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Takeda Pharmaceutical Company Ltd. v. Zydus Pharmaceuticals (USA) Inc.

United States District Court, D. New Jersey

December 19, 2018

TAKEDA PHARMACEUTICAL COMPANY LIMITED, et. al., Plaintiffs,
v.
ZYDUS PHARMACEUTICALS USA INC., et. al., Defendants.

          OPINION

          Freda L. Wolfson United States District Judge

         This matter comes before the Court on the Motion of Plaintiffs Takeda Pharmaceutical Company Limited (“Takeda Japan”), Takeda Pharmaceuticals U.S.A., Inc. (“Takeda U.S.A.”), and Takeda Pharmaceuticals America, Inc. (“Takeda America”) (cumulatively, “Plaintiffs” or “Takeda”) to dismiss the antitrust claims of Defendants Zydus Pharmaceuticals Inc. (“Zydus”) and Cadila Healthcare Limited's (“Cadilla”) (cumulatively, “Defendants” or “Zydus”), pursuant to Federal Rule of Civil Procedure 12(b)(6). For the reasons set forth below, Plaintiffs' Motion is DENIED.

         I. FACTUAL BACKGROUND AND PROCEDURAL HISTORY

         Plaintiffs are pharmaceutical companies which research, develop, as well as market pharmaceutical products, including lansoprazole orally digestible tablets. Plaintiffs own the following patents which claim the formulation for the drug Prevacid® SoluTab™: (a) U.S. Patent No. 6, 328, 994, (the “‘994 Patent”); (b) U.S. Patent No. 7, 431, 942 (the “‘942 Patent”); (c) U.S. Patent Number No. 7, 875, 292 (the “‘292 Patent”); and (d) U.S. Patent No. 7, 399, 485 (the “‘485 Patent”) (collectively, the “patents-in-suit”). Defs.' Counterclaims (“Defs.' Countercl.”), ¶¶ 18- 21, 33-36. Defendants are pharmaceutical companies which manufacture, sell, as well as market generic copies of pharmaceutical products throughout the United States, that seek to produce a generic version of Prevacid® SoluTab™. Id. ¶ 22.

         On August 30, 2002, the Food & Drug Administration (“FDA”) approved New Drug Application (“NDA”) No. 21-248 for lansoprazole orally digestible tablets (“ODT”) that Takeda sells under the name Prevacid® SoluTab™. Id. ¶ 30. Prescription Lansoprazole ODT is used to treat gastroesophageal reflux disease (“GERD”) “in a specific subset of patients for whom other treatments are not a practical option[]” and its ODT “formulation allows the tablet to disintegrate in a patient's mouth leaving behind thousands of coated granules, which are then swallowed and released into the bloodstream.” Id. ¶ 30 As Zydus alleges, “[t]his feature distinguishes Prescription Lansoprazole ODT from other GERD treatments, including other products containing the active ingredient lansoprazole, and is especially important for patients who cannot easily swallow pills in tablet form.” Id. ¶ 30.

         In February 2010, Zydus filed an Abbreviated New Drug Application (“ANDA”) No. 200816 with the FDA, seeking to obtain regulatory approval for a generic version of lansoprazole ODT. Id. ¶ 37. Zydus subsequently submitted a letter to Takeda, wherein it provided notice of ANDA No. 200816 and included a Paragraph IV Certification.[1] Id. ¶ 38. Following its receipt, on April 5, 2010, Takeda filed suit in this District against Zydus, alleging infringement of the ‘994 Patent and ‘992 Patent. Id. ¶ 39; see Takeda Pharm. Co. v. Zydus Pharms. USA Inc., No. 10-1723, 2011 U.S. Dist. LEXIS 56328 (D.N.J. May 25, 2011). Although, during the course of that separate litigation, Takeda amended its complaint to include the ‘292 Patent, it eventually dismissed all of its infringement claims against Zydus, with the exception of those relating to the ‘994 Patent. Id. ¶ 40-42.

         Trial ensued, at which the parties disputed the proper claim construction of the term “fine granules, ” as defined in the ‘994 Patent. Id. ¶ 42. Ultimately, on appeal of the District Court's decision in favor of Takeda on claim construction, the Federal Circuit Court of Appeals construed that term to mean “fine granules having an average particle diameter of precisely 400 μm or less, ” as opposed to a deviation of ± 10%. Id.; Takeda Pharm. Co. v. Zydus Pharms. USA, Inc., 743 F.3d 1359 (Fed. Cir. 2014). In that regard, because Zydus's ANDA product was measured to have an average particle size of 412.28 μm, the Court of Appeals ruled that “there can be no dispute that Zydus' ANDA product does not literally infringe . . . the ‘994 patent, ” reversed the decision below, and judgment was entered in favor of Zydus. Id.

         Subsequently, Zydus filed an amended ANDA No. 200816 with the FDA, which allegedly contains only one minor difference from the previously submitted ANDA No. 200816: “[an] immaterial addition of inactive substances (“excipients”) to the formulation . . . added to address certain issues raised by the FDA regarding administration of the product.” Id. ¶ 45. In that regard, the FDA allegedly “indicated to Zydus that it was prepared to approve Zydus's ANDA No. 200816, as amended, ” following which, on January 3, 2018, Zydus submitted a letter to Takeda notifying Takeda of the amended ANDA No. 200818. Id. ¶ 46. The letter included another Paragraph IV Certification and “detailed some of the reasons why there could be no infringement of the patents-in-suit, ” such as: “because Zydus' product has fine granules having an average particle diameter of greater than 400 um, the basis for the Federal Circuit's determination that Zydus' product does not infringe applies with equal force to all four patents-in-suit.” Id. ¶ 47 (emphasis in original).

         Following the submission of its January 3, 2018 letter, Zydus allegedly attempted to provide Takeda with the amended ANDA for its review, “no less than eight times[.]” Id. ¶ 48. However, despite also making “[s]everal telephone calls[, ]” Zydus's efforts were unsuccessful. Id.

         On February 12, 2018, Takeda brought the instant action against Zydus, alleging that Zydus directly infringed the ‘994 Patent, ‘942 Patent, ‘292 Patent, and ‘485 Patent by filing amended ANDA No. 200818 with the FDA, which, according to Zydus, is alleged to be “in every material respect, identical to [the] 2012 Lawsuit[.]” Id. ¶ 50. On March 29, 2018, Zydus filed counterclaims against Takeda, alleging, among other things, violations of: (1) the Sherman Act, 15 U.S.C. § 2; and (2) the New Jersey Antitrust Act, N.J.S.A. § 56:9-1.[2] On July 26, 2018, this Court entered a Stipulation and Order of partial dismissal, pursuant to which Takeda voluntarily dismissed with prejudice all of its infringement claims against Zydus. The Stipulation and Order, however, did not dismiss Zydus's antitrust counterclaims.

         Currently, Takeda moves to dismiss those counterclaims pursuant to Federal Rule of Civil Procedure 12(b)(6), on the basis of Noerr-Pennington immunity.[3] Zydus opposes the motion.

         II. DISCUSSION

         A. Standard of Review

         Federal Rule of Civil Procedure 12(b)(6) provides that a court may dismiss a claim “for failure to state a claim upon which relief can be granted.” Fed.R.Civ.P. 12(b)(6). When reviewing a motion to dismiss, courts must first separate the factual and legal elements of the claims, and accept all of the well-pleaded facts as true. See Fowler v. UPMC Shadyside, 578 F.3d 203, 210-11 (3d Cir. 2009). All reasonable inferences must be made in the plaintiff's favor. See In re Ins. Brokerage Antitrust Litig., 618 F.3d 300, 314 (3d Cir. 2010). In order to survive a motion to dismiss, the plaintiff must provide “enough facts to state a claim to relief that is plausible on its face.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). This standard requires the plaintiff to show “more than a sheer possibility that a defendant has acted unlawfully, ” but does not create as high of a standard as to be a “probability requirement.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009).

         The Third Circuit has required a three-step analysis to meet the plausibility standard mandated by Twombly and Iqbal. First, the court should “outline the elements a plaintiff must plead to a state a claim for relief.” Bistrian v. Levi, 696 F.3d 352, 365 (3d Cir. 2012). Next, the court should “peel away” legal conclusions that are not entitled to the assumption of truth. Id.; see also Iqbal, 556 U.S. at 678-79 (“While legal conclusions can provide the framework of a complaint, they must be supported by factual allegations.”). It is well-established that a proper complaint “requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do.” Twombly, 550 U.S. at 555 (internal quotations and citations omitted). Finally, the court should assume the veracity of all well-pled factual allegations, and then “determine whether they plausibly give rise to an entitlement to relief.” Bistrian, 696 F.3d at 365 (quoting Iqbal, 556 U.S. at 679). A claim is facially plausible when there is sufficient factual content to draw ...


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