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27 June 2016Americas

US Supreme Court denies review of Ariosa v Sequenom

The US Supreme Court has today made its decision to deny a review of the patent dispute between Sequenom and Ariosa Diagnostics over a patent covering pre-natal testing.

The dispute started in 2012 when Ariosa sought a declaration from the US District Court for the District of Northern California that its Harmony Test, a non-invasive tool for pre-natal diagnosis of foetal qualities, did not infringe a Sequenom patent.

The patent, US number 6,258,540, is directed to a method of detecting paternally inherited cell-free foetal DNA in maternal plasma in pregnant women.

This declaration was, however, counterclaimed by Sequenom, which requested a preliminary injunction. The California court ruled that the ‘540 patent was invalid.

A three-judge panel at the US Court of Appeals for the Federal Circuit affirmed the invalidity of the patent in June 2015 because it covered a natural phenomenon, citing the US Supreme Court’s decision in 2012 in the Mayo v Prometheus case.

The Mayo ruling clarified that an invention that covers a natural phenomenon cannot not be patented.

In the Ariosa case, the Supreme Court had been asked by Sequenom to consider whether a novel method is patent-eligible when a researcher has achieved three things. They are that the researcher is first to discover a natural phenomenon, that unique knowledge has motivated him or her to apply a new combination of known techniques to that discovery, and a previously impossible result is discovered without pre-empting other uses of the discovery.

Antoinette Konski, IP and life sciences attorney at law firm Foley & Lardner, said: "The Supreme Court is leaving to the Federal Circuit the application of its patent eligibility analysis to claims related to diagnostic methods, and that the Federal Circuit’s Sequenom decision is controlling."

She added: "Thus for the foreseeable future, patent claims that rely in part on a law of nature or abstract idea must also contain a claim element that is more than the application of known technology to apply the law of nature or abstract idea."

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