Inter Partes Challenge Filed Against Myriad Patents

Inter Partes Challenge Filed Against Myriad Patents Photo: Nikita G. Sidorov/iStockphoto.com

Following a bruising U.S. Supreme Court fight last year that invalidated two of its human gene patents, Myriad Genetics Inc. is using related patents to sue a new set of competitors—but faces an aggressive counterattack.

GeneDx Inc., one of Myriad’s litigation opponents in In Re: BRCA1- and BRCA2- Based Hereditary Cancer Test Patent Litigation, which is pending in Utah federal court, this week filed 11 petitions for so-called inter partes review of 11 patents owned, co-owned or licensed by Myriad.

The fast-track inter partes process allows third parties to challenge patents based on prior art—that is, information published before a patent was sought describing the claimed invention. Inter partes was rolled out in 2012 as part of the sweeping patent reform law.

Sterne, Kessler, Goldstein & Fox of Washington filed the petitions on bahalf of GeneDx, a subsidiary of Elmwood Park, N.J.-based BioReference Laboratories Inc.

In June 2013 in Association for Molecular Pathology v. Myriad Genetics Corp., the Supreme Court held that the so-called BRCA1 and BRCA2 genes are not patent-eligible. Mutations of those genes dramatically boost the risk of breast and ovarian cancer. Myriad’s discoveries about the genes’ location and sequence helped it develop tests to detect the mutations and assess a patient’s cancer risk.

“This is going to be a high profile set of [inter partes review] petitions,” said Richard Bone, a partner with virtual law firm VLP Law Group who isn’t involved in the case. “The broader community is looking at it.” Bone added that there have been relatively few inter partes reviews of life-sciences patents.

Myriad owns a huge portfolio of related patents and it’s using them to sue other companies that conduct cancer diagnostic tests, Sterne partner Jorge Goldstein said.

Aside from fighting Myriad’s infringement claims in court, GeneDx is “the first of the co-defendants in this current litigation to take this route of the parallel attack,” said Sterne partner Deborah Sterling.

Inter partes reviews are a useful way to challenge Myriad’s claims, Sterling said. “They’re conducted in front of three technically-trained, patent-savvy judges, and there’s a lower burden of proof.”

The inter partes review doesn’t mean defendants have dropped challenges to the patent-eligibility of Myriad’s technology, according to Goldstein. “Those grounds are still being maintained for these new set of claims in Salt Lake City,” he said.

Myriad spokesman Ronald Rogers said the company “continues to believe that our patents are valid and enforceable. We will defend our patents and believe that we’ll prevail based on the weight of the evidence.”

Sheri Qualters can be contacted at squalters@alm.com.

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