Responding to the patent infringement claims asserted against it by Myriad Genetics, Ambry Genetics Corp. denies that the 15 patents at issue were duly and legally issued by the U.S. Patent and Trademark Office and counterclaims seeking a declaratory judgment that the patents are invalid and not infringed and that Myriad has violated U.S. antitrust laws through bad faith enforcement of these patents. Univ. of Utah Research Found. v. Ambry Genetics Corp., No. 13-0640 (U.S. Dist. Ct., D. Utah, Cent. Div., counterclaims filed August 5, 2013). Additional details about the lawsuit appear in Issue 60 of this Bulletin.

In an apparent effort to counter Myriad’s claim that it invested $500 million and extensive efforts to develop its breast cancer tests by identifying genetic mutations, Ambry recites the parallel and collaborative efforts undertaken by national and international teams of researchers, with significant levels of government funding, to find ways other than radical surgery to address what is termed a “breast cancer epidemic.” It alleges that Myriad hoarded information that should be publicly available, improperly sought to patent isolated gene sequences that were patent-ineligible, and aggressively commercialized its discoveries, by, among other matters, litigating to keep competitors out of the marketplace. Ambry also discusses the court rulings that culminated in the U.S. Supreme Court’s June 2013 determination that certain of Myriad’s claims were not patent eligible, stating, “Myriad is wrongfully attempting to enforce claims that have common subject matter to the invalidated claims in defiance of the Supreme Court’s opinion.” The Court’s opinion is summarized in Issue 59 of this Bulletin.

The counterclaim further contends that Myriad has falsely informed genetic counselors that Ambry’s tests infringe Myriad’s patents and they produce unreliable results. Ambry also claims that Myriad urges the counselors not to send their samples to Ambry for testing, “misrepresenting that Ambry will bill the patient the balance of any difference between the retail price of Ambry’s test and the price negotiated with the insurer.” Alleging violation of the Sherman Act, through exclusionary and anticompetitive conduct and attempted monopolization, Ambry seeks to enjoin Myriad under the Clayton Act from enforcing the patents, which it asks the court to declare invalid. Ambry requests damages, triple damages, interest, attorney’s fees, and costs.

Myriad has reportedly responded that its claims will prevail and stated, “The testing process employed by Ambry infringes 10 patents covering synthetic primers, probes, and arrays, as well as methods of testing related to the BRCA1 and BRCA2 genes. The claims at issue in this case are not the same as those in the Supreme Court case, which was a separate matter.” See, August 7, 2013.