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Torrent Pharmaceuticals Limited v. Daiichi Sankyo, Inc.

United States District Court, N.D. Illinois, Eastern Division

July 25, 2016

TORRENT PHARMACEUTICALS LIMITED and TORRENT PHARMA INC., Plaintiffs,
v.
DAIICHI SANKYO, INC. and DAIICHI SANKYO CO., LTD., Defendants. MYLAN PHARMACEUTICALS INC., Intervenor-Defendant. ALEMBIC PHARMACEUTICAS LIMITED, Plaintiff,
v.
DAIICHI SANKYO CO., LTD., Defendant. MYLAN PHARMACEUTICALS INC., Intervenor-Defendant. AUROBINDO PHARMACEUTICALS, LIMITED and AUROBINDO PHARMA, INC. Plaintiffs,
v.
DAIICHI SANKYO, INC. and DAIICHI SANKYO CO., LTD., Defendants. MYLAN PHARMACEUTICALS INC., Intervenor-Defendant.

          Aurobindo Pharmaceuticals Limited, Plaintiff, represented by Stephen Arthur Wood, Chuhak & Tecson, P.C. & Kristen Elizabeth Hudson, Chuhak & Tecson, P.C..

          Aurobindo Pharma, Inc., Plaintiff, represented by Stephen Arthur Wood, Chuhak & Tecson, P.C., Steven J. Moore, Withers Bergman LLP, pro hac vice & Kristen Elizabeth Hudson, Chuhak & Tecson, P.C..

          Daiici Sankyo, Inc., Defendant, represented by David C. Van Dyke, Howard & Howard & Emily Elizabeth Bennett, Howard & Howard Attorneys, PLLC.

          Daiichi Sankyo Co., Ltd.,, Defendant, represented by David C. Van Dyke, Howard & Howard, C. Austin Ginnings, Fitzpatrick Cella Harper & Scinto, pro hac vice, Christopher Paul Borello, Fitzpatrick Cella Harper & Scinto, pro hac vice, Dominick A. Conde, Fitzpatrick Cella Harper & Scinto, pro hac vice, Emily Elizabeth Bennett, Howard & Howard Attorneys, PLLC & Nina Shreve, Fitzpatrick Cella Harper & Scinto, pro hac vice.

          Mylan Pharmaceuticals Inc., Intervenor Defendant, represented by James B. Coughlan, Perkins Coie LLP, Shannon M. Bloodworth, Perkins Coie Llp, pro hac vice, Autumn N. Nero, Perkins Coie Llp, pro hac vice, David R. Pekarek Krohn, Perkins Coie LLP & Maria Alice Stubbings, Perkins Coie LLP, pro hac vice.

          MEMORANDUM OPINION AND ORDER

          REBECCA R. PALLMEYER, District Judge.

         Plaintiffs, three manufacturers of generic drugs, are seeking a declaratory judgment, which they believe would give them the green light to produce a generic form of Defendants' popular blood pressure medicine, Benicar® (olmesartan medoxomil), at the earliest possible date. As explained here, however, this court lacks jurisdiction over Defendants. Accordingly, the case is dismissed without prejudice.

         INTRODUCTION

         Defendant Daiichi Sankyo Co., Ltd. ("DS Japan"), a Japanese pharmaceutical company, owns certain patents, including United States Patent No. 6, 878, 703 ("the '703 patent"), concerning the pharmaceutical drug product Benicar®. Defendant Daiichi Sankyo, Inc. ("DS USA"), DS Japan's United States subsidiary, is incorporated in Delaware and has its principal place of business in New Jersey. DS USA markets and sells Benicar® throughout the United States and holds the United States New Drug Application ("NDA") for the drug.[1] Plaintiffs Torrent Pharmaceuticals Limited and Torrent Pharma Inc. ("Torrent"), Alembic Pharmaceuticals Limited ("Alembic"), and Aurobindo Pharmaceuticals Limited and Aurobindo Pharma Inc. ("Aurobindo") are all seeking approval from the United States Food and Drug Administration ("FDA") to market and sell their own generic versions of Benicar®. Each has brought separate suits in this district seeking a declaratory judgment that their applications for FDA approval, as well as the sale and marketing following such approval, would not infringe the '703 patent.[2] Without such a judgment, Plaintiffs insist that Intervenor-Defendant Mylan Laboratories Limited ("Mylan") will have the exclusive right to market a generic version of Benicar® for a 180-day period beginning October 25, 2016. Under federal law, Mylan is entitled to this exclusivity period because it was the first generic manufacturer to challenge the '703 patent. Plaintiffs assert that a declaratory judgment of non-infringement in this case would result in Mylan's forfeiting the exclusivity period. Unless this court enters the judgment they seek, Plaintiffs contend, they will be deprived of sales revenue for the 180-day period, and the public will be deprived of the benefits of a competitive market for generic versions of Benicar®.

         Plaintiffs have filed motions for summary judgment ([41], Alembic Pharm. Ltd. v. Daiichi Sankyo Co., 16 C 3956 [16], Aurobindo Pharm. Ltd. v. Daiichi Sankyo Inc., 16 C 4876 [17]), contending that Plaintiffs' products, as a matter of law, could not infringe the '703 patent because Defendants have already disclaimed the patent. Mylan has filed a motion for judgment on the pleadings [54], arguing that the court lacks subject matter jurisdiction. Mylan insists the declaratory judgment Plaintiffs seek would not redress their asserted injuries because it would not cause Mylan to forfeit its exclusivity period as Plaintiffs contend. In addition, Mylan argues that there is no case or controversy regarding infringement of the '703 patent because Daiichi has already disclaimed it. Defendants, for their part, contend that the court lacks personal jurisdiction over them and should therefore dismiss Plaintiffs' complaints in their entirety. For the reasons discussed below, the court agrees with Defendants and grants their motions to dismiss ([30], Alembic, No. 16 C 3956 [43], Aurobindo, No. 16 C 4876 [29]) for lack of personal jurisdiction.

         BACKGROUND

         Benicar® is drug approved by the FDA for the treatment of hypertension. See http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders /ucm215245.htm (last visited July 20, 2016). To obtain FDA approval to market and sell Benicar®, Defendants listed two patents in the FDA's published list of Approved Drug Products with Therapeutic Equivalence Evaluations (commonly referred to as the "Orange Book"). (Pl. Torrent's Compl. For Decl. J. (hereinafter "Torrent Compl.") [1] at 28.); see 21 U.S.C. § 355(b)(1) (requiring applicants to list patents "with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use or sale of the drug"). United States Patent No. 5, 616, 599 ("the '599 patent) covers the drug's active ingredient, olmesartan medoxomil, while the '703 patent covers methods of treatment. Apotex, Inc. v. Daiichi Sankyo, Inc., 781 F.3d 1356, 1358 (Fed. Cir. 2015). The '703 patent remains listed in the Orange Book though Daiichi disclaimed every term of the patent on July 11, 2006. ( Id. ¶¶ 24, 29.)[3] With the '703 patent disclaimed, approved generic manufacturers would ordinarily be able to begin marketing a version of the drug when the '599 patent expired on April 25, 2016. Defendants, however, qualify for a six-month extension of their market exclusivity for the drug because they submitted certain data concerning the drug's effects on children. See 21 U.S.C. § 355a(b)(1)(B)(i); Apotex, 781 F.3d at 1358. As a result, FDA cannot approve any generic version of Benicar® until October 25, 2016, six months after the expiration of the '599 patent. (Torrent Compl. ¶ 32.)

         Drug manufacturers who seek FDA approval to market and sell generic versions of previously-approved drugs may do so by submitting abbreviated new drug applications ("ANDAs"). See 21 U.S.C. § 355(j). Plaintiffs have submitted ANDAs with respect to their own generic versions of Benicar®. In doing so, they certified under 21 U.S.C. § 355(j)(2)(A)(vii)(IV)[4] that the '703 patent will not be infringed by the manufacture, use, or sale of their generic products. Though each Plaintiff filed an ANDA containing such a "Paragraph IV" certification concerning the '703 patent, Intervenor-Defendant Mylan was the first generic manufacturer to do so. As a result, Mylan is presumptively entitled to a 180-day period, beginning once it enters in the market, in which it is the only generic manufacturer that can market and sell the drug. See 21 U.S.C. § 355(j)(5)(B)(iv).[5] Plaintiffs point out, however, that the first ANDA filer's 180-day exclusivity may be forfeited under certain conditions. (Torrent Compl. ¶ 26.) They assert that if the FDA grants tentative approval for another ANDA filer and that filer obtains a non-appealable court judgment of non-infringement, the first ANDA filer would be required to market the drug within 75 days of the court judgment or else forfeit the exclusivity. See 21 U.S.C. § 355(j)(5)(D)(i)(l)(bb)(AA).[6] Each Plaintiff claims that a declaratory judgment of non-infringement in this case, as long as it is entered (or, if appealed, affirmed) at least 75 days before October 25, 2016, would trigger forfeiture of Mylan's 180-day exclusivity period. (Torrent Compl. ¶ 46; Pl. Aurobindo's Compl. for Decl. J. [1] ¶ 44, Aurobindo, No. 16 C 4876 (hereinafter "Aurobindo Compl."); Pl. Alembic's Compl. for Decl. J. of Patent Non-infringement of U.S. Patent No. 6, 878, 703 [1] ¶ 94, Alembic, No. 16 C 3956 (hereinafter "Alembic Compl.").)

         In an earlier lawsuit in this district, another manufacturer of a generic version of Benicar® sought the same declaratory judgment of non-infringement of patent '703 that Plaintiffs seek here. See Apotex, Inc. v. Daiichi Sankyo, Inc., No. 12 C 9295, 2014 WL 114127, at *1 (N.D. Ill. Jan. 9, 2014). In that case, the district court initially concluded that the case did not present a case or controversy and dismissed it for lack of subject-matter jurisdiction. Id. at *4. The Federal Circuit reversed that decision on appeal, finding that the parties' dispute over the plaintiff's ability to sell the patented drug involved sufficiently concrete and substantial stakes. SeeApotex, 781 F.3d at 1361-62. On remand, the district court granted the generic manufacturer's motion for summary judgment of non-infringement. Apotex, Inc. v. Daiichi Sankyo, Inc., No. 12 C 9295, 2016 WL 98572, at *4 (N.D. Ill. Jan. 8, 2016). The court ruled that non-infringement follows as a matter of law from the fact that the '703 patent had been formally disclaimed. Id. Defendants have appealed that ruling, and the case is now pending again before the Federal Circuit. Plaintiffs suggest that for the same reason the court entered summary judgment in Apotex, this court should grant ...


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