Myriad and Gene by Gene settle BRCA litigation
Myriad and its rival genetic diagnostics company Gene by Gene have agreed to settle their patent infringement case related to BRCA tests.
BRCA tests assess an individual’s risk of developing breast and ovarian by looking for mutations in the genetic sequences of the BRCA1 and BRCA2 genes.
Under the agreement terms, Gene by Gene will stop selling or marketing clinical diagnostic tests in North America that include analysis of the BRCA1 and/or BRCA2 genes. It may continue to sell such tests outside North America.
The parties agreed that Gene by Gene may offer its whole genome and exome – a part of the genome – products and services around the world. These include the BRCA genes and custom array products that test variants for inherited Mendelian disorders – which are caused by mutations in single genes – and may include the BRCA genes.
The agreement will remain in force until February 12, 2016, or when the last of the valid BRCA patents involved in the case expires – whichever is earlier.
The patent owners have agreed to dismiss the patent infringement case without prejudice.
Myriad filed suit at the US District Court for the District of Utah, Central Division, on July 10, 2013. It accused Gene by Gene of infringing nine patents covering synthetic DNA and methods of use related to the BRCA1 and BRCA2 genes with its diagnostic tests.
It launched a series of similar cases around the same time last year.
“We believe the settlement with Gene by Gene is a good and responsible agreement,” a spokesperson for Myriad told LSIPR.
“It is in the best interest of the parties because it ends the uncertainty and expense on ongoing litigation.”
He added that Myriad and the other owners of the BRCA patents at issue, which include the University of Utah, the Hospital for Sick Children, Endorecherche, Inc., and the Trustees of the University of Pennsylvania, continue to believe that these patent claims related to BRCA1 and BRCA2 gene testing are valid and enforceable.
“We are in the early stages of the litigation regarding all the other infringement cases. With regard to Ambry, we are currently waiting for a ruling from Judge Shelby on our motion seeking a preliminary injunction in that case. No trial dates have been set at this time,” he continued.
Nabeela Rasheed, a shareholder at McAndrews Held & Malloy Ltd, said that Gene by Gene had taken a “calculated approach”.
“As a business decision it likely makes sense for them to hold off for another two years,” she said.
“The litigation could potentially have taken at least until that time if Myriad were to see the matter up to the appeal process. Given their past performance it seems quite likely they would have pursued that option.”
She added that Gene by Gene may feel it can afford to settle: “There remain at least five other lawsuits pending. Myriad is going to continue to enforce its patent rights. That has always been its position and I do not think that position will change with this settlement.
“As for Ambry, I believe that company has come out and stated categorically that it will continue with its litigation with Myriad et al,” she continued.
“Ambry seems pretty confident in its position. It remains to be seen how that lawsuit will affect the rest of Myriad’s portfolio. As I have stated in the past, while the Supreme Court decision created significant mischief for the rest of the world prosecuting diagnostic type applications, it had little effect on Myriad because Myriad continued to have method claims and took the position that it would continue its position of enforcement of the remaining portfolio."
Gene by Gene did not respond to a request for comment.
