Patent Law

BIO Top Brass Meet the Press

Posted on September 10, 2009
By 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, 2009
By 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, 2009
By 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, 2009
By 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...

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Court Report

Posted on September 08, 2009
By 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, 2009
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 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, 2009
By 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, 2009
International 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, 2009
American 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, 2009
By 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, 2009
By 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, 2009
By 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, 2009
By 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, 2009
By 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, 2009
By 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, 2009
By 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, 2009
By 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, 2009
September 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, 2009
The 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, 2009
C5 (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, 2009
By 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, 2009
By 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, 2009
By 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, 2009
By 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, 2009
By 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, 2009
The 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, 2009
September 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, 2009
By 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, 2009
By 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, 2009
By 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...

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