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Leahy Requests NIH “March-in” on BRCA Patents; Urges Wider Access to Cancer Tests

July 26, 2013—Senate Judiciary Committee Chair Patrick Leahy (D-Vt.) July 12 requested that the National Institutes of Health (NIH) exercise government “march-in” rights under the 1980 Bayh-Dole Act to permit women better access to testing for BRCA1 and BRCA2 genes linked to breast and ovarian cancer.  In a July 12 letter to NIH Director Francis Collins, M.D., Ph.D., Sen. Leahy notes that, while several patents on the BRCA genes were recently ruled invalid by the U.S. Supreme Court [See Washington Highlights, June 21], other gene patents owned or licensed to Myriad Genetics were not directly challenged in that case.

The Supreme Court’s unanimous decision does allow claims on certain types of DNA sequences that do not occur naturally, such as complementary DNA (cDNA), which some of Myriad’s other patents include.  Myriad and two universities have subsequently alleged patent infringement and sued firms that began offering competitive BRCA genes tests in the wake of the Supreme Court’s decision. 

Sen. Leahy notes that since some of the BRCA patents still controlled by Myriad derive from federally supported research, provisions of the Bayh-Dole Act permit funding agencies to march-in and reassign licensing rights under certain circumstances.  In fact, the government has never exercised federal march-in rights under the Bayh Dole Act, and questions about pricing and wider availability—two of the issues raised by Sen. Leahy—have been insufficient to trigger a march in. 

Meanwhile, legal observers expect Myriad’s new litigation will determine whether its other patents remain valid, if competitive BRCA tests infringe those patents, or if a negotiated settlement will be reached on the conduct of gene-based diagnostic tests. 

To date, there has been no public response from NIH on the request. 


Stephen Heinig
Director, Science Policy
Telephone: 202-828-0488

Heather Pierce, JD, MPH
Sr. Director, Science Policy & Regulatory Counsel
Telephone: 202-478-9926


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Washington Highlights, a weekly electronic newsletter, features brief updates on the latest legislative and regulatory activities affecting medical schools and teaching hospitals.

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Jason Kleinman
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Telephone: 202-903-0806