The US federal appeals court determined that isolated DNA molecules are patentable but methods to compare such gene sequences are not, in a much anticipated 2-1 decision on 29 July.
The decision reversed an earlier ruling by a District Court that the compositions of matter claims for Myriad Genetics’ BRACAnalysis test for Hereditary Breast and Ovarian Cancer (HBOC) syndrome were invalid.
The 29 July ruling addressed a lawsuit filed by patients and scientists represented by the American Civil Liberties Union (ACLU) and the Public Patent Foundation (PUBPAT).
ACLU staff attorney Chris Hansen called the final decision “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,” he said.
A similar argument was advanced in a brief filed by the Justice Department in the case last year, which argued that isolated DNA was not patentable.
Myriad praised the 29 July ruling. “We strongly support the court’s decision that isolated DNA and cDNA are patent-eligible material as both are new chemical matter with important utilities which can only exist as the product of human ingenuity,” stated Peter Meldrum, the company’s president and CEO.
He said the decision was in the best interests of the agriculture, biotechnology and pharmaceutical industries, as well as the public.
The Biotechnology Industry Organization also endorsed the ruling.
The group’s deputy general counsel for intellectual property, Hans Sauer, described it as the “right outcome” because if these gene patent claims had been struck down then all gene patent claims would potentially be struck down.
Nevertheless, Sauer said the decision was “not a ground-breaking opinion”, in that it effectively maintained the status quo.
PUBPAT’s take on the decision was that the court had unanimously upheld the lower court’s decision to invalidate patent claims on analysing gene sequences.
The group also emphasised that the three appeals court judges were split on whether the two so-called BRCA genes associated with hereditary breast and ovarian cancers could themselves be patented—two voted yes and one voted no.
“The judges disagreed with each other on whether pieces of the human genome are patentable, and we agree with Judge Bryson who explained they are not because no one ‘invents’ genes,” said Daniel Ravicher, PUBPAT’s executive director and counsel for plaintiffs. “Inventions are things like new genetic tools or drugs, all of which can be patented because they are not genes themselves.”
In a 29 July comment on Nature’s blog, Robert Cook Deegan, director of Duke University’s Center for Genome Ethics, Law and Policy, noted that two of the three judges appeared to indicate that the broadest claims on DNA molecules were probably invalid if challenged.
“They all agreed the broad method patents are invalid, however. They all agreed the assay claim is valid,” he wrote. “But there is considerable disagreement among the three exactly when a DNA sequence found in nature is patentable, and how specific and concrete the claims need to be to pass muster.”
The case may not be over. Sauer said it could be sent back to the Appeals Court or forwarded to the Supreme Court.