US politician calls for mandatory licensing on Myriad’s cancer tests

Senator Patrick Leahy sent a letter on Friday to Francis Collins, director of the National Institutes of Health, urging him to use “march-in rights” under the Bayh-Dole Act on Myriad’s patents covering the BRCA1 and BRCA2 genes, which can be used to screen for certain types of cancer.

The move comes after the Supreme Court’s mixed ruling in June in Association for Molecular Pathology v Myriad Genetics. The Court ruled that isolated and purified DNA is a naturally occurring phenomenon and therefore ineligible for patent protection, but synthetically created complementary DNA (cDNA) is eligible for patent protection.

In his letter, Leahy argued that Myriad’s patents were partially based on research funded by the US government. Prior to the Supreme Court’s decision, other companies were unable to offer the tests because of Myriad’s patent. Myriad charges between $3,000 and $4,000 for the tests.

Since the Supreme Court’s decision, several competitors have begun to offer the tests. Myriad has sued two of these rivals, Ambry Genetics and Gene by Gene, arguing that they infringe other Myriad patents not invalidated by the Court.

The Bayh-Dole Act allows private companies to claim the rights to inventions created with federal funds, generally without reimbursing the government, but grants the government “march-in rights” to require the patent holder to grant a licence on reasonable terms. If the patent holder refuses, the government can directly license the patent in certain circumstances.

“The health benefits of genetic testing for breast and ovarian cancer are clear,” wrote Leahy. “The healthcare cost savings are also clear.

“I am concerned, however, that the health needs of the public are not reasonably satisfied by the patentee in this situation because the testimony presented to the USPTO made clear that many women are not able to afford the testing provided by Myriad.”