Gene Patents Invalid in Early Action,
But Game Far from Over

Client Alert by Lisa M. Treannie

A federal judge in NY struck a blow to gene patents and methods of genetic analysis in this week’s ruling in Association for Molecular Pathology and ACLU v. USPTO and Myriad (S.D.N.Y. 2010). The claims at issue involved isolated DNA and methods of comparing and analyzing DNA sequences to assess an individual’s risk of breast or ovarian cancer. The judge held that isolated DNA is not patentable subject matter because it has the same fundamental quality and encodes the same information as DNA which appears in nature. He also held that the methods claimed were not patentable subject matter because they were abstract mental processes (relying heavily on the recent court decision in Bilski v. Kappos).

The Myriad decision technically has limited immediate legal effect. It does not affect any patents not specifically involved in the lawsuit, and it is not binding on any other court. A different federal district judge would be free reach a completely different conclusion on identical facts in another case. In addition, it is unlikely that the USPTO will change its gene patent examination standards based on this decision.

However, the decision is almost certain to be appealed to the Court of Appeals for the Federal Circuit (CAFC), and a CAFC decision would be binding on all federal courts except the Supreme Court. The case could ultimately end up on appeal before the Supreme Court. In addition, the Supreme Court will soon rule on the appeal in Bilski v. Kappos, which may further change the landscape given the reliance on the Bilski decision in the Myriad case. Until then, however, the ruling creates a cloud of uncertainty over the biotech industry. Moreover, should the decision be upheld on appeal, it will have far reaching consequences, affecting thousands of issued patents and the business model of the industry.

For further information, please contact Lisa M. Treannie.