Supreme Court Orders Review Of Gene Patents | Chemical & Engineering News
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Web Date: March 27, 2012

Supreme Court Orders Review Of Gene Patents

Intellectual Property: Patentability of DNA-based inventions is at stake in closely watched case
Department: Government & Policy
News Channels: Biological SCENE
Keywords: human gene patents

On Monday, the Supreme Court set aside an appeals court ruling that allows human genes to be patented and ordered that court to rehear the case.

The justices instructed the U.S. Court of Appeals for the Federal Circuit, in Washington, D.C., to reconsider its July 29, 2011, decision that allowed patents on two “isolated” human genes used in tests for breast and ovarian cancer developed by Myriad Genetics, a biotech company 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 the company are eligible for patent protection because Myriad is testing for distinctive chemical forms of the genes, and not as they appear naturally in the body. “The claims cover molecules that are markedly different—have a distinctive chemical identity and nature—from molecules that exist in nature,” the court said in its decision.

In a brief order, the Supreme Court vacated 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.

The Supreme Court has for many years limited the subject matter of patents to exclude laws of nature, natural phenomena, and abstract ideas.

Myriad holds patents on two genes: BRCA 1 and BRCA 2. Its BRACAnalysis screening test looks for gene mutations in extracted DNA that indicate a woman is at a high risk of 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.

Myriad says it will defend the claims that are the subject of the lawsuit. “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,” Myriad CEO Peter Meldrum says.

However, ACLU 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,” says Chris Hansen, ACLU staff attorney. “It’s inconceivable that a company can own a patent on something as naturally occurring as DNA.”

The case has been of great interest to the biotechnology industry, which is concerned that the loss of patent eligibility will compromise its ability to develop new products.

“Patent protection is critical for the ability of biotechnology firms to secure the private investment necessary for the research and development of innovative diagnostic, therapeutic, environmental, and agricultural products,” says James Greenwood, president of the Biotechnology Industry Organization, an industry trade association. “This innovation will lead to domestic job creation and help sustain our country’s global competitiveness.”

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