United States District Court, D. Delaware
W. Bourke and Daniel M. Attaway, WOMBLE BOND DICKINSON (US)
LLP, Wilmington, DE; Jeffrey I. Weinberger, Ted G. Dane,
Heather E. Takahashi, Elizabeth L. Laughton (argued), and
Hannah L. Dubina, MUNGER, TOLLES & OLSON LLP, Los
Angeles, CA; Celia R. Choy, MUNGER, TOLLES & OLSON LLP,
Washington, DC; Peter A. Detre, MUNGER, TOLLES & OLSON
LLP, San Francisco, CA, attorneys for Plaintiff.
Dominick T. Gattuso, HEYMAN ENERIO GATTUSO & HIRZEL LLP,
Wilmington, DE; Charles B. Klein (argued) & Ilan Wurman,
WINSTON & STRAWN LLP, Washington, DC, attorneys for
ANDREWS, U.S. DISTRICT JUDGE.
pending before the Court is Defendants West-Ward
Pharmaceutical, Hikma Americas, and Hikma
Pharmaceuticals' Motion for Summary Judgment. (D.I. 347).
The Parties have fully briefed the issues. (D.I. 349; D.I.
361; D.I. 368). The Court held oral argument on October 16,
2018. (D.I. 410). For the following reasons, Defendants'
motion for summary judgment is GRANTED.
Takeda Pharmaceuticals manufactures and markets Colcrys, a
branded 0.6 mg colchicine tablet used for the treatment of
gout prophylaxis and acute gout flares. (D.I. 362, Ex. 4). In
2010, Plaintiffs predecessor became the sole provider of
colchicine on the pharmaceutical market, after receiving FDA
authorization and the FDA removing all other colchicine
products. (D.I. 362 Ex. 1 ¶¶ 32-38). Plaintiffs
predecessor also owned several patents directed to a method
of treating acute gout flares with colchicine by
administering 1.2 mg oral colchicine at the onset of an acute
flare, followed by 0.6 mg oral colchicine one hour later
("the Acute Gout Flare Patents"). (D.I. 133 ¶
30); U.S. Patent No. 7, 964, 647 cl. 1; U.S. Patent No. 7,
981, 938 cl. 1; U.S. Patent No. 8, 415, 395 cl. 1.
Pharmaceuticals received FDA approval of a paper New Drug
Application ("paper NDA") for Mitigare on September
26, 2014. (D.I. 349 at 6-7). Mitigare is a 0.6 mg colchicine
capsule indicated solely for the prophylaxis of gout. (D.I.
362, Ex. 5). Shortly thereafter, on October 3, 2014,
Plaintiff filed suit against Defendants West-Ward
Pharamaceutical, Hikma Americas, and Hikma Pharmaceuticals
("Defendants"). (D.I. 1). After the Federal Circuit
affirmed the denial of a preliminary injunction on January 9,
2015, Takeda Pharm., U.S.A., Inc. v. West-WardPharm.
Corp., 785 F.3d 625 (Fed. Cir. 2015), Defendants
launched Mitigare and its authorized generic (Mitigare AG).
(D.I. 349 at 7). Plaintiff also launched its competing
authorized generic of Colcrys (Colcrys AG). (Id.).
Court later dismissed the suit for failure to state a claim
on May 18, 2016. (D.I. 122). The Court then granted
Plaintiffs Motion to Alter Judgment of Dismissal and for
Leave to Amend its Complaint on December 15, 2016 (D.I. 124;
D.I. 132) and implemented phased discovery. (D.I. 150).
Second Amended Complaint alleges Defendants induced
infringement of the Acute Gout Flare Patents through
post-launch marketing efforts for Mitigare. (D.I. 133). The
Complaint asserted two different sets of patents: the
Drug-Drug Interaction patents and the Acute Gout Flare Patents.
(D.I. 133 ¶ 28). Defendants filed a motion for summary
judgment on May 4, 2018. (D.I. 347). After this filing,
Plaintiff voluntarily dismissed its infringement claims under
the Drug-Drug Interaction patents. (D.I. 376). Thus, only the
Acute Gout Flare Patents remain at issue for the purposes of
parties do not dispute that Defendants (1) negotiated both
exclusive and nonexclusive contracts with insurance payers
(D.I. 349 at 17), (2) hired InVentiv Health as a
pharmaceutical marketing force focused on encouraging
prescribers to prescribe Mitigare or Mitigare AG (D.I. 361 at
9), (3) created promotional materials which direct readers to
the American College of Rheumatology Guidelines for the
treatment of gout (D.I. 133-14, Ex. N at 6 and 8 n.6), and
(4) provided samples of Mitigare directly to prescribers.
(D.I. 361 at 15). Mitigare's label also includes language
that directs patients to consult their physician if they
experience an acute gout flare. (D.I. 133, Ex. K).
Defendants' exclusive contracts contain either a
"block" or a "step edit." (D.I. 362, Ex.
13-15). A "block" is where Defendants have agreed
to provide a manufacturer rebate to the insurance payer to
cover only Mitigare/Mitigare AG and to exclude
Colcrys/Colcrys AG from the payer's formulary. (D.I. 410
at 34:14-19). A formulary determines how much of the
prescription cost will be the patient's responsibility. A
"step edit" is where the insurance payer agrees to
require that a patient has tried Mitigare or Mitigare AG and
failed before the insurance payer will cover a prescription
for Colcrys or Colcrys AG. (D.I. 361 at 10; D.I. 410 at
alleges that Defendants' post-launch marketing activities
have induced infringement of the Acute Gout Flare Patents.
(D.I. 133). Defendants now seek summary judgment on the
induced infringement claims. (D.I. 347).
court shall grant summary judgment if the movant shows that
there is no genuine dispute as to any material fact and the
movant is entitled to judgment as a matter of law."
Fed.R.Civ.P. 56(a). The moving party has the initial burden
of proving the absence of a genuinely disputed material fact
relative to the claims in question. Celotex Corp. v.
Catrett,477U.S. 317, 330 (1986). Material facts are
those "that could affect the outcome" of the
proceeding, and "a dispute about a material fact is
'genuine' if the evidence is sufficient to permit a
reasonable jury to return a verdict for the nonmoving
party." Lamont v. New Jersey,637 F.3d 177, 181
(3d Cir. 2011) (quoting Anderson v. Liberty Lobby,
Inc.,477 U.S. 242, 248 (1986)). The burden on the