Takeda Pharmaceutical v. Zydus Pharmaceuticals

358 F. Supp. 3d 389
CourtDistrict Court, D. New Jersey
DecidedDecember 19, 2018
DocketCivil Action No.: 18-1994 (FLW)
StatusPublished
Cited by10 cases

This text of 358 F. Supp. 3d 389 (Takeda Pharmaceutical v. Zydus Pharmaceuticals) is published on Counsel Stack Legal Research, covering District Court, D. New Jersey primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Takeda Pharmaceutical v. Zydus Pharmaceuticals, 358 F. Supp. 3d 389 (D.N.J. 2018).

Opinion

WOLFSON, United States District Judge:

*391This 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 *392April 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 WL 2115819, 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.

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358 F. Supp. 3d 389, Counsel Stack Legal Research, https://law.counselstack.com/opinion/takeda-pharmaceutical-v-zydus-pharmaceuticals-njd-2018.