Isolated DNA molecules are patentable in the US

The US Court of Appeals for the Federal Circuit has held that isolated DNA molecules are patentable, it announced on July 29.

The American Civil Liberties Union (ACLU) filed a patent case in district court against pharmaceutical company Myriad Genetics and others, including the US Patent and Trademark Office, in May 2009.

ACLU wanted Myriad’s patents for the BRCA1 and BRCA2 breast cancer genes to be invalidated because, it argued, they were incorrectly granted in terms of composition and method.

The Federal Circuit’s decision reversed the district court’s March 2010 declaratory judgment in Association for Molecular Pathology et al v Myriad Genetics et al in part and affirmed it in part.

The district court invalidated 15 Myriad patents because their composition claims for isolated DNA molecules covered “patent-ineligible product of nature”.

It also found that the patents’ method claims, which involve the comparison and analysis of DNA strands to identify genetic mutations that increase the risk of breast cancer, failed the ‘machine or transformation’ test because they were too vague and general. Myriad appealed against the district court’s decision.

Reversing the district court’s composition claim finding, Federal Circuit Judge Bryson Lourie said: “[T]he PTO has issued patents directed to DNA molecules for almost thirty years...If the law is to be changed, and DNA inventions excluded from the broad scope of § 101 contrary to the settled expectation of the inventing community, the decision must come not from the courts, but from Congress.”

Judge Lourie also affirmed all but one of the district court’s method claim findings. He said: “[W]e conclude that all but one of Myriad’s method claims are directed to patent-ineligible, abstract mental processes, and fail the machine-or-transformation test.”

Chris Hansen, a staff attorney with the ACLU Speech, Privacy and Technology Project, said: “[The] ruling is a blow to the idea that patent law cannot impede the free flow of ideas in scientific research. Human DNA is not a manufactured invention, but a natural entity like air or water. To claim ownership of genetic information is to unnecessarily block the free exchange of ideas.”

Commentators have said that they expect the case to be taken to the US Supreme Court on appeal.