107th Congress

Gene Patenting

H.R. 3966 and H.R. 3967

Background

As we continue to learn more about the human genome, questions have been raised about the extent to which "ownership" via patent protection ought to be conferred on human genetic information. Concerns have been raised about whether the patenting and/or licensing of genetic information is inhibiting important biomedical research and interfering with patient care. Although Congress has generally been supportive of intellectual property protection for genetic material, legitimate questions have been raised about how much one must know about a gene before intellectual property rights are conferred. Concerns also have been raised that patent holders are imposing onerous licensing terms, which may ultimately inhibit the discovery of new treatments.

To address some of the general concerns about gene patents, Representative Lynn Rivers (D-MI) introduced two bills, H.R. 3966 and H.R. 3967. Representative Rivers stated that her goal is to "carve out some limited exceptions to the applicability of gene patents. These exemptions are designed to minimize some of the negative impacts of patents on the practice of medicine and the advancement of science."

In November 2002, the General Accounting Office initiated a review of gene patenting and licensing issues.

Provisions of the Legislation/Impact on NIH

H.R. 3966—Genomic Science and Technology Innovation Act of 2002

• The bill would require the Office of Science and Technology Policy (OSTP) to conduct a study that assesses the impact of Federal policies, including intellectual property policies, on the innovation process for genomic technologies.
• In conducting the study, OSTP would have consulted with the National Science and Technology Council, the National Science Foundation, the Secretary of Energy, the Secretary of Commerce, and the Secretary of Health and Human Services.
• The study would have explicitly considered various alternative levels of intellectual property protection that genomic materials may receive and the likely impact of the various levels of protection on each element of the innovation pipeline, including whether there are barriers to research through denial of use of a research tool or increased costs of licensing.
• OSTP would have been required to submit a report to Congress on the results of the study within 9 months after passage of the Act.

H.R. 3967—Genomic Research and Diagnostic Accessibility Act of 2002

• Section 2 would have exempted from patent infringement those individuals who use patented genetic sequence information for noncommercial research purposes. This provision would have applied to all genetic sequence patents, not just human gene patents. Upon introduction of the bill, Representative Rivers compared this provision to the "fair use" doctrine in copyright law, which "permits socially valuable uses without a license."
• Section 3 would have exempted medical practitioners using genetic diagnostic tests from patent infringement remedies.
• Section 4 of the bill would have required public disclosure of genomic sequence information contained within a patent application when Federal funds were used in the development of the invention.

Status and Outlook

H.R. 3966 was introduced on March 14, 2002. The bill had three cosponsors and was referred to the House Science Committee and House Judiciary Committee.

H.R. 3967 was introduced on March 14, 2002. The bill had three cosponsors and was referred to the House Judiciary Committee.

There was no further action on this legislation during the 107th Congress. Representative Rivers lost her bid for reelection, and it is unclear whether any other Member of Congress will be interested in pursuing these issues when the 108th Congress convenes.