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Otsuka Pharmaceutical Co., Ltd. v. Mylan Inc.

United States District Court, D. New Jersey

November 7, 2017

OTSUKA PHARMACEUTICAL CO., LTD., Plaintiff,
v.
MYLAN INC. and MYLAN PHARMACEUTICALS INC., and MYLAN LABORATORIES LIMITED, Defendants.

          REDACTED VERSION OPINION OF SEPT. 29, 2017

          JEROME B. SIMANDLE U.S. District Judge

         I. INTRODUCTION

         These related patent infringement actions under the Hatch-Waxman Act, 35 U.S.C. §§ 271, 281, generally concern Plaintiff Otsuka Pharmaceutical Co, Ltd.'s (hereinafter, “Otsuka”) position that Defendants' submissions of abbreviated new drug applications (hereinafter, “ANDAs”) infringe the various patents covering Otsuka's Abilify® aripiprazole product, U.S. Patent Nos. 8, 017, 615 (“the '615 patent”), 8, 580, 796 (“the '796 patent”) and 8, 642, 760 (“the '760 patent”). and collectively, the “patents-in-suit”). Defendants Mylan Inc., Mylan Pharmaceuticals Inc., and Mylan Laboratories Limited (hereinafter “Mylan”) have filed a motion for summary judgment of non-infringement [Docket Item 205]. Plaintiff Otsuka has filed a motion for discovery under Rule 56(d), Fed. R. Civ. P., in response to Mylan's motion [Docket Item 232]. The Court has had the benefit of extensive briefing and oral argument.

         II. BACKGROUND

         A. Factual and Procedural Background [1]

         As this Court has summarized previously, Otsuka holds New Drug Application (hereinafter, “NDA”) No. 21-436, approved by the Food and Drug Administration (hereinafter, the “FDA”), for aripiprazole tablets, which Otsuka markets for the treatment of certain psychiatric conditions under the trade name Abilify®. In connection with Abilify's® listing in the Orange Book, the FDA's book of drug products approved under the Food, Drug, and Cosmetic Act (hereinafter, the “Orange Book”), 21 U.S.C. § 355(j), Otsuka identifies, in relevant part, the '615, the '796, and the '760 Patents.[2]

         In simple terms, the '615, the '796, and the '760 Patents claim novel forms of anhydrous aripiprazole that have low hygroscopicity.

         The asserted claims of the '615, the '796, and the '760 Patents, teach the process for preparing the low hygroscopic aripiprazole (the '615 Patent), as well as claiming two of its forms: one in a pure crystal form (the '796 Patent) and the other in a finalized form (the '760 Patent)[3] The '796 and '760 Patents, each of which contain only two claims, then identify a specific low hygroscopic form of “anhydrous aripiprazole crystals B” and an “aripiprazole drug substance, ” both of which have a moisture content below either 0.40% or 0.10% even after being placed in a dessicator maintained at a temperature of 60° C and a humidity level of 100%. (See '796 Patent at 44:23-32; '760 Patent at 44:23-32.) Simply put, these forms do not take on water, despite exposure to a high-moisture environment.

         1. Otsuka's Infringement Litigation in this District

         XXXXX the generic Defendants involved in these related infringement actions began to file ANDAs with the FDA, seeking approval to market generic aripiprazole tablets and/or orally disintegrating aripiprazole tablets, prior to the expiration of the '615, '796, and '760, Patents.[4]Each Defendant's ANDA, however, included a “paragraph iv” certification, advancing their positions that their ANDAs would not infringe any of the valid patents-in-suit, and/or a “section viii” statement, certifying that the applicant would not seek approval for any indications or uses asserted to be covered by the '350 Patent. See Otsuka Pharm. Co., Ltd. v. Torrent Pharmaceuticals Ltd., Inc., 99 F.Supp.3d 461 (D.N.J. 2015)(“TRO Opinion”) In other words, Mylan purports to seek approval for a noninfringing aripiprazole product. See generally id.

         Otsuka filed infringement actions in this District, alleging that these Defendants' proposed generic aripiprazole products will infringe at least one claim of the ‘615, ‘796, and/or the ‘760 patents, among the other patents covering Otsuka's Abilify® product.

         “Low hygroscopicity” refers to a measurement of hygroscopicity employing the “Hygroscopicity-Test Method, ” (or “HTM”) described as:

One g of the sample was accurately weighed in a weighing bottle (diameter 5 cm), covered with kimwipes and left to rest in a 60ºC/100% RH environment (water/dessicator). 24 hours later, the weighing bottle was removed, transferred to an environment of a room temperature and about 30% REH (magnesium chloride hexahydrate saturated water solution/dessicator) and left to rest for 24 hours and the water content of the sample was measured by the Karl Fischer method.

         On XXXXX Mylan submitted ANDA No. 206-240 to the FDA seeking approval to market generic aripiprazole tablets in the United States (Mylan SMF at ¶ 9.) Specifically, Otsuka originally asserted against Mylan, claims of infringement of claims 1 and 2 of the '760 patent, as well as claims 1 and 2 of the '796 patent and claims 3, 4, 15 and 16 of the '615 patent. (Id. at ¶ 32.) Otsuka is dismissing its claims under the ‘615 and ‘796 patents, and only the ‘760 patent is in dispute. (Otsuka Opp. Br. at 2.) [Docket Item 236.]

         Mylan first produced a sample of its aripiprazole API to Otsuka on October 14, 2015 and produced additional API samples on August 15, 2016, but both times, Otsuka objected because the samples were provided in packaging that did not comply with XXXXX specifications. (Id. at ¶¶ 29-30; Otsuka RSMF at ¶¶ 29-30.) XXXXX (Id. at ¶ 41.)

         Dr. Myerson opined that Mylan's samples had XXXXX specifications call for, and that statements XXXXX support his infringement opinion. (Mylan SMF at ¶ 35.)

         2. Markman hearing and Claim Construction

         The Court conducted a Markman hearing on October 19, 2015 and issued its Markman opinion on November 16, 2015. The Court stated that “[i]n simple terms, [the patents-in-suit] claim novel forms of anhydrous aripiprazole that have low hygroscopicity.” See Otsuka Pharmaceutical Co., Ltd v. Torrent Pharmaceuticals Limited, Inc, 151 F.Supp.3d 525, 551 (D.N.J. 2015). Additionally, the Court stated that “[t]he asserted claims of the '615, the '796 and the '760 patents, in turn, teach the process for preparing the low hygroscopic aripiprazole (the ‘615 patent), as well as claiming the two of its forms: one in a pure crystal form (the '796 patent) and the other in a finalized form (the '760 patent). Id. at 533-34. The Court construed the term “Anhydrous Aripiprazole Crystals B, ” as it appears in asserted claims 3, 4, 15 and 16 of the '615 patent, and claims 1 and 2 of the '796 parent, to mean “Anhydrous aripiprazole Crystalline substance, having: 1) a proton nuclear magnetic resonance spectrum (DMSO-d6, TMS) having characteristic peaks at [specified levels]; 2) a powder x-ray diffraction spectrum having characteristic peaks at [specified levels]; 3) clear infrared absorption bands at [specified levels] on ...


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