Isolated DNA Claims are Not Patentable, US

A federal judge on Monday struck down patents on two genes — BRCA1 and BRCA2 — linked to breast and ovarian cancer. Shares of Myriad Genetics (MYGN.O) fell as much as 7 percent, a day after the ruling.

Myriad Genetics, Inc. (Nasdaq:MYGN) announced that Judge Robert W. Sweet of the Federal District Court for the Southern District of New York ruled that certain claims covering isolated DNA sequences in seven of the 23 patents covering BRACAnalysis(R) are invalid.

Myriad will appeal the decision to the Court of Appeals for the Federal Circuit and will continue to vigorously defend this litigation.

“While we are disappointed that Judge Sweet did not follow prior judicial precedent or Congress’s intent that the Patent Act be broadly construed and applied, we are very confident that the Court of Appeals for the Federal Circuit will reverse this decision and uphold the patent claims being challenged in this litigation,” said Peter Meldrum, President and CEO of Myriad Genetics. “More importantly, we do not believe that the final outcome of this litigation will have a material impact on Myriad’s operations due to the patent protection afforded Myriad by its remaining patents.”

In this case, the ACLU Plaintiffs sought a declaratory ruling that 15 claims under seven BRCA patents owned or exclusively licensed to Myriad were invalid and unenforceable. However, there are 164 claims remaining under these seven patents which were not challenged, and Myriad holds an additional 16 patents covering BRACAnalysis(R) which also were not challenged.

“Notwithstanding today’s decision, we are extremely proud of what Myriad has been able to accomplish over the years in promoting women’s health in the area of hereditary breast and ovarian cancer,” Meldrum said. “Countless lives have been saved as a result of our efforts in concert with the health care community.”

BRACAnalysis is an analysis of the BRCA1 and BRCA2 genes developed by Myriad Genetics for assessing a woman’s risk for hereditary breast and ovarian cancer. A woman who tests positive with the BRACAnalysis test has, on average, an 82% risk of developing breast cancer during her lifetime and a 44% risk of developing ovarian cancer. BRACAnalysis provides important information that the Company believes will help patients and their physicians make better informed lifestyle, surveillance, preventive medication and treatment decisions.

Source: Myriad Genetics, USA

Leave a Comment