DOJ says no to gene patents
The US Department of Justice (DOJ) has surprised many by declaring that unaltered genetic material should not be patentable under 35 USC § 101.
The amicus brief was filed in the US Court of Appeals for the Federal Circuit on October 29 as the United States officially lodged its interest in The Association For Molecular Pathology and et al v. US Patent and Trademark Office and Myriad Genetics.
Amicus briefs were also filed by the Biotechnology Industry Organization (BIO) and the Association of University Technology Managers.
According to the DOJ brief, methods of “identifying, isolating, and using” DNA molecules may be patented, because “human intervention” produces “new and useful” alterations of these molecules.
But it added: “Genomic DNA itself, however, is a product of nature that is ineligible for patent protection, whether or not claimed in ‘isolated’ form.”
Judge Robert Sweet of the US District Court for the Southern District of New York invalidated the patents-in-suit in March on the grounds that they were not “sufficiently distinct” from natural phenomena. That decision is on appeal.
Myriad’s patents involve the comparison and analysis of DNA strands to identify genetic mutations that increase the risk of breast cancer, and claim rights over the BRCA1 and BRCA2 breast cancer genes.
Daniel Ravicher, executive director of the Public Patent Foundation and a co-counsel in the case, said: “The US brief is a substantial confirmation of our views and Judge Sweet’s decision. The impact of the US now taking the position that isolated or purified genetic sequences are indeed not patentable is a substantial boon for society and the biotech industry.”
BIO has warned that the biotechnology industry in the US could be at risk if the lower court decision is not reversed.
Jim Greenwood, president and chief executive officer of BIO, said: “Unless reversed, the district court’s ruling will seriously harm the US biotechnology industry, which consists largely of small firms that are engaged in foundational research and are dependent on private investment to fund their work.”
Despite the United States’ position on the subject, the US Patent and Trademark Office is not altering its view on the examination of similar patents. It has granted them in the past.
A USPTO spokesperson said: “The [agency] will maintain the status quo regarding examination practice while the issue is pending before the [US] Court of Appeals for the Federal Circuit.”
