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Eagle Pharmaceuticals, Inc. v. Hospira, Inc.

United States District Court, D. Delaware

December 16, 2019

EAGLE PHARMACEUTICALS, INC., TEVA PHARMACEUTICALS INTERNATIONAL GMBH, AND CEPHALON, INC. Plaintiffs,
v.
HOSPIRA, INC. Defendant.

          John Shaw, Karen Keller, Nathan Hoeschen, SHAW KELLER LLP, Wilmington, Delaware; Daniel Brown, Michelle Ernst, LATHAM & WATKINS LLP, New York, New York; Kenneth Schuler, Marc Zubick, LATHAM & WATKINS LLP, Chicago, Illinois; Elise Baumgarten, David Berl, Adam Harber, Shaun Mahaffy, Ben Picozzi, WILLIAMS & CONNOLLY LLP, Washington, District of Columbia Counsel for Plaintiff

          Arthur Connolly III, Ryan Newell, CONNOLLY GALLAGHER LLP, Wilmington, Delaware; Aaron Barlow, Yusuf Esat, Sara Horton, JENNER & BLOCK LLP, Chicago, Illinois Counsel for Defendant

          MEMORANDUM OPINION

          COLM F. CONNOLLY UNITED STATES DISTRICT JUDGE

         Plaintiffs Eagle Pharmaceuticals, Inc., Teva Pharmaceuticals International GMBH, and Cephalon, Inc. have sued Defendant Hospira, Inc., alleging infringement of nine patents listed in the Orange Book maintained by the Food and Drug Administration (FDA). The nine patents cover liquid formulations of the cancer drug bendamustine. Plaintiffs allege that Hospira's submission to the FDA of a New Drug Application (NDA) for a liquid bendamustine drug product constituted an artificial act of infringement of the nine patents pursuant to 21 U.S.C. § 355(b)(2) and 35 U.S.C. § 271(e)(2).

         Pending before me is Hospira's motion to dismiss pursuant to Federal Rule of Civil Procedure 12(b)(6). D.I. 13. The matter is fully briefed. D.I. 14; D.I. 15; D.I. 27.

         I. BACKGROUND

         The claims of eight of the asserted patents[1] literally require some combination of two solvents in the claimed liquid bendamustine formulation: propylene glycol and polyethylene glycol. Following the parties' lead, I will refer to these patents as the "PG patents." In Counts II through IX and XI through XVIII of the Complaint, Plaintiffs allege that Hospira's NDA product, which contains polyethylene glycol but uses ethanol instead of propylene glycol as its second solvent, [2] infringes the PG patents under the doctrine of equivalents. D.I. 1 ¶¶ 55, 61, 72, 83, 94, 105, 116, 127, 149, 156, 168, 180, 192, 204, 216, 228.

         The ninth asserted patent, U.S. Patent No. 9, 572, 887 (the "#887 patent"), requires a "non-aqueous" bendamustine formulation. In Counts I and X of the Complaint, Plaintiffs allege that Hospira's NDA product, which contains 2%-4% water, [3] infringes the claims of the #887 patent both literally and under the doctrine of equivalents. Id. ¶¶ 44-47, 140.

         II. LEGAL STANDARDS

         To state a claim on which relief can be granted, a complaint must contain "a short and plain statement of the claim showing that the pleader is entitled to relief." Fed.R.Civ.P. 8(a)(2). Detailed factual allegations are not required, but the complaint must include more than mere "labels and conclusions" or "a formulaic recitation of the elements of a cause of action." Bell Atl Corp. v. Twombly, 550 U.S. 544, 555 (2007) (citation omitted). The complaint must set forth enough facts, accepted as true, to "state a claim to relief that is plausible on its face." Id. at 570. A claim is facially plausible "when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (citation omitted). Deciding whether a claim is plausible is a "context-specific task that requires the reviewing court to draw on its judicial experience and common sense." Id. at 679 (citation omitted).

         III. DISCUSSION

         A. The #887 Patent

         Hospira argues that the Complaint fails to state a claim of infringement of the #887 patent because Hospira's NDA product is not "non-aqueous" and because Plaintiffs are barred by the doctrine of claim vitiation and prosecution history estoppel from alleging equivalence infringement.

         The premise of Hospira's arguments is that "non-aqueous" means the complete absence of water. Hospira contends that its NDA product does not literally infringe the #887 patent because it contains some amount of water. D.I. 14 at 9. It similarly contends that claim vitiation bars application of the doctrine of equivalents to its NDA product because "[t]he term 'non-aqueous' presents a black-or-white proposition: either a composition is non-aqueous [i.e. completely lacking in water] or, if it is not, it is the complete opposite (i.e., aqueous)." Id. at 18. And, finally, Hospira contends that prosecution history estoppel applies because the patentee amended the ...


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