Patent infringement lawsuit over breast cancer testing genes settled this month

A patent infringement lawsuit over breast cancer testing - one of several lawsuits involving Penn - ended in settlement earlier this month.

Gene by Gene, Ltd. and Myriad Genetics, Inc., along with the University of Utah Research Foundation, HSC Research and Development Limited Partnership, Endorecherche, Inc. and the Trustees of the University of Pennsylvania announced on Feb. 7 that they reached an agreement in a lawsuit pertaining to patents for BRCA1 and BRCA2, two genes that can determine whether a person is at risk for breast and/or ovarian cancer.

As part of the settlement, Gene by Gene has agreed to stop selling or marketing clinical diagnostic tests that make use of BRCA1 and/or BRCA2 analysis, but only in North America. Gene by Gene will continue to offer the testing outside of North America.

Additionally, Gene by Gene will still provide its “whole genome and exome products and services” as well as other testing products for other inherited disorders that include the BRCA gene analysis.

In exchange for these concessions, Myriad and the other plaintiffs have dismissed the patent infringement case against Gene by Gene without prejudice. The arrangement will stand until Feb. 12, 2016 or until the last BRCA1 and BRCA2 patent claim relevant to the case expires.

Gene by Gene started offering BRCA1 and BRCA2 testing in June 2013 after the Supreme Court ruled that products of nature, such as genes, cannot be patented. Though the Court cited BRCA1 and BRCA2 in its ruling, the decision did not address every single aspect of the patents.

In response to Gene by Gene’s action, Myriad filed the now-settled lawsuit against the company the following month.

“When you get a patent, you have the right to exclude people from doing things with the patented material,” Lee Petherbridge, a 2002 Penn Law graduate and professor at Loyola Law School, said. “These limitations are enumerated in the patent documents ... the Supreme Court’s decision was only directed at a small number of these claims, not the majority,” Petherbridge explained.

The suit alleged that Gene by Gene infringed upon nine BRCA1/ BRCA2 patents that were either owned by or exclusively licensed to Myriad. Two of the patents named in the suit are co-owned by Penn.

“We believe the settlement with Gene by Gene is a good and responsible agreement,” Ronald Rogers, a spokesperson for Myriad, said in a statement. “It is in the best interest of the parties because it ends the uncertainty and expense [of] ongoing litigation.”

“Myriad and the other owners of the BRCA patents at issue ... continue to believe that these patent claims related to BRCA1 and BRCA2 gene testing are valid and enforceable,” he added.

“We are pleased that this matter has been amicably resolved,” Susan Phillips, a spokesperson for Penn Medicine, stated.

Officials from the University of Utah Research Foundation, HSC and Endorecherche were unavailable for comment.

The lawsuit against Gene by Gene was one in a series of court actions that Myriad took last year in the wake of the Supreme Court’s decision. Both Myriad and Penn are involved in ongoing lawsuits against GeneDx, Quest Diagnostics, Invitae, LabCorp and Ambry Genetics, all of which concern the BRCA1 and BRCA2 patents.

“We are in the early stages of the litigation regarding all the other infringement cases,” Rogers said.

Since the lawsuits are “independent,” it is not likely that Myriad’s settlement with Gene by Gene will impact the other pending lawsuits, Richard Gold, a professor at McGill University’s Faculty of Law, explained.

“Gene by Gene likely made the business determination that it was not worth fighting this since others will do so and there are only two years left on the patents,” Gold said. “Myriad’s case is not, in my opinion, strong but as litigation is expensive, Gene by Gene probably decided it was not worth the expense of fighting at this time.”

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