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Utah Court Denies Myriad, BRCA Patent Holders' Preliminary Injunction Request Against Ambry

NEW YORK (GenomeWeb News) – A US federal district court has denied Myriad Genetics and other patent holders' request for a preliminary injunction against competitor Ambry Genetics to stop it from performing and selling tests that gauge BRCA genetic mutations.

"The court concludes plaintiffs are not entitled to the extraordinary remedy of a preliminary injunction to halt defendant from selling its own BRCA1 and BRCA2 genetic tests," Robert Shelby, district judge in the US District Court for the District of Utah, wrote in the ruling. "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 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."

Myriad, the University of Utah Research Foundation, and several other co-owners of patents underlying Myriad's BRACAnalysis test sued Ambry in July, alleging the firm was infringing claims in 10 of their patents. The lawsuit came shortly after the US Supreme Court ruled in Association for Molecular Pathology et al. v Myriad that Myriad's claims on isolated BRCA sequences were patent ineligible under Section 101 of the US patent law, because such sequences occur in nature. The court also decided that several claims on cDNA, used readily in gene cloning, are patent eligible because they are synthesized in a lab and do not occur in nature.

The US Patent and Trademark Office recently issued guidelines to its examiners on how to apply the Supreme Court's rulings in AMP v. Myriad and Mayo v. Prometheus. Both decisions have implications on what is required to transform a naturally occurring principle or abstract idea into patent eligible subject matter.

Myriad's BRACAnalysis and Ambry's BRCA tests assess whether patients harbor mutations in BRCA1/2 genes, which are associated with heightened risk for hereditary breast and ovarian cancer. In response to the latest federal district court decision, Myriad emphasized that the court has only made a ruling as to whether or not to grant a preliminary injunction.

"It is important to maintain perspective," Myriad spokesperson Ron Rogers told GenomeWeb Daily News. "The ruling is a denial of the preliminary injunction only and it isn't a ruling on the underlying merits of the case. We remain in the early stages of the litigation and look forward to presenting our case in court."

Without a preliminary injunction, Ambry is free to continue marketing its various BRCA testing products, including BRCAplus, BreastNext, OvaNext, and CancerNext tests, which were all mentioned in the lawsuit against the company. "Competition stemming from a free market drives all of us to improve and ultimately increases patient access to life-changing information," Ambry CEO Charles Dunlop said in a statement.

Judge Shelby addresses in his ruling how Myriad's business practices may have negatively impacted research and patient access to testing. On the one hand, the judge acknowledges that Myriad has obtained broad insurance coverage for its BRCA test and has implemented patient assistance programs that have enabled some 35,000 women to get tested, but he also takes issue with the company's competitive practices.

"The practical result of Myriad's patents has been to hinder or halt follow-up research, data sharing, patient testing, and the creation of additional and more affordable technologies for BRCA1 and BRCA2 testing," Shelby wrote. "For example, since about 2005, Myriad has declined to publicly share critical information regarding its classification of variants, including with its own patients. Instead, Myriad retains that information in a private database.

"In so doing, Myriad distorts rather than serves the patent system's goal of public disclosure in exchange for exclusive rights," he added. "In this way, Myriad has chosen a commercial path that turns much of our patent system policy on its head." Ambry has also countersued Myriad alleging antitrust violations.

A few weeks earlier, Gene by Gene – another testing firm that launched BRCA testing after the Supreme Court's ruling in AMP v. Myriad and was sued by Myriad – settled the dispute out of court.

Under the agreement, Gene by Gene will stop selling in North America standalone diagnostic tests that gauge BRCA1/2 genes or tests that include the genes as part of broader diagnostic panels. However, the company will continue selling and marketing these tests outside of North America. Gene by Gene can also globally provide its whole-genome and exome sequencing products that gauge BRCA genes, as well as its custom array products that assess variants for Mendelian disorders, including variants for BRCA1 and BRCA2.

Myriad has taken legal action against a number of other labs performing BRCA testing, alleging patent infringement, including LabCorp, Quest Diagnostics, GeneDx.