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Big Pharma to Face Off at Federal Circuit Oral Arguments Over Antibody Genus Patentability

Reported by Caitlin Wilmot on

Caitlin Wilmot summarizes the issues in, Amgen Inc. v. Sanofi, an upcoming case that will be heard by the Federal Circuit on December 9th concerning the enablement requirement. The dispute concerns two patents on Amgen’s cholesterol-lowering drug, Repatha. The patents were found to be invalid for lack of enablement by US District Judge Richard G. Andrews. Judge Andrews found that it would take undue experimentation to practice the full scope of the inventions as described in the patents. Caitlin Wilmot summarizes the broader implications as follows:

The question of antibody genus patentability raises unique challenges considering the industry of big pharma and the research and development efforts that goes into antibody-based drugs. On one hand, antibody development has been described as extremely costly, complex, unpredictable, and time-consuming, such that it makes more sense for a company to seek patent protection for the genus as soon as they have a discernible universe of antibody species. But on the other hand, as Sanofi argues, allowing such broad claims to antibodies not actually discovered may be just a strategic means to stifle competition.

No Patent? No Problem! The Federal Circuit Paves The Way For Non-Patent Owners To Sue Infringers

Reported by Intellectual Property Team at Vedder Price on

This article summarizes a recent Federal Circuit decision that concerns what happens in a patent lawsuit when not all of the parties that have an ownership interest in a patent are joined as plaintiffs. In its opinion in Lone Star Silicon Innovations LLC v. Nanya Tech. Corp., the Intellectual Property Team at Vedder Price argues that the Federal Circuit reframed the issue of failure to join a patent owner from one of standing to a defense on the merits. In light of AntennaSys, Inc. v. AQYR Technologies, Inc., the authors conclude that lack of joinder may now be treated as an affirmative defense subject to waiver. The authors speculate that:

The new rule that objections to having the patent owner (or all patent owners) as a plaintiff is a waivable defense raises a number of worrisome questions. One obvious result is if a co-owner tries to enforce a patent without joining or notifying the other co-owner(s), and the defendant does not raise the issue, and the other co-owner(s) do not intervene, the absent co-owner’s rights might be litigated without their knowledge.

Federal Circuit Tries To Demystify Venue in Hatch-Waxman Actions

Reported by Scott J. Bornstein and Giancarlo L. Scaccia on

In Valeant Pharms. N. Am. v. Mylan Pharms., the Federal Circuit attempted to clarify where “acts of infringement” for venue purposes under §1400(b) occur in Hatch-Waxman actions. The plaintiff, Valeant argued that “acts of infringement” extended to planned future conduct. In contrast, the court held that acts of infringement occur “only in districts where actions related to the submission of an Abbreviated New Drug Application (ANDA) occur, not in all locations where the future distribution of the generic products specified in the ANDA is contemplated.” The authors conclude that:

[a]lthough this decision provides some clarity on venue in Hatch-Waxman cases, it leaves open several questions that could impact branded and generic litigants. Whether this decision will have any far-reaching implications, however, remains to be seen.