Global biotech associations back Sequenom in Ariosa row

A group of biotechnology industry associations has stepped into the Ariosa v Sequenom dispute, which may be reviewed by the US Supreme Court.

The UK BioIndustry Association, EuropaBio, AusBiotech, the Swiss Biotech Association, HollandBio, BioteCanada, and the Japan BioIndustry Association have all joined forces to file an amicus brief backing Sequenom.

The brief urges the Supreme Court to reconsider the interpretation of patentable subject matter and argues that the current approach hinders investment in the development of new diagnostics and medicines.

In the brief, the associations argue that the US Court of Appeals for the Federal Circuit’s ruling against Sequenom was the result of an interpretation and application of the 2012 Supreme Court ruling in Mayo v Prometheus that was too broad.

In that ruling, the court said because Sequenom’s patent covered a natural phenomenon, the method could not be patented. The dispute concerns Ariosa’s Harmony Test, a non-invasive tool for pre-natal diagnosis of foetal qualities, which Sequenom claimed infringed its US patent number 6,258,540, obtained in 2001.

The ‘540 patent is directed to a method of detecting paternally inherited cell-free fetal DNA in maternal plasma in pregnant women.

If left unchanged, the ruling could prevent patents on any method that involves something that is naturally occurring, the brief said.

The associations also expressed concerns over the disparity between patent eligibility standards in the US and Europe, Australia, Canada, and Japan, and called for a harmonisation of IP laws.

Sequenom filed a writ of certiorari on March 21, urging the Supreme Court to hear the case in light of the earlier decision by the federal circuit.

In 2012, Ariosa sought a declaratory judgment of non-infringement from the US District Court for the District of Northern California. Sequenom counterclaimed and asked for a preliminary injunction. The district court ruled that the ‘540 patent was invalid.

A three-judge panel at the federal circuit affirmed the invalidity of the patent in June, citing the 2012 Mayo decision. In December last year, the federal circuit rejected Sequenom’s request for a re-hearing of the dispute en banc.

Konstantin Linnik, partner at law firm Nutter McClennen & Fish, which filed the brief on behalf of the organisations, said: “The current US jurisprudence puts the US out of sync with the rest of the industrialised world.

“It effectively deprives the emerging field of personalised medicine of any intellectual property protection in the US, while most other countries are taking a different approach.”