A federal court has rejected a preliminary injunction filed by Myriad Genetics seeking to stop Ambry Genetics from selling its own version of a BRCA breast cancer gene test temporarily pending a trial on Myriad’s contention that patents it co-owns were infringed by Ambry.
Judge Robert J. Shelby of the U.S. District Court for the District of Utah, Central Division, ruled Monday that Myriad had failed to establish that it would likely succeed in the case on the merits of its arguments, while acknowledging Myriad and the other co-owners of the BRCA patents in question faced economic harm from competition by Ambry.
Myriad contends that Ambry and several other rival gene testing providers are infringing on 10 of 24 patents covering synthetic primers, probes, and arrays, plus testing methods related to BRCA1 and BRCA2. Myriad owns five of the 10 patents and licenses the rest from co-plaintiffs University of Utah, University of Pennsylvania, Toronto’s Hospital for Sick Children, and Canadian company Endorecherche.
“Although Plaintiffs have shown that they are likely to suffer irreparable harm through erosion of their test pricing structure, loss of their share of the testing market, and loss of their exclusive patent terms if an injunction does not issue, Defendant [Ambry] has raised a substantial question concerning whether Plaintiffs’ Primer and Method Claims are directed toward patent eligible products of nature and abstract ideas under 35 U.S.C. § 101.,” Judge Shelby wrote in a 106-page decision.
Ambry began offering its BRCA test on June 13, the day the U.S. Supreme Court unanimously overturned seven of Myriad Genetics’ 24 patents related to its discovery of the precise location and sequence of breast cancer susceptibility genes BRCA 1 and 2. The high court also held that companies can patent composite DNA (cDNA) and other synthetic genetic material that does not meet the “product of nature” exemption from patentability.
The mixed ruling prompted several of Myriad’s competitors to launch BRCA testing, only to be challenged by Myriad with patent infringement suits. In addition to Ambry, Myriad has also sued Gene by Gene, GeneDx, Invitae, LabCorp, and Quest Diagnostics.
Last month, Gene by Gene settled its suit with Myriad and the other BRCA patent owners. Gene by Gene agreed to stop offering tests in North America that include analysis of the BRCA1 and/or BRCA2 genes—alone or with gene panels—until either February 12, 2016, or when the last valid patent claim of any of the BRCA patents involved in the case expires, whichever comes first. Gene by Gene can, however, continue offering such tests everywhere else in the world.
Ambry CEO Charles Dunlop in a statement hailed the decision as “a victory for the entire genetics community. We’ve all believed for years that products of nature should not be patentable and were thrilled with the Supreme Court ruling in June 2013 affirming this principle. We stood by our convictions after Myriad sued Ambry and are exhilarated by today’s ruling.
“Competition stemming from a free market drives all of us to improve and ultimately increases patient access to life-changing information,” Dunlop added.
Myriad spokesman Ron Rogers told GEN the company and co-owners of the BRCA patents remained confident they would prevail at trial with Ambry. A trial date has yet to be set.
“What [Judge Shelby] didn’t decide on were the merits of the case. We remain in the early stages of the litigation. The case will continue forward. Yesterday’s ruling does not change anything from a business perspective,” Rogers said. “While it wasn’t the outcome that we had hoped for, preliminary injunctions are very difficult to obtain and are very rarely granted, so it really wasn’t an unexpected decision.”
Asked why the patent co-owners pursued the longshot of a preliminary injunction, he replied: “We had a fiduciary responsibility to do that. We continue to believe that our patents at issue are valid and enforceable. It made sense to go ahead and seek a preliminary injunction.”
Myriad has argued that it spent more than $500 million to develop its BRACAnalysis diagnostic test for hereditary breast and ovarian cancer, and that its rivals’ tests would reduce royalties for the patent holders.
[This report updates a previous version by including comments to GEN by Myriad spokesman Ron Rogers].