July 29, 2013

Post-AMP, Myriad Files Patent Infringement Suits Against BRCA1 and BRCA2 Testing Competitors

Several developments have followed last month's Supreme Court decision that invalidated Myriad Genetics patent claims to isolated genes; (AMP v. Myriad opinion). Within hours of the Court’s decision, several competitors announced plans to offer BRCA1 and BRCA2 genetic tests. Myriad has recently filed patent infringement suits against Ambry Genetics (California) and Gene by Gene (Texas), based on the assertion of patent claims from ten patents it holds to BRCA1 and BRCA2 related genetic materials and methods (including some with contested claims in the Supreme Court). The complaint against Ambry is here; the complaint against Gene by Gene complaint is here. The suits, filed in Utah federal court, could be an opening play to fully litigate these other patents or a maneuver to create licensing structures for these patented materials and methods. A strategy by Myriad to obtain a preliminary injunction against these companies would have to contend with the more rigorous scrutiny for such requests after eBay v. MercExchange (2006), where the Supreme Court reaffirmed the need to consider "public interest" in the award of injunctions, and the current climate might lend support for such an argument against any injunction. Ambry has indicated that it will “vigorously defend” its right to offer testing services.The Court’s invalidation of some of Myriad’s patent portfolio related to BRCA1/2 testing has clearly led to altered expectations regarding the state of the genetic testing marketplace. Evidence of this is the response from Senator Patrick Leahy, Chair of the Senate Judiciary Committee, to Myriad’s lawsuit, calling for the National Institutes of Health (NIH) to exercise “march-in” rights that it holds pursuant to the Bayh-Dole Act of 1980. That option applies to patents for which NIH provided federal funding (or other federal agencies). Apart from the march-in authority, the U.S. government retains a default mechanism, a compulsory license that allows it to use any patented invention (or authorize 3rd parties to do so) under the statutory authority of 28 U.S.C. 1498, which requires “reasonable and entire compensation for such use and manufacture.” Since the march-in authority has never been exercised by the NIH (see here), it is unlikely to respond to Leahy’s call. Nor is it likely that the government would regard the BRCA1/2 genetic testing controversies as critical enough to trigger the compulsory license mechanism. These disputes are likely to be settled more informally, and more quickly, as the high visibility of these tests will retain public attention and maintain pressure on Myriad to support the expansion of genetic testing options.

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