New CHI White Paper Analyzes Patent Reform
CHI’s new white paper released May 31, “Impact of Patent Law Changes on Biomedical Investment and Innovation,” analyzes recent developments related to patent law that could have serious implications to the biomedical industry in California and nationwide. These include: (1) recent U.S. Supreme Court decisions that weaken patents; (2) comprehensive patent reform legislation being considered by Congress; and (3) the hostile approach taken by the U.S. Patent and Trademark Office (USPTO) toward making and promulgating new patent rules. View the white paper.
Senate to Hold Patent Hearing
Today the Senate Judiciary Committee will hold a hearing titled “Patent Reform: The Future of American Innovation,” to discuss S. 1145, the Patent Reform Act of 2007. CHI has been working with members of the California congressional delegation to outline our industry’s concerns about the current draft. Specifically, provisions addressing apportionment of damages, expansive PTO rule-making authority, and a post-grant review “second window” threaten to reduce patent certainty, weaken protections against patent infringement, and undermine intellectual property protection of biomedical investment and innovation. For more information, contact Todd Gillenwater, CHI vice president-public policy (858-551-6677 or gillenwater@chi.org).
House Pushes Forward on Drug and Device User Fee Legislation
Members of the House Energy and Commerce Committee continue to work on a legislative package allocating industry user fees for the Food and Drug Administration (FDA). The package is composed of six pieces of legislation that includes drug/device safety issues and pediatric exclusivity. On June 12, the Subcommittee on Health will hold a hearing on the measure, with a mark-up expected on June 18. The Senate version of the FDA Revitalization Act (FDARA) was passed last month. Meanwhile, members in both the House and Senate continue to discuss follow-on biologics provisions in an attempt to reach an agreement that would allow a measure to be attached when the FDARA bill goes to conference.
House to Continue Work on Funding Bills
The House Appropriations Committee has released a tentative schedule outlining plans to move the majority of its funding packages from subcommittee through the House floor in the month of June. Two funding packages are of particular interest to the life sciences industry:
(1) Labor, Health and Human Services, Education and Related Services – CHI will continue to advocate for a six percent increase in funding for the National Institutes of Health (NIH) as well as the final installment of money from President Bush’s pandemic influenza preparedness plan. The subcommittee mark-up expected week of June 11.
(2) Agriculture, Rural Development, FDA and Related Agencies – CHI will stress providing adequate funding of the FDA through congressional appropriations and decreasing the percentage of the agency budget that is currently financed by industry user fees. The subcommittee mark-up expected on June 12.
For more information, contact David Burt, CHI legislative director (858-551-6677 or burt@chi.org).
House to Consider Senate Stem Cell Measure
Embryonic stem cell research will again be a major topic in Congress this week as a vote on S. 5, the Stem Cell Research Enhancement Act of 2007, is expected on the House floor on Thursday. The legislation is expected to pass, marking the third time in the past two years that the House has passed legislation to remove the federal ban on funding for embryonic stem cell research. President Bush has stated his intention to veto the measure, and it appears that neither the House or the Senate will be able to garner the two-thirds vote necessary to override a presidential veto. CHI will continue to advocate for a reasonable national stem cell policy that will provide appropriate resources to allow the U.S. to retain its position as the global leader in biomedical research.
Upcoming Hearings and Events
June 6 – 10:00 am (EST)
Senate Judiciary Committee
Full committee hearing on "Patent Reform: The Future of American Innovation."
226 Dirksen Senate Office Building
Link
June 6 – 2:00 pm (EST)
House Science and Technology Committee
Research and Science Education Subcommittee hearing on "Federal STEM (Science, Technology, Engineering and Mathematics) Education Programs."
2318 Rayburn House Office Building
Link
June 7 – 10:00 am (EST)
House Floor
House meets to discuss S.5, the "Stem Cell Research Enhancement Act of 2007."
Link
June 12 – 10:00 am (EST)
House Energy and Commerce Committee
Health Subcommittee hearing on "Discussion Drafts Concerning, Prescription Drug User Fee Act Reauthorization, Medical Device User Fee and Modernization Act Reauthorization, Drug Safety, and Certain Pediatric Pharmaceutical and Device Legislation."
2123 Rayburn House Office Building
Link
June 12 – 10:00 am (EST)
House Ways and Means Committee
Health Subcommittee hearing on "Strategies to Increase Information on Comparative Clinical Effectiveness."
1100 Longworth House Office Building
Link
June 12 – 1:00 pm (EST)
House Science and Technology Committee
Full committee hearing on "The Globalization of R&D (research and development) and Innovation."
2318 Rayburn House Office Building
Link