Nonobviousness Standard for Promoting Ongoing Drug Discovery: A Lesson from Sanofi-Aventis U.S., LLC v. Dr. Reddy`s Laboratories, Inc.

Abstract

This article explores Sanofi-Aventis U.S., LLC v. Dr. Reddy’s Laboratories, Inc., 933 F.3d 1367, 1375 (Fed. Cir. 2019), and focuses on the issue of nonobviousness under 35 U.S.C. § 103. The Federal Circuit has developed the lead compound analysis for determining whether a pharmaceutical compound is obvious in view of a lead compound and other prior art references. The key question is whether an ordinary skilled chemist would have a motivation or reason to select a lead compound and modify it to arrive at the claim compound. The Sanofi-Aventis court further provided an evidentiary rule that the motivation or reason should be based on both the structural similarity of tested prior art compounds and the test results of these compounds. This article argues that the Sanofi-Aventis approach not only follows the Supreme Court’s principles, but also is beneficial to ongoing drug development.