Myriad reaches agreement with Gene by Gene on BRCA patent

Myriad Genetics reached an agreement with Gene by Gene that will keep the smaller provider of laboratory tests from selling stand-alone BRCA testing in the U.S. for at least two years.

Until last year, Myriad, based in Salt Lake City, was the sole provider of tests for the BRCA1 and BRCA genes, which are associated with higher risks of hereditary breast and ovarian cancer.

The Supreme Court in June ruled that companies cannot patent human DNA, which opened the door for new entrants into the BRCA testing market. The ruling was applauded by patient advocates and clinicians who argued that Myriad's high prices and refusal to share BRCA data had a negative impact on patient care.

Myriad filed lawsuits against at least seven companies— Ambry Genetics, Gene by Gene, Invitae, Laboratory Corporation of America, Quest Diagnostics, Counsyl and GeneDx—after they announced plans to market BRCA testing, according to securities filings. Other companies, including Pathway Genomics and Genome Liberty, have decided not to enter the market because of the risk of lawsuits.

Much is at stake for Myriad. The BRCA tests generated 75% of Myriad's revenues in its past fiscal year.

Several of the companies have said they planned to lower the price of BRCA testing. Myriad charges about $3,300 to test for the BRCA1 and BRCA2 genes.

Under the terms of the agreement with Gene by Gene, the Houston-based company can continue to market BRCA testing outside of the U.S. Within the U.S. the company can continue to offer its whole genomic and exome products and services, some of which include testing for the BRCA genes.

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

The other owners of the patent along with Myriad include the University of Utah Research Foundation, the HSC Research and Development Limited Partnership, Endorecherche and the University of Pennsylvania.

Gene by Gene announced that it planned to offer BRCA testing on June 13, the same day the ruling was issued. Myriad sued the company a month later, alleging that Gene by Gene's testing process infringed on certain claims in patents covering synthetic DNA and methods of use related to the BRCA1 and BRCA2 genes.

“I think it's a reasonable compromise,” David Mittelman, Gene by Gene's chief scientific officer, said in an e-mail. “We can sell array, exome and whole genome products unrestricted—all of which can report BRCA gene changes. However, for the single BRCA test product, we will sell outside North America until patents are invalidated or expired, which ever happens first.”

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