United States District Court, D. New Jersey
TAKEDA PHARMACEUTICAL COMPANY LIMITED, et. al., Plaintiffs,
ZYDUS PHARMACEUTICALS USA INC., et. al., Defendants.
L. Wolfson United States District Judge
matter comes before the Court on the Motion of Plaintiffs
Takeda Pharmaceutical Company Limited (“Takeda
Japan”), Takeda Pharmaceuticals U.S.A., Inc.
(“Takeda U.S.A.”), and Takeda Pharmaceuticals
America, Inc. (“Takeda America”) (cumulatively,
“Plaintiffs” or “Takeda”) to dismiss
the antitrust claims of Defendants Zydus Pharmaceuticals Inc.
(“Zydus”) and Cadila Healthcare Limited's
“Defendants” or “Zydus”), pursuant to
Federal Rule of Civil Procedure 12(b)(6). For the reasons set
forth below, Plaintiffs' Motion is
FACTUAL BACKGROUND AND PROCEDURAL HISTORY
are pharmaceutical companies which research, develop, as well
as market pharmaceutical products, including lansoprazole
orally digestible tablets. Plaintiffs own the following
patents which claim the formulation for the drug
Prevacid® SoluTab™: (a) U.S. Patent No.
6, 328, 994, (the “‘994 Patent”); (b) U.S.
Patent No. 7, 431, 942 (the “‘942 Patent”);
(c) U.S. Patent Number No. 7, 875, 292 (the “‘292
Patent”); and (d) U.S. Patent No. 7, 399, 485 (the
“‘485 Patent”) (collectively, the
“patents-in-suit”). Defs.' Counterclaims
(“Defs.' Countercl.”), ¶¶ 18- 21,
33-36. Defendants are pharmaceutical companies which
manufacture, sell, as well as market generic copies of
pharmaceutical products throughout the United States, that
seek to produce a generic version of Prevacid®
SoluTab™. Id. ¶ 22.
August 30, 2002, the Food & Drug Administration
(“FDA”) approved New Drug Application
(“NDA”) No. 21-248 for lansoprazole orally
digestible tablets (“ODT”) that Takeda sells
under the name Prevacid® SoluTab™.
Id. ¶ 30. Prescription Lansoprazole ODT is used
to treat gastroesophageal reflux disease (“GERD”)
“in a specific subset of patients for whom other
treatments are not a practical option” and its ODT
“formulation allows the tablet to disintegrate in a
patient's mouth leaving behind thousands of coated
granules, which are then swallowed and released into the
bloodstream.” Id. ¶ 30 As Zydus alleges,
“[t]his feature distinguishes Prescription Lansoprazole
ODT from other GERD treatments, including other products
containing the active ingredient lansoprazole, and is
especially important for patients who cannot easily swallow
pills in tablet form.” Id. ¶ 30.
February 2010, Zydus filed an Abbreviated New Drug
Application (“ANDA”) No. 200816 with the FDA,
seeking to obtain regulatory approval for a generic version
of lansoprazole ODT. Id. ¶ 37. Zydus
subsequently submitted a letter to Takeda, wherein it
provided notice of ANDA No. 200816 and included a Paragraph
IV Certification. Id. ¶ 38. Following its
receipt, on April 5, 2010, Takeda filed suit in this District
against Zydus, alleging infringement of the ‘994 Patent
and ‘992 Patent. Id. ¶ 39; see Takeda
Pharm. Co. v. Zydus Pharms. USA Inc., No. 10-1723, 2011
U.S. Dist. LEXIS 56328 (D.N.J. May 25, 2011). Although,
during the course of that separate litigation, Takeda amended
its complaint to include the ‘292 Patent, it eventually
dismissed all of its infringement claims against Zydus, with
the exception of those relating to the ‘994 Patent.
Id. ¶ 40-42.
ensued, at which the parties disputed the proper claim
construction of the term “fine granules, ” as
defined in the ‘994 Patent. Id. ¶ 42.
Ultimately, on appeal of the District Court's decision in
favor of Takeda on claim construction, the Federal Circuit
Court of Appeals construed that term to mean “fine
granules having an average particle diameter of precisely 400
μm or less, ” as opposed to a deviation of ±
10%. Id.; Takeda Pharm. Co. v. Zydus Pharms.
USA, Inc., 743 F.3d 1359 (Fed. Cir. 2014). In that
regard, because Zydus's ANDA product was measured to have
an average particle size of 412.28 μm, the Court of
Appeals ruled that “there can be no dispute that
Zydus' ANDA product does not literally infringe . . . the
‘994 patent, ” reversed the decision below, and
judgment was entered in favor of Zydus. Id.
Zydus filed an amended ANDA No. 200816 with the FDA, which
allegedly contains only one minor difference from the
previously submitted ANDA No. 200816: “[an] immaterial
addition of inactive substances (“excipients”) to
the formulation . . . added to address certain issues raised
by the FDA regarding administration of the product.”
Id. ¶ 45. In that regard, the FDA allegedly
“indicated to Zydus that it was prepared to approve
Zydus's ANDA No. 200816, as amended, ” following
which, on January 3, 2018, Zydus submitted a letter to Takeda
notifying Takeda of the amended ANDA No. 200818. Id.
¶ 46. The letter included another Paragraph IV
Certification and “detailed some of the reasons why
there could be no infringement of the patents-in-suit,
” such as: “because Zydus' product has fine
granules having an average particle diameter of greater
than 400 um, the basis for the Federal Circuit's
determination that Zydus' product does not infringe
applies with equal force to all four patents-in-suit.”
Id. ¶ 47 (emphasis in original).
the submission of its January 3, 2018 letter, Zydus allegedly
attempted to provide Takeda with the amended ANDA for its
review, “no less than eight times[.]”
Id. ¶ 48. However, despite also making
“[s]everal telephone calls[, ]” Zydus's
efforts were unsuccessful. Id.
February 12, 2018, Takeda brought the instant action against
Zydus, alleging that Zydus directly infringed the ‘994
Patent, ‘942 Patent, ‘292 Patent, and ‘485
Patent by filing amended ANDA No. 200818 with the FDA, which,
according to Zydus, is alleged to be “in every material
respect, identical to [the] 2012 Lawsuit[.]”
Id. ¶ 50. On March 29, 2018, Zydus filed
counterclaims against Takeda, alleging, among other things,
violations of: (1) the Sherman Act, 15 U.S.C. § 2; and
(2) the New Jersey Antitrust Act, N.J.S.A. §
56:9-1. On July 26, 2018, this Court entered a
Stipulation and Order of partial dismissal, pursuant to which
Takeda voluntarily dismissed with prejudice all of its
infringement claims against Zydus. The Stipulation and Order,
however, did not dismiss Zydus's antitrust counterclaims.
Takeda moves to dismiss those counterclaims pursuant to
Federal Rule of Civil Procedure 12(b)(6), on the basis of
Noerr-Pennington immunity. Zydus opposes the motion.
Standard of Review
Rule of Civil Procedure 12(b)(6) provides that a court may
dismiss a claim “for failure to state a claim upon
which relief can be granted.” Fed.R.Civ.P. 12(b)(6).
When reviewing a motion to dismiss, courts must first
separate the factual and legal elements of the claims, and
accept all of the well-pleaded facts as true. See Fowler
v. UPMC Shadyside, 578 F.3d 203, 210-11 (3d Cir. 2009).
All reasonable inferences must be made in the plaintiff's
favor. See In re Ins. Brokerage Antitrust Litig.,
618 F.3d 300, 314 (3d Cir. 2010). In order to survive a
motion to dismiss, the plaintiff must provide “enough
facts to state a claim to relief that is plausible on its
face.” Bell Atl. Corp. v. Twombly, 550 U.S.
544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). This
standard requires the plaintiff to show “more than a
sheer possibility that a defendant has acted unlawfully,
” but does not create as high of a standard as to be a
“probability requirement.” Ashcroft v.
Iqbal, 556 U.S. 662, 678 (2009).
Third Circuit has required a three-step analysis to meet the
plausibility standard mandated by Twombly and
Iqbal. First, the court should “outline the
elements a plaintiff must plead to a state a claim for
relief.” Bistrian v. Levi, 696 F.3d 352, 365
(3d Cir. 2012). Next, the court should “peel
away” legal conclusions that are not entitled to the
assumption of truth. Id.; see also Iqbal,
556 U.S. at 678-79 (“While legal conclusions can
provide the framework of a complaint, they must be supported
by factual allegations.”). It is well-established that
a proper complaint “requires more than labels and
conclusions, and a formulaic recitation of the elements of a
cause of action will not do.” Twombly, 550
U.S. at 555 (internal quotations and citations omitted).
Finally, the court should assume the veracity of all
well-pled factual allegations, and then “determine
whether they plausibly give rise to an entitlement to
relief.” Bistrian, 696 F.3d at 365 (quoting
Iqbal, 556 U.S. at 679). A claim is facially
plausible when there is sufficient factual content to draw ...