NEW YORK (GenomeWeb News) – Invitae has countersued Myriad Genetics in the US District Court for the Northern District of California seeking declaratory judgment that certain claims held by Myriad on BRCA1/2 and MUTYH genes are invalid and are not infringed by Invitae.
The action is in response to a suit Myriad and several other assignees filed against InVitae last week in the US District Court for the District of Utah accusing the firm of infringing claims in 11 patents underlying Myriad's BRACAnalysis test for hereditary breast and ovarian cancer risk. To date, Myriad has sued five companies alleging such infringement.
"Invitae's announcement today reinforces its commitment to defend its right to provide naturally occurring genetic information and services to physicians for their cancer patients," the company said in a statement.
Myriad for long has been the only provider of commercial BRCA mutation testing services in the US. But after the US Supreme Court this summer ruled in Association for Molecular Pathology et al. v. Myriad that several of Myriad's patent claims on isolated gene sequences were invalid, several testing firms began offering commercial tests for BRCA1/2 mutations.
However, the court also found several of Myriad's claims on synthetic, or cDNA, patent eligible. With this two-part ruling, Myriad believes its patent suite for BRACAnalysis is still intact and competitors cannot perform BRCA testing without infringing its still-valid IP. As such, when competing firms, such as Ambry Genetics, Gene by Gene, GeneDx, and Quest Diagnostics, launched BRCA testing, Myriad sued them.
These firms maintain that the Supreme Court's ruling opens up the field for competition and that their testing methods are not infringing Myriad's patents. Ambry and Gene by Gene have countersued Myriad alleging it of antitrust violations. Meanwhile, Quest and Counsyl have separately sued Myriad seeking preemptive declarations that they do not infringe Myriad's patents.
"We believe the Supreme Court rulings validate Invitae's view that no company can claim ownership over naturally occurring genetic information," Randy Scott, co-founder of Invitae, said in a statement today. "Our suit is based on the teachings of these cases. The legal process will take its course, and we are steadfast in our resolve."
"We believe that our patent claims are valid and enforceable, and we are confident in our case," Myriad said in a statement sent to GenomeWeb Daily News this morning. "This suit is nothing more than an attempt to change the venue of existing litigation against InVitae away from Utah."