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Supreme court sets aside Myriad gene patent ruling

March 27, 2012

Last Updated: 2012-03-26 14:15:17 -0400 (Reuters Health)

By James Vicini

WASHINGTON (Reuters) - The Supreme Court set aside on Monday a ruling that Myriad Genetics Inc can patent two genes linked to breast and ovarian cancers, in a case closely watched by the biotechnology industry.

The justices set aside a ruling by the U.S. Court of Appeals for the Federal Circuit that Myriad has the right to patent two human genes, known as BRCA1 and BRCA2, that account for most inherited forms of breast and ovarian cancers, and sent the matter back for more proceedings.

The Supreme Court ordered the further proceedings at the lower court in view of the high court's ruling last week in a case that raised similar issues and that held that companies cannot patent observations about a natural phenomenon.

Women who test positive using Myriad's gene test, called BRACAnalysis, have an 82 percent higher risk of breast cancer and a 44 percent higher risk of ovarian cancer in their lifetimes.

The appeals court by a 2-1 vote ruled the genes isolated by the company can be patented because Myriad is testing for distinctive chemical forms of the genes, and not as they appear naturally in the body.

The dissenting judge said the genes could not be patented just because they were isolated from the body.

The appeals court overturned a ruling by a federal judge in New York that the genes could not be patented, a decision that caused widespread concern for the biotechnology industry. It said such patents were essential to foster innovation.

The patents granted to Myriad give the company the exclusive right to perform the genetic tests, which cost patients between $3,000 and $4,000. The appeals court in its ruling in July also found that Myriad's method for screening potential therapies can be patented.

The lawsuit filed in 2009 claimed the patents violated patent law, restricting scientific research and patients' access to medical care.

The appeal to the Supreme Court was backed by a number of organizations representing health care professionals, including the American Medical Association, and other groups.

The appeal argued that the question of whether genes and the information they convey can be patented is of "paramount importance to the future of patent law, the advancement of medical science and patients' health."

Myriad opposed the appeal. Its shares rose more than 2 percent after the Supreme Court's order.

The attorney representing the company, Gregory Castanias, told the Supreme Court that patents involving isolated DNA molecules have been issued for nearly 30 years, resulting in significant investment by biotechnology companies.

Castanias said the challenged patents at issue in the case were filed more than 16 years ago. He said the appeals court's decision was correct and the "questions presented are unique to this case, factbound and unlikely to recur."

The Supreme Court case is the Association for Molecular pathology v. Myriad Genetics, No. 11-725.

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Supreme court sets aside Myriad gene patent ruling

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