Just when you thought that last month’s Supreme Court ruling in Association for Molecular Pathology v. Myriad Genetics, Inc. might be the end of the gene patent debate, new developments are changing that theory.
Shortly after the Supreme Court ruled that Myriad’s patent claims to isolated DNA were not patent eligible subject matter because they occur naturally in the human body, Ambry Genetics Corp. and Gene by Gene Ltd. announced they would make the breast cancer-testing products available at a lower cost.
Unfortunately for them, they apparently forgot that Myriad’s patent claims to complimentary DNA (cDNA) were specifically upheld by the Court and that the plaintiffs did not challenge the method claims to the Supreme Court. Using the still valid claims, Myriad sued each company for infringement. Myriad Genetics v. Ambry Genetics; Myriad Genetics v. Gene by Gene Ltd.
It’s not surprising that there would be confusion as to the actual outcome of the case given that both the ACLU and PUBPAT trumpeted the case as a victory. These entities effectively filed the lawsuit on behalf of the named plantiffs. The ACLU stated that “the court’s ruling lifted the patent obstacle to offering genetic diagnostic testing,” while PUBPAT noted that “[b]ottom line, diagnostic genetic testing is now free from any patent threat, forever, and the poor can now have their genes tested as freely as the rich.”
Myriad clearly does not agree with these assessments.
Senator Patrick Leahy (D-VT) has decided to step into the fray. On Friday, he sent a letter to the National Institutes of Health (NIH) urging them to exercise “march-in rights” to license its patent on reasonable terms. Under a provision of the Bayh-Dole Act, government agencies can require the patentee to license the patent if the research behind it was federally funded.
Although not the first request made that it do so, the government has never exercised these rights under Bayh-Dole. Leahy asserts that the $3,000-4,000 price tag for the genetic tests is too expensive. Other companies can perform the tests at much lower cost, thereby increasing access to a greater number of potentially affected women.