Eagle Pharmaceuticals Inc. v. Slayback Pharma LLC, No. 19-1924 (Fed. Cir. 2020)
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Eage filed suit, alleging infringement of four patents under the doctrine of equivalents, stemming from Slayback’s new drug application for a generic version of Eagle’s branded bendamustine product, BELRAPZO®. Bendamustine is used to treat chronic lymphocytic leukemia and indolent B-cell non-Hodgkin lymphoma. The district court entered a judgment of non-infringement on the pleadings.
The Federal Circuit affirmed, rejecting Eagle’s arguments that the district court erred when it concluded that the asserted patents disclose, but do not claim, ethanol—and therefore dedicated ethanol to the public and 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. The disclosure-dedication doctrine bars application of the doctrine of equivalents: “when a patent drafter discloses but declines to claim subject matter, . . . this action dedicates the unclaimed subject matter to the public.” The application of the doctrine is a question of law. The asserted patents disclose ethanol as an alternative to propylene glycol in the “pharmaceutically acceptable fluid” claim limitation. The only reasonable inference that can be made from the disclosures is that a skilled artisan would understand the patents to disclose ethanol as an alternative to the claimed propylene glycol.
The court issued a subsequent related opinion or order on May 12, 2020.
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