Will the future of gene patents be "markedly different" after Myriad?


Lee Crews and Vicki Norton

A US district court decision threatens the future of so-called ‘gene patents’ in the US. Lee Crews and Vicki Norton look at the current position and assess the possible futures for the case.

On October 22, 2010, Myriad Genetics, Inc filed a brief on appeal to the US Court of Appeals for the Federal Circuit in its widely watched ‘gene patenting’ case. While many patent attorneys speculated that the ruling would not stand on appeal, recent developments, including the US Department of Justice’s (DOJ) filing of an amicus brief taking the position that isolated genes are not patentable, and Judge Dyk’s dissenting opinion in Intervet Inc. v. Merial Limited and Merial SAS, are providing room for doubt.

An affirmation would have a tremendous impact on the biotechnology community because the decision turns on whether isolated DNA and methods that require assessing its sequence are eligible for patent protection. The US Patent and Trademark Office (USPTO) has taken the position that this subject matter is patent-eligible, and thousands of US patents include such claims.

Myriad’s position is that the US District Court of the Southern District of New York improperly held invalid patent claims related to the BRCA1 and BRCA2 genes and to methods of using nucleotide sequences within those genes to assess susceptibility to cancer. The district court held that the isolated DNA was a product of nature and the methods constituted nothing more than a mental process, neither of which are eligible for patent protection.

Myriad, gene patent