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Eagle Pharmaceuticals, Inc. v. Slayback Pharma LLC

United States District Court, D. Delaware

May 9, 2019

EAGLE PHARMACEUTICALS, INC., Plaintiff,
v.
SLAYBACK PHARMA LLC, Defendant.

          John W. Shaw, Karen E. Keller, Nathan R. Hoeschen, SHAW KELLER LLP, Wilmington, Delaware Counsel for Plaintiff.

          Neal C. Belgam, Eve H. Ormerod, SMITH, KATZENSTEIN & JENKINS, LLP, Wilmington, Delaware Counsel for Defendant.

          REVISED MEMORANDUM OPINION

          COLM F. CONNOLLY UNITED STATES DISTRICT JUDGE.

         Plaintiff Eagle Pharmaceuticals, Inc. has sued Defendant Slayback Pharma LLC, alleging infringement under the doctrine of equivalents of four patents: U.S. Patent Nos. 9, 265, 831 (the "#831 patent"), 9, 572, 796 (the "#796 patent"), 9, 572, 797 (the "#797 patent"), and 10, 010, 533 (the "#533 patent"). See generally D.I. 1. Pending before me is Slayback's motion for judgment on the pleadings pursuant to Federal Rule of Civil Procedure 12(c). D.I. 14. The matter is fully briefed. D.I. 15, 20, 25. For the reasons discussed below, I will grant Slayback's motion.

         I. BACKGROUND

         Eagle is the holder of New Drug Application (NDA) No. 205580 for BALRAPZO®, a drug with the active ingredient bendamustine, that was approved by the Federal Drug Administration (FDA) to treat patients with chronic lymphocytic leukemia and indolent B-cell non-Hodgkin lymphoma. D.I. 1 at ¶¶ 13-14. Eagle initiated this lawsuit in response to Slayback's submission to the FDA of NDA No. 212209 for approval to manufacture and sell before the four asserted patents expire a bendamustine drug that is bioequivalent to BALRAPZO®. Id. At ¶ 1.

         The four asserted patents share in all material respects the same written description; and all the independent claims of the patents require the presence of three limitations in the claimed pharmaceutical composition: (1) bendamustine or a pharmaceutically acceptable salt thereof; (2) a pharmaceutically acceptable fluid that contains some combination of two solvents: propylene glycol and polyethylene glycol; and (3) a stabilizing amount of an antioxidant. Claim 1 of the #796 patent, for instance, recites in relevant part:

A non-aqueous liquid composition comprising:
bendamustine, or a pharmaceutically acceptable salt thereof; a pharmaceutically acceptable fluid comprising a mixture of polyethylene glycol and propylene glycol, wherein the ratio of polyethylene glycol to propylene glycol in the pharmaceutically acceptable fluid is from about 95:5 to about 50:50; and
a stabilizing amount of an antioxidant; wherein the composition has less than about 5% total impurities after 15 months of storage at about 5° C....

         #796 patent at claim 1.

         Slayback's motion focuses on the second claim limitation-a pharmaceutically acceptable fluid that contains some combination of propylene glycol and polyethylene glycol. I will refer to this limitation as the "solvent limitation." Slayback's proposed bendamustine drug contains polyethylene glycol, but instead of propylene glycol it uses another, second solvent ("Slayback's second solvent"). D.I. 15-1 at Ex. B (Slayback's NDA).[1] Eagle alleges that Slayback's drug infringes the solvent limitation under the doctrine of equivalents. D.I. 1 at ¶¶ 29, 36, 47, 58, 64, 71, 83, 95. Slayback has moved to dismiss on the ground that the so-called disclosure-dedication doctrine bars application of the doctrine of equivalents to the solvent limitation.

         II. LEGAL STANDARDS

         Pursuant to Federal Rule of Civil Procedure 12(c), a party may move for judgment on the pleadings "[a]fter pleadings are closed-but early enough not to delay trial." Regional circuit law governs a court's review of motions for judgment on the pleadings in patent cases. Amdocs (Israel) Ltd. v. Openet Telecom, Inc.,841 F.3d 1288, 1293 (Fed. Cir. 2016). Under Third Circuit law, in ruling on a Rule 12(c) motion, the court must accept as true all well-pleaded allegations in the non-movant's pleadings and draw all reasonable inferences in the non-movant's favor. Zimmerman v. Corbett,873 F.3d 414, 417-18 (3d Cir. 2017). A court may grant a Rule 12(c) motion only where "the movant clearly establishes that no material issue of fact remains to be resolved and [the movant] is entitled to judgment as a matter of law." Rosenau v. Unifund Corp.,539 F.3d 218, 221 (3d Cir. 2008). Application of the disclosure-dedication doctrine presents a question of law suitable for resolution on a motion for ...


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