United States District Court, D. Delaware
EAGLE PHARMACEUTICALS, INC., TEVA PHARMACEUTICALS INTERNATIONAL GMBH, AND CEPHALON, INC. Plaintiffs,
HOSPIRA, INC. Defendant.
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
Connolly III, Ryan Newell, CONNOLLY GALLAGHER LLP,
Wilmington, Delaware; Aaron Barlow, Yusuf Esat, Sara Horton,
JENNER & BLOCK LLP, Chicago, Illinois Counsel for
F. CONNOLLY UNITED STATES DISTRICT JUDGE
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.
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.
claims of eight of the asserted patents 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,  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,
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,  infringes the claims of the #887 patent
both literally and under the doctrine of equivalents.
Id. ¶¶ 44-47, 140.
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).
The #887 Patent
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.
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 ...