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Federal Legislation Would Relax Genomic Patent Regulations

NEW YORK, March 14 - A US Congresswoman has introduced two pieces of legislation: one that seeks to ease domestic genomic-based patent regulations and one that would investigate the impact the federal government has had on genomic innovation.

The first act, called the Genomic Research and Diagnostic Accessibility Act of 2002, seeks to ensure "non-infringing uses of patents" on sequence data related to genetic-diagnostic testing, according to a fact sheet distributed by Lynn Rivers (D-Mich.), who authored the legislation.


Specifically, if passed, the act would "exempt from patent infringement [those] individuals who use patented genetic sequence information for non-commercial research purposes." Broadly, the act, introduced on Thursday, defines research as a "systematic investigation designed to develop or contribute to generalizable knowledge."

The act further exempts "medical practitioners" who use genomic-based diagnostic tests. It defines "genetic diagnostic, prognostic, or predictive test" as "any test designed to detect disease, to predict the potential for a medical disorder, or to predict the effectiveness of therapeutics which use either human or human pathogen genetic sequence information or the proteins encoded by such information."


The second act, called the Genomic Science and Technology Innovation Act of 2002, would require the US Office of Science and Technology Policy "to assess the impact of federal policies, including intellectual property policies, on the innovation process for genomic technologies." 

Specifically, the act asks the OSTP to "identify and quantify the effects of current policies on genomic science and technology innovation and ... analyze alternative intellectual property protection policies and their likely impact on genomic innovation." 

Areas that will likely be affected by the legislation include researchers' access to genomic materials; rate and quality of innovation; cost and public availability of new genomic technologies, including genomic diagnostics; and possible research barriers.    


If passed, the act will require the OSTP to develop "a coordinated interagency policy to promote innovation in genomic science and technology policy," said Rep. Rivers, who serves on the House Science Committee. "Federal innovation policies may stimulate genomic innovation by attracting commercial investment but may also inhibit basic research and information sharing, thereby slowing the innovation process."

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