Patent Reform Negotiations Stall in Senate
Negotiations on sweeping changes to the U.S. patent system broke down in the Senate on Wednesday, April 9. Judiciary Committee Ranking Member Arlen Specter (R-Pennsylvania) withdrew his support owing to a dispute with Committee Chairman Patrick Leahy (D-Vermont) about damage awards in infringement lawsuits. Despite the breakdown, other Senators influential in this debate, including Majority Leader Harry Reid (D-Nevada) and Orrin Hatch (R-Utah) maintain that an agreement can still be reached this year. CHI continues to work closely with Senator Dianne Feinstein (D-California), who has recently proposed language on damages, inequitable conduct and post-grant oppositions. CHI’s goal is to ensure patent certainty and patent protections for California's life sciences community. For more information contact Todd Gillenwater, CHI vice president-public policy (202-974-6313 or gillenwater@chi.org).
Court Rejects Patent Office Rule Opposed by CHI
The U.S. District Court for the Eastern District of Virginia ruled in favor of GlaxoSmithKline Plc on Tuesday, April 2, throwing out new U.S. Patent and Trademark Office rules designed to limit the size of patent applications and reduce a growing backlog of patent requests. The ruling was a victory for the biomedical industry, which depends on secure intellectual property (IP) protections to develop life saving therapies and devices. IP, particularly patents, are often a biomedical company’s most valuable assets and essential to funding innovation. CHI had submitted comments to the original rule in May 2006.
Tax Incentive for Research and Development Gaining Traction in Washington
Senate Finance Chairman Max Baucus (D-Montana) and Ranking Member Charles Grassley (R-Iowa) introduced a $100 billion-plus tax extenders package today that includes a two-year extension of the research and development (R&D) tax credit. Currently the measure is not offset by spending reductions in other areas, which could prove to be a sticking point with House Democrats who have been insistent that an extenders package be offset under current pay/go rules. R&D has also been gaining momentum in the House where members of the California Delegation have been pushing for Congressional action. On April 10, Reps. Jerry McNerney (D-Stockton) and Brian Bilbray (D-Solana Beach) co-authored a letter signed by 23 of their colleagues, urging House and Ways & Means Committee leadership to approve a seamless extension and expansion of the credit. CHI applauds their leadership. Rep McNerney also introduced H.R. 5681, the Innovation Tax Credit Act, on Wednesday, April 2, legislation that mirrors a proposal in the Senate authored by Senator Hatch (R-Utah). CHI will continue to highlight this and other R&D proposals as we push to get a strengthened and permanent credit enacted.
Lawmakers Seek Industry Consensus on Follow-on Biologics Legislation
In an attempt to negotiate legislation enabling the FDA to create a pathway for the approval of follow-on biologics, leaders of the House Energy and Commerce Health Subcommittee have reached out to CHI and other health industry stakeholders. Topics of debate include potential safety issues; the appropriate duration of data exclusivity protections for innovator products; the extent to which follow-on approval requires clinical trials; whether follow-on biologics can be substituted for their brand name counterparts at the pharmacy; and the role that patents will play in protecting innovators. In March, following the introduction of H.R. 5629, the Pathway for Biosimilars Act, by Rep. Anna Eshoo (D-Palo Alto), CHI weighed in with the author and other members of the California Delegation to support the proposal. It is anticipated that Subcommittee Chairman Frank Pallone (D-New Jersey) and Ranking Member Nathan Deal (R-Georgia) will have final say over the language that moves through their jurisdiction.