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Eagle Pharmaceuticals Inc. v. Slayback Pharma LLC

Description of Unclaimed Embodiment May Bar Doctrine of Equivalents on Infringement

Eagle Pharmaceuticals Inc. v. Slayback Pharma LLC, __ F.3d __, 2020 WL 2296871 (Fed. Cir. May 8, 2020) (O’Malley, REYNA, Chen) (D. Del.: Connolly) (3 of 5 stars)

Fed Cir affirms judgment on the pleadings of no infringement in Hatch-Waxman case. Eagle’s four patents relate to its branded bendamustine product, BELRAPZO, used to treat chronic lymphocytic leukemia and indolent B-cell non-Hodgkin lymphoma. There was no literal infringement because Slayback’s product did not use propylene glycol, which the claims require. The opinion describes how the dedication-disclosure doctrine barred Eagle from contending that the ethanol in Slayback’s product is insubstantially different from propylene glycol. This is because Eagle’s patents describe, but do not claim, ethanol. See Johnson & Johnston, 285 F.3d 1046 (Fed. Cir. 2002) (en banc). That the disclosure of ethanol related to an unclaimed embodiment did not require otherwise. “The disclosure-dedication doctrine does not require the specification to disclose the allegedly dedicated subject matter in an embodiment that exactly matches the claimed embodiment.” Op. at 7. Pfizer, 429 F.3d 1364 (Fed. Cir. 2005), is not contrary because there, disclosure-dedication was inapplicable because the claim recited a specific purpose for the relevant compound, and the description of the alleged equivalent had no relation to that purpose. There was no error in resolving the case on the pleadings, and the opinion describes how the record was sufficient to support the district court’s exercise of discretion in setting aside an expert declaration tendered by Eagle as “merely an attempt to manufacture a factual dispute.” Id. at 10. “Expert testimony is not always required for a district court to determine how a skilled artisan would understand a patent’s disclosure and claimed invention.” Id. at 10–11.

KEYWORDS: HATCH-WAXMAN; INFRINGEMENT (NO); DOCTRINE OF EQUIVALENTS; DISCLOSURE-DEDICATION