Galderma Labs., L.P. v. Amneal Pharms. LLC

The Federal Circuit affirmed an infringement finding on one set of patents-in-suit and reversed an infringement finding on another.

March 25, 2020

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name: Galderma Labs., L.P. v. Amneal Pharms. LLC, No. 2019-1021, 2020 U.S. App. LEXIS 9341 (Fed. Cir. Mar. 25, 2020) (Circuit Judges Lourie, Moore, and Stoll presiding; Opinion by Moore, J.) (Appeal from D. Del., Stark, J.)

Drug Product and Patent(s)-in-Suit: Oracea® (doxycycline); U.S. Patents Nos. 8,206,740 (“the ’740 patent”), 8,394,405 (“the ’405 patent”), and 8,470,364 (“the ’364 patent”) (collectively, the Chang Patents), and U.S. Patents Nos. 8,603,506 (“the ’506 patent”) and 9,241,946 (“the ’946 patent”) (collectively, the Ashley II Patents).

Nature of the Case and Issue(s) Presented: The Chang and Ashley II Patents claimed low-dose doxycycline formulations to treat, among other diseases, acne or rosacea. Plaintiffs alleged that Defendants infringed the patents-in-suit under the doctrine of equivalents. The Chang patents described compositions of doxycycline with an immediate-release (IR) component and a delayed-release (DR) component, combined into one unit for once-daily dosing. In a previous inter partes review proceeding, the Board disagreed with Plaintiff’s position that the DR portion of the pharmaceutical composition “requires no substantial release from the [DR] portion until some time other than promptly after administration – and in particular, until after the DR portion passes through the acidic stomach and sections of the GI tract below pH 4.5” (emphasis in opinion). Instead, the Board construed the claims to mean that the DR component of the claimed pharmaceutical composition “is not limited to formulations requiring that there be no substantial release in the stomach” and “[t]he portion of the ’740 patent specification upon which [Patent Owner] relies to support its narrower construction addresses properties of ‘enteric coated pellets,’ not a delayed-release component” and as such did not provide a basis for distinguishing the claims. The District Court adopted a similar construction as the Board’s, and found that Defendant’s product contained the equivalent of the claimed 10 mg DR portion. On appeal, the Federal Circuit affirmed the District Court's decision regarding infringement under the doctrine of equivalents of the asserted Chang patents and reversed as to the doctrine of equivalents infringement of the Ashley II patents.

Why Plaintiff’s Prevailed: On appeal, Defendants argued argument-based estoppel as to the Chang patents, pointing to Plaintiff’s representations to the Board during the IPR to the effect that infringing formulations should not encompass ones that began dissolving in the stomach. The Federal Circuit rejected this argument, finding no disclaimer where Plaintiff’s statements were “clearly and expressly rejected by the Patent Office” and the record thus “clearly put the public on notice that the meaning of delayed release with respect to the Chang Patents is not limited to formulations requiring that there be no substantial release in the stomach.” As to the Ashley II patents, Defendants argued that Plaintiff’s presented no argument or evidence regarding the doctrine of equivalents, which requires “particularized testimony and linking argument as to the ‘insubstantiality of the differences’ between the claim invention and the accused process.” The Federal Circuit agreed with Defendants, noting that Plaintiff did not present particularized testimony and linking argument as to its doctrine of equivalents argument and that record “wholly lacked the requisite particularized testimony.”


Oren D. Langer


Assistant Managing Partner, New York Office
Member of Executive Board

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