Vermont Senator Patrick Leahy, a primary sponsor of the America Invents Act, is once again exploring pressing patent management issues by urging the National Institutes of Health to invoke the march-in rights afforded to it under the Bayh-Dole Act and force Myriad Genetics to license its breast and ovarian cancer testing protocols in the name of public health.
Last month, the U.S. Supreme Court invalidated Myriad's patent claims associated with "naturally occurring" DNA samples. However, the company retained its exclusive title to several inventions associated with complementary DNA synthesized via laboratory procedures. As a result, Leahy fears that Myriad could continue on its path to becoming the only company capable of performing certain genetic tests which could greatly inform consumer healthcare decisions.
"Myriad has developed a test for which it has testified that, if a woman tests positive, she has up to an 87 percent risk of developing breast cancer and up to a 44 percent risk of developing ovarian cancer," Leahy noted in a letter addressed to NIH director Francis Collins. "Unfortunately, testimony before the USPTO revealed that Myriad does all of this testing in-house, and charges between $3,000 and $4,000."
According to Bloomberg, the Bayh-Dole Act affords government offices the right to require certain patent holders supported by federal research funding to license their assets on equitable terms - or license them directly in limited scenarios where the owner initially refuses. Although the Myriad case likely satisfies the criteria for a public health concern that may merit government intervention, there is some doubt as to whether the patents in question were the result of NIH-funded initiatives or if they would be subject to the Bayh-Dole Act provisions.