology (OGT) announced a settlement of the patent infringement lawsuit OGT filed against BioArray Solutions, Ltd...
Ex parte Chuang (B.P.A.I. 2008)
Posted on February 02, 2009By Kevin E. Noonan --The correspondence between a nucleic acid sequence and its encoded amino acid sequence is the basis for a great deal of how the U.S. Patent and Trademark Office examines biotechnology claims. In many instances the Office treats these sequences differently...
Amendment to Japanese IP Law Creates New After Final Deadlines for Foreign Applicants
Posted on February 02, 2009By Christopher P. Singer -- Last week, one of our Japanese associates, Kawaguti & Partners, published a newsletter outlining the impact on foreign applicants that amendments to the Japanese Patent Law will have on patent applications after final rejection...
USPTO News: Pilot PPH Program Between Singapore and U.S.
Posted on February 01, 2009By Christopher P. Singer -- The list of Patent Prosecution Highway (PPH) participants continues to grow. On Friday, the U.S. Patent and Trademark Office published a press release announcing a new pilot PPH program with the Intellectual Property Office of Singapore (IPOS) that will begin on Monday, February 2, 2009...
Court Report
Posted on February 01, 2009By Sherri Oslick --About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.Procter & Gamble Co. et al. v. Sun Pharma Global, Inc.2:09-cv-10342; filed January 29, 2009 in the Eastern District of MichiganProctor & Gamble Co...
Conference & CLE Calendar
Posted on February 01, 2009February 12, 2009 - Patent Portfolio Strategies in the Post-KSR Environment (FX Conferences) - 11:30 AM to 12:30 PM (EST)February 12, 2009 - Stanford IP Litigation Clearinghouse: A Pioneering Database with "Life and Death" Statistics for Patent Litigators (Practising Law Institute) - 1:00-2:00 PM (EST)February 13, 2009 - Fourth Annual Workshop on Patent Claim Construction (Law Seminars International) - Chicago, ILFebruary 14, 2009 - Compulsory Licensing and Other IP Controls (American Bar Association) - 7:30-9:00 AM (CST)February 17-18, 2009 - Pharma/Biotech Patent Litigation (C5) - Amsterdam, NetherlandsFebruary 23-24, 2009 - Pharmaceutical and Biotech Patent Claim Drafting*** (American Conference Institute) -...
FDA Boot Camp Conference
Posted on January 31, 2009American Conference Institute (ACI) will be holding the next session of its FDA Boot Camp conference on March 20-31, 2009 in New York, NY. The conference will allow attendees to:? Master the basics of the application and approval processes for drugs, biologics, and devices;? Comprehend the structure of the FDA and the roles of the CDER, CBER, & CDRH;? Gain a practical working knowledge of the essential clinical trials processesfor drugs and biologics, and the clearance process for devices;? Uunderstand how devices are classified, monitored, and regulated;? Explore the pivotal role of labeling in the drug and biologics approval process;?...
CLE on Stanford IP Litigation Clearinghouse
Posted on January 31, 2009Practising Law Institute (PLI) will be offering an audio webcast entitled: "Stanford IP Litigation Clearinghouse: A Pioneering Database with 'Life and Death' Statistics for Patent Litigators" on February 12, 2009 from 1:00-2:00 PM (EST). Professor Mark Lemley of Stanford Law School; Matthew Lynde of Cornerstone Research; and Joshua Walker, Executive Director of the IP Litigation Clearinghouse, will provide a one-hour audio briefing on the Stanford IP Litigation Clearinghouse, a new database on U...
CLE on Post-KSR Patent Portfolio Strategies
Posted on January 31, 2009FX Conferences will be offering an audio conference entitled "Patent Portfolio Strategies in the Post-KSR Environment" on February 12, 2009 from 11:30 AM to 12:30 PM (EST). Bruce Sunstein of Bromberg & Sunstein LLP will examine how the Supreme Court?s decision in KSR Int'l Co...
CLE on Compulsory Licensing
Posted on January 31, 2009The ABA Center for Continuing Legal Education will be offering a webcast entitled: "Compulsory Licensing and Other IP Controls" on February 14, 2009 from 7:30-9:00 AM (CST). William Fisher, Professor of Intellectual Property Law at Harvard University; Ronald Cass of Cass & Associates; Greg Slater of Intel Corp...
Biotech/Pharma Business Briefs
Posted on January 31, 2009By Jason Derry --ZymoGenetics Licenses Ex-North American Rights to IL-21 ZymoGenetics, Inc. has announced that it has licensed worldwide development and commercialization rights to interleukin 21 (IL-21) from Novo Nordisk A/S. Novo Nordisk will retain such rights in North America...
Patent Profile: Neuralstem Announces Allowance of Neural Stem Cell Application
Posted on January 30, 2009By Donald Zuhn -- On Monday, Neuralstem, Inc. announced that the U.S. Patent and Trademark Office allowed U.S. Application No. 10/047,352 (U.S. Patent Publication No. 2002/0064873), entitled "Stable neural stem cell lines." The '352 application, which was allowed on January 13th, is directed to a method for establishing stable neural stem cell lines and neuronal progenitor lines...
Bilski and Aventis Petition for Certiorari from the Supreme Court
Posted on January 30, 2009By Kevin E. Noonan -- The Supreme Court was petitioned today to grant certiorari in two cases important to biotechnology patenting: In re Bilski, involving the standard for determining that method claims are patentable subject matter; and Aventis Pharma S...
Science Progress Article Addresses Global Patent Protection
Posted on January 29, 2009By Donald Zuhn -- Earlier this month, Science Progress, a semi-annual journal published by the Center for American Progress, issued a series of reports on the U.S. patent system. The series, outlined in an article entitled: "Patent Reform 101," consists of four reports:? "Tackling the Challenge of Patent Reform: Recommendations for the Obama administration and Congress," by Rick Weiss;? "Improving the Effectiveness of the U...
USPTO News: Full Time Patent Prosecution Highway Between Korea and US
Posted on January 29, 2009By Christopher P. Singer -- In a January 28, 2008 press release, the U.S. Patent and Trademark Office announced that the existing pilot Patent Prosecution Highway (PPH) program with the Korean Intellectual Property Office (KIPO) will expire in favor of a permanent PPH which begins on January 29, 2009...
WTO Panel Rules for U.S. in Chinese Copyright and Trademark Infringement Complaint
Posted on January 28, 2009By Kevin E. Noonan -- Intellectual property rights (particularly Western intellectual property rights) were intended to receive improved protection under the Trade-related Aspects of Intellectual Property Rights (TRIPS) provisions of the General Agreement on Tariffs and Trade (GATT)...
Sequence Listing e-Filing Options Using EFS-Web
Posted on January 27, 2009By Christopher P. Singer -- Since the launch of EFS-Web in the fall of 2006, applicants have had the option of e-filing sequence listings as text (.txt) files only, rather than filing sequence listings in both paper and computer readable copies. Several biotech prosecutors in our office have had recent discussion and debate about what files and statements can or must be filed with an EFS-Web filed sequence listing in order to be compliant with the requirements under the Legal Framework and in order for it to be considered as part of the original application...
Newsweek Joins the Anti-patent Bandwagon
Posted on January 27, 2009By Kevin E. Noonan --Ah, the popular press! Purported protectors of our fundamental freedoms, their behavior (at least in the mainstream press) has recently been less than noble. Eschewing the role of crusader (or even muckraker), the press seems to look for the common popular denominator of received wisdom, and then to trumpet it...
USPTO News: USPTO Schedules Roundtable Discussion on Deferred Examination
Posted on January 27, 2009By Christopher P. Singer -- In a Federal Register pre-publication Notice scheduled to be published officially in tomorrow's Federal Register, the U.S. Patent and Trademark Office announced that it plans to hold a roundtable discussion regarding deferred examination options...
Court Report
Posted on January 26, 2009By Sherri Oslick --About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.Elan Pharma International Ltd. v. Alcon Laboratories, Inc. et al.4:09-cv-00032; filed January 22, 2009 in the Eastern District of TexasInfringement of U...
Pfizer Expected to Announce Wyeth Acquisition on Monday
Posted on January 26, 2009By Donald Zuhn -- The New York Times reported this evening that Pfizer has agreed in principle to acquire Wyeth for $68 billion. The Times notes that barring an 11th-hour twist, the deal, which would be the largest in the U.S. since March 2006, will be announced tomorrow morning...
Geron Gets Approval for First Human Clinical Trial Using Embryonic Stem Cells
Posted on January 26, 2009By Donald Zuhn -- On Friday, Geron Corporation announced that the U.S. Food and Drug Administration has approved the biopharmaceutical company's Investigational New Drug (IND) application for the clinical trial of GRNOPC1 in patients with acute spinal cord injury...
Conference & CLE Calendar
Posted on January 25, 2009January 26-27, 2009 - Structuring and Negotiating Pharma & Biotech Collaborative Agreements (C5) - London, EnglandJanuary 27-28, 2009 - ITC Litigation (American Conference Institute)*** - Washington, DC January 28-29, 2009 - 6th National Conference on Pharma/Biotech IP Due Diligence (American Conference Institute) - New York, NYJanuary 29, 2009 - Effective Licensing in the Wake of MedImmune v...
USPTO to Hold "Innovation Week"
Posted on January 24, 2009By Donald Zuhn --The U.S. Patent and Trademark Office announced today that it will be holding Innovation Week 2009 at the Office's headquarters in Arlington, VA from June 22-27. The Patent Office describes Innovation Week 2009 as a weeklong celebration of the vital role patents and the USPTO play in our economy and for the advancement of science and technology...
FX Conferences to Offer Licensing CLE
Posted on January 24, 2009FX Conferences will be offering an audio conference entitled "Effective Licensing in the Wake of MedImmune v. Genentech" on January 29, 2009 from 11:30 AM to 12:30 PM (EDT). Dr. Michael Samardzija of Bracewell & Giuliani will explore the Supreme Court's decision in MedImmune v...
Biotech/Pharma Business Briefs
Posted on January 24, 2009By Jason Derry --Peptimmune and Novartis Sign $500 Million Deal Peptimmune Inc. and Novartis AG recently announced a licensing deal for Peptimmune's multiple sclerosis drug candidate, PI-2301. The deal gives Novartis an exclusive license to the drug candidate...
BIO CEO Outlines Challenges for Obama Administration
Posted on January 23, 2009By Donald Zuhn -- In an interview with TechJournal South, Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood discussed the state of the biotech industry and the biotech issues the new Administration will be facing in the coming year (see "BIO President Sees Biotech Industry Challenges for New Administration")...
Science Progress Tackles Patent Reform
Posted on January 22, 2009By Donald Zuhn -- Last week, Science Progress, a semi-annual journal published by the Center for American Progress, a liberal think tank headed by John Podesta, former White House Chief of Staff under President Clinton (as well as recent co-chairman of the Obama-Biden transition team), issued a series of reports on the U...
Obama Acts to Limit New Federal Rules
Posted on January 22, 2009By Kevin E. Noonan -- President Obama, through his chief of staff Rahm Emanuel (at right), has acted swiftly to stall implementation of the spate of rulemaking by the outgoing Bush Administration. In the last days of the last administration, several rules concerning important, sensitive, and controversial issues were promulgated by various branches of the Federal government, despite pledges to not do so after opposing similar (but much less controversial or extensive) actions by the Clinton administration in its last days...
Heritage Foundation Offers Patent Reform Proposals to the New President
Posted on January 21, 2009By Donald Zuhn --Earlier today, in a historic moment on the steps of the U.S. Capitol, President Barack Hussein Obama was sworn in as the 44th President of the United States. Tomorrow, his Administration will begin to tackle the many serious issues that face our country (the Administration's agenda can be found on the newly revamped White House website)...
Western Reaction to Changes in Chinese Patent Law
Posted on January 21, 2009By Kevin E. Noonan --The recent changes in Chinese patent law have not received universal approval from a number of Western groups. Two of these, the Intellectual Property Owners Association (IPO) and the Biotechnology Industry Organization, have taken different tacks to the same end: disapproval of changes seen as harming their members' interests...
Changes in Chinese Patent Law Adopted
Posted on January 20, 2009By Kevin E. Noonan -- One of our foreign associates in China, Vivien Chan & Co., informs us of a number of important changes in Chinese patent law adopted by the People's Congress on December 27th. The following new rules for patent practice will come into force in China on October 1, 2009:? China will now accept first foreign filings by Chinese companies or individual inventors who "complete" an invention in China...
Court Report
Posted on January 18, 2009By Sherri Oslick --About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.Oscient Pharmaceuticals Corp. et al. v. Lupin Ltd. et al.1:09-cv-00083; filed January 14, 2009 in the District Court of MarylandInfringement of U...
Conference & CLE Calendar
Posted on January 18, 2009January 20-21, 2009 - Bio/Pharmaceutical Summit on Legal and Regulatory Product Lifecycle Strategies*** (Center for Business Intelligence) - Baltimore, MDJanuary 26-27, 2009 - Structuring and Negotiating Pharma & Biotech Collaborative Agreements (C5) - London, EnglandJanuary 27-28, 2009 - ITC Litigation (American Conference Institute)*** - Washington, DC January 28-29, 2009 - 6th National Conference on Pharma/Biotech IP Due Diligence (American Conference Institute) - New York, NYJanuary 29-30, 2009 - Commercialization of Life Sciences Inventions (Law Seminars International) - Phoenix, AZJanuary 29-30, 2009 - Fourth Annual Conference on Best Practices in Patent Monetization (Law Seminars International) - San Francisco, CAFebruary 13, 2009...
Biotech/Pharma Business Briefs
Posted on January 17, 2009By Jason Derry --Medicines Co. to Buy Targanta The Medicines Company and Targanta Therapeutics have announced that Medicines Co. will buy Targanta for $42 million. Medicines Co. has agreed to increase the purchase price by an additional $1.20 a share if Targanta's oritavancin, a product for treating skin infections, is approved by the FDA as a single dose infusion product...
Manufacturing Alliance on Patent Policy: Apportionment of Damages Provision Will Have Adverse Effects
Posted on January 16, 2009In re Kubin: The Obviousness of DNA
Posted on January 15, 2009By Kevin E. Noonan --The Federal Circuit heard oral argument for In re Kubin last week, and a very hot bench (Judge Rader presiding, joined by Judges Linn and Friedman) sharply challenged the positions of both Kubin and the Patent Office. While it is foolish to attempt to read the tea leaves of judicial intention when listening to oral argument, the questions from the bench point out once again that obviousness remains a legal issue intimately dependent on the underlying facts (and misapprehension of those facts)...
PatentBuddy.com Examines Impact of Economic Recession on Patent Practice
Posted on January 14, 2009By Donald Zuhn -- Last week, we received a press release from PatentBuddy.com regarding an analysis of employment statistics performed by the patent networking website. PatentBuddy.com is an online database of patent attorneys and agents registered to practice before the U...
Patent Profile: Cytori Therapeutics Announces Issuance of Adipose-Derived Stem Cell Patents
Posted on January 14, 2009By Donald Zuhn -- Last week, Cytori Therapeutics, Inc. announced that the U.S. Patent and Trademark Office had issued U.S. Patent No. 7,473,420. The '420 patent, which is directed to a method of treating patients with stem cells obtained from adipose tissue, is Cytori's sixth U...
Three More Patentees File § 154(b)(4)(A) Actions against Director Dudas
Posted on January 13, 2009By Donald Zuhn --Last month, Medarex, Inc., Eurand, Inc., and Alexion Pharmaceuticals, Inc. joined the growing list of patentees that have filed complaints against U.S. Patent and Trademark Office Director Jon Dudas alleging that the Patent Office miscalculated the Patent Term Adjustment (PTA) for their patents...
USPTO News: Patent Office Closed on January 19th & 20th
Posted on January 13, 2009By Christopher P. Singer -- The U.S. Patent and Trademark Office announced in a Notice posted on its website today that January 19th (Martin Luther King Day) and January 20th (Inauguration Day) are considered Federal holidays within the District of Columbia, under 35 U...
Conference & CLE Calendar
Posted on January 11, 2009January 12-13, 2009 - Pharmaceutical and Biotech Patent Opinion Writing*** (American Conference Institute) - San Diego, CAJanuary 20-21, 2009 - Bio/Pharmaceutical Summit on Legal and Regulatory Product Lifecycle Strategies*** (Center for Business Intelligence) - Baltimore, MDJanuary 26-27, 2009 - Structuring and Negotiating Pharma & Biotech Collaborative Agreements (C5) - London, EnglandJanuary 27-28, 2009 - ITC Litigation (American Conference Institute)*** - Washington, DC January 28-29, 2009 - 6th National Conference on Pharma/Biotech IP Due Diligence (American Conference Institute) - New York, NYJanuary 29-30, 2009 - Commercialization of Life Sciences Inventions (Law Seminars International) - Phoenix, AZJanuary 29-30, 2009 - Fourth Annual...
Court Report
Posted on January 11, 2009By Sherri Oslick --About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.Eurand Inc. et al. v. Impax Laboratories Inc.1:09-cv-00018; filed January 7, 2009 in the District Court of DelawareInfringement of U...
U.S. Chamber of Commerce Provides Detailed Recommendations to New Administration Regarding USPTO
Posted on January 09, 2009By Christopher P. Singer -- Given the recent news of Governor Bill Richardson's withdrawal from consideration as Commerce Secretary, and the impending resignation of U.S. Patent and Trademark Office Director Jon Dudas, the incoming administration may be giving renewed attention and interest to the Department of Commerce and the USPTO in particular...
Kubin Panel Questions Motivation behind Reversal in New Written Description Training Materials
Posted on January 09, 2009By Donald Zuhn -- As we reported yesterday, the Federal Circuit heard oral argument today in In re Kubin (see "In re Kubin to Be Argued before the Federal Circuit on Thursday"). Kevin Noonan will be providing a complete analysis of the oral argument in this case in a subsequent post...
Biotech/Pharma Business Briefs
Posted on January 09, 2009By Jason Derry --Endo to Acquire Indevus On January 5, 2009, Endo Pharmaceuticals Holdings Inc. announced that it will buy Indevus Pharmaceuticals Inc. for an initial payment of about $370 million and an additional $267 million, based on certain milestones...
In re Kubin to Be Argued before the Federal Circuit on Thursday
Posted on January 08, 2009By Kevin E. Noonan -- The Federal Circuit will hear oral argument on Thursday for In re Kubin, a case having great significance for biotechnology patenting. At issue is the question of whether the existence in the prior art of a purified protein, combined with "routine" cloning methods, renders obvious a claim to a nucleic acid encoding the protein...
BIO Gives President-elect Obama Its Ideas on Patent Reform
Posted on January 07, 2009By Kevin E. Noonan --A change of administration always gives stakeholders a chance to make their policy views known, in an effort to influence the new people and policies taking power in Washington. This is particularly true in this season of (welcome) change, and even more important for U...
Top Stories of 2008: #5 to #1
Posted on January 05, 2009By Donald Zuhn -- Yesterday, we counted down stories #9 to #6 of the top stories covered at Patent Docs in 2008 (see "Top Stories of 2008: #9 to #6"), and on New Year's Day, we listed stories #13 to #10 (see "Top Stories of 2008: #13 to #10"). Today, we conclude our second annual list of top stories by counting down the top five stories of 2008...
Top Stories of 2008: #9 to #6
Posted on January 04, 2009By Donald Zuhn -- On New Year's Day, we counted down the first four of the top thirteen stories covered on Patent Docs in 2008 (see "Top Stories of 2008: #13 to #10"). Today, we count down stories #9 to #6, and tomorrow, we will count down last year's top five stories...
Court Report
Posted on January 04, 2009By Sherri Oslick --About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.Monsanto Co. et al. v. Pilman4:08-cv-02020; filed December 30, 2008 in the Eastern District of MissouriInfringement of U...
Conference & CLE Calendar
Posted on January 04, 2009January 12-13, 2009 - Pharmaceutical and Biotech Patent Opinion Writing*** (American Conference Institute) - San Diego, CAJanuary 20-21, 2009 - Bio/Pharmaceutical Summit on Legal and Regulatory Product Lifecycle Strategies*** (Center for Business Intelligence) - Baltimore, MDJanuary 26-27, 2009 - Structuring and Negotiating Pharma & Biotech Collaborative Agreements (C5) - London, EnglandJanuary 27-28, 2009 - ITC Litigation (American Conference Institute)*** - Washington, DC January 28-29, 2009 - 6th National Conference on Pharma/Biotech IP Due Diligence (American Conference Institute) - New York, NYJanuary 29-30, 2009 - Commercialization of Life Sciences Inventions (Law Seminars International) - Phoenix, AZJanuary 29-30, 2009 - Fourth Annual...
Teva CEO Predicts Passage of Follow-on Biologics Bill in 2009
Posted on January 02, 2009By Donald Zuhn --In November, we noted that the nation's largest mail order pharmacy, Franklin Lakes, NJ-based Medco Health Solutions, Inc., had announced that consumers could expect to see the establishment of a follow-on biologics regulatory pathway in the United States by 2011 (see "Medco Predicts Follow-on Biologics Regulatory Pathway by 2011")...
Top Stories of 2008: #13 to #10
Posted on January 01, 2009By Donald Zuhn --Reflecting upon the events of the past twelve months, Patent Docs presents its second annual list of top biotech/pharma stories. For 2008, we identified a baker's dozen of top stories covered on Patent Docs. Today we will count down stories #13 to #10...
Biotech/Pharma Lobbying Scoreboard - Third Quarter Update - Part II
Posted on December 31, 2008By Donald Zuhn --Earlier this month, we reported on the lobbying efforts of nine biotech/pharma companies and organizations in the third quarter of 2008 (see "Biotech/Pharma Lobbying Scoreboard - Third Quarter Update; BIO Lobbies for Biotech 'Bailout'")...
Acumed LLC v. Stryker Corp. (Fed. Cir. 2008)
Posted on December 31, 2008By Kevin E. Noonan --There are the inklings of a stratagem taking shape in certain of the Federal Circuit's decisions since the spate of Supreme Court rejections of large portions of its jurisprudence. That stratagem involves refusing to overturn district court decisions based on applying an abuse of discretion standard, as evidenced in the Federal Circuit's decision to affirm grant of a permanent injunction in Acumed LLC v...
BIO Says CBO Estimate of Follow-on Biologics Savings Is Based on "Troubling Assumption"
Posted on December 30, 2008By Donald Zuhn -- Earlier this month, the Congressional Budget Office (CBO) issued a report, entitled "Budget Options, Volume I, Health Care," that presents 115 options for changing U.S. health care policy. In the Preface to the report, the CBO states that "[t]he inclusion or exclusion of a particular policy change does not represent an endorsement or rejection" by the CBO, and that the report provides arguments for and against each option...
Court Report
Posted on December 28, 2008By Sherri Oslick --About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.Bayer HealthCare LLC v. Abbott Laboratories et al.6:08-cv-00507; filed December 24, 2008 in the Eastern District of TexasInfringement of U...
Conference & CLE Calendar
Posted on December 28, 2008January 3-7, 2009 - 26th Annual National CLE Conference (Law Education Institute) - Vail, CO January 12-13, 2009 - Pharmaceutical and Biotech Patent Opinion Writing*** (American Conference Institute) - San Diego, CAJanuary 20-21, 2009 - Bio/Pharmaceutical Summit on Legal and Regulatory Product Lifecycle Strategies*** (Center for Business Intelligence) - Baltimore, MDJanuary 26-27, 2009 - Structuring and Negotiating Pharma & Biotech Collaborative Agreements (C5) - London, EnglandJanuary 27-28, 2009 - ITC Litigation (American Conference Institute)*** - Washington, DC January 28-29, 2009 - 6th National Conference on Pharma/Biotech IP Due Diligence (American Conference Institute) - New York, NYJanuary 29-30, 2009 - Commercialization...
USPTO News: Patent Prosecution Highway Pilot with CIPO Is Extended
Posted on December 24, 2008By Donald Zuhn -- Yesterday, the U.S. Patent and Trademark Office announced that the USPTO and Canadian Intellectual Property Office (CIPO) will be extending the Patent Prosecution Highway (PPH) pilot program between the Offices for an additional two years to January 28, 2011...
USPTO News: Patent Office Closed on December 26th
Posted on December 24, 2008By Donald Zuhn -- Yesterday, the U.S. Patent and Trademark Office (USPTO) announced that the USPTO will be closed on Friday, December 26, 2008. The USPTO notice states that because December 25th is a federal holiday, the Office will consider December 26th to be a "Federal holiday within the District of Columbia...
Classen Immunotherapies, Inc. v. Biogen Idec (Fed. Cir. 2008)
Posted on December 22, 2008By Kevin E. Noonan -- The Federal Circuit engaged in judicial parsimony last week, in affirming the decision below that the asserted claims of U.S. Patent No. 5,723,283 are invalid for failure to encompass statutory subject matter. The opinion, written by Judge Moore and joined by Judge Newman and District Court Judge Joseph Farnan of the District of Delaware, sitting by designation, reads in its entirety as follows:In light of our decision in In re Bilski, 545 F...
Court Report
Posted on December 21, 2008By Sherri Oslick --About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.Pfizer Inc. et al. v. Apotex Inc. et al.1:08-cv-00948; filed December 17, 2008 in the District Court of DelawarePfizer Inc...
Conference CLE Calendar
Posted on December 21, 2008January 3-7, 2009 - 26th Annual National CLE Conference (Law Education Institute) - Vail, CO January 12-13, 2009 - Pharmaceutical and Biotech Patent Opinion Writing*** (American Conference Institute) - San Diego, CAJanuary 20-21, 2009 - Bio/Pharmaceutical Summit on Legal and Regulatory Product Lifecycle Strategies*** (Center for Business Intelligence) - Baltimore, MDJanuary 26-27, 2009 - Structuring and Negotiating Pharma Biotech Collaborative Agreements (C5) - London, EnglandJanuary 27-28, 2009 - ITC Litigation (American Conference Institute)*** - Washington, DC January 28-29, 2009 - 6th National Conference on Pharma/Biotech IP Due Diligence (American Conference Institute) - New York, NYJanuary 29-30, 2009 - Commercialization...
NVCA Predicts Another Slow Year for Venture-backed Businesses in 2009
Posted on December 19, 2008By Donald Zuhn -- Earlier this week, the National Venture Capital Association (NVCA), a trade association representing the U.S. venture capital industry, released the results of its third annual survey on venture investment. Perhaps not surprisingly, the trade organization forecasts that most sectors will see a continued slowdown in venture investment in 2009...
Stanford Law School Announces Launch of Patent Litigation Database
Posted on December 19, 2008By Donald Zuhn -- Last week, the Law, Science & Technology Program at Stanford Law School announced the launch of the Stanford IP Litigation Clearinghouse (IPLC) Patent Litigation Module, a database of more than 23,000 cases filed in U.S. district courts since 2000...
Biotech/Pharma Lobbying Scoreboard - Third Quarter Update; BIO Lobbies for Biotech "Bailout"
Posted on December 19, 2008By Donald Zuhn --Patent Docs periodically reports on the lobbying efforts of various players in the biotech/pharma industry (see links below for reports on first and second quarter lobbying this year). Our interest in the lobbying expenditures of these companies and organizations stems from the push by Congress over the past two years to pass patent reform and follow-on biologics legislation...
Science Article Should Help Allay Gene Patenting Fears
Posted on December 17, 2008By Donald Zuhn -- An article in the October 10th issue of Science magazine presents the results of an analysis of litigated gene patents, and reaches the conclusion that "for the most part, fears expressed concerning human gene patents have not been manifested overtly in patent litigation...
Sanofi-Synthelabo v. Apotex, Inc. (Fed. Cir. 2008)
Posted on December 16, 2008By Kevin E. Noonan --Denial of an ANDA validity challenge by generic pharmaceutical company Apotex of the Sanofi-Synthelabo's Orange Book-listed patent for Plavix® was affirmed by the Federal Circuit last week. The decision, by Judge Newman, joined by Judges Lourie and Bryson, was unremarkable and should remain so, unless the Supreme Court were to grant certiorari and work more of its particular brand of mischief on U...
Takeda Chem. Indus., Ltd. v. Mylan Labs., Inc. (Fed. Cir. 2008)
Posted on December 16, 2008By Donald Zuhn --Last week, the Federal Circuit affirmed a finding of exceptionality and award of $16.8 million in attorneys fees by the District Court for the Southern District of New York in a case involving two Hatch-Waxman challenges to U.S. Patent No...
Court Report
Posted on December 14, 2008By Sherri Oslick --About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.Merial Ltd. v. Intervet, Inc.3:08-cv-00121; filed December 10, 2008 in the Middle District of GeorgiaMerial Ltd...
Conference & CLE Calendar
Posted on December 14, 2008January 3-7, 2009 - 26th Annual National CLE Conference (Law Education Institute) - Vail, CO January 12-13, 2009 - Pharmaceutical and Biotech Patent Opinion Writing*** (American Conference Institute) - San Diego, CAJanuary 20-21, 2009 - Bio/Pharmaceutical Summit on Legal and Regulatory Product Lifecycle Strategies*** (Center for Business Intelligence) - Baltimore, MDJanuary 26-27, 2009 - Structuring and Negotiating Pharma & Biotech Collaborative Agreements (C5) - London, EnglandJanuary 27-28, 2009 - ITC Litigation (American Conference Institute)*** - Washington, DC January 28-29, 2009 - 6th National Conference on Pharma/Biotech IP Due Diligence (American Conference Institute) - New York, NYJanuary 29-30, 2009 - Commercialization...
USPTO News: Patent Office Reminds Patent Practitioners to Update Contact Information
Posted on December 13, 2008By Donald Zuhn -- On Thursday, the U.S. Patent and Trademark Office issued a reminder notice to all registered patent attorneys and agents to update their contact information via the Office's new online registration system. Patent Docs first reported on the new online registration system last summer...
ACI Pharmaceutical and Biotech Patent Claim Drafting Conference
Posted on December 13, 2008American Conference Institute (ACI) will be holding its Pharmaceutical and Biotech Patent Claim Drafting conference on February 23-24 in Palo Alto, California. The course will be repeated on March 9-10, 2009 in Research Triangle Park, North Carolina and on March 30-31, 2009 in New York...
Personalized Medicine: A Patent Office Perspective
Posted on December 12, 2008By Kevin E. Noonan -- On December 3rd, the biotechnology, chemical, and pharmaceuticals (BCP) technology groups at the U.S. Patent and Trademark Office held their most recent quarterly customer partnership meeting. During one of six presentations, Kathleen Bragdon, a Quality Assurance Specialist from Technology Center 1600, presented "A Look at Personalized Medicine...
USPTO News: Additional Application Types Eligible for Participation in PPH Between USPTO and EPO
Posted on December 12, 2008By Christopher P. Singer -- In a memorandum dated December 10, 2008, the USPTO announced that, in response to comments from its customers, it has modified the requirements for requesting participation in the patent prosecution highway (PPH) pilot program...
USPTO News: Patent Office Announces Delay for New Appeals Rules
Posted on December 10, 2008By Donald Zuhn --Yesterday, we reported on a Notice published by the U.S. Patent and Trademark Office in today's Federal Register announcing a delay in the effective date of the new rules relating to Practice before the Board of Patent Appeals and Interferences in Ex Parte Appeals (Appeals rules)...
Proponent of Gene Patent Ban to Leave Congress
Posted on December 10, 2008By Kevin E. Noonan -- Roll Call, the Newspaper of Capitol Hill since 1955, announced today that Rep. Xavier Becerra (D-CA, 31st Dist.) "appears poised to accept a post as U.S. trade representative" in the Obama administration. We here at Patent Docs, and all reasoning members of the patent community, wish Rep...
USPTO News: Patent Office Announces Delay in Changes to Appeals Rules
Posted on December 09, 2008By Christopher P. Singer -- In a Notice to be published in tomorrow's Federal Register, the U.S. Patent and Trademark Office announced that the new rules relating to Practice before the Board of Patent Appeals and Interferences in Ex Parte Appeals (Appeal rules) will not take effect on December 10, 2008, as originally scheduled...
Federal Circuit Hears Oral Argument on Tafas Appeal
Posted on December 09, 2008By Donald Zuhn --Last Friday, the Federal Circuit heard oral argument in the Tafas v. Dudas appeal. Arguing on behalf of Defendants-Appellants Director Jon Dudas and the U.S. Patent and Trademark Office was USPTO General Counsel James Toupin. Plaintiffs-Appellees SmithKline Beecham Corp...
Europe Bans Stem Cell Patenting
Posted on December 09, 2008By Kevin E. Noonan -- The Enlarged Board of the European Patent Office issued its decision denying a European patent on European Patent Application No. 96903521.1 (EP 0 770 125) to the Wisconsin Alumni Research Foundation (WARF), directed to human embryonic stem cells (hESCs)...
Court Report
Posted on December 08, 2008By Sherri Oslick --About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.Eli Lilly and Company v. Sun Pharmaceutical Industries Ltd. et al...
Conference & CLE Calendar
Posted on December 08, 2008December 8-9, 2008 - Pharmaceutical and Biotech Patent Opinion Writing*** (American Conference Institute) - Atlanta, GAJanuary 3-7, 2009 - 26th Annual National CLE Conference (Law Education Institute) - Vail, CO January 12-13, 2009 - Pharmaceutical and Biotech Patent Opinion Writing*** (American Conference Institute) - San Diego, CAJanuary 20-21, 2009 - Bio/Pharmaceutical Summit on Legal and Regulatory Product Lifecycle Strategies*** (Center for Business Intelligence) - Baltimore, MDJanuary 26-27, 2009 - Structuring and Negotiating Pharma & Biotech Collaborative Agreements (C5) - London, EnglandJanuary 27-28, 2009 - ITC Litigation (American Conference Institute)*** - Washington, DC January 28-29, 2009 - 6th National Conference on...
LSI Best Practices in Patent Monetization Conference
Posted on December 06, 2008Law Seminars International (LSI) will be holding its Fourth Annual Conference on Beast Practices in Patent Monetization conference on January 29-30, 2009 in San Francisco, CA. During the conference, LSI's faculty will offer presentations on the following topics:? How do you get useful patents?? Creating and implementing decision rules for patent portfolio mining and management (hold, sell, license or abandon?);? Challenges and uncertainties in patent law: Keeping on top of evolving standards for patentable subject matter and obviousness;? Strategies in the how and why of buying patents;? Designing a purchasing model to meet specific needs; ? Continue the exchange of...
C5 Pharma/Biotech Patent Litigation Conference
Posted on December 06, 2008C5 (UK) will be holding its Pharma/Biotech Patent Litigation conference on February 17-18, 2009 in Amsterdam, Netherlands. At this conference, C5 faculty will offer presentations on the following topics:? Review of 2008 European case law developments;? Assessing the likely ramifications of the German olanzapine decision;? Inventive step post Angiotech: Has UK patent law returned to the European fold?? Where is obviousness in the U...
USPTO Implements New Program to Teach Examiners How to Read and Understand Case Law
Posted on December 05, 2008By Donald Zuhn -- On Wednesday, the biotechnology, chemical, and pharmaceuticals (BCP) technology groups at the U.S. Patent and Trademark Office held their most recent quarterly customer partnership meeting. During the last of six presentations, Associate Solicitor Janet Gongola outlined a new training module that the Office has begun using to instruct examining corps about case law...
Mylan and Novartis Settle Femara® Litigation
Posted on December 05, 2008By Mark Chael -- On December 2nd, Mylan, Inc. and Mylan Pharmaceuticals, Inc. announced that they had settled their dispute with Novartis Pharmaceuticals Corp., Novartis Corp., and Novartis International AG over a generic version of Novartis' Femara® tablets...
USPTO to Appeal Wyeth v. Dudas
Posted on December 03, 2008By Donald Zuhn -- Last Friday, U.S. Patent and Trademark Office Director Jon Dudas filed a Notice of Appeal in the District Court for the District of Columbia appealing the Court's September 30th decision in Wyeth v. Dudas to the United States Court of Appeals for the District of Columbia Circuit...
Claim Construction at the Federal Circuit: A District Court Judge's View
Posted on December 03, 2008Medegen MMS, Inc. v. ICU Medical, Inc. (Fed. Cir. 2008) By Kevin E. Noonan -- The Federal Circuit recently had the opportunity to appreciate firsthand the frustrations of district court judges with its review of claim construction under Markman v. Westview Instruments, Inc...
USPTO News: USPTO e-Commerce Update
Posted on December 03, 2008By Christopher P. Singer -- The U.S. Patent and Trademark Office sent out an e-Commerce e-Alert on December 2, 2008 that included information regarding its recent announcements about the Priority Document Exchange (PDX) Program with the Korean Intellectual Property Office (KIPO); preventing Digital Certificates from expiring; and using the EFS-Web with Adobe 9...
More Patentees Follow Wyeth's Lead in Seeking Additional PTA
Posted on December 03, 2008By Donald Zuhn --As we reported yesterday, on November 28th, Director Jon Dudas of the U.S. Patent and Trademark Office filed a Notice of Appeal in the District Court for the District of Columbia appealing the Court's decision in Wyeth v. Dudas to the United States Court of Appeals for the District of Columbia Circuit (see "USPTO to Appeal Wyeth v...
Impax and Medicis Settle Solodyn® Litigation
Posted on December 03, 2008By Sherri Oslick --Earlier this week, Impax Laboratoriesm, Inc. and Medicis Pharmaceutical Corp. announced that they have entered a Joint Development Agreement and a Settlement and License Agreement that brings to an end their pending lawsuit over Impax's plans to manufacture a generic version of Medics' Solodyn® (minocycline hydrochloride extended release tablets, used to treat acne)...
European Commission Releases Preliminary Report on Competition in Pharmaceutical Sector
Posted on December 02, 2008By Donald Zuhn -- Last Friday, the European Commission published a 426-page preliminary report regarding its competition inquiry into the European pharmaceutical sector. The Commission commenced the sector inquiry last January to examine why fewer new medicines were being brought to market in Europe and why generic entry seemed to be delayed in some cases (the report notes that while 40 new medicines were introduced annually between 1995 and 1999, only 27 were introduced annually between 2000 and 2007)...
Court Report
Posted on November 30, 2008By Sherri Oslick --About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.Eurand, Inc. et al. v. Mylan Pharmaceuticals, Inc. et al.1:08-cv-00210; filed November 26, 2008 in the Northern District of West VirginiaEurand, Inc...
Conference & CLE Calendar
Posted on November 30, 2008December 1, 2008 - 19th Annual Conference on U.S. Patent and Trademark Office Law and Practice (PTO Day) (Intellectual Property Owners Association) - Washington, DCDecember 2, 2008 - Patent Interferences Rules & Practice (Intellectual Property Owners Association) - Washington, DCDecember 3, 2008 - Biotechnology, Chemical, and Pharmaceuticals (BCP) Customer Partnership Meeting (U...
USPTO News: Agenda for Next BCP Meeting
Posted on November 26, 2008The biotechnology, chemical, and pharmaceuticals (BCP) technology groups at the U.S. Patent and Trademark Office will hold their next first quarterly customer partnership meeting of the year on December 3, 2008. The schedule of topics for discussion include (all times Eastern):Morning Session? Greetings and Overvie (9:00 - 9:15 AM): John LeGuyader, George Elliot, and Remy Yucel, Directors, Technology Center 1600? TC1600 Chemical Non-Statutory Double Patenting Examples (9:15 - 10:00 AM): Daniel Sullivan SPE, Art Unit 1621? Personalized Medicine (10:00 - 10:45 AM): Kathleen Bragdon, QAS, TC 1600? Break (10:45 - 11:00 AM)? Restriction Burden and Petition Data (11:00 AM -...
Pinkos Appointment Provokes Allegations
Posted on November 25, 2008By Kevin E. Noonan -- Maybe Hal Wegner (at right) is surprised by the continuing shenanigans of the current Patent Office administration. Maybe he is genuinely offended by their many actions and appointments made with seemingly little or no heed of the legal requirements for holding positions of authority in the Office...
King Pharmaceuticals and Johnson & Johnson Announce Acquisitions
Posted on November 25, 2008By Jason Derry -- King Pharmaceuticals, Inc. has announced that it will purchase Alpharma Inc. for about $1.6 billion in cash. King had been trying to convince Alpharma to accept an offer for the past couple of months (see "King Pharmaceuticals Extends Tender Offer to Acquire Alpharma")...
Medco Predicts Follow-on Biologics Regulatory Pathway by 2011
Posted on November 25, 2008By Donald Zuhn -- Last Friday, Medco Health Solutions, Inc. added its name to the list of companies seeking a follow-on biologics (FOB) regulatory pathway (see Reuters report). The endorsement was not entirely surprising given Medco's vested interest -- the company, based in Franklin Lakes, NJ, is the nation's largest mail order pharmacy and a leading pharmacy benefit manager (PBM)...
Court Report
Posted on November 23, 2008By Sherri Oslick --About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.Abbott Laboratories et al. v. Teva Pharmaceuticals USA, Inc. et al...
Conference & CLE Calendar
Posted on November 23, 2008December 1, 2008 - 19th Annual Conference on U.S. Patent and Trademark Office Law and Practice (PTO Day) (Intellectual Property Owners Association) - Washington, DCDecember 2, 2008 - Patent Interferences Rules & Practice (Intellectual Property Owners Association) - Washington, DCDecember 3, 3008 - Parallel Patent Reexamination and Litigation 2008: The Latest Developments and Their Impact (Practising Law Institute) - San Francisco, CA December 8-9, 2008 - Pharmaceutical and Biotech Patent Opinion Writing*** (American Conference Institute) - Atlanta, GAJanuary 3-7, 2009 - 26th Annual National CLE Conference (Law Education Institute) - Vail, CO January 12-13, 2009 - Pharmaceutical and Biotech Patent...
USPTO News: Patent Office Issues Appeals Rules Clarification
Posted on November 22, 2008By Donald Zuhn -- Yesterday, the U.S. Patent and Trademark Office published a notice in the Federal Register (73 Fed. Reg. 70282) clarifying the new appeals rules scheduled to take effect on December 10, 2008. The Patent Office also posted a statement regarding the clarification on its website...
Former House Ways and Means Economist Claims 7-Year Data Exclusivity Period Is Sufficient
Posted on November 21, 2008By Donald Zuhn -- On Tuesday, Alex Brill (at right), a principal at Matrix Global Advisors, LLC and former chief economist to the House Ways and Means Committee, released a white paper which asserts that a follow-on biologics regulatory pathway providing a data exclusivity period of seven years would be "sufficient for maintaining strong incentives to innovate while fostering a competitive marketplace...
Pfizer and Stem Cell Sciences Sign Services Agreement
Posted on November 21, 2008By Jason Derry -- Stem Cell Sciences plc has announced an agreement with Pfizer Ltd., under which Stem Cell Sciences (SCS) will provide services that will support Pfizer's new regenerative medicine unit. The partnership provides Pfizer with access to SCS's research services, cell lines, media, and reagents...
USPTO News: Annual Fee Announced for Registered Practitioners
Posted on November 20, 2008By Christopher P. Singer -- In a Notice published in the Federal Register (73 Fed. Reg. 67750) on Monday, November 17, 2008, the U.S. Patent and Trademark Office announced a new rule that would institute an annual fee for all registered practitioners...
King Pharmaceuticals Extends Tender Offer to Acquire Alpharma
Posted on November 19, 2008By Kwame Mensah --Last month, King Pharmaceuticals, Inc. announced that it is extending its previously announced tender offer for all outstanding shares of Class A Common Stock of Alpharma Inc. (representing a total equity value of approximately $1.6 billion and an enterprise value of approximately $1...
USPTO News: USPTO Announces "Highest Performance Levels in Agency?s History" in 2008
Posted on November 19, 2008By Donald Zuhn -- The U.S. Patent and Trademark Office released its FY 2008 Performance and Accountability Report yesterday and announced that the Office had for the first time "met 100 percent of its Government Performance and Results Act (GPRA) goals...
USPTO News: New PCT Transmittal and Search Fees Effective in January
Posted on November 19, 2008By Christopher P. Singer -- In a Notice published in the Federal Register (73 Fed. Reg. 47534) on Wednesday, November 12, 2008, the U.S. Patent and Trademark Office announced new fees for the transmittal and search for international applications filed under the Patent Cooperation Treaty (PCT)...
The Relevance of In re Bilski to the Patentability of the Metabolite Claim
Posted on November 18, 2008By Kevin E. Noonan -- In the Bilski case, the Federal Circuit confirmed that the judges have learned the hard lessons of ten years of Supreme Court reversals. The decision is based solely and completely on what the judges seem to believe is the "test" mandated by Supreme Court precedent, based in large part on the Supreme Court's decision in Gottschalk v...
Court Report
Posted on November 16, 2008By Sherri Oslick --About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.University of Kansas Center for Research, Inc. v. United States of America2:08-cv-02565; filed November 12, 2008 in the District Court of KansasCorrection of inventorship of U...
Conference & CLE Calendar
Posted on November 16, 2008November 17-18, 2008 - Pharmaceutical and Biotech Patent Opinion Writing*** (American Conference Institute) - Boston, MA November 17-18, 2008 - Patent Litigation 2008 (Practising Law Institute) - New York, NY November 19-20, 2008 - Paragraph IV on Trial*** (American Conference Institute) - New York, NYDecember 1, 2008 - 19th Annual Conference on U...
PLI Seminar on Parallel Patent Reexamination and Litigation 2008
Posted on November 15, 2008Practising Law Institute (PLI) will be holding a live seminar entitled "Parallel Patent Reexamination and Litigation 2008: The Latest Developments and Their Impact" on December 3, 2008 in San Francisco. The conference will offer presentations on the following topics:? Understanding Patent Reexamination Procedure and the Impact of the Process? Overview of the ex parte and inter partes patent reexamination process before the USPTO;? Strategies to consider when initiating a reexamination process in view of litigation; and? Recent statistics on patent reexaminations: What they may mean...
C5 Pharma & Biotech Collaborative Agreements Conference
Posted on November 15, 2008C5 (UK) will be holding its Structuring and Negotiating Pharma & Biotech Collaborative Agreements conference on January 26-27, 2009 in London, England. The conference will allow attendees to:? Factor takeaways from recent deals and trends into collaborations;? Determine when to introduce M&A considerations into collaboration strategy;? Ensure that collaboration agreements meet competition law guidelines;? Negotiate critical IP terms to accelerate development and maximize profits;? Minimize collaboration risks through strategic partner selection and due diligence;? Select the most viable and profitable collaboration structures; and? Design profitable agreements with academic institutions...
Washington Legal Foundation "Conversations With" Series Examines IP Issues
Posted on November 14, 2008By Donald Zuhn -- As part of its ongoing "Conversations With" series, the Washington Legal Foundation (WLF) recently made available its latest question-and-answer offering, which examines the ongoing evolution of intellectual property rights in the United States and internationally...
Icon Acquires Prevalere
Posted on November 14, 2008By Jason Derry -- Icon plc has announced its acquisition of Prevalere Life Sciences Inc., a move that will expand Icon's bioanalytics and immunoassay business in the United States. Prevalere, identified in the announcement as a wholly owned subsidiary of ORS Labs Inc, is a New York-based contract research organization that provides consulting and testing services for biotechnology and pharmaceutical companies...
In re Bilski: Additional Perspectives Provided by IP Colloquium
Posted on November 13, 2008By Christopher P. Singer -- Professor Douglas Lichtman (at right) from the UCLA School of Law contacted Patent Docs to let us know about a free audio podcast regarding the recent Federal Circuit decision in In re Bilski, which is available for download at the Intellectual Property Colloquium...
New Administration Will Act Quickly to Jump-Start Stem Cell Research
Posted on November 12, 2008By Donald Zuhn -- Last week, we reviewed prior Patent Docs reports discussing some aspects of President-elect Barack Obama's technology platform, including his positions on patent issues and follow-on biologics (see "A Second Look at President-elect Obama's Technology Platform")...
Patent Profile: Epitomics Announces Issuance of Patents for Anti-TNF Antibody and Cell Line for Producing Monoclonal Antibodies
Posted on November 11, 2008Court Report
Posted on November 09, 2008By Sherri Oslick --About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.Bayer Healthcare LLC v. Norbrook Laboratories Limited et al.2:08-cv-02556; filed November 6, 2008 in the District Court of KansasInfringement of U...
Conference & CLE Calendar
Posted on November 09, 2008November 10-11, 2008 - Patent Litigation 2008 (Practising Law Institute) - Atlanta, GA November 11-13, 2008 - 4th Biosimilars conference (Visiongain) - Philadelphia, PA November 12-14, 2008 - Structuring, Negotiating and Managing Pharma/Biotech Collaborative Agreements (American Conference Institute) - New York, NY November 17-18, 2008 - Pharmaceutical and Biotech Patent Opinion Writing*** (American Conference Institute) - Boston, MA November 17-18, 2008 - Patent Litigation 2008 (Practising Law Institute) - New York, NY November 19-20, 2008 - Paragraph IV on Trial*** (American Conference Institute) - New York, NYDecember 1, 2008 - 19th Annual Conference on U...
LEI National CLE Conference (and Skiing!)
Posted on November 08, 2008Law Education Institute, Inc. (LEI) will be holding the 26th Annual National CLE Conference on January 3-7, 2009 in Vail, Colorado. The Intellectual Property program of the conference, which will be held at the Vail Marriott Mountain Resort, will offer presentations on a number of topics, including:? In-house analysis -- Strategic considerations for filing a patent law suit;? Proving obviousness and non-obviousness in a post-KSR world;? Strategies for initiating patent infringement actions: Cease & desist letters, DJ actions, and preliminary injunctions;? Corporate counsel panel: Patent issues that keep corporate counsel awake at night;? Is there a disconnect between the Supreme...
Reaction to Historic Presidential Election
Posted on November 06, 2008By Donald Zuhn -- Yesterday, as President-Elect Barack Obama addressed hundreds of thousands of Chicagoans in Grant Park and millions of viewers around the world, we took a look back at a number of prior Patent Docs reports that discussed some aspects of the President-Elect's technology platform, including his positions on patent issues and follow-on biologics (see "A Second Look at President-Elect Obama's Technology Platform")...
USPTO News: "Blueprint" Announced for Work Sharing Initiative Between Five IP Offices
Posted on November 06, 2008By Christopher P. Singer --In an October 31, 2008 press release, the U.S. Patent and Trademark Office announced the development of a work sharing plan between five major intellectual property offices. The representatives of the five offices, including Dr...
A Second Look at President-Elect Obama's Technology Platform
Posted on November 05, 2008By Donald Zuhn -- Like many Americans, we spent Tuesday evening watching the presidential election returns come in, and now that Senator Barack Obama has been elected the 44th president of the United States, we thought it would be a good idea to take a look back at some of our previous reports discussing some aspects of President-Elect Obama's technology platform...
In re Alonso (Fed. Cir. 2008)
Posted on November 04, 2008By Kevin E. Noonan --In the excitement of the Federal Circuit's en banc decision in In re Bielski, handed down last Thursday, it could be understandable that another opinion from the Federal Circuit reviewing a Patent Office determination of unpatentability, In re Alonso, might go unnoticed...
USPTO News: IP Australia Now Competent ISA for PCT Applications Received by USPTO
Posted on November 03, 2008By Sherri Oslick -- Applicants filing a PCT application with the U.S. Patent and Trademark Office as the Receiving Office now have another option for their selection of an International Search Authority (ISA) -- IP Australia, the Australian Patent Office...
Court Report
Posted on November 02, 2008By Sherri Oslick --About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.AstraZeneca Pharmaceuticals LP et al. v. Handa Pharmaceuticals, LLC et al...
Conference & CLE Calendar
Posted on November 02, 2008November 10-11, 2008 - Patent Litigation 2008 (Practising Law Institute) - Atlanta, GA November 11-13, 2008 - 4th Biosimilars conference (Visiongain) - Philadelphia, PA November 12-14, 2008 - Structuring, Negotiating and Managing Pharma/Biotech Collaborative Agreements (American Conference Institute) - New York, NY November 17-18, 2008 - Pharmaceutical and Biotech Patent Opinion Writing*** (American Conference Institute) - Boston, MA November 17-18, 2008 - Patent Litigation 2008 (Practising Law Institute) - New York, NY November 19-20, 2008 - Paragraph IV on Trial*** (American Conference Institute) - New York, NYDecember 1, 2008 - 19th Annual Conference on U...
USPTO News: PTO Seeks Comments Regarding Maintenance Fees Notice
Posted on November 01, 2008By Christopher P. Singer -- In a Notice published in the Federal Register (73 Fed. Reg. 47534) on Thursday, October 30, 2008, the U.S. Patent and Trademark Office published its burden and cost analysis for proposed continuing information collection relating to maintenance fee submissions, and requested comments to the proposed collection...
IPO PTO Day & Patent Interferences Rules & Practice Conference
Posted on November 01, 2008The Intellectual Property Owners Association (IPO) has released a preliminary program for its 19th Annual Conference on U.S. Patent and Trademark Office Law and Practice (PTO Day) on December 1, 2008 in Washington, D.C. The patent portion of the conference will address the following topics:? Accelerated Examination Practice? Design Patent Protection After the Egyptian Goddess Case? Patentable Subject Matter After In re Bilski? Other Recent Federal Circuit Decisions Affecting USPTO Practice? Luncheon Address by Gerald J...
USPTO News: Patent Prosecution Highway Pilot Program Between U.S. and Danish Patent Offices
Posted on October 30, 2008By Christopher P. Singer -- In a memorandum dated October 20, 2008, the U.S. Patent and Trademark Office announced that it will expand the patent prosecution highway (PPH) pilot program to include the Danish Patent and Trademark Office (DKPTO). The PPH program becomes effective on November 3, 2008 for a term of one year, and is extendable for another year...
Speak No Evil (Don't Even Hint at It): Declaratory Judgment Jurisprudence After Medimmune
Posted on October 30, 2008By Michael H. Baniak & Suresh B. Pillai --I. INTRODUCTIONPatent owners enjoy most of the same benefits, including the right to exclude and the freedom to contract, as the owners of other types of personal property. Balanced with these ordinary rights, however, is Congress's concern that the property rights of the patent owners do not conflict with the underlying purpose of patent grants: "[t]o promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries...
Abbott Laboratories v. Sandoz, Inc. (Fed. Cir. 2008) - Part II
Posted on October 30, 2008Opposing Federal Circuit Preliminary Injunction Standards in Abbott Laboratories v. Sandoz By Kevin E. Noonan -- The decision of the Court of Appeals for the Federal Circuit in Abbott Laboratories v. Sandoz, affirming the District Court's grant of a preliminary injunction, nicely illustrates the way the Federal Circuit exercises its prerogatives in applying the abuse of discretion standard...
Abbott Laboratories v. Sandoz, Inc. (Fed. Cir. 2008)
Posted on October 29, 2008Opposing Federal Circuit Preliminary Injunction Standards in Abbott Laboratories v. Sandoz By Kevin E. Noonan --The Court of Appeals for the Federal Circuit affirmed grant of a preliminary injunction in Abbott Laboratories v. Sandoz on October 21, and also affirmed the District Court's determination that the patents-in-suit were not rendered unenforceable by inequitable conduct during prosecution (although defendant Sandoz will be able to pursue this defense at trial)...
PTO Announces No IDS or Markush Rules During Bush Administration
Posted on October 28, 2008By Kevin E. Noonan -- The American Intellectual Property Lawyers Association (AIPLA) reported today that two of the pending U.S. Patent and Trademark Office rules packages, regarding changes in the rules governing Information Disclosure Statements ("the IDS rules") and claims encompassing multiple alternative embodiments ("the Markush rules") will not be published as final rules (and thus, will not go into effect) before the end of the Bush administration...
Court Report
Posted on October 26, 2008By Sherri Oslick --About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.Endo Pharmaceuticals Inc. et al. v. Barr Laboratories Inc.1:08-cv-00782; filed October 20, 2008 in the District Court of DelawareInfringement of U...
Conference & CLE Calendar
Posted on October 26, 2008October 28-29, 2008 - Pharma/Biotech IP Due Diligence*** (C5) - Amsterdam, Netherlands November 10-11, 2008 - Patent Litigation 2008 (Practising Law Institute) - Atlanta, GA November 11-13, 2008 - 4th Biosimilars conference (Visiongain) - Philadelphia, PA November 12-14, 2008 - Structuring, Negotiating and Managing Pharma/Biotech Collaborative Agreements (American Conference Institute) - New York, NY November 17-18, 2008 - Pharmaceutical and Biotech Patent Opinion Writing*** (American Conference Institute) - Boston, MA November 17-18, 2008 - Patent Litigation 2008 (Practising Law Institute) - New York, NY November 19-20, 2008 - Paragraph IV on Trial*** (American Conference Institute) - New York, NY December...
ACI ITC Litigation Conference
Posted on October 25, 2008American Conference Institute (ACI) will be holding its Advanced Forum on ITC Litigation from January 27-28, 2009 in Washington, DC. The conference will offer insights into current trends and issues involved in an ITC action, including:? The fallout from the decision in Broadcomm v...
LSI Commercialization of Life Sciences Inventions Conference
Posted on October 25, 2008Law Seminars International (LSI) will be holding a conference on Innovative Strategies for Accelerating the Commercialization of Life Sciences Inventions on January 29-30, 2009 in Phoenix, AZ. During the conference, LSI's faculty will offer presentations on the following topics: ? Accelerating the "gap" from discovery to development to commercialization;? Valuation of discoveries from discovery to development to commercialization;? Consortia and other multi-party collaborations: Increasingly important mechanisms for accelerating commercialization;? Patent pools: Another innovative tool to accelerate commercialization;? Unique challenges associated with licensing inventions from academic research environment to private-sector life sciences company;? Venture philanthropy as creative funding source; and? Exit...
Law Professors Back USPTO in Tafas v. Dudas Appeal
Posted on October 24, 2008By Donald Zuhn -- Last week, the U.S. Patent and Trademark Office and USPTO Director Jon Dudas filed their reply brief in the Tafas v. Dudas appeal. On the same day that the Patent Office filed its reply brief, Patently-O provided links to the fifteen amicus briefs filed in the appeal, thirteen of which support Plaintiffs-Appellees Dr...
Patent Profile: Immunomedics Announces Issuance of Patent for anti-CD20 Antibody
Posted on October 23, 2008By Donald Zuhn -- Last week, Immunomedics, Inc. announced that the U.S. Patent and Trademark Office has issued U.S. Patent No. 7,435,803, which is directed to humanized and chimeric anti-CD20 antibodies and CD20 antibody fusion proteins. Such antibodies are useful for the treatment and diagnosis of B-cell disorders, such as B-cell malignancies and autoimmune diseases...
In re Tzipori (Fed. Cir. 2008)
Posted on October 21, 2008By Donald Zuhn --Last week, the Federal Circuit affirmed a determination by the Board of Patent Appeals and Interferences that the claims of U.S. Application No. 10/041,958 would have been obvious in view of five prior art references.The '958 application, filed by Appellants Saul Tzipori, Ramaswamy Balakrishnan, and Arthur Donohue-Rolfe (Tzipori), relates to antibodies that bind Shiga-like toxin II (SLT-II), which is secreted by some strains of Escherichia coli in the intestinal tracts of mammals...
USPTO News: KIPO Becomes Participating Foreign Office in PDX Program
Posted on October 21, 2008By Christopher P. Singer -- In a Notice dated October 14, 2008, the U.S. Patent and Trademark Office announced that the Korean Intellectual Property Office (KIPO) has become the third participating foreign intellectual property office in the electronic priority document exchange program...
Court Report
Posted on October 19, 2008By Sherri Oslick --About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.Zydus Pharmaceuticals, Inc., USA et al. v. Teva Pharmaceutical Industries Ltd et al...
Conference & CLE Calendar
Posted on October 19, 2008October 15, 2008 - Developments in Pharmaceutical and Biotech Patent Law (Practising Law Institute) - San Francisco, CA October 15-16, 2008 - Pharmaceutical Congress on Paragraph IV Disputes*** (Center for Business Intelligence) - Philadelphia, PA October 15-16, 2008 - Advanced Courses (Patent Resources Group) - Santa Ana Pueblo, NM October 15-17, 2008 - Maximizing Pharmaceutical Patent Lifecycles*** (American Conference Institute) - New York, NY October 23-24, 2008 - Patent Litigation 2008 (Practising Law Institute) - Chicago, IL October 28-29, 2008 - Pharma/Biotech IP Due Diligence*** (C5) - Amsterdam, Netherlands November 10-11, 2008 - Patent Litigation 2008 (Practising Law Institute) -...
CBI Bio/Pharmaceutical Summit on Legal and Regulatory Product Lifecycle Strategies
Posted on October 18, 2008The Center for Business Intelligence (CBI) will be holding its Bio/Pharmaceutical Summit on Legal and Regulatory Product Lifecycle Strategies on January 20-21, 2009 in Baltimore, MD. The conference will address the current challenges, policies, and practical strategies from both legal and regulatory perspectives to help companies implement a more effective and modern approach to lifecycle management (LCM)...
Wyeth v. Dudas (D.D.C. 2008)
Posted on October 17, 2008District Court Decision Impacts PTA Determinations By Donald Zuhn -- On September 30th, the District Court for the District of Columbia granted summary judgment in favor of Wyeth, determining that the U.S. Patent and Trademark Office had misconstrued 35 U...
PTO Files Reply Brief in Tafas v. Dudas Appeal
Posted on October 16, 2008By Donald Zuhn -- The U.S. Patent and Trademark Office and USPTO Director Jon Dudas filed their reply brief today in the Tafas v. Dudas appeal (a copy of the brief can be obtained here). We previously reported on the filing of opening appeal briefs by the PTO, GSK, and Dr...
In re Ciprofloxacin Hydrochloride Antitrust Litigation (Fed. Cir. 2008)
Posted on October 16, 2008By Kevin E. Noonan --The Federal Circuit today issued its decision in the Ciprofloxacin antitrust litigation, in an opinion that addressed the extent to which a patent-holding innovator drug company can enter into an agreement with a generic competitor that keeps the generic drug off the market...
Presidential "Debate" on U.S. Patent Policy
Posted on October 15, 2008By Donald Zuhn --On Wednesday Senator Barack Obama and Senator John McCain will be participating in their third, and final, presidential debate. While the third debate will address the economy and domestic policy issues, there is a strong likelihood, particularly in view of the current financial crisis, that U...
Amgen v. Hoffmann-LaRoche: Remaining Issues
Posted on October 14, 2008By Kevin E. Noonan -- On October 2, 2008, Judge William Young of the District Court of the District of Massachusetts issued his 150-page opinion in Amgen Inc. v. F. Hoffmann-La Roche Ltd. , Amgen's patent infringement suit over Roche's Mircera® drug product (see "Victory for Amgen in District Court Decision - Part I")...
Patents Online Announces New Patent Search Engine
Posted on October 14, 2008By Donald Zuhn -- Patents Online, LLC, the company behind FreePatentsOnline, today announced the release of a companion online service, SumoBrain. The service, which was launched this summer, offers an alternative to patent search pay services by providing free cross-collection searching, portfolios, saved search capabilities, alerts, bulk PDF download capabilities, and collaboration tools...
Patents Docs Web Addresses
Posted on October 13, 2008Due to some problems associated with the renewal of our alternate domain names, the Patent Docs weblog can no longer be reached via the patentdocs.net or patentdocs.us web addresses. We recommend that you replace bookmarks to either of the above addresses with the following address: http://www...
Court Report
Posted on October 12, 2008By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Invitrogen Corp. v. Oxford Biomedical Research, Inc. et al.3:08-cv-00599; filed October 8, 2008 in the Western District of Wisconsin Declaratory judgment of invalidity, non-infringement, and unenforceability (due to lapse) of U...
Conference & CLE Calendar
Posted on October 12, 2008October 15, 2008 - Developments in Pharmaceutical and Biotech Patent Law (Practising Law Institute) - San Francisco, CA October 15-16, 2008 - Pharmaceutical Congress on Paragraph IV Disputes*** (Center for Business Intelligence) - Philadelphia, PA October 15-16, 2008 - Advanced Courses (Patent Resources Group) - Santa Ana Pueblo, NM October 15-17, 2008 - Maximizing Pharmaceutical Patent Lifecycles*** (American Conference Institute) - New York, NY October 23-24, 2008 - Patent Litigation 2008 (Practising Law Institute) - Chicago, IL October 28-29, 2008 - Pharma/Biotech IP Due Diligence*** (C5) - Amsterdam, Netherlands November 10-11, 2008 - Patent Litigation 2008 (Practising Law Institute) -...
Amgen v. Hoffmann-LaRoche: Back to the District Court
Posted on October 11, 2008By Kevin E. Noonan -- The Federal Circuit today issued an Order, pursuant to Federal Circuit Rule 36, affirming the District Court's grant of a preliminary injunction in Amgen Inc. v. F. Hoffmann-La Roche Ltd., Amgen's patent infringement suit over Roche's Mircera® drug product...
More on Ex parte Appeal Rule
Posted on October 11, 2008On Wednesday, we published a request from Dr. Richard Belzer to patent practitioners and patent applicants to submit comments regarding the Ex parte Appeal Rule to the Office and Management and Budget (OMB) (see "Unhappy with the Ex parte Appeal Rule? Read This Now -- Updated")...
USPTO News: Online Priority Document Exchange Service Between USPTO and KIPO
Posted on October 10, 2008By Christopher P. Singer -- We have learned from one of our foreign associates that the Korean Intellectual Property Office (KIPO) announced that it will launch an online priority document exchange (PDX) service with the U.S. Patent and Trademark Office (USPTO) beginning on October 14, 2008...
USPTO News: USPTO Performance Review Board Members Announced
Posted on October 10, 2008By Christopher P. Singer -- In a Notice published in the Federal Register on October 9, 2008, the U.S. Patent and Trademark Office announced the names of persons that have been appointed to the Performance Review Board. Among the twelve familiar names constituting the Board, Margaret J...
Victory for Amgen in District Court Decision - Part III
Posted on October 10, 2008By Kevin E. Noonan -- As Patent Docs has reported (see Part I and Part II), last week District Court Judge William G. Young (D. Mass) issued a 150-page decision on post-trial motions and a permanent injunction, and provided his rationale for a number of pretrial summary judgment motion decisions, in Amgen Inc...
Impax Laboratories, Inc. v. Aventis Pharmaceuticals Inc. (Fed. Cir. 2008)
Posted on October 08, 2008By Donald Zuhn -- Last Friday, the Federal Circuit affirmed the determination by the District Court for the District of Delaware that U.S. Patent No. 5,236,940 does not qualify as an enabling prior art reference, and therefore, does not anticipate claims 1-5 of U...
Unhappy with the Ex parte Appeal Rule? Read This Now -- Updated
Posted on October 08, 2008By Richard Belzer -- The U.S. Patent and Trademark Office (PTO) today published a notice in the Federal Register inviting public comments on paperwork burdens associated with the changes in the procedural requirements for ex parte appeals (73 Fed. Reg...
Victory for Amgen in District Court Decision - Part II
Posted on October 08, 2008By Kevin E. Noonan -- On October 2nd, District Court Judge William G. Young (D. Mass) issued a decision on post-trial motions and a permanent injunction in Amgen Inc. v. Hoffmann-LaRoche, Amgen's patent infringement suit over Roche's Mircera® drug product...
Complete Victory for Amgen in District Court Decision
Posted on October 07, 2008By Kevin E. Noonan -- On October 2nd, District Court Judge William G. Young (D. Mass) entered final judgment in Amgen Inc. v. Hoffmann-LaRoche, Amgen's patent infringement suit over Roche's Mircera® drug product. In a 150-page opinion, Judge Williams handed Amgen nothing less than a complete victory...
Victory for Amgen in District Court Decision - Part I
Posted on October 07, 2008By Kevin E. Noonan -- On October 2nd, District Court Judge William G. Young (D. Mass) issued a decision on post-trial motions and a permanent injunction in Amgen Inc. v. Hoffmann-LaRoche, Amgen's patent infringement suit over Roche's Mircera® drug product...
Court Report
Posted on October 05, 2008By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Proctor & Gamble Co. et al. v. Teva Pharmaceuticals USA Inc.1:08-cv-00627; filed September 26, 2009 in the District Court of Delaware Infringement of U...
Conference & CLE Calendar
Posted on October 05, 2008October 6-7, 2008 - Patent Litigation 2008 (Practising Law Institute) - McLean, VA October 7-8, 2008 - Global Patent Litigation*** (American Conference Institute) - New York, NY October 15, 2008 - Developments in Pharmaceutical and Biotech Patent Law (Practising Law Institute) - San Francisco, CA October 15-16, 2008 - Pharmaceutical Congress on Paragraph IV Disputes*** (Center for Business Intelligence) - Philadelphia, PA October 15-16, 2008 - Advanced Courses (Patent Resources Group) - Santa Ana Pueblo, NM October 15-17, 2008 - Maximizing Pharmaceutical Patent Lifecycles*** (American Conference Institute) - New York, NY October 23-24, 2008 - Patent Litigation 2008 (Practising Law...
ACI Pharma/Biotech IP Due Diligence Conference
Posted on October 04, 2008American Conference Institute (ACI) will be holding its 6th National Conference on Pharma/Biotech IP Due Diligence from January 28-29, 2009 in New York. The conference will allow attendees to: ? Define the company's business goals before you begin a due diligence review;? Navigate the dynamic labyrinth of cases that can impact the company's IP rights;? Ensure a data trail that tracks the disclosure of appropriate information;? Gauge the effect of the patents in question on the company's freedom to operate;? Cultivate a sufficient search strategy to enhance your knowledge base of the IP's strengths, weaknesses, and potential;? Evaluate the benefits,...
Inequitable Conduct Standard Remains Fluid in Praxair v. ATMI
Posted on October 03, 2008By Kevin E. Noonan -- The Federal Circuit's inequitable conduct jurisprudence has appeared for some time to be unduly fact- and panel-dependent, straying in the opinion of at least Judge Rader from the principle enunciated in the Court's en banc decision in Kingsdown Medical Consultants, Ltd...
Nature Biotechnology Study Finds Declining Litigation Rates for DNA-based Patents
Posted on October 02, 2008By Donald Zuhn -- A study in last month's issue of Nature Biotechnology calls into question the perception that litigation rates -- at least for one particular industry -- are rising. The study, entitled "DNA-based patents: an empirical analysis" (the full text of the article can be obtained here for $32), was conducted by Ann Mills, Associate Professor of Medical Education and Director of Outreach Programs at the University of Virginia Center for Biomedical Ethics, and Dr...
Dr. Tafas Files Brief in New Rules Appeal
Posted on October 01, 2008By Donald Zuhn -- Last Wednesday, Plaintiffs-Appellees SmithKline Beecham Corp., SmithKline Beecham plc, and Glaxo Group Ltd. (GSK) filed their brief in the Tafas v. Dudas appeal (see "GSK Files Brief in Tafas v. Dudas Appeal"). As we previously reported, the Plaintiffs-Appellees had until September 24th to serve and file their brief...
Court Report
Posted on September 28, 2008By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Sepracor Inc. and University of Massachusetts v. Pharmaceutical Associates, Inc...
Conference & CLE Calendar
Posted on September 28, 2008October 6-7, 2008 - Patent Litigation 2008 (Practising Law Institute) - McLean, VA October 7-8, 2008 - Global Patent Litigation*** (American Conference Institute) - New York, NY October 15, 2008 - Developments in Pharmaceutical and Biotech Patent Law (Practising Law Institute) - San Francisco, CA October 15-16, 2008 - Pharmaceutical Congress on Paragraph IV Disputes*** (Center for Business Intelligence) - Philadelphia, PA October 15-16, 2008 - Advanced Courses (Patent Resources Group) - Santa Ana Pueblo, NM October 15-17, 2008 - Maximizing Pharmaceutical Patent Lifecycles*** (American Conference Institute) - New York, NY October 23-24, 2008 - Patent Litigation 2008 (Practising Law...
BIO Praises Senator Kyl's Patent Reform Bill
Posted on September 26, 2008By Kevin E. Noonan -- Yesterday, we reported on the introduction of a new patent reform bill (S. 3600) in the Senate (see "Senator Kyl's Patent Reform Bill Introduced Today"). Soon after Senator Jon Kyl's (R-AZ) patent reform bill was introduced, the Biotechnology Industry Organization (BIO) released a statement in which BIO President and CEO Jim Greenwood (below) called the legislation "a vast improvement" over S...
USPTO News: USPTO and KIPO Sign Memoradum on Cooperative Patent Examination
Posted on September 25, 2008By Christopher P. Singer -- The U.S. Patent and Trademark Office (USPTO) issued a press release on September 24, 2008 announcing that the Office had signed a memorandum of understanding with the Korean Intellectual Property Office (KIPO) regarding a comprehensive plan on cooperative patent examination...
Teva Receives EU Marketing Authorization for G-CSF Biosimilar
Posted on September 25, 2008By Donald Zuhn -- Last week, Teva Pharmaceutical Industries Ltd. announced that the European Commission's Directorate General for Enterprise and Industry has granted the company a marketing authorization for its human granulocyte colony stimulating factor (G-CSF) product...
Has the Federal Circuit Gotten Gunshy?
Posted on September 23, 2008By Kevin E. Noonan -- After several years of having its decisions reversed by the Supreme Court -- including KSR Int'l Co. v. Teleflex Inc., eBay Inc. v. MercExchange, LLC, Quanta Computer, Inc. v. LG Electronics, Inc., Merck KGAA v. Integra Lifesciences I, Ltd...
USPTO News: PTO Declares Mail Service Interruption and Emergency
Posted on September 23, 2008By Christopher P. Singer -- In a Notice dated September 18, 2008, the U.S. Patent and Trademark Office announced that the postal interruptions cause by Hurricane Gustav in regions of Louisiana and Texas (beginning on August 30, 2008) and by Hurricane Ike in regions of Florida, Louisiana, and Texas (beginning on September 7, 2008) have been deemed to be a "service interruption and emergency" falling within the provisions of 35 U...
Court Report
Posted on September 21, 2008By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. National Genetics Institute et al. v. Talecris Biotherapeutics, Inc...
Biosimilars Conference
Posted on September 20, 2008Visiongain will be holding its 4th Biosimilars conference on November 11-13, 2008 in Philadelphia, PA. The conference is intended to help attendees: ? Identify the trends that will shape future market development of follow-on biologics;? Explore the current market and regulatory environment for biosimilars in Europe and the relevance to U...
BU Economics Professor Releases Report on the Impact of Marketing Exclusivity on Biologics Innovation
Posted on September 19, 2008By Donald Zuhn -- On Wednesday, Dr. Laurence J. Kotlikoff, a professor of economics at Boston University, released the results of his analysis of the impact of varying lengths of market exclusivity on innovation in the biotechnology sector. The 20-page report, entitled "Stimulating Innovation in the Biologics Industry: A Balanced Approach to Marketing Exclusivity," was funded by Teva Pharmaceuticals USA (see Teva press release)...
Biotech Cases to Watch According to Professor Harold Wegner
Posted on September 17, 2008By Kevin E. Noonan -- Harold Wegner, dean of patent law cognoscenti and a partner at Foley & Lardner LLP in Washington, DC, regaled the audience at ACI's Biotech Patent Law conference on Monday with a talk on "Key Biotech Cases to Watch and How They May Impact Your Practice...
Patent Profile: Allele Biotech Announces Issuance of siRNA Patent
Posted on September 16, 2008By Donald Zuhn -- Last week, Allele Biotechnology & Pharmaceuticals, Inc. announced that the U.S. Patent and Trademark Office has issued U.S. Patent No. 7,422,896, which is directed to DNA compositions that mediate RNA interference (RNAi) gene silencing, wherein the DNA compositions include an RNA polymerase III promoter that drives the expression of a nucleotide sequence encoding an intermediate small interfering RNA (siRNA) molecule, and RNA polymerase III terminator...
Conference & CLE Calendar
Posted on September 14, 2008September 15-16, 2008 - Biotech Patents*** (American Conference Institute) September 16, 2008 - The Legacy of Judge Howard T. Markey*** (The Center for Intellectual Property Law, John Marshall Law School) - Chicago, IL September 21-23, 2008 - 2008 Annual Meeting (Intellectual Property Owners Association) - San Diego, CA September 22-23, 2008 - FDA Boot Camp*** (American Conference Institute) September 22-23, 2008 - Patent Litigation 2008 (Practising Law Institute) - San Francisco, CA September 22-23, 2008 - 2008 World Stem Cell Summit (Genetics Policy Institute) - Madison, WI September 23-24, 2008 - Biotech Patenting (C5) - London, England October 6-7, 2008...
Biotech/Pharma Lobbying Scoreboard - Second Quarter Update - Part II
Posted on September 13, 2008By Donald Zuhn -- Last month, we reported on the lobbying expenditures for fourteen biotech and pharma companies and organizations in the second quarter of 2008. Recent news reports have allowed us to add four more companies to the list: ? Sanofi-Aventis' U...
USPTO News: Patent Office Posts Comments on New Appeals Rules
Posted on September 12, 2008By Donald Zuhn -- On June 10, 2008, the U.S. Patent and Trademark Office published a notice in the Federal Register setting forth amended rules of practice before the Board of Patent Appeals and Interferences (BPAI) in ex parte appeals (see "New Appeals Rules Published")...
Janssen Pharaceutica, N.V. v. Apotex, Inc. (Fed. Cir. 2008)
Posted on September 11, 2008By Kevin E. Noonan -- Over the past year, the Federal Circuit has addressed on many occasions the scope of the "case or controversy" requirement for a court to have jurisdiction under Article III of the Constitution. Several of these decisions have been directed to the proper jurisdictional scope of declaratory judgment actions filed in ANDA cases, where a generic drug company has filed its ANDA on a drug having at least one patent listed by the innovator in the FDA Orange Book...
Carnegie Mellon University v. Hoffman-La Roche Inc. (Fed. Cir. 2008)
Posted on September 10, 2008By Donald Zuhn -- On Monday, the Federal Circuit affirmed a finding on summary judgment by the District Court for the Northern District of California that the asserted claims of U.S. Patent Nos. 4,767,708 and 5,126,270 and certain asserted claims of U...
In re Swanson (Fed. Cir. 2008)
Posted on September 09, 2008By Kevin E. Noonan -- Re-examination, whether ex parte under 35 U.S.C. § 302-307 or inter partes under 35 U.S.C. § 311-318, is a procedure intended to provide an alternative to patent litigation, which Congress characterized as being expensive and inefficient in passing legislation establishing these two routes of post-grant challenge (see H...
Court Report
Posted on September 08, 2008By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Glaxo Group Ltd. et al. v. Lupin Ltd. et al.1:08-cv-00551; filed August 29, 2008 in the District Court of Delaware Infringement of U...
New Attack on Patenting in The New York Times
Posted on September 08, 2008By Kevin E. Noonan -- The New York Times seems to have an unending supply of pundits willing to support its anti-patent agenda, as has been noted on this blog before (see below). The latest example is an article in this Saturday's paper, entitled "When Academia Puts Profit Ahead of Wonder," by Janet Rae-Dupree...
Isis Pharmaceuticals Adds to Crooke RNAi Patent Estate
Posted on September 05, 2008By Donald Zuhn -- Isis Pharmaceuticals, Inc. announced today that the U.S. Patent and Trademark Office has issued notices of allowance for U.S. Application Nos. 10/281,312 and 10/281,297. According to the company's press release, the two allowances "significantly expand" the scope of Isis' Crooke patent estate -- a family of patents based on the research of Dr...
BIO Discusses Legislative Accomplishments
Posted on September 04, 2008By Kevin E. Noonan -- Earlier today, Patent Docs participated in a conference call with Jim Greenwood, the President and CEO of the Biotechnology Industry Organization (BIO) and Joshua Boger, Ph.D., Chairman of BIO's Board and President and CEO of Vertex Pharmaceuticals Inc...
USPTO News: USPTO and UKIPO Extend Patent Prosecution Highway Pilot Program
Posted on September 04, 2008By Donald Zuhn -- Last week, the U.S. Patent and Trademark Office announced that the Patent Prosecution Highway (PPH) pilot program with the United Kingdom Intellectual Property Office (UKIPO), which was initiated on September 4, 2007, would be extended until further notice...
Tafas v. Dudas Update
Posted on September 03, 2008By Sherri Oslick -- Patent Docs readers anxiously awaiting GSK/Tafas' brief will have to wait a little longer. On August 14, the parties jointly moved to modify the briefing schedule; the motion was granted today (September 2). The schedule as it now stands is as follows:? September 24, 2008: Appellees' briefs due ? October 15, 2008: Appellants' reply brief and joint appendix due By an additional joint motion, also granted today, oral arguments will be scheduled on the December 2008 argument calendar...
USPTO News: Patent Office Seeking Volunteers to Test Continuing Education System
Posted on September 02, 2008By Donald Zuhn -- In an e-Commerce e-Alert distributed on Friday, the U.S. Patent and Trademark Office announced that it was seeking up to 1,000 registered practitioners to help with a pilot test of the Office's new online Continuing Education for Practitioners (CEP) system...
Court Report
Posted on September 01, 2008By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Sanofi-Aventis et al. v. Apotex, Inc. et al.3:08-cv-04320; filed August 27, 2008 in the District Court of Delaware Infringement of U...
Conference & CLE Calendar
Posted on September 01, 2008September 11, 2008 - Developments in Pharmaceutical and Biotech Patent Law (Practising Law Institute) - New York, NY September 11-12, 2008 - Current Issues in Complex IP Licensing (Law Seminars International) - Philadelphia, PA September 15-16, 2008 - Biotech Patents*** (American Conference Institute) September 21-23, 2008 - 2008 Annual Meeting (Intellectual Property Owners Association) - San Diego, CA September 22-23, 2008 - USPTO Boot Camp: Patent Edition*** (American Conference Institute) - Alexandria, VA September 22-23, 2008 - FDA Boot Camp*** (American Conference Institute) September 22-23, 2008 - Patent Litigation 2008 (Practising Law Institute) - San Francisco, CA September 22-23, 2008...
2008 World Stem Cell Summit
Posted on August 30, 2008The Genetics Policy Institute will be holding the 2008 World Stem Cell Summit on September 22-23 in Madison, WI. The Summit, which is being hosted by the University of Wisconsin Stem Cell & Regenerative Medicine Center and WiCell Research Institute, will bring together researchers, clinicians, business pathfinders, key policy-makers, regulators, advocates, and experts in law and ethics to give presentations, share information, and chart the future of regenerative medicine...
USPTO News: Patent Office Puts End to Submission of Duplicate Copies of Forms
Posted on August 29, 2008By Christopher P. Singer -- In an August 27, 2008 notice, the U.S. Patent and Trademark Office (USPTO) announced that it is changing certain forms to remove language that requests a duplicate copy of the form be submitted for fee processing purposes. Previously, the duplicate copy of forms that contained an authorization to charge fees to a deposit account allowed for faster processing, because hardcopy paper application files were maintained in one area of the Office, while fee processing was done in another area of the Office...
ABA Issues Opinion on Outsourcing
Posted on August 28, 2008By Donald Zuhn -- On Monday, the American Bar Association (ABA) Standing Committee on Ethics and Professional Responsibility released a statement regarding a new ethics opinion (Formal Opinion 08-451), which concludes that U.S. lawyers can outsource legal and nonlegal work provided that they adhere to ethics rules regarding competence, supervision, protection of confidential information, reasonable fees, and not assisting in the unauthorized practice of law...
Star Scientific, Inc. v. R.J. Reynolds Tobacco Co. (Fed. Cir. 2008)
Posted on August 27, 2008By Kevin E. Noonan -- We may have reached the high-water mark on the expansion of the inequitable conduct doctrine. Recent decisions from the Federal Circuit seem to signal a retrenchment in the Court's treatment of the doctrine, and its willingness to affirm district court judgments finding inequitable conduct, particularly in the context of summary judgment decisions...
Patent Profile: Helix BioMedix Announces Issuance of Patent for Antimicrobial Peptide
Posted on August 26, 2008By Donald Zuhn -- Helix BioMedix, Inc. announced that the U.S. Patent and Trademark Office has issued U.S. Patent No. 7,407,940, which is directed to hexapeptides that exhibit antimicrobial activity against infections caused by a variety of pathogens...
Conference & CLE Calendar
Posted on August 24, 2008September 11, 2008 - Developments in Pharmaceutical and Biotech Patent Law (Practising Law Institute) - New York, NY September 11-12, 2008 - Current Issues in Complex IP Licensing (Law Seminars International) - Philadelphia, PA September 15-16, 2008 - Biotech Patents*** (American Conference Institute) September 21-23, 2008 - 2008 Annual Meeting (Intellectual Property Owners Association) - San Diego, CA September 22-23, 2008 - USPTO Boot Camp: Patent Edition*** (American Conference Institute) - Alexandria, VA September 22-23, 2008 - FDA Boot Camp*** (American Conference Institute) September 22-23, 2008 - Patent Litigation 2008 (Practising Law Institute) - San Francisco, CA September 23-24, 2008...
Biotech/Pharma Lobbying Scoreboard - Second Quarter Update
Posted on August 22, 2008By Donald Zuhn -- Regular Patent Docs readers have likely noticed that we have been paying close attention to the lobbying efforts of various players in the biotech/pharma industry. Our interest in the lobbying expenditures of these companies and organizations stems from the push by Congress over the past year to pass patent reform and follow-on biologics legislation...
ACI Pharma/Biotech Collaborative Agreements Conference
Posted on August 22, 2008American Conference Institute (ACI) will be holding its 11th Advanced Forum on Structuring, Negotiating and Managing Pharma/Biotech Collaborative Agreements from November 12-14, 2008 in New York. The conference will allow attendees to: ? Leverage intellectual property and draft favorable exclusivity provisions;? Anticipate the potential impact of M&A activity on your transaction;? Negotiate co-development rights;? Protect rights relating to future developments and improvements;? Evaluate viable compensation structures;? Minimize risks through partner selection and due diligence;? Ensure effective alliance management;? Negotiate hotly contested issues with universities; and? Avoid the top pitfalls of international deals...
In re Omeprazole Patent Litigation (Fed. Cir. 2008)
Posted on August 21, 2008By Kevin E. Noonan -- The Federal Circuit today affirmed AstraZeneca's latest victory in its long-running battle against generic drug companies who filed ANDAs for its (former) blockbuster drug, Prilosec®. The Court affirmed in toto the decisions of Judge Barbara S...
Prasco, LLC v. Medicis Pharmaceutical Corp. (Fed. Cir. 2008)
Posted on August 19, 2008By Kevin E. Noonan -- The Supreme Court has spent the past few years issuing decision after decision circumscribing the Federal Circuit's Congressionally-mandated authority over U.S. patent law, pursuant to its plenary powers under Article III of the Constitution...
Court Report
Posted on August 17, 2008By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Janssen Pharmaceutica N.V. et al. v. Sandoz, Inc. 1:08-cv-00511; filed August 13, 2008 in the District Court of Delaware Infringement of U...
UK High Court Invalidates HGS Neutrokine-alpha Patent
Posted on August 15, 2008By Donald Zuhn -- Earlier this month, several European news outlets reported on a decision by the UK High Court of Justice declaring a Human Genome Sciences (HGS) patent disclosing the nucleotide and amino acid sequence of Neutrokine-alpha, a novel member of the TNF ligand superfamily, to be invalid...
USPTO News: USPTO Announces Revisions to Patent Fees
Posted on August 14, 2008By Christopher P. Singer -- In a Notice published in the Federal Register (73 Fed. Reg. 47534) on Thursday, August 14, 2008, the U.S. Patent and Trademark Office announced that certain patent fee amounts are being adjusted to reflect fluctuations in the Consumer Price Index (CPI) for financial year 2009...
Congressional Fact-finding on Follow-on Biologics
Posted on August 14, 2008By Kevin E. Noonan -- The Subcommittee on Health of the House of Representatives' Committee on Energy and Commerce recently solicited comments and information on so-called "follow-on biologics" (FOBs) from stakeholders and other interested parties. The Subcommittee on Health's letter, signed by Subcommittee chairman Frank Pallone, Jr...
Insmed's Follow-on Biologics Campaign Continues
Posted on August 14, 2008By Donald Zuhn -- Earlier this year, we reported on the campaign undertaken by Insmed Inc., a biopharmaceutical company based in Richmond, VA, to raise national awareness about the importance of establishing a regulatory pathway in the U.S. for follow-on biologics...
Patent Profile: Ulysses Pharmaceuticals Announces Issuance of Patent for Novel Class of Antibiotics
Posted on August 13, 2008By Donald Zuhn -- Ulysses Pharmaceuticals announced today that the U.S. Patent and Trademark Office has issued U.S. Patent No. 7,410,974, which is directed to a class of compounds that exhibit antibiotic activity against a wide spectrum of microorganisms, including organisms that are resistant to multiple antibiotic families (the so-called "superbugs")...
Senate Patent Reform Legislation -- One Old Bill and One New Bill
Posted on August 12, 2008By Donald Zuhn -- Last Tuesday, CongressDaily reported that Senate Judiciary Chairman Patrick Leahy (D-VT) (at right) and ranking member Arlen Specter (R-PA) have indicated that patent reform will be a top priority for the new session. Coalition for Patent Fairness lobbyist Steve Elmendorf told the publication that he expects to begin working in earnest early next year to help push the Senate bill through, and predicted that it was "highly probable" that a bill would pass in the 111th Congress, given the Democratic leadership's support of the House bill, which passed in September 2007...
Once Again, The New Yorker Gets It Wrong on Patents -- Update
Posted on August 11, 2008Last week, Patent Docs posted an article by Kevin Noonan (see "Once Again, The New Yorker Gets It Wrong on Patents") regarding "The Permission Problem," an article by James Surowiecki that appears in the August 11th edition of The New Yorker. Over the weekend, Mr...
Conference & CLE Calendar
Posted on August 10, 2008August 11-12, 2008 - Advanced Patent Prosecution Workshop 2008: Claim Drafting & Amendment Writing (Practising Law Institute) - San Francisco, CA August 10-15, 2008 - Advanced Courses (Patent Resources Group) - Washington, DC September 11, 2008 - Developments in Pharmaceutical and Biotech Patent Law (Practising Law Institute) - New York, NY September 11-12, 2008 - Current Issues in Complex IP Licensing (Law Seminars International) - Philadelphia, PA September 15-16, 2008 - Biotech Patents*** (American Conference Institute) September 21-23, 2008 - 2008 Annual Meeting (Intellectual Property Owners Association) - San Diego, CA September 22-23, 2008 - USPTO Boot Camp: Patent Edition***...
CBI Pharmaceutical Congress on Paragraph IV Disputes
Posted on August 09, 2008The Center for Business Intelligence (CBI) will be holding its Pharmaceutical Congress on Paragraph IV Disputes on October 15-16 in Philadelphia, PA. The conference will cover important issues for both brand and generic companies during two days of presentations and panel discussions on litigation strategies, statutory guidelines, current cases, and their landmark decisions...
USPTO News: Enjoined Rule Will Not Be Applied Retroactively . . . If PTO Prevails in Tafas v. Dudas
Posted on August 08, 2008By Donald Zuhn and Christopher P. Singer -- In a Notice published in the Federal Register on August 7, 2008 ("Clarification of Patent Regulations Currently in Effect, and Revision in Applicability Date of Provisions Relating to Patent Applications Containing Patentably Indistinct Claims," 73 Fed...
Once Again, The New Yorker Gets It Wrong on Patents
Posted on August 08, 2008By Kevin E. Noonan -- James Surowiecki is exercising his antipatent animus once again in the August 11th edition of The New Yorker. Mr. Surowiecki (at right) writes a weekly column called "The Financial Page" in the magazine, and he has shown that he doesn't like patents several times in his work...
Predictions Dire for U.S. Pharmaceutical Industry
Posted on August 07, 2008By Kevin E. Noonan -- EvaluatePharma, a London-based company providing forecasting and industry analysis to the biotech and pharma sector, released a report today predicting the big pharma landscape in 2014, based on industry trends, current and prospective drug pipelines, acquisitions and partnering and the predicted "patent cliff" that will occur as blockbuster drugs come "off-patent" and are subject to generic competition...
USPTO News: Patent Office Proposes Rules Limiting Facsimile Submission of Papers and Setting Font Size Requirement
Posted on August 07, 2008By Christopher P. Singer -- In a Notice published in the Federal Register (73 Fed. Reg. 45662) on August 6, 2008, the U.S. Patent and Trademark Office proposes new rules that severely limit the types of papers that can be submitted to the Office by facsimile...
Public Interest Groups Back USPTO in Tafas v. Dudas Appeal
Posted on August 06, 2008By Donald Zuhn -- Last week, the Public Patent Foundation (PUBPAT) announced that a coalition of consumer advocacy and public interest groups had filed an amici brief in the Tafas v. Dudas appeal. The brief, which was signed by PUBPAT Executive Director Dan Ravicher (below left), was filed on behalf of PUBPAT, AARP, the Computer & Communications Industry Association (CCIA), Consumer Watchdog, Essential Action, Initiative for Medicines, Access & Knowledge (I-MAK), Prescription Access Litigation (PAL), Public Knowledge (PK), Research on Innovation (ROI), and the Software Freedom Law Center (SFLC)...
Book Review: The Generic Challenge
Posted on August 05, 2008Patent Docs provides two reviews for the price of one as Kevin Noonan and Donald Zuhn each discuss the second edition of Martin Voet's book "The Generic Challenge: Understanding Patents, FDA & Pharmaceutical Life-Cycle Management." By Kevin Noonan -- Martin A...
Court Report
Posted on August 03, 2008By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Sepracor Inc. et al. v. Barr Pharmaceuticals, Inc. et al. 5:08-cv-00362; filed July 30, 2008 in the Eastern District of North Carolina Infringement of U...
Conference & CLE Calendar
Posted on August 03, 2008August 5, 2008 - Intellectual Property Due Diligence and Audit Bootcamp (West Legalworks) - 1:00-2:00 PM (EDT) August 11-12, 2008 - Advanced Patent Prosecution Workshop 2008: Claim Drafting & Amendment Writing (Practising Law Institute) - San Francisco, CA August 10-15, 2008 - Advanced Courses (Patent Resources Group) - Washington, DC September 11, 2008 - Developments in Pharmaceutical and Biotech Patent Law (Practising Law Institute) - New York, NY September 11-12, 2008 - Current Issues in Complex IP Licensing (Law Seminars International) - Philadelphia, PA September 15-16, 2008 - Biotech Patents*** (American Conference Institute) September 21-23, 2008 - 2008 Annual Meeting...
JEC Holds Hearing on Drug Pricing; GPhA Lobbies for Follow-on Biologics Pathway
Posted on August 01, 2008By Donald Zuhn -- Last week, Senator Amy Klobuchar (D-MN) (at right) convened a hearing of the Joint Economic Committee (JEC), a bicameral Congressional Committee composed of ten members from both the Senate and the House of Representatives, to examine rising pharmaceutical prices and the impact of such price increases on the pharmaceutical market and patient medical bills...
USPTO News: EFS-Web 1.4 Enhancements Coming Soon
Posted on August 01, 2008By Christopher P. Singer -- The U.S. Patent and Trademark Office sent out an e-Commerce update on July 31, 2008, notifying EFS users of enhancements that will be introduced with EFS-Web 1.4 (to be released on August 17, 2008). For one, users will be able to launch their e-mail programs in EFS-Web and send Acknowledgement Receipts and Pre-Acknowledgement Receipts to any desired address (such as a dedicated docketing e-mail address)...