Federal Circuit Weighs in on Applicability of Prosecution History Estoppel in View of Statements Made During Co-pending IPR
In Galderma Laboratories, L.P. v. Amneal Pharmaceuticals LLC, No. 19-1021, 806 F. App’x 1007 (Fed. Cir. 2020) [hereinafter “Op.”], the Federal Circuit recently revisited the issue of whether arguments during proceedings before the Patent Trial and Appeal Board (PTAB) can result in a surrender of claim scope in district court proceedings. The court’s rationale in holding that Galderma was not estopped due to unsuccessful arguments made during inter partes review (IPR) proceedings provides helpful guidance for parties in the common position of facing actions both in district court and before the PTAB.
Amneal’s Unsuccessful IPR Challenges to the Chang Patents
In 2011, Amneal filed an Abbreviated New Drug Application (ANDA) for its generic version of Oracea, an orally administered medication (in pill form) for treating acne. Galderma Labs., L.P. v. Amneal Pharms. LLC, No. 1:16-cv-00207-LPS, Compl. ¶ 42 (D. Del.). In June 2013, Amneal filed IPR petitions against three Galderma patents related to Oracea (the “Chang Patents”). Appellant’s Opening Br. 14 & n.3; J.A. 17018. The Chang Patents are all directed to particular formulations of Oracea in which one portion of the pill (30 mg) is an “immediate release” component, and another portion (10 mg) is a “delayed release” component. Op. 3.
Amneal sought to invalidate the Chang Patents in view of a combination based primarily on U.S. Patent No. 5,348,748 (“Sheth”). Id. at 3–4. Galderma responded by attempting to distinguish Sheth on the grounds that the claim term “delayed release (DR) portion” requires that there be no “substantial release” until after the pill passed through the stomach and upper gastrointestinal tract. Id. By contrast, Galderma argued, Sheth disclosed formulations where the alleged delayed release potion (the “‘secondary loading’ portion”) was intentionally designed to “leak” in the stomach. Id. at 4.
The PTAB disagreed with Galderma’s proposed construction, instead concluding that “delayed release” (under a “broadest reasonable interpretation standard) was more properly construed as requiring release only “at a time other than immediately following oral administration.” Id. at 5 (emphasis added). However, because Sheth disclosed water-soluble coatings permitting at least some release immediately after administration, the PTAB found that, under the appropriate...
