End of the Road: Myriad Settles Its Patent Lawsuits

Roxanne Nelson, RN

January 29, 2015

The long saga of Myriad Genetics and its battle for control of the BRCA1 and BRCA2 genes might finally be winding down.

After trying to enforce its patents on these two genes and bringing suit against a number of laboratories, the end of the road appears to be in sight. Myriad has now settled, or is in the process of reaching a settlement, with all of the corporations it sued for patent infringement.

In June 2013, the Supreme Court effectively invalidated the patents held by Myriad Genetics for the two genes after a protracted legal battle that began in 2009. The Court unanimously ruled that although naturally isolated DNA is not patentable, synthetically created exon-only strands of nucleotides — complementary DNA — is patentable.

In essence, the Court ruled that five of Myriad's claims covering isolated DNA are not eligible for patents. But according to Myriad, the company held more than "500 valid and enforceable claims in 24 different patents, conferring strong patent protection for its BRACAnalysis test.

When the ink was barely dry on that ruling, Myriad filed suit against two companies that immediately began offering less-expensive testing for the genes. That lawsuit alleged that the competitors — Ambry Genetics and Gene by Gene, Ltd. — were infringing on specific Myriad patents that are distinct from those invalidated by the Supreme Court a month before. The battle intensified as Myriad took legal action against a number of other companies that began performing BRCA testing, including LabCorp, Quest Diagnostics, GeneDx, and Invitae.

Gene by Gene, the first company to be sued by Myriad, was also the first to settle the dispute, which it did in February 2014. Under that agreement, Gene by Gene had to immediately stop "selling or marketing" BRCA gene tests, either as standalone tests or as part of a wider panel, in the United States. However, they will be able to offer whole-genome and exome testing, as well as "custom" array products for Mendelian-inherited disease and disorders (which can involve the BRCA genes). That agreement is effective until 2016, when the first set of BRCA patents are due to expire, or until the last valid BRCA claims expire.

In March 2014, a federal district court denied Myriad's attempt to stop a competitor from offering testing. And in December 2014, the US Court of Appeals for the Federal Circuit ruled against Myriad, saying that three of the patents covering DNA-based BRCA1 and BRCA2 tests that Myriad claimed as proprietary did not contain subject matter that is eligible for patent protection.

GenomeWeb has reported that Myriad has decided to settle with LabCorp and Ambry Genetics, and that the lawsuits have been dismissed by a Utah court.

Last week, Myriad, Pathway Genomics, and Invitae dropped their claims and counterclaims against each other, resolving all pending litigation between them.

"We are very pleased to close this chapter and continue our focus on providing innovative cancer risk testing to patients around the world," said Jim Plante, founder and CEO of Pathway Genomics, in a statement.

Myriad is currently in talks with the remaining companies, although settlements have not yet been announced.


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