With the reaffirmation of an earlier ruling from the U.S. Court of Appeals for the Federal Circuit, a major breakthrough took place for molecular diagnostic company Myriad Genetics, Inc. ( MYGN ). The earlier ruling given on July 29, 2011 confirmed Myriad's right to patent two isolated human genes - BRCA 1 and BRCA 2 - directly related to breast and ovarian cancer. However, the Supreme Court asked for a reconsideration of the whole matter.
The lawsuit was initiated on May 12, 2009 by the Association for Molecular Pathology, et al. (Plaintiffs) in the U.S. District Court for the Southern District of New York with the allegation that Myriad's patents on BRCA 1 and BRCA 2 human genes were invalid and unlawful. Currently, Myriad has exclusive license rights to 525 claims in 24 issued U.S. patents related to Bracanalysis testing.
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We consider Myriad's Bracanalysis system a valuable asset for top-line growth as it has the potential to tap a widely unexplored market. The company considers the oncology market to be huge, with Bracanalysis having penetrated about 50% of the cancer segment. As a result, the favourable second ruling by the U.S. federal appeals court may be considered a positive development for Myriad. The company is currently undertaking various strategies to increase both the market size and penetration level of Bracanalysis. During fiscal 2012, the company entered into agreements with Cephalon, a subsidiary of Teva Pharmaceutical ( TEVA ) and Pharma Mar to conduct companion diagnostic testing for their clinical trials.