The US Supreme Court has ordered that the two gene patents held by Myriad Genetics be sent back to the US Court of Appeals for the Federal Circuit, to be re-examined.
Myriad Genetics has held patents for two genes, BRCA1 and BRCA2, since 1994. Mutations in these genes are associated with increased risk of breast and ovarian cancers, and the patents give the company exclusive rights to test for them. The test, called BRACAnalysis, costs around $3,000 per patient.
In 2009, the Public Patent Foundation, American Civil Liberties Union and the Association for Molecular Pathology filed a lawsuit against Myriad genetics, claiming that the patents violate patent law as they cover natural phenomena, and restrict scientific research and patients' access to medical care.
In 2010 a federal judge in New York ruled that genes cannot be patented, but this was overturned in July 22053 by the Court of Appeals, who also ruled that Myriad's technique for screening potential therapies was patentable.
The latest instalment of this long-running case came on 26 March, following a contradictory decision in a related case, where the Supreme Court denied Nestlé's Prometheus Laboratories' patents of biomarkers that help calibrate drug dosage. Justice Stephen Breyer wrote that inventors must do more than 'recite a law of nature and then add the instruction "apply the law"'.
'A unanimous Supreme Court has now undeniably declared that a trivial noninventive transformation' is insufficient for a patent, Daniel Ravicher, executive director of the Public Patent Foundation and co-counsel in the lawsuit, told the New York Times. He said that, as isolating DNA is a trivial, well-understood process, this new ruling contradicts the appellate court's decision to uphold Myriad's patents.
However, others doubt it will have that much influence, as the Myriad patents involve both composition-of-matter and process claims, while the Prometheus case only involves process claims.
According to an interview with Reuters, Junaid Husain, a research analyst for Dougherty & Co, said the choice to send the case back to the Appeal Court to be reheard could delay the verdict by another 'two to three years, keeping the BRACAnalysis franchise safe from competition'. This may explain why shares in Myriad rose over three percent following the decision.
The case is the Association for Molecular Pathology vs. Myriad Genetics, No. 11-725.