Leahy Urges Action To Ensure Access To Affordable Life-Saving Diagnostic Tests For Breast And Ovarian Cancer

WASHINGTON – Senate Judiciary Committee Chairman Patrick Leahy (D-Vt.) on Friday sent a letter to the National Institutes of Health (NIH) urging the agency to consider using its authority to ensure greater access to life-saving genetic testing that was developed with federal research dollars.  Patents for the genetic test for the BRCA1 and BRCA2 genes associated with breast and ovarian cancers are owned by Myriad Genetics, which was the subject of a Supreme Court ruling last month that struck down some, but not all, of Myriad’s patent claims.  Following the decision, Myriad this week filed infringement suits against two companies that had announced they would begin offering lower-cost tests for the BRCA genes.

Under federal law, the National Institutes of Health may exercise “march-in rights” on patents that were developed with federally funded research, pursuant to which NIH can require the patent holder to license the patent on reasonable terms to other parties.  Myriad’s technology was developed in part with federally funded research.  Testimony presented to the U.S. Patent and Trademark Office last year made clear that many women are not able to afford the testing provided by Myriad.  According to the company, individuals who test positive for the BRCA1 and BRCA2 genes can reduce their risk of developing these cancers by more than 50 percent. 

“The health benefits of genetic testing for breast and ovarian cancer are clear,” Leahy wrote.  “The healthcare cost savings are equally clear.  I am concerned, however, that the health needs of the public are not reasonably satisfied by the patentee in this situation because testimony presented to the USPTO made clear that many women are not able to afford the testing provided by Myriad.  I encourage you to consider using your march-in rights in this situation.”

A copy of the letter is available here.

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