The U.S. Department of Justice has filed an amicus brief in a lawsuit pending before the Federal Circuit Court of Appeals to address the question of whether and to what extent genetic discoveries may be patented. The Ass’n for Molecular Pathology v. U.S. Pat. & Trademark Office (Myriad Genetics, Inc.), No. 2010-1406 (Fed. Cir., filed October 29, 2010).

Public reaction to the government’s argument that genomic DNA isolated from the human body, without further alteration or manipulation, should not be eligible for patents was swift; some argued that the policy will “undermine U.S. global leadership and investment in the life sciences,” while others applauded the decision, claiming such patents would hamper medical progress and force individuals to pay for access to information about themselves. According to the government, “The chemical structure of native human genes is a product of nature, and it is no less a product of nature when that structure is ‘isolated’ from its natural environment than are cotton fibers that have been separated from cotton seeds or coal that has been extracted from the earth.”

The government also contends that “the district court erroneously cast doubt on the patent-eligibility of a broad range of man-made compositions of matter whose value derives from the information-encoding capacity of DNA. Such compositions—e.g., cDNAs, vectors, recombinant plasmids, and chimeric proteins, as well as countless industrial products, such as vaccines and genetically modified crops, created with the aid of such molecules—are in every meaningful sense the fruits of human ingenuity and thus qualify as ‘humanmade inventions’ eligible for patent protection under section 101.” Not only is manipulated material patentable, according to the government, so are “[n]ew and useful methods of identifying, isolating, extracting, or using genes and genetic information . . . (subject to the prohibition against patenting abstract ideas), as [is] nearly any man-made transformation or manipulation of the raw materials of the genome.”

Briefing in the case should be completed in mid December 2010, and the case will then be scheduled for oral argument. See The New York Times, November 1, 2010.