110th Congress

Patenting of Genetic Material

H.R. 977

Background

Related to public concerns about human genetic nondiscrimination, the issue of whether discoveries pertaining to the human genome should be patent protected has come under scrutiny by some scientists, legal scholars, and politicians.  Currently, the U.S. Patent and Trademark Office grants patents for inventions relating to human genetic material based on a specific set of legal definitions and guidelines.  This practice involves various ethical, legal, and economic components that are not necessarily mutually exclusive.  To some, gene patents block researchers from developing gene therapies or prevent doctors from performing certain diagnostic tests.  Other experts argue that there is little evidence of the negative impact of patents on scientific research activity in general and that patents are the most effective method to protect inventions and encourage future investments by the private sector in research and development.  They maintain that public science has flourished by permitting scientists to challenge and build upon the work of rivals.

Provisions of the Legislation/Impact on NIH

H.R. 977 would amend chapter 10 of Title 35, U.S.C. by appending a new section prohibiting the patenting of human genetic material.  The bill’s single provision language states that “no patent may be obtained for a nucleotide sequence, or its functions or correlations, or the naturally occurring products it specifies.”  According to experts, the brief bill language in its present form is too broad and does not consider incentives for the future development of genetic material‑based diagnostic tools or therapeutics nor does it strike a balance with regard to encouraging free access and data sharing for the purposes of basic research.  The bill does, however, state that the prohibition would not invalidate patents that were issued before the bill’s enactment.

Status and Outlook

H.R. 977, the Genomic Research and Accessibility Act, was introduced by Representatives Xavier Becerra (D‑CA) and Dave Weldon (R‑FL) on February 9, 2007, and was referred to the House Committee on the Judiciary.  On March 1, it was referred to the House Judiciary Subcommittee on Courts, the Internet, and Intellectual Property.  H.R. 977 currently has six cosponsors.  No further action has occurred on this legislation.

June, 2008