Patent Suits that Held Up Personalized Medicine Are Being Settled

In the mid-1990s, Myriad Genetics discovered that inherited mutations in the BRCA1 and BRCA2 genes can increase a woman’s risk for breast and ovarian cancer. Myriad patented the sequences and used these patents to leverage patent infringement lawsuits against other biotech companies developing competing diagnostic tests.

Now, Myriad might finally be loosening its chokehold on the market for BRCA diagnostics. On Monday, after a round of announced settlements and dismissals of lawsuits related to Myriad’s patents, Ambry Genetics was the latest to announce a settlement, this time for a suit Myriad filed 2013. However, later that night Ambry retracted the announcement.

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A 2013 Supreme Court ruling started a chain of events that led Myriad to settle many of its patent infringement lawsuits against competitors.

“My understanding is that there is no final settlement agreement between Myriad and Ambry at this time,” Ron Rogers, a representative of Myriad, said yesterday afternoon. Ambry confirmed the news. “It was inadvertently sent out, and we are still waiting on additional signatures on the settlement agreement,” wrote Humberto Huerta, director of marketing at Ambry, in an email.

Here’s Andrew Pollack, reporting for the New York Times:

Settlements have been reached with LabCorp, Invitae and Pathway Genomics. Mr. Rogers said Myriad was in talks with Ambry, Quest Diagnostics, GeneDx and Counsyl.

In the settlements announced so far, the companies have agreed to dismiss the claims and counterclaims against one another, and Myriad has promised not to sue the companies on any remaining patents in the litigation.

These settlements trace back to a June 2013 ruling by the U.S. Supreme Court, which stated that Myriad may have “found an important and useful gene,” but that usefulness on its own is insufficient to justify a patent—“concluding that Myriad’s claims were invalid because they covered products of nature.”

This past December, the US Court of Appeals for the Federal Circuit invalidated three of Myriad’s patents on the grounds that the techniques used in their diagnostic tests were too close to nature in both structure and function to be patent eligible, starting what appears to be a cascade of lawsuit settlements. Ron Rogers told the New York Times, “We decided it was in the best interest of the company to settle these matters.”

In addition to reducing the costs of genetic testing, the settlements also promise to further progress toward more precise, personalized approach to medicine. As Amy Maxmen reported for NOVA Next in March 2013, gene patents owned by Myriad and other companies make effective genetic testing in the clinic less—not more—likely.

…for roughly twice the price of Myriad’s test, all 22,000 genes in a person’s genome can be sequenced. But because of concerns about patent infringement, these tests usually do not reveal the status of BRCA1, BRCA2, and patented genes related to dozens of other diseases. Instead, doctors have to order multiple tests from various vendors, even though a single test is possible with current technologies.

By streamlining testing, doctors should be able to get a more complete snapshot of a patient’s genetic makeup so they can tailor treatments and preventative measures accordingly, an approach championed by President Obama in his recent State of the Union address.