Case Name: Takeda Pharm. Co., Ltd. v. Mylan Inc., Civ. Nos. 14-cv-00314-LHK, 13-cv-04001-LHK, 13-cv-04002-LHK, 2014 U.S. Dist. LEXIS 105861 (N.D. Cal. Aug. 1, 2014) (Koh, J.)

Drug Product and Patent(s)-in-Suit: Dexilant^® (dexlansoprazole); U.S. Pat. No. 7,339,064 (“the ’064 patent”) 

Nature of the Case and Issue(s) Presented: The issue here concerns whether the owner of a pharmaceutical patent may simultaneously assert a claim for infringement under § 271(e)(2), and a claim pursuant to the Declaratory Judgment Act for infringement under § 271(a)-(c).

The ’064 patent claims crystalline forms of benzimidazole derivatives in a pharmaceutical composition for treating or preventing digestive ulcers. In July 2013, Takeda received notice letters from Mylan containing a paragraph IV certification against Takeda’s Orange Book-listed patents. On Jan. 21, 2014, Takeda filed suit, asserting infringement of the ’064 patent. On Feb. 7, 2014, the court consolidated this case with two others that Takeda previously filed against Mylan asserting seven other patents related to the same compound claimed in the ’064 patent.

In Count I of the instant suit, Takeda asserted a claim of infringement under 35 U.S.C. § 271(e)(2). In Count II, Takeda sought a declaration under 28 U.S.C. § 2201 that Mylan will infringe the ’064 patent directly or indirectly under 35 U.S.C. § 271(a), (b), and/or (c). Mylan filed a motion seeking the dismissal of Count II under Federal Rule 12(b)(1). The court grated Mylan’s motion.

Why Mylan Inc. Prevailed:  The court first addressed Mylan’s argument that the court did not have declaratory judgment jurisdiction because the 30-month stay would last until January 2016, and the FDA had not yet approved Mylan’s ANDA submission. Takeda argued that the filing of an ANDA alone provided sufficient basis to establish the existence of a justiciable controversy. The court declined to assert jurisdiction over the declaratory judgment count as a matter of discretion. The court reasoned that district courts were instructed to exercise such discretion when it would enable the court to make a reasoned judgment as to whether the investment of judicial time and resources in a declaratory judgment action would prove worthwhile in resolving a justiciable dispute. Applying this rationale, the court found that exercising jurisdiction over the declaratory judgment count failed to serve a useful purpose and would not resolve any issues that the infringement count would not also resolve. The court noted that permitting a party to assert a duplicate declaratory judgment count in addition to an infringement count under § 271(e)(2) seemed to run counter to the congressional intent of the Hatch-Waxman Act. The lack of availability of a declaratory judgment cause of action in ANDA litigation was apparently a motivating factor in creating the § 271(e)(2) cause of action.

Next, the court found that the declaratory judgment claim would not serve a useful purpose or terminate and afford relief from uncertainty, insecurity and controversy because it was duplicative of the same type of relief that was already available to Takeda in Count I. Plaintiffs’ Count I already provided relief for infringement and also permitted Takeda to obtain an order delaying the effective date of the FDA’s approval of Mylan’s ANDA until after the expiration of the ’064 patent, along with any other appropriate injunctive or monetary relief.

Last, the court addressed Takeda’s concern that it needed to assert Count II in the event that Federal Circuit were to decide that its § 271(e)(2) count did not apply to patents not listed in the Orange Book (the ’064 patent was not listed in the Orange Book). But the court noted that if this were to occur, Takeda could simply re-file Count II at a later time.

The court extended its decision to the declaratory judgment counts that Takeda had asserted in the two related suits it had filed against Mylan. The court noted that it had asked the litigants to explain how those counts differed from Count II of the instant suit during the hearing held in relation to Mylan’s motion to dismiss. The parties were unable to make such a distinction, and the court dismissed those declaratory judgment counts as well.