DOJ Says No to Isolated Gene Patents
The Department of Justice (DOJ) has submitted an Amicus Curiae brief regarding the appeal pending before the federal circuit, Association for Molecular Pathology v. USPTO (Myriad). The DOJ frames the question before the Federal Circuit as (1) whether “human-engineered DNA molecules, such as cDNAs, are patent-eligible subject matter,” and (2) whether “isolated but otherwise unmodified genomic DNA is patent-eligible subject matter.” The department draws a distinction between isolated genomic DNA and that which has undergone human manipulation, such as cDNA.
Contrary to long-standing policy, the DOJ considers isolated genomic DNA to be outside the scope of patentable subject mater under 35 U.S.C. § 101. However, the DOJ supports reversal of the district court’s declaration that the method claims are unpatentable abstract ideas. The brief draws the distinction between “products of nature” and “human-made inventions,” such that composition of matter claims should be patent-eligible for manmade compositions including “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.”
The brief goes on to state, “Genomic DNA itself, however, is a product of nature that is ineligible for patent protection, whether or not claimed in ‘isolated’ form.” The DOJ’s reasoning is contrary to the USPTO guidance on patentability, Utility Examination Guidelines, 66 Fed. Reg. 1092, 1093 (Jan. 5, 2001), which states, “DNA molecules are eligible for patents when isolated from their natural state and purified or when synthesized in a laboratory from chemical starting materials.” It remains to be seen whether the USPTO will be bound by the policies contained in this brief, as no lawyer from the Patent Office is listed on the brief.
