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US Senator Asks NIH's Collins to License Out Myriad's BRCA 1/2 Gene Patents

NEW YORK (GenomeWeb News) – The chairman of the US Senate Judiciary Committee has asked National Institutes of Health Director Francis Collins to invoke a provision in federal law, which has never been used before, to license out Myriad Genetic's BRCA 1 and BRCA 2 gene patents.

Sen. Patrick Leahy (D-Vt.) last week sent a letter to Collins asking him to consider use of the so-called march-in rights under the Bayh-Dole Act "to ensure greater access to genetic testing for breast and ovarian cancer."

The Bayh-Dole Act, enacted in 1980, made it possible for universities and other entities to own inventions resulting from federal funding, and then to pursue commercialization of the inventions through licensing agreements.

One of the provisions in the legislation, however, gives the federal agency that provided funding for the invention the right to grant licenses to the invention to other parties if one of four criteria is met. The provision is known as march-in rights.

In his letter, Leahy notes one such criteria. "The government can require the patent holder to grant a license to the patent on reasonable terms," he said. "If the patent owner refuses, the government can directly license the patent in limited circumstances, including if it 'is necessary to alleviate health or safety needs which are not reasonably satisfied' by the patentee."

The patents covering Myriad's BRACAnalysis test were based in part on federally funded research, Leahy said, and while the US Supreme Court recently invalidated certain claims related to those patents, it allowed to stand claims related to complementary DNA.

"As a result, Myriad may continue to be the only company able to provide women with the genetic testing they need to make important health care decisions," Leahy said.

Immediately after the Supreme Court decision, a number of firms and universities announced their intentions to offer BRCA 1/2 testing, including Pathway Genomics and the University of Washington. Quest Diagnostics also has expressed interest in offering BRCA testing later this year.

But Myriad last week signaled it would not back down in protecting its BRCA testing franchise. Along with other assignees of the BRCA 1/2 patents, it sued two such firms, Ambry Genetics and Gene by Gene, which offers its BRCA 1/2 testing through its DNA Traits division.

Leahy also said in his letter that as a result of the price of BRACAnalysis — between $3,000 and $4,000 — "the health needs of the public are not reasonably satisfied by the patentee … because testimony presented to the [US Patent and Trademark Office] made clear that many women are not able to afford the testing provided by Myriad."

This week, Myriad announced it was expanding its financial assistant program for those who can't afford any of its molecular diagnostics tests. Under the expanded program, certain underinsured patients would pay no more than $375 out of pocket for one of Myriad's molecular diagnostic tests. To be eligible, patients must have private insurance, meet their insurers' coverage criteria for testing, and have a household income that does not exceed 200 percent of the Federal financial poverty level, Myriad said.

In a statement today, Ron Rogers, a spokesman for Myriad, said, "Myriad’s BRCA test is widely accessible and reimbursed and march-in rights are inappropriate and unnecessary in this case."

"We agree with Sen. Leahy that genetic testing for risks of hereditary breast cancer and ovarian cancer is a vital service, and we have invested more than $500 million to insure that genetic testing is widely available," he said. "More than 1 million patients have benefitted from the BRCA test offered by Myriad.

"As of today, BRCA testing is widely covered by public and private insurance for the vast majority of at-risk patients, and their average out-of-pocket cost is less than $100. Even [Health and Human Services] Secretary Kathleen Sebelius recently acknowledged that BRCA testing is widely available with no cost sharing for most patients," Rogers added. "Myriad also offers financial assistance programs or free testing for uninsured and underinsured patients in need.

A spokesperson for the University of Utah, a patent holder on the BRCA 1/2 technology, declined to comment specifically about Leahy's letter but said that the university generally supports the Bayh-Dole Act and the rights of individuals, companies, and universities to enforce their IP rights.

A spokesperson for the Hospital for Sick Children, another BRCA 1/2 gene patent holder, declined to comment, while the technology transfer office of the University of Pennsylvania, another BRCA 1/2 patent holder, did not respond to a message seeking comment. Officials for the remaining BRCA 1/2 patent holder, Endorecherche, could not be reached for comment.

It is not clear what action, if any, Collins or NIH will take in response to Leahy's request. A spokesperson for NIH said Collins has received the letter and will respond to it, but has no timeframe for a response.

In the 30-plus year history of the Bayh-Dole Act, no federal agency has ever exercised march-in rights. The NIH had received four march-in petitions through the end of 2012.