United States District Court, D. New Jersey
MERCK SHARP & DOHME CORP. Plaintiff,
ACTAVIS LABORATORIES FL, INC., et al. Defendants.
MEMORANDUM & ORDER
G. SHERIDAN, U.S.D.J.
matter comes before the Court on defendant Actavis, Inc.
n/k/a Allergan Finance LLC's (“Allergan
Finance”) motion to dismiss plaintiff Merck Sharp &
Dohme Corp.'s (“Merck”) complaint for lack of
subject matter jurisdiction under Fed.R.Civ.P. 12(b)(1)
(“Rule 12(b)(1)”). Defendants Actavis
Laboratories FL, Inc., Andrx Corporation, & Actavis
Pharma, Inc. (collectively, “Teva Defendants”),
consent to this motion. (See Defs.' Br. at 1;
Dkt. No. 114-1).
Finance argues that Merck's complaint lacks subject
matter jurisdiction against Allergan Finance because it
divested its interests in an Abbreviated New Drug Application
(“ANDA”) upon acquiring of its business by Teva
Pharmaceuticals USA. The ANDA application is directed to
posaconazole drug, which is protected by U.S. Pat. 5, 661,
151 (the “'151 patent”). Because of its
divestiture of the ANDA application, Allergan Finance argues
that it lacks the involvement in the marketing, distribution,
or sale of Teva Defendants' ANDA products. As a result,
extinguishing this Court's jurisdiction conferred by 35
U.S.C. § 271(e)(2).
opposition, Merck argues that the subject matter jurisdiction
under Rule 12(b)(1) was satisfied at the time of filing of
the complaint. In the complaint, Merck alleged that Allergan
Finance submitted the ANDA application for purposes of
engaging in commercial manufacture, use, or sale of the
posaconazole (i.e., the ANDA product) prior to the expiration
of the '151 patent. As such, Merck purports that this
Court does have subject matter jurisdiction over Allergan
on the arguments made in the briefs, arguments presented on
the record on March 20, 2016, and for the reasons set forth
below, this Court denies Allergan Finance's motion to
dismiss Merck's complaint for lack of subject matter
jurisdiction under Rules 12(b)(1).
25, 2015, Merck received a letter from Actavis Laboratories
FL, Inc. (“Actavis Florida”), which indicated
that Actavis Florida had submitted the ANDA application
207355 to the Food and Drug Administration
(“FDA”). The ANDA application sought approval to
engage in the manufacture, use or sale of a generic version
of the tablet formulation of Merck's drug
NOXAFIL®. This letter is on Actavis
Florida's letter head, signed by Janet Vaugh, Director of
Regulatory Affairs of Actavis Florida. (See
Pl.'s Opp. Br., Dkt. No. 119 (“Pl.'s Opp.
Br.”) at 5, citing Declaration of Charles H.
Chevalier, Dkt. No. 119-1 (“Decl. of Chevalier”)
at Ex. 1).
August 6, 2015 Merck initiated this suit alleging
infringement of the '151 Patent against Actavis Florida,
Actavis, Inc., and two other Actavis entities, which Merck
believed were also actively involved in the preparation or
submission of the ANDA application. (See Defs.'
Br., Dkt. No. 114-1 (“Defs.' Br.”) at 6;
citing Complaint (“Compl.”) at Dkt. No.
1). In its complaint, Merck alleged that-(i) Actavis, Inc.
ultimately controlled Actavis Florida and other Actavis
entities (Compl. at ¶ 12); (ii) defendants filed or
caused the ANDA application to be filed, with the intent to
seek to market and sell the ANDA product prior to the
expiration of the '151 patent (Id. at ¶
19); and (iii) thereby committing the tort of infringement
under 35 U.S.C. § 271(e)(2) (Id. at ¶ 26).
October 16, 2015, defendants filed their answer in which they
admitted that-(i) they did file the ANDA application; (ii)
they did send the letter on or about June 25, 2015 to Merck;
and (iii) that “Actavis” (a term defined to
include all defendants) sought approval to market the Actavis
ANDA product. (Pl.'s Opp. Br. at 7, citing
Defendants' Answer, Defenses, and Counterclaims (Dkt. No.
16)). Further, defendants' stipulated that filing of the
ANDA application would constitute infringement under 35
U.S.C. § 271(e)(2) if the asserted claims the '151
patent are found valid and enforceable. (See Decl.
of Chevalier, Ex. 4 at ¶ 1).
the initiation of this suit, Actavis, Inc. was a parent
company of Teva Defendants, which includes Actavis Florida;
and was a subsidiary of Allergan plc (f/k/a Actavis plc). At
that time Actavis Florida submitted the ANDA application.
(See Declaration of Brian Anderson, Dkt. No. 114-2
(“Decl. of Anderson”) at ¶ 3).
year after this lawsuit was filed, Allergan plc divested its
generic pharmaceutical business to Teva Pharmaceutical USA
(“Teva”), and as such Teva acquired Actavis
Florida. At the oral argument, Merck did not contest this
point. Thereafter, Actavis, Inc. changed its name to Allergan
Finance, and remains a wholly owned subsidiary of Allergan
plc. (Decl. of Chevalier, Ex. 3). Accordingly, the documents
submitted indicate that Allergan Finance does not retain any
interest in the ANDA application, and it submits that it has
no plans to market, distribute, or sell the posaconazole drug
described in the ANDA application. (Decl. of Anderson at
of the divestment of its generic pharmaceuticals business,
Teva Pharmaceutical Industries, Ltd. assumed all the
liabilities of Allergan plc's generic pharmaceuticals
business, including liabilities for infringement.
(Id. at ¶ 9; citing Exhibit A: Master
Purchase Agreement between Allergan plc and Teva
Pharmaceutical Industries, Ltd., dated July 26, 2015).
to the Federal Rules of Civil Procedure, Rule 12(b)(1), a
claim can be dismissed for “lack of jurisdiction over
the subject matter.” This motion to dismiss may be
asserted at any time in a case. In re Kaiser Group
Int”l, Inc., 399 F.3d 558, 565 (3d Cir.2005). The
court, when faced with a Rule 12(b)(1) motion to dismiss,
usually determines jurisdiction based on the date the
complaint is filed. 28 U.S.C.A. § 1338 (“The