Gene Patents Under Review

The Supreme Court last week voided an appeals court ruling that allows human genes to be patented. The justices further instructed the U.S. Court of Appeals for the Federal Circuit, in Washington, D.C., to reconsider its July 29, 2011, decision.

That appelate court decision allowed patents on two “isolated” human genes used in tests for breast and ovarian cancer developed by Myriad Genetics, a biotechnology company based in Salt Lake City.

In its 2011 ruling, the Federal Circuit overturned a March 2010 decision by the U.S. District Court for the Southern District of New York that ruled the patents had been improperly granted because they encompassed nothing more than a “law of nature.”

The Federal Circuit said in its decision that the genes isolated by Myriad are eligible for patent protection because the company is testing for distinctive chemical forms of the genes, which are not as they appear naturally in the body.

In a terse order, the Supreme Court nullified that decision and sent the case back to the appellate court for further consideration in light of the justices’ ruling on March 20 in a similar dispute. In that case, the justices invalidated gene-related patents on a medical test held by Prometheus Laboratories, ruling the patents were ineligible because they simply described naturally occurring activities in the body ( see page 20). Natural phenomena cannot be patented.

Myriad holds patents on two genes: BRCA1 and BRCA2. Its BRACAnalysis screen looks for gene mutations in extracted DNA that indicate a high risk of a woman developing breast or ovarian cancer.

The American Civil Liberties Union (ACLU) filed a lawsuit against Myriad in 2009 that sought to have the patents invalidated, arguing that genes are “products of nature.” The suit contends that the patents stifle research and limit access to potentially lifesaving genetic tests for at-risk women.

Peter D. Meldrum, president and CEO of Myriad, says the case is important to the medical, pharmaceutical, and biotechnology industries, and to the “hundreds of millions of people whose lives are bettered by the products these industries develop based on the promise of strong patent protection.”