CHI Joins Coalition on Patent Reform
Today CHI joined more than 100 companies, associations, venture capital firms and universities in addressing concerns that certain provisions included in recently introduced patent reform legislation (H.R. 1908/S. 1145, The Patent Reform Act of 2007) pose serious threats to medical innovation and American technological leadership in the 21st century global economy. View press release and coalition letter.
Patent Reform Legislation Mark-Up Expected in House Subcommittee
Following a recent closed-door session with major stakeholders, H.R. 1908, the Patent Reform Act of 2007, the House Judiciary Subcommittee on Courts, the Internet, and Intellectual Property likely will conduct a formal legislative mark-up of the bill. CHI has been working with representatives from the life sciences, academic research, venture capital and information technology sectors to outline concerns in 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).
Senate Passes Comprehensive FDA Legislation
The Senate passed the Food and Drug Administration Reauthorization Act (FDARA) on Wednesday, May 9 by a vote of 93-1. The legislation will raise user fees for the drug and device industries as well as grant the agency greater authority to monitor safety. Legislators attempted to attach several proposals to the bill during the floor debate including:
· Drug importation: An amendment by Senator Byron Dorgan (D-ND) allowing for the importation of prescription drugs was included in the final package; however a second degree amendment by Senator Thad Cochran (R-MS) requires that such a policy could not go into effect until the Secretary of Health and Human Services (HHS) certifies importation will pose no additional safety risks, and significant savings would occur.
· Follow-on biologics: Specific language to create a pathway for follow-on biologics was excluded from the measure, but an amendment expressing the sense of the Senate was filed outlining the intent to hold a mark-up on June 13 in the Senate Health, Education, Labor and Pensions (HELP) Committee with the expectation that language would be included when the bill goes to conference with the House.
· International patent protection: An amendment expressing the sense of the Senate that the U.S. Trade Representative should utilize all tools at his or her disposal to address international intellectual property violations was included.
The debate will now move to the House where it is likely that legislators with jurisdiction over FDA reauthorization will attempt to pass a more limited package.
House Passes NSF Reauthorization Highlighting CHI Initiative
The House approved H.R. 1867, the National Science Foundation (NSF) Authorization Act of 2007, on Wednesday, May 2 by a vote of 399-17. The legislation would keep NSF funding on path to doubling in 10 years by providing $16.4 billion for research while allocating $2.8 billion to improve education in science, technology, engineering and mathematics (STEM) fields. As this legislation made its way through the Science Committee, CHI actively worked with congressional offices, particularly Congressman Brian Bilbray (R-San Diego), to emphasize the importance of interdisciplinary research. Report language accompanying the bill highlights this dynamic within the NSF as well as across other agencies including the National Institutes of Health (NIH). CHI will work for inclusion of similar language as this issue moves to the Senate.
Senate Committee to Hold Hearing on NIH Budget
On Wednesday, May 16, the Senate Appropriations Labor, Health and Human Services and Education Subcommittee will hold a hearing on the FY 2008 budget for the National Institutes of Health (NIH). Five directors of institutes within the agency will testify before the subcommittee. Since the doubling of the NIH budget from 1998 to 2003, the budget has remained flat, and inflation has resulted in the agency losing 13% of its purchasing power. CHI will continue to advocate increases to the NIH budget that provide the resources necessary to fuel basic biomedical research and technology transfer in the state.
Upcoming Hearing and Events:
May 15 – 10:00 am (EST)
House Science and Technology Committee
Research and Science Education Subcommittee hearing on "Federal STEM (Science, Technology, Engineering, and Mathematics) Education Programs: Educators' Perspectives."
2318 Rayburn House Office Building
Link
May 16 – 9:30 am (EST)
Senate Appropriations Committee
Labor, Health and Human Services, Education, and Related Agencies Subcommittee hearing on the FY2008 budget for the National Institutes of Health (NIH).
116 Dirksen Senate Office Building
Link
May 16 – 10:00 am (EST)
Senate Judiciary Committee
Full committee hearing on "Rogue Online Pharmacies: The Growing Problem of Internet Drug Trafficking."
226 Dirksen Senate Office Building
Link
May 16 – 10:00 am (EST)
House Energy and Commerce Committee
Health Subcommittee hearing on "Reauthorization of the Medical Device User Fee and Modernization Act."
2322 Rayburn House Office Building
Link
May 17
House Judiciary Committee
Scheduled Courts, the Internet and Intellectual Property Subcommittee markup of patent reform legislation.
2141 Rayburn House Office Building
Link
May 21 – 2:00 pm (EST)
Senate Appropriations Committee
Labor, HHS, Education, and Related Agencies Subcommittee hearing on budget estimates for FY2008 for the National Institutes of Health.
116 Dirksen Senate Office Building
Link