What Are The Top Hatch-Waxman And BPCIA Developments For July 2018?

This month, we highlight significant developments from July 2018, including the FDA’s Biosimilar Action Plan for “reducing gaming of FDA requirements or other attempts to unfairly delay competition” and the much anticipated Federal Circuit decision on tribal sovereign immunity in inter partes review (IPR) proceedings.

CASES

FEDERAL CIRCUIT

FDA Advisory Committee Materials Qualify as 102(b) Prior Art

Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, 07/13/18 (Fed. Cir. Nos. 2017-1671, 2017-1673, 2017-1674, 2017-1675, 2017-1676, 2017-1677, 2017-2075)

In this consolidated appeal from decisions invalidating as obvious certain claims in six IPRs, appellant argued that the PTAB erroneously found certain FDA advisory committee materials qualified as printed publication prior art. The Federal Circuit affirmed, holding that substantial evidence supported the PTAB’s finding. The advisory committee meeting at issue was announced in the Federal Register