Apotex, Inc. v. Senju Pharm. Co.

• Decision Date: 07 February 2013
• Docket Number: Civ. No. 12–196–SLR.
• Parties: APOTEX, INC. and Apotex Corp., Plaintiffs, v. SENJU PHARMACEUTICAL CO., LTD., Kyorin Pharmaceutical Co., Ltd., and Allergan, Inc., Defendants.
• Court: U.S. District Court — District of Delaware

921 F.Supp.2d 308

APOTEX, INC. and Apotex Corp., Plaintiffs,

v.SENJU PHARMACEUTICAL CO., LTD., Kyorin Pharmaceutical Co., Ltd., and Allergan, Inc., Defendants.

Civ. No. 12–196–SLR.

United States District Court, D. Delaware.

Feb. 7, 2013.

Francis J. Murphy, Esquire of Murphy & Landon, Wilmington, DE, for Plaintiffs. Of Counsel: Alan B. Clement, Esquire, Keith D. Parr, Esquire, Michael J. Gaertner, Esquire, Scott B. Feder, Esquire, David B. Abramowitz, Esquire, and Patrick C. Gallagher, Esquire of Locke Lord LLP.

Richard D. Kirk, Esquire, and Stephen B. Brauerman, Esquire of Bayard, P.A., Wilmington, DE, for Defendant Senju Pharmaceutical Co., Ltd. Of Counsel: William F. Sondericker, Esquire, Keith D. Nowak, Esquire, and Gerald W. Griffin, Esquire of Carter, Ledyard & Milburn LLP; Derrik K. Takeuchi, Esquire of Greenberg, Whitcombe & Takeuchi, LLP.

David E. Ross, Esquire, and Benjamin J. Schladweiler, Esquire of Seitz Ross Aronstam & Moritz LLP, Wilmington, DE, for Defendant Kyorin Pharmaceutical Co., Ltd. Of Counsel: John M. Majoras, Esquire, Kevin D. McDonald, Esquire, and Rosanna K. McCalips, Esquire of Jones Day.

Jack B. Blumenfeld, Esquire, and Regina S.E. Murphy, Esquire of Morris, Nichols, Arsht & Tunnell LLP, Wilmington, DE, for Defendant Allergan, Inc. Of Counsel: M. Sean Royall, Esquire, Ashley E. Johnson, Esquire, and Jeffrey T. Thomas, Esquire of Gibson, Dunn & Crutcher.

MEMORANDUM OPINION

SUE L. ROBINSON, District Judge.

I. INTRODUCTION

This antitrust litigation arises following a series of patent lawsuits between Apotex, Inc. and Apotex Corp. (collectively, “Apotex”) and Senju Pharmaceutical Co., Ltd. (“Senju Pharma”), Kyorin Pharmaceutical Co., Ltd. (“Kyorin”), and Allergan, Inc. (“Allergan”) (collectively, “Senju”) regarding aqueous liquid pharmaceutical compositions for treating bacterial conjunctivitis. Allergan is the holder of two approved New Drug Applications (“NDAs”) that cover a 0.3% ophthalmic solution of gatifloxacin, sold under the trade name Zymar®, and a 0.5% ophthalmic solution of gatifloxacin, sold under the trade name Zymaxid®. (D.I. 1 at ¶¶ 21–22, 39, 45) ¹ Senju Pharma, Kyorin, and Allergan are the owners or licensees of U.S. Patent Nos. 6,333,045 (“the '045 patent”) and 5,880,283 (“the '283 patent”), which are listed in the United States Food and Drug Administration's (“FDA's”) publication titled “Approved Drug Products with Therapeutic Equivalence Evaluations” (known as the “Orange Book”) for Zymar® and Zymaxid®. ²( Id. at ¶¶ 29, 46) After Apotex filed Abbreviated New Drug Applications (“ANDAs”) for generic 0.3% and 0.5% ophthalmic solutions of gatifloxacin, Senju initiated several patent actions against Apotex in this court asserting infringement of the ' 045 patent and/or the ' 283 patent—Civ. Nos. 07–779, 11–1171, and 12–159 (collectively, “the related proceedings”). As will be discussed in more detail infra, the related proceedings are currently at various stages of litigation.

On February 16, 2012, Apotex filed the instant action against Senju alleging antitrust violations under the Sherman Act. (D.I. 1) Apotex asserts that Senju used the related proceedings and other alleged anticompetitive conduct to unlawfully delay and frustrate Apotex's entry into the market for gatifloxacin ophthalmic solutions, thereby denying consumers access to its low-cost generic gatifloxacin ophthalmic product. ( Id. at ¶¶ 59, 72, 74–75, 79–80, 95–96, 112–13, 129–30) Presently before the court are various motions: Senju's motion to stay the case pending resolution of the related proceedings (D.I. 17); Senju Pharma and Kyorin's motion to dismiss for failure to state a claim ³ (D.I. 11); and Allergan's motion to dismiss based upon failure to allege antitrust injury.⁴ (D.I. 14) The court has jurisdiction over this matter pursuant to 28 U.S.C. § 1331, 28 U.S.C. § 1337(a), and 15 U.S.C. § 15.

II. BACKGROUNDA. The Parties

Apotex, Inc. is a corporation organized under the laws of Canada, with a place of business in Ontario, Canada. (D.I. 1 at ¶ 1) Apotex Corp. is a Delaware corporation with a place of business in Florida. ( Id. at ¶ 2) Senju Pharma and Kyorin are corporations organized under the laws of Japan with principal places of business in Japan. ( Id. at ¶¶ 3–4) Allergan is a Delaware corporation with a principal place of business in California. ( Id. at ¶¶ 5, 7) Because the instant action arises from a history of litigation between the parties in this court, a brief summary will help frame the issues.

B. The Development of 0.3% Gatifloxacin Ophthalmic Solution

Apotex characterizes gatifloxacin as a quinolone antibiotic that was first patented in 1990 by Kyorin researchers in U.S. Patent No. 4,980,470 (“the '470 patent”). ( Id. at ¶ 10) The '470 patent, which expired in 2010, claims the gatifloxacin molecule and teaches that gatifloxacin can be formulated in various dosage forms, including as eye drops. In 1997, Kyorin entered into a license agreement with Senju Pharma that, inter alia, required any patent filed by Senju Pharma in gatifloxacin ophthalmic formulations to be jointly assigned to Kyorin and Senju Pharma. ( Id. at ¶ 13) In 2001, Senju Pharma obtained the '045 patent claiming aqueous liquid ophthalmic formulations comprising gatifloxacin and disodium edetate and methods for preparing these formulations; the patent was assigned to Kyorin and Senju Pharma. ( Id. at ¶¶ 15–16, 18)

Senju Pharma and Kyorin licensed to Allergan the right to practice the '045 patent and to market aqueous liquid gatifloxacin ophthalmic products in the United States. ( Id. at ¶ 20) In 2002, Allergan filed NDA No. 21–493 for a 0.3% gatifloxacin ophthalmic solution (Zymar®), and the FDA approved it in 2003.⁵( Id. at ¶¶ 21–22) Domestic sales for Zymar® allegedly reached approximately $100 million by 2009. ( Id. at ¶ 24)

C. The 07–779 Action

On July 18, 2007, Apotex filed ANDA No. 79–084 seeking FDA approval for a generic 0.3% gatifloxacin ophthalmic solution (“generic 0.3% product”). ⁶( Id. at ¶ 30) Pursuant to 21 U.S.C. § 355(j)(2)(B), Apotex notified Senju that it had submitted the ANDA with a Paragraph IV certification alleging that the '283 and ' 045 patents are invalid and/or will not be infringedby the generic 0.3% product.⁷( Id. at ¶ 32) In response, Senju initiated Civ. No. 07–779 (“the 07–779 action”) against Apotex in this court, alleging infringement of the '283 and ' 045 patents. ( Id. at ¶ 33)

Senju eventually dismissed its claims related to the '283 patent and, following a bench trial, the court found claims 1–3 and 6–9 of the '045 patent invalid as obvious. Senju Pharm. Co. v. Apotex Inc., 717 F.Supp.2d 404, 433 (D.Del.2010). After reopening the judgment on claim 7 and reviewing additional evidence, the court issued a final judgment confirming the invalidity of claim 7. Senju Pharm. Co. v. Apotex Inc., 836 F.Supp.2d 196, 201–11 (D.Del.2011). On October 5, 2012, the Federal Circuit affirmed the court's decision. Senju Pharm. Co. v. Apotex, Inc., 485 Fed.Appx. 433 (Fed.Cir.2012).

D. Reexamination of the '045 Patent

On February 25, 2011, before final judgment was entered by this court in the 07–779 action, Senju Pharma and Kyorin filed an ex parte request for reexamination of claims 1–3, 6, 8, and 9 of the '045 patent with the U.S. Patent and Trademark Office (“PTO”). (D.I. 1 at ¶ 56) As part of the request, portions of the record from the 07–779 action that were favorable to the patent owners' position were provided, but other information unfavorable to patentability was allegedly withheld or misrepresented. ( Id. at ¶¶ 57–63) A reexamination certificate was issued for the '045 patent on October 25, 2011, cancelling claims 1–3 and 8–11, amending claim 6, and adding new claims 12–16. ( Id. at ¶ 69)

E. The 11–1171 Action

On November 28, 2011, Senju filed a second lawsuit, Civ. No. 11–1171 (“the 11–1171 action”), against Apotex alleging that the same generic 0.3% product accused of infringement in the 07–779 action infringes the reexamined ' 045 patent. ( Id. at ¶ 77) The 11–1171 action was dismissed by this court on grounds of claim preclusion, or res judicata. Senju Pharm. Co. v. Apotex Inc., 891 F.Supp.2d 656, 662 (D.Del.2012). The dismissal is currently on appeal at the Federal Circuit. (Civ. No. 11–1171, D.I. 24)

F. The 12–159 Action

During the pendency of the 07–779 action, Allergan filed NDA No. 22–548 and received FDA approval for a 0.5% gatifloxacin ophthalmic solution (Zymaxid®).⁸ (D.I. 1 at ¶¶ 39, 45) According to Apotex, Zymaxid® is substantially similar to Zymar®—except that the concentration of gatifloxacin is 0.5% instead of 0.3%—and “does not possess any clinical or therapeutic benefit or superiority in comparison to Zymar®.” ( Id. at ¶¶ 40, 47–49)

Apotex subsequently filed ANDA No. 203–523 for a generic 0.5% ophthalmic solution of gatifloxacin (“generic 0.5% product”).⁹ (Civ. No. 12–159, D.I. 1 at ¶ 33) Pursuant to 21 U.S.C. § 355(j)(2)(B), Apotex notified Senju in a letter dated January 13, 2012 that it had submitted the ANDA with a Paragraph IV certification. (Civ. No. 12–159, D.I. 1 at ¶ 34) In response, on February 10, 2012, Senju filed Civ. No. 12–159 (“the 12–159 action”) against Apotex, alleging that the generic 0.5% product infringes the ' 045 and '283 patents. (Civ. No. 12–159, D.I. 1) The court recently granted in part and denied in part a motion to dismiss and to strike Apotex's invalidity and inequitable conduct defenses in that case. (Civ. No. 12–159, D.I. 44)

G. The Instant Litigation

In the instant litigation, Apotex claims that Senju unlawfully delayed Apotex's entry into the market for gatifloxacin ophthalmic solutions, fraudulently obtained reexamination of the '045 patent, and filed the NDA for Zymaxid® in order “to exclude further competition” and to execute a “product switching strategy to deny patients access to Apotex's low cost generic [0.3% product].” (D.I. 1 at ¶¶ 41–42, 75, 79–80) In this regard, the complaint focuses on four categories of...