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Eagle Pharms. Inc. v. Slayback Pharma LLC

United States Court of Appeals for the Federal Circuit

May 8, 2020, Decided

2019-1924

Opinion

Reyna, Circuit Judge.

Eagle Pharmaceuticals appeals a district court judgment of non-infringement on the pleadings. Eagle sued Slayback Pharma LLC for infringing four patents covering Eagle's brand name bendamustine pharmaceutical product. Eagle argues that the district court committed two errors when it concluded that the dedication-disclosure doctrine barred Eagle's claim of infringement under the doctrine of equivalents. First, Eagle contends that the district court erred when it concluded that the asserted patents disclose, but do not claim, ethanol—and [*2]  therefore dedicated ethanol to the public. Second, Eagle contends that the district court improperly applied the dedication-disclosure doctrine at the pleadings stage, in the presence of factual disputes and without drawing all inferences in Eagle's favor. Because we find no error in the district court's judgment on the pleadings, we affirm.

Background

Eagle Pharmaceuticals Inc. ("Eagle") filed suit in the U.S. District Court for the District of Delaware accusing Slayback Pharma LLC ("Slayback") of infringing four patents under the doctrine of equivalents.1 Eagle's infringement claims stem from Slayback's new drug application ("NDA") for a generic version of Eagle's branded bendamustine product, BELRAPZO®. J.A. 105. Bendamustine is used to treat chronic lymphocytic leukemia and indolent B-cell non-Hodgkin lymphoma.

For purposes of this appeal, Eagle's four asserted patents share essentially the same written description and all independent claims recite essentially the same limitations. The parties agree that Claim 1 of U.S. Patent No. 9,572,796 ("the '796 patent"), shown below in relevant part, is representative. 2

1. A non-aqueous liquid composition comprising:

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2020 U.S. App. LEXIS 14696 *; 958 F.3d 1171; 2020 U.S.P.Q.2D (BNA) 10493

EAGLE PHARMACEUTICALS INC., Plaintiff-Appellant v. SLAYBACK PHARMA LLC, Defendant-Appellee

Subsequent History: Counsel Amended May 12, 2020.

Prior History:  [*1] Appeal from the United States District Court for the District of Delaware in No. 1:18-cv-01953-CFC, United States District Judge Colm F. Connolly.

Eagle Pharms., Inc. v. Slayback Pharma LLC, 382 F. Supp. 3d 341, 2019 U.S. Dist. LEXIS 78146 (D. Del., May 9, 2019)

Disposition: AFFIRMED.

CORE TERMS

ethanol, patents, disclose, specification, district court, pharmaceutically, pleadings, infringement, formulations, skilled, doctrine of equivalents, disclosure-dedication, artisan, fluid, invention, glycol, antioxidant, disclosure, embodiment, unclaimed, salt, non-infringement, subject matter, dedicated, propylene, chloride, factual dispute, bendamustine, declaration, contends

Civil Procedure, Appeals, Standards of Review, De Novo Review, Judgments, Pretrial Judgments, Judgment on Pleadings, Patent Law, Doctrine of Equivalents, Elements, Equivalence, Infringement Actions, Doctrine of Equivalents, Summary Judgment, Motions for Summary Judgment, Fact & Law Issues, Evidence, Types of Evidence, Testimony, Expert Witnesses