Brief of Amicus Curiae Law Professor Christopher M. Holman in Support of Neither Party in Ariad v. Eli Lilly
Federal Circuit Court of Appeals, 2009 WL 3711551
42 Pages Posted: 13 Nov 2009 Last revised: 5 May 2020
Date Written: October 13, 2009
Regents of the University of California v. Eli Lilly established a novel interpretation of the written description requirement, referred to herein as Lilly written description (LWD), which unlike traditional written description applies to originally filed claims. The LWD test for “possession” has in the vast majority of cases been applied in a manner that is essentially redundant with the enablement requirement. However, LWD can and sometimes does function as a super- enablement requirement for patent claims reciting proteins and DNA sequences. With respect to these claims, LWD has sometimes been applied in a manner that imposes biotechnology-specific requirements of “possession” more stringent than the enablement requirement, referred to in this brief as the "species possession requirement" and the "genus possession requirement." These biotechnology-specific possession requirements have been applied in an inconsistent and arbitrary manner lacking any basis in science, and at times precluding adequate patent protection for important inventions relating to proteins and DNA molecules.
Assessing the degree of disclosure necessary to support the patenting of biotechnological inventions, and achieving optimal claim scope for genus claims reciting proteins and DNA, are undoubtedly challenging and important issues that patent law must address in order to maintain adequate incentives for innovation without unduly inhibiting subsequent innovators. But the enablement requirement, which prior to Lilly was invoked as a potent and largely effective doctrinal tool for calibrating biotechnological patent claims to a scope commensurate with the disclosure, is better suited to the task. In deciding Ariad v. Eli Lilly, the en banc Federal Circuit should rule that there is no Lilly written description requirement applicable to originally filed claims.
Keywords: Ariad, Eli Lilly, biotechnology, patent law, written description requirement, amicus
JEL Classification: J3, O3
Suggested Citation: Suggested Citation