Product of Nature Doctrine: Myriad's Effect Beyond Nucleic Acids

Abstract

Subject matter eligibility doctrine is dubbed “the ‘substantive due process’ of patent law.” And this is not without good reason. The Patent Act of 1952 broadly details categories of eligible subject matter, but the wrinkles appear in the judicially-created exceptions that are excluded from eligible subject matter: “laws of nature, physical phenomena, and abstract ideas.” From these exclusions, the products of nature doctrine evolved. Though recent scholars question this doctrine’s foundation in case law, it can be traced back to 1889. Broadly, this doctrine excludes from patent-eligible subject matter products of nature. Within this doctrine, though, is the “isolation or purification” exception: Some courts permit patenting of “purified” or “isolated” natural products. The USPTO embraced this line of decisions in 2001, and issued revised Utility Examination Guidelines supporting the eligibility of patents covering isolated, naturally-occurring DNA. This exception also extends to isolated stem cells, and isolated amino acid products (e.g., proteins, antibodies, polypeptides). The patent-eligibility of isolated DNA recently came under attack in Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F. Supp. 2d 181 (S.D.N.Y. 2010). The ACLU, along with other plaintiffs, challenged Myriad’s patents covering, inter alia, the isolated BRCA1/2 gene and gene segments, and the corresponding cDNA, arguing that the claims covered products of nature outside the scope of §101. The case has made its way to the Supreme Court. Both parties, and the Government in an amicus brief, interpret the product of nature doctrine as applied to isolated nucleic acids. However, no brief considers the effect of this holding on products other than nucleic acids. This Paper fills the void by conducting an empirical study that quantifies the effect of the narrow view of the product of nature doctrine that disallows patents on natural products based on or purification. Part I traces the product of nature doctrine from its inception to the 2001 USPTO Utility Guidelines. Part II details the Myriad litigation, from the district court through oral arguments in front of the Supreme Court, and outlines the Government’s and each party’s position on the product of nature doctrine. Part III presents the results of a novel empirical study that analyzes each recently issued patent containing “isolated” or “purified” in the claims to determine whether the patent would pass the ACLU’s stringent test for the subject matter eligibility that effectively reads out the isolation or purification exception from the products of nature exclusion. Surprisingly, this study finds that the vast majority of patents would be ineligible.