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Myriad Settles BRCA Testing Patent Fray with Pathway Genomics, Invitae

NEW YORK (GenomeWeb) – Myriad Genetics and other patent owners have settled their BRCA testing patent lawsuit with Pathway Genomics and Invitae.

Myriad sued Pathway on June 13, 2014, for infringement of its patent claims underlying BRCA1 and BRCA2 genetic testing. The legal tussle began soon after Pathway launched a next-generation sequencing test for gauging alterations in BRCA1 and BRCA2 genes, called BRCATrue.

Under the agreement struck between Myriad and four other patent holders with Pathway, all parties have dropped "their respective claims and counterclaims against one another in the BRCA patent litigation," Pathway announced in a statement today.

In a separate announcement on Monday morning, Invitae said that it also had settled litigation with Myriad and other parties including the University of Utah Research Foundation and the Trustees of the University of Pennsylvania, among others, regarding the firm's dispute over BRCA1, BRCA2, and MUTYH genes. The parties agreed to dismiss their claims and counterclaims against each other, resolving all pending litigation between them.

In late 2013 Invitae launched a 29-gene, next-generation sequencing test that doctors can use to learn their patients' risk for hereditary breast and ovarian cancer. That test includes analysis of BRCA1/2 genes. Just prior to that launch, Myriad sued Invitae for alleged infringement of its patents covering BRCA1 and BRCA2 gene testing.

The US Supreme Court ruled in 2013 in Association for Molecular Pathology v Myriad Genetics that DNA segments isolated from the body are patent-ineligible. In the same decision, the court also ruled that cDNA or synthetically created DNA is patent-eligible when the sequence in different from that found in nature. The decision impacted patent claims underlying Myriad's BRACAnalysis test for gauging risk of hereditary breast and ovarian cancer. 

After this decision, Myriad sued a number of labs that began offering BRCA testing, including Ambry Genetics, Laboratory Corporation of America, Quest Diagnostics, Gene by Gene, GeneDx, Pathway, and Invitae. Myriad argued that based on the Supreme Court's ruling these competing firms were infringing its still valid BRCA testing IP.

Gene by Gene settled the dispute with Myriad out of court. For one of these cases, in March 2014, Judge Robert Shelby of the US District Court for the District of Utah denied Myriad's request for a preliminary injunction against Ambry. Myriad challenged that decision with the US Court of Appeals for the Federal Circuit, which in December upheld the lower court's decision.

The appeals court reasoned that the Utah court was right not to grant an injunction against Ambry since claims in the three patents underlying Myriad's BRACAnalysis test that Myriad was asserting were patent ineligible. Specifically, the court said that Myriad's four composition-of-matter claims directed at primers were patent ineligible because they "are not distinguishable from the isolated DNA found patent ineligible in Myriad and are not similar to the cDNA found to be patent eligible," Judge Timothy Dyk wrote in his opinion. "Primers necessarily contain the identical sequence of the BRCA sequence directly opposite to the strand to which they are designed to bind. They are structurally identical to the ends of DNA strands found in nature."

As for the method claims at issue in the case, the appeals court found they are directed at the abstract mental process of comparing a patient's genes against a normal reference sequence and analyzing the differences. These claims, therefore represent a patent ineligible abstract idea, according to the law. Moreover, according to Dyk, the non-patent-ineligible parts of the method claims "do not add 'enough' to make the claims as a whole patent-eligible."

The settlement between Pathway and Myriad comes just over a month after the appeals court's ruling on Myriad's patent claims. Ardy Arianpour, Pathway's chief commercial officer, told GenomeWeb that the company will continue to offer its BRCA-related testing products as it has been during the period of litigation. Myriad did not respond to questions ahead of publication.