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Supreme Court sends Myriad gene decision back for review

Published March 26, 2012 7:34 pm

Genetics • Justices want Myriad patenting case reheard in light of its recent ruling.
This is an archived article that was published on sltrib.com in 2012, and information in the article may be outdated. It is provided only for personal research purposes and may not be reprinted.

In a closely watched case, the U.S. Supreme Court ordered a lower court to revisit a decision that had upheld Myriad Genetic's patents related to two human genes that drastically affect rates of breast and ovarian cancer.

The top court ordered the reconsideration in light of its recent ruling that tossed out gene-related patents held by another company.

Myriad Genetics CEO and President Peter Meldrum said the Supreme Court's action shouldn't have an adverse impact on the Salt Lake City-based company, and in fact its stock rose on Monday 2.46 percent, to $23.34, in trading. That could be because the court will not be hearing the case, instead leaving it to the presumably more patent-friendly appellate court.

But he said medical research might be affected, as might companies hoping to patent gene-related detection or treatment products.

"While this case should not have any direct impact to Myriad and its operations because of our extensive patent estate, it has great importance to the medical, pharmaceutical, biotechnology and other commercial industries, as well as the hundreds of millions of people whose lives are bettered by the products these industries develop based on the promise of strong patent protection," Meldrum said in a news release.

However, the American Civil Liberties Union, whose lawsuit is the basis of the challenge against Myriad's patents, applauded the high court's action.

"In light of recent rulings from the court that mere laws of nature cannot be patented, we hope that the lower court will come to the correct conclusion this time around," Chris Hansen, ACLU staff attorney, said in a statement. "It's inconceivable that a company can own a patent on something as naturally occurring as DNA."

The ACLU and the Public Patent Foundation sued Myriad in 2009 on behalf of researchers, medical groups, cancer victims and women's and health care advocates.

The lawsuit sought to invalidate certain parts of patents held or licensed by Myriad that were related to the BRAC1 and BRAC2 genes, mutations of which are related to high risk of breast and ovarian cancer. Myriad sells tests that detect mutations in the BRAC genes.

The ACLU argued the genes are products of nature and not eligible for patents, and that granting them had stifled research and hurt patients who might want second opinions or could not afford the $3,000 Myriad tests.

Myriad has argued that although the genes inside the body are not patented, they can be patented when they are isolated by special methods developed by the company.

A U.S. District judge in New York sided with the ACLU, but that decision was largely overturned in a 2-1 decision by the Federal Circuit Court of Appeals in Washington, D.C.

Now the Supreme Court has sent the case back to the appeals court, asking it to rehear the case in light of another high court ruling that tossed out several patents held by Prometheus Laboratories Inc.

The decision to ask the appeals court to reconsider its ruling means more delays before there is a final outcome in the case, which has been of great interest to the nation's biomedical industry. It fears that the loss of patent-eligibility will hurt its ability to develop new products by making such research unprofitable.

Myriad's patents related to the BRAC genes begin to expire in 2015, but it can continue to enforce them unless the patents are overturned in a final decision in the case.

Myriad spokeswoman Rebecca Chambers said only 15 out of more than 500 parts of the company's 23 patents have been challenged, with the rest "providing Myriad with extensive patent protection."

In the Prometheus case, the company sold diagnostic tests based on gene-related patents. The tests can tell doctors whether certain drugs administered for autoimmune diseases were at effective levels.

The Federal Circuit Court had overturned a lower-court ruling that went against Prometheus. But the Supreme Court held that the processes for measuring drug effectiveness simply described naturally occurring activities in the body and were not eligible for patenting.

Justice Stephen Bryer, who authored the unanimous court decision against Prometheus, wrote, "We conclude that the patent claims at issue here effectively claim the underlying laws of nature themselves. The claims are consequently invalid."

The New York Times contributed to this story.

tharvey@sltrib.com

Twitter: @TomHarveySltrib #uttech