Both sides presented oral arguments supporting motions for summary judgment before U.S. District Judge Robert Sweet at a Feb. 2 hearing in New York City, marking the first time that a challenge to gene patenting has been heard in federal court.

The core of the case is whether the patent claims cover "products of nature" and "laws of nature" and are therefore invalid. The lawsuit, Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al, was filed in May 2009 by the American Civil Liberties Union (ACLU) on behalf of an estimated 150,000 researchers, physicians, laboratory professionals, and patients.

The suit also alleged that the patents violate the First Amendment by giving exclusive control of the BRCA knowledge to patent holders, restricting scientific research, the development of new tests, and patients’ access to medical care, including the right to a second opinion on test results.

Speaking for Myriad, Brian Poisssant said, “This is not a patent on information. This is a patent on a chemical composition.” The U.S. Patent and Trademark Office has ruled that genes can be patented if they are “isolated from their natural state and purified.” Myriad says its patents cover how to sequence the gene to identify its components, then map that sequence to look for mutations indicative of cancer.

The ACLU’s Chris Hansen retorted that “isolating” a gene, no matter how difficult and ingenious, does not alter the structure of the DNA itself, and so what has been patented is indeed a product of nature. “Uncovering a law of nature — while deserving of praise for the time, ingenuity, and hard work that it takes — is not patentable. Einstein certainly deserved praise and awards for discovering E = mc2, but he could not patent it.”

Myriad said a decision to invalidate the patents would “lead to the invalidity of thousands of biotechnology patents, and effectively unravel the foundation of the entire biotechnology industry. Numerous therapeutic drugs and diagnostic tests in development would be jeopardized.”

Judge Sweet’s decision is expected in the next few months, the ACLU said. It is likely to be appealed to a court in Washington, D.C., that specializes in patent law, according to legal sources following the case.

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