January 30, 2015

Myriad Genetics Ends Patent Infringement Litigation Against Breast Cancer Testing Competitors

Myriad Genetics has ended its patent infringement litigation against its competitors over the patents on the BRCA1 and BRCA2 genes in the breast cancer genetic testing field. Myriad’s long campaign to enforce its patents is well known, and led to landmark patentable subject matter litigation that considered whether patent claims to isolated genes were valid. In the Supreme Court’s 2013 decision in AMP v. Myriad, the Court invalidated some of Myriad’s patent claims to isolated BRCA1 and BRCA2 genes. After that decision, a number of biotech companies immediately jumped into the BRCA1 and BRCA2 testing field, offering competitive genetic testing services. Myriad shifted its focus to allege new infringement allegations against a number of mostly smaller biotech companies, asserted different patent claims from the Supreme Court case, and the next round of litigation ensued. Last month, the Federal Circuit upheld a lower court’s decision that the second round of Myriad patent claims asserted against Ambry Genetics – to primers and isolated genes – were not patentable subject matter (see earlier post). Now, the company has ended its litigation against the other genetic testing companies after that ruling. One company is Pathway Genomics and they issued a statement:
Under the agreement, Myriad Genetics, Inc., the University of Utah Research Foundation, HSC Research and Development Limited Partnership, Endorecherche, Inc., and the Trustees of the University of Pennsylvania (the “Patent Owners”) and Pathway dismiss their respective claims and counterclaims against one another in the BRCA patent litigation. Additionally, the Patent Owners granted a covenant to not sue Pathway under the patents asserted in the litigation proceedings.
As one of the lead plaintiffs in the Supreme Court litigation, the ACLU reacted to the decision to end litigation: 
Patients who need access to life-changing genetic testing should not be caught in the legal battle that Myriad Genetics has unfairly waged against competing laboratories, nor should scientists face the threat and cost of patent litigation. Myriad’s decision reinforces the basic principle that patents should never permit one company to lock up a product of nature, such as our own genetic information.
The breast cancer testing field has only diversified in the nearly two decades since BRCA1 and BRCA2 were discovered and then patented; as thousands of mutations in these genes have been identified, the identification of clinical risk has become more complex. Scientists have identified other genes that may contribute to breast cancer susceptibility and testing for mutations in those genes could be equally important to determining clinical risk. Even Myriad recognizes a more complex genetic picture for patients; it now offers a 25-gene panel test that discerns cancer susceptibility to breast cancer and other cancers in one round of testing.

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