Myriad Genetics stymied in BRCA breast cancer test patent battle

Myriad Genetics ($MYGN) lost big in its fight to keep competing breast cancer DNA tests off the market, as a U.S. appeals court ruled that its patents are not eligible for legal protection.

As Bloomberg reports, a three-judge panel in the U.S. Court of Appeals for the Federal Circuit found that three patents for Myriad's BRCA1 and BRCA2 breast cancer genetic tests should have never been issued, and affirmed a trial judge's decision to allow competing products, including those made by companies such as Ambry Genetics and Quest Diagnostics ($DGX), to remain on the market. Salt Lake City, UT-based Myriad had been the only company offering the tests until the U.S. Supreme Court last year exempted human genes from patent protection. The company's patent claims in this case were similar to those invalidated by the high court, the U.S. appeals panel ruled.

"They are structurally identical to the ends of DNA strands found in nature," Circuit Judge Timothy Dyk wrote for the panel, as quoted by Bloomberg. "A DNA structure with a function similar to that found in nature can only be patent eligible as a composition of matter if it has a unique structure, different from anything found in nature."

Myriad is staying mum about a potential appeal, but said that it was disappointed in the court's ruling. "We are currently reviewing the decision and will consider all of our options," Ron Rogers, a Myriad spokesman, told Bloomberg.

The company's courtroom drama dates back to 2013, when the U.S. Supreme Court nullified 5 of Myriad's patents on isolated genes for its BRCA tests for breast cancer. Companies like Ambry Genetics and Gene By Gene launched BRCA tests of their own, spurring a patent infringement lawsuit from Myriad. But the company's rivals struck back, claiming that Myriad's patent claims were unfounded and that it was suing to monopolize the BRCA market.

Myriad and at least one rival outfit, Gene By Gene, settled the score in their ongoing feud, agreeing in February to resolve their differences over BRCA cancer tests. As part of the deal, Texas-based Gene By Gene said it wouldn't sell or market tests in North America that cover the analysis of BRCA1 and BRCA2 as a standalone diagnostic, but could sell the products outside of North America.

Although the recent ruling does not bode well for Myriad, the company continues to forge ahead R&D for its cancer diagnostics and diversify its portfolio. In March, Myriad touted promising data from a study demonstrating that 65% of physicians changed their initial treatment plan for prostate cancer patients after consulting results from a Prolaris test. In November, the company inked an expanded deal with pharma giant AbbVie ($ABBV) to use its tumor companion diagnostic product with AbbVie's veliparib to help detect breast cancer.

- read the Bloomberg story

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