Humbled Myriad Caves on BRCA Patents

By Aaron Krol 

January 28, 2015 | The long courtroom fights are at long last coming to an end as Myriad Genetics has announced it will settle its complex web of suits and countersuits and end claims to ownership of certain genetic testing targets and methods.

Myriad did the world an enormous service in developing the first tests for breast cancer-related BRCA mutations, among the most decisive and actionable genetic variants known to modern medicine. (The tests were later made famous when Angelina Jolie declared that she had tested positive for a high-risk mutation and elected to undergo a double mastectomy, helping to bring mass popular awareness to genetic testing.) Unfortunately, Myriad went on to probe the extreme limits of patent exclusivity in the virgin territory of genetic medicine, making controversial claims that its discovery of disease risks related to specific genetic variants could be used to exclude others from reporting the same variants to patients. The strategy led to a unanimous Supreme Court decision that naturally occurring DNA sequences were not eligible for patent, and Myriad has been dealt repeated setbacks in court ever since. (Bio-IT World has regularly covered the ongoing litigation, most recently here.)

Now, Myriad is calling it quits, conceding that its competitors (some of which have taken a notably more open approach by sharing newly discovered variants in public databases) have the legal right to test BRCA mutations with their own technology and processes, including some testing methods that Myriad had previously believed were covered by its intellectual property. Suits have already been settled with LabCorp, Invitae, Ambry Genetics, and Pathway Genomics; while at least three additional companies are still suing Myriad, being sued by Myriad, or both, these cases are also likely to end in settlements in the near future.

Although Myriad will not have the monopoly power it once sought, the company still has some of the best-validated BRCA tests available, thanks to its head start sequencing DNA from thousands of patients to discover new disease-relevant variants. Myriad is currently expanding its range of offerings to cover many more genes and indications.