Body of work: myriad genetics faces Supreme Court battle over patents.

• Author: Stewart, Heather
• Position: Techknowledge

A Utah life science company soon will be a microscope as the U.S. Supreme Court weighs in on a challenge to its patents. Myriad Genetics will be defending itself against an objection to the idea that it can patent an isolated DNA molecule.

Is DNA a product of nature that no one can own rights to? Or is it the result of inventive research and processes that can be patented? The answer to these questions will have far-reaching impacts on life science companies, researchers, the healthcare industry and patients.

Origins of the Dispute

Myriad Genetics was born out of a collaboration with researchers at the University of Utah, the National Institutes of Health and other academic researchers. Together, they sequenced BRCA1, a gene associated with an increased risk for hereditary breast cancer. The company later sequenced BRCA2, another breast cancer gene, and patented both BRCA1 and BRCA2 in concert with the University of Utah Research Foundation.

Myriad then developed a predictive test for breast and ovarian cancer associated with these genes, and that test, BRACAnalysis, has proved lucrative for the company. In total, the BRACAnalysis tests brought the company $405 million in revenue for fiscal year 2012, according to Myriad's annual report.

The lawsuit was brought by the Association for Molecular Biology (AMP), along with several university researchers, patient advocacy groups and individual patients. These plaintiffs, who are represented by the American Civil Liberties Union, say that genes should not be patentable, and that such patents stifle additional research and drive up costs for patients and the healthcare system.

The case was originally decided in the plaintiffs' favor by the U.S. District Court in New York, but Myriad appealed to the Federal Circuit Court. That court reversed the original decision, and then upheld the reversal upon a second review.

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At that point, the ACLU requested the U.S. Supreme Court hear an appeal of the case. In late 2012, the Supreme Court agreed to hear the case and is expected to do so this session.

The Battle Lines

The plaintiffs' chief argument is that "you can't patent naturally occurring items--chemicals, compositions that occur in nature," says Grant Foster, partner with Holland & Hart. Foster, who is not part of the case, is registered to practice before the U.S. Patent and Trademark Office and has extensive experience litigating patent infringement cases.

If the patents were...