Patent Law

Senators Hatch and Enzi Champion 12-Year Data Exclusivity in Senate

Posted on July 14, 2009
By 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, 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. Max-Planck-Gesellschaft zur Frderung der Wissenschaften e.V. v. Wolf Greenfield & Sacks, P...

Conference & CLE Calendar

Posted on July 13, 2009
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) - 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, 2009
American 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...

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Summit on Biosimilars and Follow-on Biologics

Posted on July 11, 2009
The 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, 2009
American 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, 2009
By 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, 2009
By 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, 2009
By 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, 2009
By 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, 2009
By 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, 2009
By 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, 2009
By 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, 2009
By 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, 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. 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, 2009
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 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, 2009
Law 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, 2009
By 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, 2009
By 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, 2009
By 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, 2009
By 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, 2009
By 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, 2009
By 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, 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. 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, 2009
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) - 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, 2009
By 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, 2009
By 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, 2009
By 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, 2009
By 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, 2009
By 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...

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