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 incentives to innovate while fostering a competitive marketplace" (see "Former House Ways and Means Economist Claims 7-Year Data Exclusivity Period Is Sufficient"); and Jack Lasersohn, a General Partner at the Verticle Group and representative of the National Venture Capital Association (NVCA), which last week 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" (see "NVCA Study Supports 12-Year Data Exclusivity Period"). Also appearing before the Subcommittee were Bruce Leicher, the Senior Vice President and General Counsel for Momenta Pharmaceuticals, Inc.; Jeffrey Kushan, who appeared on behalf of the Biotechnology Industry Organization (BIO); Larry McNeely, a Healthcare Reform Advocate with U.S. Public Interest Research Groups (USPIRG); and Teresa Stanek Rea, the President of the American Intellectual Property Law Association (AIPLA). While Patent Docs plans to provide reports on the written testimony provided by many of these witnesses, today we begin with Rep. Eshoo's testimony.
Rep. Eshoo (at left) began by discussing the findings of the NVCA study (which were released last week during a Capitol Hill briefing she hosted), noting that the study determined that "the 'cost of capital' for start-up biotech companies is more than double the costs that other companies must pay," and that "[t]hese costs stem from long developmental timelines of typically 10 years or more, extraordinary levels of risk (fewer than 1% of biologics make it to market), and the large amounts of capital required to support development." Rep. Eshoo also noted that the Congressional Budget Office (CBO) has determined that "11.5 years is the average length of time that drugs are marketed under patent."
Rep. Eshoo explained that H.R. 1548 would "establish a simple, streamlined patent resolution process" that would "take place within a short window of time -- roughly 6-8 months after the biosimilar application has been filed with the FDA." The Eshoo bill would also establish a listing of FDA approved biosimilars that included a designated agent for each biosimilar applicant, and provide an innovator patent holder with a limited time within which to enforce its patent against a biosimilar applicant.
On a related note, yesterday we reported that Rep. Eshoo's bill enjoyed the support of 127 co-sponsors, and that Rep. Waxman's bill (H.R. 1427) had the support of 12 co-sponsors. Since then, Rep. Eshoo's bill has picked up four more co-sponsors and Rep. Waxman's bill has picked up one additional co-sponsor -- Rep. Eshoo's bill thus maintains its sizeable (131-13) advantage over Rep. Waxman's bill. Of the fifteen members of the House Subcommittee on the Courts and Competition Policy (which includes nine Democrats and five Republicans), Ranking Member Howard Coble (R-NC), Rep. Charles Gonzalez (D-TX), and Rep. Darrell Issa (R-CA) are co-sponsors of H.R. 1548, and Rep. John Conyers, Jr. (D-MI) is a co-sponsor of H.R. 1427. It remains to be seen whether Rep. Eshoo's testimony was persuasive enough to convince any of the eleven uncommitted members to join in co-sponsoring her bill.
Testimony for the other witnesses appearing at today's Subcommittee meeting can be obtained at the following links: