Breast cancer gene patents once again found valid by US appeals court

In Insights, Uncategorized

23 August, 2012

In the “Myriad case” an ongoing legal battle with many twists and turns, the Court of Appeals for the Federal Circuit, CAFC, has decided to once again uphold patent claims covering isolated human genes BRCA1 and BRCA2, owned at least partly by Myriad Genetics Inc in Utah, USA. The patent claims were initially invalidated in March 2010 by a federal district court in New York, after a complaint had been filed by a group of parties including the American Civil Liberties Union and the Association for Molecular Pathology. After appeal, the CAFC overturned this decision in a first judgment in July 2011. The plaintiffs then sought leave to appeal to the US Supreme Court.

Here is where the story gets a little complicated. One of the claims at issue in the Myriad patents related to genetic diagnosis of breast cancer predisposition. As such, the claim is analogous to claims that were at issue in another Supreme Court case, a patent dispute between Mayo and Prometheus. Because of the analogy between the claims at issue, and because the Supreme Court came to its decision the “Prometheus case” while still considering the Myriad case, the Supreme Court wanted the CAFC to take a new look at the Myriad case in the light of their judgment in the Prometheus case. So, the Supreme Court granted the request to appeal, vacated the July 2011 judgment by the CAFC, and ordered the case back to the CAFC for a new determination.

After an oral hearing in July, the second decision from the CAFC issued on 16 August 2012. In the new decision, available here, the CAFC concludes that the Prometheus decision does not alter their previous outcome, and has now stated twice that isolated genes are, per se, considered eligible for patent protection if all other requirements are met.

Perhaps this is not so surprising – after all, the CAFC decisions follow the established legal practice and reasoning that has been valid for at least twenty years, and maintain the status quo in the biotech industry. The really interesting question in this case has still not received an answer: What will happen if and when the question is brought up for final judgment by the Supreme Court?

Niklas Mattsson, European Patent Attorney

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