Amgen Enablement and its Undue Burden on an Overburdened Biomedical Industry.

Abstract

This paper examines the Supreme Court decision in Amgen Inc. v. Sanofi and its profound impact on the patentability of biotechnology inventions, particularly biologic drugs. By virtually eliminating the possibility of claiming genera patents, the decision exacerbates existing challenges within the biologic sector, including high development costs and rigorous regulatory hurdles. The analysis sets forth the enablement requirement's precedent, emphasizing historical case law and the unforeseen implications of setting a stringent standard for biotechnology patents. This paper further critiques suggested industry compromises, deeming them insufficient to address the ramifications of Amgen, and proposes legislative intervention. Options include granting biologics a special exemption from Amgen's requirements or implementing temporary exclusivity periods analogous to the Orphan Drug Act--aimed at balancing public disclosure and innovation incentives. The article argues that without such measures, the research and development of new biologic drug classes may decline significantly, contrary to the Framers' intent of promoting progress through limited monopolies as established in the Constitution.