Takeda Pharmaceuticals U.S.A., Inc. v. Mylan Pharmaceuticals Inc.
MEMORANDUM ORDER: Defendant's request to dismiss or transfer (D.I. 50 ) is DENIED. The Motion to Dismiss the Declaratory Judgement Act Counts IV-XVII (D.I. 10 ) is GRANTED. Signed by Judge Richard G. Andrews on 8/3/2017. (nms)
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
TAKEDA PHARMA. U.S.A., INC.,
No. 16-cv-987 (RGA)
MYLAN PHARMA. INC.,
Defendant Mylan filed Abbreviated New Drug Application No. 294 70 seeking
Food and Drug Administration approval to sell a generic colchicine product for
treatment of Familial Mediterranean Fever. (D.I. 1 at iii! 1, 39). In late October
2016, Plaintiff Takeda filed a seventeen count complaint against Defendant on the
basis of the ANDA. (D.I. 1). The complaint includes three counts with claims under
the Hatch-Waxman Act, 35 U.S.C. § 271(e)(2)(A), for infringement of Plaintiffs
patents covering the use of colchicine to treat FMF, twelve counts with claims under
the Declaratory Judgment Act, 28 U.S.C. § 2201, for contributory infringement of
Plaintiffs patents covering the use of colchicine to treat gout, and two counts with
In response, on December 15, 2016, Defendant filed a motion to dismiss the
declaratory judgment claims under Federal Rule of Civil Procedure 12(b) for lack of
subject matter jurisdiction and for failure to state a claim of contributory
infringement. (D.I. 10). That same day, Defendant also filed an answer contesting
venue. (D.I. 9 at 5-6). Defendant did not, however, include an objection to venue in
its Rule 12(b) motion. (See D.I. 10).
Defendant now seeks to press its objection to venue, spurred by the Supreme
Court's opinion in TC Heartland LLC v. Kraft Foods Grp. Brands LLC, 137 S. Ct.
1514 (2017), overturning the Federal Circuit's interpretation of the patent venue
statute. (D.I. 50). Under Rule 12, Defendant waived its objection to venue by not
bringing the objection in its first filed motion to dismiss. Fed. R. Civ. P. 12(g)(2) ("a
party that makes a motion under this rule must not make another motion under
this rule raising a defense or objection that was available to the party but omitted
from its earlier motion."); Fed. R. Civ. P. 12(h) ("A party waives any defense listed
in Rule 12(b)(2)-(5) by .... omitting it from a motion in the circumstances described
in Rule 12(g)(2) ... "). While Defendant may have faced adverse circuit law on venue
when it filed its Rule 12 motion, the objection was available to it. In fact, the
Supreme Court granted certiorari in TC Heartland on December 14, 2016, the day
before Defendant filed the Rule 12 motion. 137 S. Ct. 614 (2016).
Because Defendant waived its objection to venue, Defendant's request (D.I.
50) to dismiss or transfer the case is DENIED.
With that, I turn to the merits of Defendant's motion to dismiss Plaintiffs
declaratory judgment claims for lack of subject matter jurisdiction. The Act requires
an "actual controversy .... " 28 U.S.C. § 2201(a). An "actual controversy," as referred
to in the statute, means a claim that is justiciable under Article III of the United
States Constitution. Medimmune, Inc. v. Genentech, Inc., 549 U.S. 118, 126-27
(2007). To meet Article Ill's requirement, the threatened injury to Plaintiff in the
absence of judicial intervention must be sufficiently imminent and real, not
conjectural or hypothetical. Summers v. Earth Island Institute, 555 U.S. 488, 505
Through its declaratory judgment claims, Plaintiff seeks a declaration that, if
Defendant is allowed to bring a generic colchicine to market, even one indicated
only for treatment of FMF, Defendant will infringe Plaintiffs gout patents under a
contributory infringement theory. An entity commits contributory infringement
when, with the requisite knowledge, it sells an item that is a material part of a
patented process and that item is not "suitable for substantial noninfringing use .... "
35 U.S.C. § 271(c).
Plaintiffs argument runs that colchicine is prescribed to treat gout 99. 77
percent of the time and only .23 percent of the time to treat FMF. (D.I. 1atif32).
Plaintiffs patents cover a significant portion of the gout market (although there is a
substantial part of the gout market not covered by its patents). Because of physician
prescribing practices, pharmacy policy, and mandatory generic substitution laws,
the primary use of a colchicine generic, even one indicated only for treatment of
FMF, will be to treat gout. (Id. at i!ir 34-37).
Under Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562, 1571 (Fed. Cir. 1997), I
have jurisdiction over Plaintiffs declaratory judgment claims. In Glaxo, the Federal
Circuit allowed a declaratory judgment claim for a method of manufacturing patent
based on an ANDA, ancillary to Hatch-Waxman litigation. Id. That case is not
meaningfully different from this one. While there is an additional contingency here,
off-label prescribing practices, there is no dispute that doctors will prescribe, and
pharmacies will fill, Defendant's generic for use to treat gout.
Even though I can exercise jurisdiction over Plaintiffs declaratory judgment
claims, I have discretion to decline to do so. Id. at 1570 ("[T]he exercise of
jurisdiction over [a declaratory judgment] action is within the discretion of the
district court."). I decline jurisdiction over Plaintiffs declaratory judgment claims
for four reasons.
For one, the addition of gout claims from fourteen patents will unnecessarily
complicate resolution of the case. The FMF claims from the five patents implicated
in the Hatch-Waxman counts represent a current controversy. With these claims
alone, it is a substantial case. Including the gout claims, which are only tangentially
related to the FMF claims, would more than triple the patents in the case.
For two, while Glaxo dictates that jurisdiction exists here, Plaintiffs claimed
injury is still fairly conjectural. For Plaintiff to suffer the injury it fears, three
contingencies would have to occur. First, I would have to decide against Plaintiff on
its FMF patents, finding either that Defendant's ANDA, which by law must match
the NDA those patents cover, does not infringe Plaintiffs patents or that these
presumptively valid patents are invalid. Second, the FDA would have to approve
the ANDA. Third, doctors would have to prescribe the generic for an off-label use.
For three, the law provides an adequate remedy to Plaintiff even without the
declaratory judgment act. If Plaintiffs allegations are correct, it will have a good
case for induced infringement once Defendant starts to offer generic colchicine for
sale. Plaintiff may be able to avail itself of the remedies for intentional
For four, Plaintiffs claim is, by design, a weak case for contributory
infringement at best. As is necessary to file an ANDA with a carve-out, Plaintiffs
ANDA implicates an FDA approved use, treatment of FMF. It is hard to see how an
FDA approved use would not qualify as a substantial non-infringing use. The better
statutory framework for Plaintiffs claim is induced infringement; but, as Plaintiff
concedes, it is premature for adjudication of an induced infringement claim.
For these reasons, I am declining jurisdiction over Plaintiffs declaratory
judgment counts. Defendant's motion to dismiss (D.I. 10) the declaratory judgment
claims in counts IV and V and to dismiss counts VI, VII, VIII, IX, X, XI, XII, XIII,
XIV, XV, XVI, and XVII is GRANTED.
IT IS SO ORDERED
this~ day of August 2017.
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