Patent Docs

The Risk of Biogenerics

2009-07-15T23:59:00-05:00

By 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. In this Congress, as in the last Congress, several bills have been introduced to "correct" this situation and provide a means for regulatory approval of generic versions of biologic drugs. A good deal of the debate...

House Subcommittee Holds Hearing on Follow-on Biologics

2009-07-14T23:59:00-05:00

By 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. Anna Eshoo (D-CA), who introduced follow-on biologics legislation (H.R. 1548) in the House that would provide up to 14.5 years of data exclusivity; Alex Brill, a Research Fellow at the American Enterprise Institute (AEI), who authored a white paper last November asserting that a follow-on biologics regulatory pathway providing a data exclusivity period of seven years would be "sufficient for maintaining strong...

Biotech/Pharma Docket

2009-07-14T23:55:00-05:00

By 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. This settlement puts an end to two years of litigation that commenced when Sanofi and Debiopharm, the patent holder of U.S. Patent Nos. 5,338,874 and 5,716,988, filed suit against Ebewe alleging patent infringement (see "Court Report," December 28, 2008). Ebewe had earlier filed ANDAs for Eloxatin®. In response to Sanofi's and Debiopharm's complaint, Ebewe...

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

2009-07-14T13:33:38-05:00

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. The committee voted 16-7 in favor of a proposal put forth by Senators Orrin Hatch (R-UT; at left) and Michael Enzi (R-WY; below right), and rejected Senator Sherrod Brown's (D-OH) amendment for a 5-year data exclusivity term. In doing so, the committee also rejected the Federal Trade Commission's rationale that data exclusivity...

NVCA Study Supports 12-Year Data Exclusivity Period

2009-07-13T23:57:11-05:00

By 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." The results of the NVCA-commissioned study were released during a Capitol Hill briefing hosted by Rep. Anna Eshoo (D-CA), who has introduced legislation (H.R. 1548) that would provide up to 14.5 years of data exclusivity. According to a statement released by the NVCA, a trade association representing some 460 U.S. venture capital...

Court Report

2009-07-12T23:21:14-05:00

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.C. 1:09-cv-11168; filed July 9, 2009 in the District Court of Massachusetts Various claims, including legal malpractice and breach of fiduciary duty, for a conflict of interest in prosecuting "Tuschl I" inventions related to RNAi. Removed from state court; view the original complaint (filed June 26, 2009) here. Takeda Pharmaceutical Co. et al. v. Torrent Pharmaceuticals Ltd. et...

Conference & CLE Calendar

2009-07-12T22:52:39-05:00

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

2009-07-10T23:36:11-05:00

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...

Summit on Biosimilars and Follow-on Biologics

2009-07-10T23:18:36-05:00

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. CBI's faculty will offer presentations on the following topics: • Policy update and analysis; • Pathway for the Biosimilars Act (H.R. 1548 introduced by Rep. Anna Eshoo); • Promoting Innovation and Access to Life-Saving Medicines Act (H.R. 1427 introduced by Rep. Henry Waxman); • Explore the...

CLE on Pharmaceutical Antitrust Initiatives and Developments

2009-07-10T23:02:04-05:00

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.S. pharmaceutical industry can expect to see in terms of antitrust enforcement, particularly in light of the recent release of the European Commission (EC) Pharmaceutical Sector Inquiry Report. In particular, the speakers will address the following topics: • An overview of...