United States District Court, D. Delaware
HONORABLE LEONARD P. STARK UNITED STATES DISTRICT JUDGE
MPI Pharmaceutical Inc. ("Defendant" or
"MPI") has moved to dismiss this action as against
it due to improper venue. (D.I. 118) Plaintiff Novartis
Pharmaceuticals Corporation ("Novartis" or
"Plaintiff) sued MPI and 22 additional groups of generic
drug makers, all of whom had filed abbreviated new drug
applications ("AND As") related to the drug
fingolimod, pursuant to the Hatch-Waxman Act, 21 U.S.C.
§ 355(j). The parties and the Court have coordinated
discovery and scheduling for all of the related cases.
(See D.I. 216) (joint scheduling
West Virginia corporation, filed its motion to dismiss
pursuant to Federal Rule of Civil Procedure 12(b)(3). After
the matter was fully briefed, this Court issued its decision
in Bristol-Meyers Squibb Co. v. Aurobindo Pharma USA
Inc., 2018 WL 5109836 (D. Del. Oct. 18, 2018)
("BMS IF), which dismissed a different
Hatch-Waxman action against MPI based on improper venue here
in the District of Delaware. The Court then ordered
supplemental briefing, to permit the parties to address the
impact of BMSII on MPI's motion here.
(See D.I. 209; see also D.I. 119, 163, 206,
219, 220, 224, 225) In its supplemental briefing, Novartis
insisted MPI's motion should still be denied and also
sought, in the alternative, venue-related discovery (a
request it had also made in its original briefing) and leave
to file an amended complaint. MPI argued that the BMS
II decision only strengthened the basis for dismissal
carefully considered all of the materials before the Court,
IT IS HEREBY ORDERED THAT MPI's motion
(D.I. 118) is GRANTED and Plaintiffs request
for discovery and to file an amended complaint is
"venue provisions are designed, not to keep suits out of
the federal courts, but merely to allocate suits to the most
appropriate or convenient federal forum." Brunette
Mack Works, Ltd. v. Kockum Indus., Inc., 406 U.S. 706,
710 (1972). When a party feels it has been sued in an
improper federal venue, it may move to dismiss or transfer
venue under Rule 12(b)(3). See also 28 U.S.C. §
1406(a) (stating that court granting Rule 12(b)(3) motion
based on improper venue "shall dismiss, or if it be in
the interest of justice, transfer such case to any district
or division in which it could have been brought"). When
such a motion is filed, the Court must determine whether
venue is proper in accordance with the applicable statutes.
See Albright v. W.L. Gore & Assocs., Inc., 2002
WL 1765340, at *3 (D. Del. July 31, 2002).
patent infringement action, venue is governed solely and
exclusively by the patent venue statute, 28 U.S.C. §
1400(b) ("Section 1400(b)"). See TC Heartland
LLC v. Kraft Foods Grp. Brands LLC, 137 S.Ct. 1514, 1516
(2017). The general venue statute, 28 U.S.C. § 1391
("Section 1391"), does not have any application in
a patent case. See Id. at 1521. Section 1400(b)
provides: "Any civil action for patent infringement may
be brought in the judicial district [i] where the defendant
resides, or [ii] where the defendant has committed acts of
infringement and has a regular and established place of
business" (internal numbering added).
"it is not necessary for the plaintiff to include
allegations in his complaint showing that venue is
proper." Great W. Mining & Mineral Co. v. ADR
Options, Inc., 434 Fed.Appx. 83, 86-87 (3d Cir. 2011).
However, "upon motion by the Defendant challenging venue
in a patent case, the Plaintiff bears the burden of
establishing proper venue." In re ZTE (USA)
Inc., 890 F.3d 1008, 1013 (Fed. Cir. 2018). The Court
will accept any venue-related allegations in the complaint as
true, unless they are contradicted by the defendant's
evidence. See Bockman v. First Am. Mktg. Corp., 459
Fed.Appx. 157, 158 n.l (3d Cir. 2012); In re First Solar,
Inc. Derivative Litig., 2013 WL 817132, at *2 (D. Del.
Mar. 4, 2013). In addition, the Court may consider
affidavits. See Bockman, 459 Fed.Appx. at 161
(affirming dismissal of complaint "because Defendants
satisfied their burden of showing improper venue by offering
evidence that the wrongful acts alleged in the Complaint did
not occur in Pennsylvania, and Plaintiffs failed to rebut
then, the burden is on Novartis to demonstrate that venue in
this District is proper either because [i] MPI resides in
Delaware or [ii] MPI has a regular and established place of
business in Delaware and has committed infringing acts here.
MPI contends that Novartis has failed to make the required
showing under either prong of Section 1400(b). (See
D.I. 119 at 4-6)
first responds that MPI is urging the Court to undertake an
incorrect analysis. To Novartis, the general venue statute,
Section 1391, and not the patent venue statute, Section
1400(b), governs venue in Hatch-Waxman cases. (D.I. 163 at
7-15; D.I. 220 at 1) Specifically, Novartis asserts that
"a Hatch-Waxman case under 35 U.S.C. § 271(e) is
not a 'civil action for patent infringement' under
Section 1400(b)," because it "provides for unique
forms of regulatory relief prior to actual
infringement." (D.I. 163 at 9-10) Novartis likens
Hatch-Waxman claims to suits for a declaratory judgment,
arguing that "[n]o principled reason exists to treat
those two sorts of claims differently for venue
purposes." (Id. at 11-12) In making this
argument, Novartis emphasizes the disconnect between the word
choice of the patent venue statute - "has
committed" acts of infringement - and Hatch-Waxman
cases, in which the proposed infringing product has not yet
been marketed or sold. (Id. at 13) (citing
Bristol-Myers Squibb Co. v. MP I Pharm. Inc., 2017
WL 3980155, at *6 (D. Del. Sept. 11, 2017)) Novartis
concludes that using Section 1391 leads to the most efficient
outcome of permitting it to litigate its similar patent
disputes against all ANDA-filing defendants in a single
action in a single District, thus "encouraging the
uniform determination of patent rights." (Id.
Novartis filed its answering brief, but before MPI filed its
reply brief, this Court issued its decision in
BMSII, rejecting the patentee's argument there
that Section 1391, and not Section 1400(b), governs venue in
Hatch-Waxman cases. See BMS II at *5-6. In its
supplemental briefing, Novartis asks the Court to
"reconsider its decision" in BMS II. (D.I.
220 at 3) While Novartis' briefing on the issue is far
more extensive than BMS' had been, it does not persuade
the Court to reach a different conclusion.
BMS II, the Court finds that the instant action is
"incontestably a 'civil action for patent
infringement,' governed solely and exclusively by §
1400(b)." BMS II at *6. Novartis, like BMS,
expressly alleged in its complaint that it was filing a
"patent infringement" action against MPI and cited
solely Section 1400(b) as the statutory basis for venue.
Novartis' cause of action arises under Section
271(e)(2)(A), which makes it an "act of patent
infringement" to do as MPI is alleged to have done here:
file an ANDA with the U.S. Food and Drug Administration
seeking approval of a pharmaceutical product that reads on a
valid, enforceable, unexpired patent. Under TC
Heartland, the proper venues for such patent
infringement actions are determined solely and exclusively by
rejected Novartis' contention that Section 1391, and not
Section 1400(b), should govern the venue analysis in this
Hatch-Waxman infringement action, the Court next turns to
whether Novartis has met its burden to show that venue is
proper in this District under Section 1400(b). MPI is not
incorporated in Delaware and, therefore, indisputably does
not reside here. Nevertheless, Novartis contends that it
should be given an opportunity to pursue venue-related
discovery, which would, it insists, likely yield sufficient
evidence that some MPI-related entity is incorporated in
Delaware and/or maintains a regular and established place of
business here, and these contacts might be imputable to MPI
itself. (D.I. 163 at 17-19)
issues arise as to jurisdiction or venue, discovery is
available to ascertain the facts bearing on such
issues." Oppenheimer Fund, Inc. v. Sanders, 437
U.S. 340, 351 n.13 (1978). In the context of jurisdictional
discovery, the Third Circuit has instructed that "unless
a plaintiffs claim is 'clearly frivolous,'
jurisdictional discovery should be allowed." Rocke
v. Pebble Beach Co., 541 Fed.Appx. 208, 212 (3d Cir.
2013). The law is equally clear, however, that a plaintiff
may not "undertake a fishing expedition based only upon
bare allegations, under the guise of jurisdictional
discovery." Eurofins Pharma U.S. Holdings v.
BioAlliane Pharma SA, 623 F.3d 147, 157 (3d Cir. 2010).
To show that discovery is warranted, a party must, at a
minimum, state a non-frivolous basis for venue and do so with
"reasonable particularity." Eastman Chem. Co.
v. AlphaPet, Inc., 2011 WL 6004079, at *2 (D. Del. Nov.
BMS II, this Court found that, after a year of
discovery directed at (in part) MPI, any further discovery
would amount to a fishing expedition. See BMS II at
*5. There, the parties debated the relevance of the
"relationship between MPI and [MPI] Securitization"
(a sister company incorporated in Delaware), which the Court
found not to be a basis for venue. Id. at *4-5.
Importantly, this Court also found no "evidence of
fraud, unfairness, or injustice," nor any likelihood
that further ...