Judge Hears Arguments In Challenge To Patents On Genes Tied To Breast, Ovarian Cancer

Main Category: Litigation / Medical Malpractice
Also Included In: Genetics;  Pharma Industry / Biotech Industry;  Women's Health / Gynecology
Article Date: 05 Feb 2010 - 4:00 PDT

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U.S. District Judge Robert Sweet on Tuesday considered whether to invalidate Myriad Genetics' patents on two genes associated with an increased risk of breast and ovarian cancers in a lawsuit that could have far-reaching implications for the biotechnology industry and genetics-based research, the AP/ABC News reports. In March 2009, the American Civil Liberties Union and the Public Patent Foundation filed suit in the U.S. District Court in Manhattan against Myriad, the University of Utah Research Foundation and the U.S. Patent and Trademark Office. After hearing arguments from both sides Tuesday, Sweet declined to immediately rule (Neumeister, AP/ABC News, 2/3).

The government more than a decade ago granted Myriad the patent on the BRCA1 and BRCA2 genes, as well as the company's genetic test that measures a patient's risk for the cancers (Women's Health Policy Report, 5/14/09). ACLU and the patent foundation on Tuesday argued that patents on genes are unconstitutional. The Patent Office allows patents on genes as soon as the DNA is isolated from the cell, according to ACLU attorney Sandra Park. "We're arguing that isolating it does not make it patentable," she said, adding, "It's a natural phenomenon, and the Supreme Court has always said natural phenomena are not patentable."

The plaintiffs also argue that because all humans have genes, the patents infringe on freedom of scientific inquiry and the free exchange of ideas, as well as undermine a person's right to know about his or her genetic makeup. They contend that gene patents make cancer research more difficult by requiring scientists to obtain licenses from the patent holder.

Myriad general counsel Rick Marsh said, "Without the patents, there wouldn't have been the financial incentive" to create the tests (Weise, USA Today, 2/3). Attorney Brian Poissant, also representing the defendants, argued that the patents are particularly justified because they apply to the process that was developed to isolate chemical composition. He also said that invalidating the patents could lead to the reversal of thousands of other genetic patents and cripple the biotech industry (AP/ABC News, 2/3).

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