Myriad Loses Appeals Court Bid to Block Breast Cancer Tests

by jeeg 18. December 2014 00:54


Myriad Genetics Inc. can’t block competitors’ DNA tests to determine risk for breast and ovarian cancer after a U.S. appeals court said three patents on the tests never should have been issued.

The patents cover products of nature and ideas that aren’t eligible for legal protection, the U.S. Court of Appeals for the Federal Circuit said in an opinion posted today on the court’s docket. The court upheld a trial judge’s decision to allow the competing tests, including those made by Ambry Genetics Corp., to remain on the market.

The tests check genes known as BRCA to determine if there is a hereditary risk of developing the diseases. Myriad had been the only company offering the tests until the U.S. Supreme Court last year limited the ability to obtain patents on human genetic sequences. Some patent claims in this case were similar to those invalidated by the high court, a three-judge panel ruled.

“They are structurally identical to the ends of DNA strands found in nature,” Circuit Judge Timothy Dyk wrote for the panel. “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.”

Other claims, involving diagnostic methods, “do nothing more than spell out what practitioners already knew -- how to compare gene sequences using routine, ordinary techniques,” Dyk said in the opinion.

Myriad Disappointed

Myriad said it was disappointed in the decision.

“We are currently reviewing the decision and will consider all of our options,” Ron Rogers, a Myriad spokesman, said.

Public awareness of the tests has grown since Academy Award-winning actress Angelina Jolie said she had a double mastectomy after Myriad’s product showed she had a mutation linked to the cancer that killed her mother at 56. Myriad gets the majority of its revenue from the tests, though it has been expanding into other types of tests, such as one for prostate cancer.

In saying the patents are invalid, the Federal Circuit panel went beyond what it was asked -- whether the trial judge was correct to deny Myriad’s request to block competing sales.

It also illustrates how once cutting-edge steps in diagnosing diseases have become routine, said Matthew Dowd, a patent lawyer with Wiley Rein in Washington who has represented James Watson, the co-discoverer of DNA’s double helix.

Research Incentive

“You’re seeing a freeing up of research space for some of this diagnostic work,” Dowd said. “There are arguments on both sides of the aisle. There’s something to be said for incentivizing researchers to find new diagnostic tools and research methods. At the same time, if it’s just the routine use of lab tools to find different gene sequences, at least in this panel’s view, that’s not going to get a patent.”

Myriad had other patent claims in its infringement suit that weren’t part of the case heard today. Dowd said they also may be deemed invalid once the case returns to the trial judge.

The University of Utah, the University of Pennsylvania, the Hospital for Sick Children in Toronto and Endorecherche Inc., which helped develop the tests, are co-owners of the patents and also joined Myriad in filing suit.

Ambry, based in Aliso Viejo, California, and other testing companies have accused Myriad of antitrust violations, claiming it filed the patent suits to prevent competition.

The appeal is University of Utah Research v. Ambry Genetics Corp., 14-1361, U.S. Court of Appeals for the Federal Circuit (Washington).

The Ambry case is University of Utah Research Foundation v. Ambry Genetics, 13cv640, and the combined case is In Re: BRCA1 and BRCA2-based Hereditary Cancer Test Patent Litigation, 14md2510, both U.S. District Court for the District of Utah (Salt Lake City).

 Susan Decker , Bloomberg Businessweek



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