8 October 2014Genetics

Myriad and Ambry face off at appeals court

A US appeals court has heard oral arguments in a case between Myriad Genetics and a generics company it wants to prevent from marketing its own test for BRCA gene mutations that can lead to breast cancer.

Utah-based Myriad and California-based Ambry Genetics began the second round of their dispute at the US Court of Appeals for the Federal Circuit on Monday (October 6).

Myriad is appealing against a decision by the US District Court for the District of Utah in March this year denying it a request for a preliminary injunction that would have stopped Ambry from selling its own test at a cheaper rate.

Although Myriad was likely to suffer harm, the district court found that “substantial questions” had been raised about whether the claims at issue were patent eligible following the landmark Supreme Court decision last year that invalidated seven Myriad patents related to BRCA testing.

That decision, in June 2013, ruled that genes are not patent eligible “simply because they have been isolated from the surrounding genetic material”.

Myriad’s initial claim asserted several BRCA-test patents against Ambry that were not part of the Supreme Court decision.

But according to Antoinette Konski, attorney at Foley & Lardner in Palo Alto, California, who attended the hearing, the court was interested in the parties’ interpretation of the Supreme Court’s decision and what would remain patent-eligible when applied to Myriad’s claims.

“Myriad’s counsel countered questions regarding what would remain patentable after removing the ineligible content from the claim if the remaining steps or elements were conventional in the art,” she said.

“He noted that the Supreme Court held that cDNA was patent-eligible and that the creation of cDNA was made using conventional techniques. Thus, the fact that conventional techniques or elements appear in the claims, in combination with a law or product of nature, should not preclude the claim from patent-eligibility.”

Konski added that Myriad had argued that the claim should be analysed to determine if the claimed subject matter has a new or expanded function.

Ambry launched its BRCA test the day after the Supreme Court overturned the Myriad patents.

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