Limited v. Daiichi Sankyo, Inc.

196 F. Supp. 3d 871, 2016 WL 3976992
CourtDistrict Court, N.D. Illinois
DecidedJuly 25, 2016
DocketNo. 16 C 2988; No. 16 C 3956; No. 16 C 4876
StatusPublished
Cited by3 cases

This text of 196 F. Supp. 3d 871 (Limited v. Daiichi Sankyo, Inc.) is published on Counsel Stack Legal Research, covering District Court, N.D. Illinois primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Limited v. Daiichi Sankyo, Inc., 196 F. Supp. 3d 871, 2016 WL 3976992 (N.D. Ill. 2016).

Opinion

MEMORANDUM OPINION AND ORDER

REBECCA R. PALLMEYER, United States 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 medoxom-il), 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 Phar-ma Inc. (“Aurobindo”) are all seeking approval from the United States Food and Drug Administration (“FDA”) to market and sell their own generic versions of Be-nicar®. 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 Mylaris 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 [875]*875regarding 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

Beniear® is drug approved by the FDA for the treatment of hypertension. See http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetylnformationfor PatientsandProviders /ucm215245.htm (last visited July 20, 2016). To obtain FDA approval to market and sell Beniear®, 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”). (PI. 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)(l)(B)(i); Apotex, 781 F.3d at 1358. As a result, FDA cannot approve any generic version of Beniear® 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 Be-niear®. In doing so, they certified under 21 U.S.C. § 355(j)(2)(A)(vii)(IV)4that 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, In-[876]*876tervenor-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)(£ )(bb)(AA).6

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Cite This Page — Counsel Stack

Bluebook (online)
196 F. Supp. 3d 871, 2016 WL 3976992, Counsel Stack Legal Research, https://law.counselstack.com/opinion/limited-v-daiichi-sankyo-inc-ilnd-2016.