GeneDx Seeks Invalidation of Myriad's BRCA Patents

By Bio-IT World Staff  

August 20, 2014 | GeneDx, a commercial genetic diagnostics lab located in Gaithersburg, Maryland, this week filed eleven petitions to invalidate patent claims held by Myriad Genetics, adding another new thread to the increasingly complicated web of litigation surrounding Myriad. This action by GeneDx is unique in being the first move against Myriad’s patent holdings to take advantage of a new pathway opened up by the America Invents Act of 2011, which allows claimants to directly petition the U.S. Patent and Trademark Office to invalidate patents on the basis of prior art. GeneDx contends that several of Myriad’s patents, affecting tests for mutations to the cancer-related genes BRCA1, BRCA2 and MUTYH, represent scientific discoveries that were already public knowledge before the patents were filed.

Myriad, one of the world’s largest providers of genetic tests to clinicians and hospitals, is most famous as the defendant in the 2013 U.S. Supreme Court case Association for Molecular Pathology v. Myriad Genetics, which established that a naturally occurring DNA sequence cannot be patented. Since that case, testing for mutations to the BRCA genes, which can confer dramatically higher risks of developing breast cancer, has been widely adopted by both commercial and academic labs. Myriad has responded by suing a series of these providers — including, in October of last year, GeneDx — on the basis that its surviving patents are still sufficient to cover its competitors’ testing methods. Many of Myriad’s targets have countersued, while yet further players in the genetic testing market have preemptively sued, with the result that seven companies are now embroiled in unresolved patent suits with Myriad.

Beneath the patent conflict between Myriad and GeneDx is a more profound ethical divide. Myriad, which boasts the most accurate BRCA tests on the market thanks to its long history gathering data on mutations to the gene, has declined to share the novel mutations it has discovered with the scientific community at large. This gives the company a competitive advantage, but denies potentially lifesaving information to others. GeneDx, meanwhile, like some other testing companies, has regularly contributed to public databases that seek to catalogue disease-causing mutations in humans. As Sherri Bale, the co-founder and managing director of GeneDx, has previously told Bio-IT World, “If we cannot share our data, talk about what we find, and come to conclusions on what things mean, the whole genomics area is going to fall flat on its face. We have to share the data.”