United States District Court, D. Delaware
UCB, INC, UCB MANUFACTURING IRELAND LIMITED, UCB PHARMA GMBH, and LTS LOHMANN THERAPIE-SYSTEMEAG, Plaintiffs,
MYLAN TECHNOLOGIES, INC, MYLAN PHARMACEUTICALS INC, and MYLAN, INC, Defendants.
LEONARD P. STARK, UNITED STATES DISTRICT COURT JUDGE
before the Court are Defendants Mylan Technologies, Inc.
("MTI"), Mylan Pharmaceuticals Inc.
("MPI"), and Mylan, Inc.'s ("Inc., "
and collectively with MTI and MPI, "Mylan" or
"Defendants") motion to dismiss for improper venue
(D.I. 13) and Plaintiffs UCB, Inc., UCB Manufacturing Ireland
Limited, UCB Pharma GmbH, and LTS Lohmann Therapie-Systeme
AG's (collectively, "UCB" or
"Plaintiffs") conditional motion to transfer the
case to the District of Vermont (D.I. 22). Having considered
the parties' motion briefing (D.I. 14, 23, 26) and letter
briefing in response to the Court's September 11, 2017
Oral Order (D.I. 35, 36, 37, 38), and for the reasons stated
below, IT IS HEREBY ORDERED that Mylan's motion to
dismiss (D.I. 13) and UCB's motion to transfer (D.I. 22)
are DENIED WITHOUT PREJUDICE to renew after a period of
venue-related discovery. IT IS FURTHER ORDERED that the
parties shall meet and confer and, no later than December 8,
2017, submit a joint status report with their position(s) as
to the scope and timing of the discovery to be taken pursuant
to this Order.
Venue Defense Was Not Forfeited
initial matter, Mylan's venue challenge is not untimely.
As the Court of Appeals for the Federal Circuit recently
held, "[t]he Supreme Court changed the controlling law
when it decided TC Heartlandin May 2017." In re
Micron Tech., Inc., F.3d, 2017 WL 5474215, at *6 (Fed.
Cir. Nov. 15, 2017). Therefore, "[t]he venue objection
was not available until the Supreme Court decided TC
Heartland because, before then, it would have been
improper, given controlling precedent, for the district court
to dismiss or to transfer for lack of venue."
Id. at *3.
does the Court find that Mylan forfeited its challenge to
venue due to its conduct in this litigation. See
Micron, 2017 WL 5474215, at *7 ("[D]istrict courts
have authority to find forfeiture of a venue
objection."); Boston Sci. Corp. v. Cook Grp.
Inc., 2017 WL 3996110, at *9 (D. Del. Sept. 11, 2017)
("Prototypical examples of where the Court might reach
such a conclusion [that a defendant has forfeited its venue
challenge] include whether a defendant raises venue for the
first time on the eve of trial, or many months (or years)
after TC Heartland was handed down, or where
dismissal or transfer would unduly prejudice a plaintiff. Or
a party may have taken affirmative steps in the litigation
that should, in particular circumstances, be viewed as
essentially estopping that party from prevailing on an
improper [venue] defense.") (internal citations
filed their complaint on March 24, 2017. (D.I. 1) In its
answer, filed on April 19, 2017, Mylan contended that venue
was not proper in this District (D.I. 8 at 4, 20), which put
Plaintiffs (and the Court) on notice that Mylan believed it
should not have to litigate this case in Delaware. Then, on
July 13, 2017, less than two months after TC
Heartland was decided, Mylan filed its pending motion to
dismiss, due to improper venue, pursuant to Federal Rule of
Civil Procedure 12(b)(3). Trial in this case has not yet been
scheduled and the 30-month stay on FDA approval of
Mylan's AND A for its generic drug product does not
expire until August 2019 (D.I. 3).
Court discerns nothing in Mylan's participation in this
litigation that should be deemed as having forfeited a now
potentially-meritorious venue objection. See Micron,
2017 WL 5474215, at *7-8 (identifying non-exclusive bases on
which forfeiture of venue challenge may be found, including
"untimeliness or consent, " "submission
through conduct, " and where objection "was not
made until long after" change in law "took
effect") (internal quotation marks omitted). Nor does
the Court's conclusion of no forfeiture threaten
Plaintiffs with any undue prejudice, particularly given that
the Court has not yet scheduled the trial date. Regardless of
which side has the burden with respect to waiver, forfeiture,
and estoppel, the Court finds that none of these doctrines
here precludes Mylan from proceeding with its challenge to
venue in this case.
Are Not Delaware Residents for Purposes of Patent Venue
in a patent case is governed exclusively by 28 U.S.C. §
1400(b), TC Heartland, 137 S.Ct. at 1516, which
provides: "[a]ny civil action for patent infringement
may be brought in the judicial district where the defendant
resides, or where the defendant has committed acts of
infringement and has a regular and established place of
business." For purposes of § 1400(b), a defendant
which is a domestic corporation "resides" only in
its state of incorporation. See TC Heartland, 137
S.Ct. at 1517. It is undisputed that MTI, MPI, and Inc. -
which are, respectively, incorporated in West Virginia, West
Virginia, and Pennsylvania (D.I. 15 ¶¶ 3, 10, 15) -
do not "reside" in Delaware.
Is Potentially Proper Here Under the Second Prong of §
is proper in this District unless Mylan can show that the
second prong of § 1400(b) is not satisfied. See
Bristol-Myers Squibb Co. v. Mylan Pharm. Inc., 2017 WL
3980155, at *5 (D. Del. Sept. 11, 2017)
("BMS") (holding that burden is on party
opposing venue). That is, Delaware is a proper venue for this
lawsuit unless Mylan can meet its burden to show either that
(i) a defendant has not committed acts of infringement in
Delaware, or (ii) a defendant does not have a regular and
established place of business in Delaware. If Mylan can show
either of the foregoing is true with respect to one or more
of the Defendants, then venue here is improper with respect
to such Defendant(s), and the Court will have to dismiss or
transfer this case (at least as to one or more Defendants).
Mylan contends it has met its burden with respect to both
requirements of this second prong of § 1400(b).
First Requirement: Acts of Infringement
has failed to show that any of the Defendants has not
committed acts of infringement in Delaware, given the
Court's understanding of the meaning of this statutory
requirement in the context of Hatch-Waxman litigation.
See BMS, 2017 WL 3980155, at *12 (holding that
"acts of infringement" in this context include acts
"the ANDA applicant non-speculatively intends to take if
its ANDA receives final FDA approval, plus steps already
taken by the applicant indicating its intent to market the
ANDA product in this District"). Mylan gives the Court no
persuasive reason to reconsider this determination.
Second Requirement: Regular and Established Place of