Another Patent-Infringement Setback for Myriad Genetics

Another Patent-Infringement Setback for Myriad Genetics

Myriad Genetics Inc., the maker of tests for hereditary risks of breast and ovarian cancer that lost its patent fight at the U.S. Supreme Court last year, failed to convince a federal court to block a competitor from selling its own genetic tests while another patent-infringement case is pending.

Myriad had asked U.S. District Judge Robert Shelby in Salt Lake City to issue a preliminary injunction to stop Ambry Genetics Corp. from offering its tests while the lawsuit against the company, University of Utah Research Foundation v. Ambry Genetics, is pending. But on Monday the judge issued a 106-page decision in which he said Myriad is unlikely to win lawsuits claiming tests sold by Ambry violate its patents.

“The court finds that although Plaintiffs have shown they are likely to be irreparably harmed if an injunction does not issue, Defendant has raised substantial questions concerning whether any of the patent claims at issue in Plaintiffs’ Motion are directed toward patent eligible subject matter under 35 U.S.C. § 101,” Shelby wrote. “In light of Defendant’s showing, Plaintiffs are unable to establish that they are likely to succeed on the merits of their claims.”

Myriad lost a Supreme Court battle last June (Association for Molecular Pathology v. Myriad Genetics Inc.) when a challenge to its patents for tests on mutations in two genes linked to breast-cancer risk—known as BRCA1 and BRCA2—resulted in the court ruling that genes are not eligible for patents because they are products of nature. Several companies, including Ambry, quickly began offering similar tests at much lower prices.

Myriad sued, arguing that these tests infringed other patent claims that were not invalidated by the Supreme Court.

Myriad argued that it would suffer “irreparable harm” if Ambry were allowed to continue offering the tests while litigation that could take more than a year is pending. The company said health insurance companies have pressured it to lower its prices since competitors entered the market. Ambry offers its tests for $2,280, while Myriad charges $4,040. In addition, Medicare and Medicaid have proposed cutting the reimbursement for Myriad’s test roughly in half.

But while agreeing that Myriad would suffer economic harm if he did not issue a preliminary injunction, the judge said other factors prevented him from doing so. Shelby was not convinced that Myriad would succeed on the merits. And in considering the public interest, he conceded that Myriad was correct in its assertion that “there generally exists a strong public interest in upholding a patentee’s exclusive rights.” But he added that preserving patent rights “will not always trump other considerations, especially when public health issues are at stake.”

“The practical result of Myriad’s patents has been to hinder or halt follow-up research, data sharing, patient testing, and the creation of additional and more affordable technologies for BRCA1 and BRCA2 testing,” Shelby wrote.

Myriad can appeal Shelby’s decision to the U.S. Court of Appeals for the Federal Circuit. The lawsuit, meanwhile, will proceed in the district court.

“We are pleased that the court found we made a clear and convincing showing that the Myriad’s claims encompassed unpatentable subject matter,” Ambry’s attorney, McDermott Will & Emery partner Bill Gaede, told CorpCounsel.com. “The court’s ruling is consistent with the Supreme Court’s AMP and Mayo decisions.”

Myriad’s lead counsel, David Magnum of Parsons Behle & Latimer, said he was not authorized to speak about the case.

Other companies, including GeneDx, Invitae, Quest Diagnostics and Laboratory Corporation of America Holdings, have also started offering tests for BRCA1 and BRCA2. Myriad has lawsuits pending against them as well, but it is unlikely to pursue preliminary injunctions against them since Judge Shelby is also handing those cases.

The other owners of the patents—the University of Utah, the University of Pennsylvania, the Hospital for Sick Children in Toronto and Endorecherche Inc.—have joined in the suits.

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