Senju Pharm. Co. v. Apotex, Inc.

• Decision Date: 06 February 2013
• Docket Number: Civ. No. 12–159–SLR.
• Citation: 921 F.Supp.2d 297
• Parties: SENJU PHARMACEUTICAL CO., LTD., Kyorin Pharmaceutical Co., Ltd. and Allergan, Inc., Plaintiffs, v. APOTEX, INC. and Apotex Corp., Defendants.
• Court: U.S. District Court — District of Delaware

921 F.Supp.2d 297

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

v.APOTEX, INC. and Apotex Corp., Defendants.

Civ. No. 12–159–SLR.

United States District Court,

D. Delaware.

Feb. 6, 2013.

Jack B. Blumenfeld, Esquire, and Maryellen Noreika, Esquire of Morris, Nichols, Arsht & Tunnell LLP, Wilmington, DE. Counsel for Plaintiffs. Of Counsel: Richard D. Kelly, Esquire, Stephen G. Baxter, Esquire, Frank J. West, Esquire, and Tia D. Fenton, Esquire of Oblon, Spivak, McClelland, Maier & Neustadt, L.L.P.

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

MEMORANDUM OPINION

SUE L. ROBINSON, District Judge.

I. INTRODUCTION

This action arises out of the filing of an Abbreviated New Drug Application (“ANDA”) with the United States Food and Drug Administration (“FDA”) by defendants Apotex, Inc. and Apotex Corp. (collectively, “Apotex”). Allergan, Inc. (“Allergan”) is the holder of approved New Drug Application (“NDA”) No. 22–548 that covers Zymaxid®, a 0.5% ophthalmic solution of gatifloxacin. (D.I. 1 at ¶ 29) Senju Pharmaceutical Co., Ltd. (“Senju Pharma”), Kyorin Pharmaceutical Co., Ltd. (“Kyorin”), and Allergan (collectively, “Senju”) 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 FDA's publication titled “Approved Drug Products with Therapeutic Equivalence Evaluations” (known as the “Orange Book”) for Zymaxid®.¹( Id. at ¶¶ 15–16, 18–19, 30)

In a letter dated January 13, 2012, pursuant to 21 U.S.C. § 355(j)(2)(B), Apotex notified Senju that it had submitted ANDA No. 203523, for a generic 0.5% ophthalmic solution of gatifloxacin, with a Paragraph IV certification. ²( Id. at ¶ 33) On February 10, 2012, Senju responded by filing a complaint against Apotex, alleging that ANDA No. 203523 infringes the '045 and ' 283 patents (collectively, “the patents-at-issue”). ( Id.)

On March 16, 2012, Apotex filed its answer in the action and asserted counterclaims, including non-infringement, invalidity, and unenforceability of the patents-at-issue. (D.I. 9) Presently before the court is Senju's motion for partial dismissal of Apotex's counterclaims and to strike certain affirmative defenses, filed May 9, 2012.³ (D.I. 20) The court has jurisdiction over this matter pursuant to 28 U.S.C. §§ 1331, 1338(a), and 1400(b).

II. BACKGROUNDA. The Parties

Senju Pharma and Kyorin are corporations organized under the laws of Japan with principal places of business in Japan. (D.I. 1 at ¶¶ 2–3) Allergan is a Delaware corporation with a principal place of business in California. ( Id. at ¶ 4) Apotex Corp. is a Delaware corporation with a place of business in Florida, and Apotex, Inc. is a corporation organized under the laws of Canada, with a place of business in Ontario, Canada. ( Id. at ¶¶ 5, 7)B. Reexamination of the '045 Patent

The parties to this action were previously engaged in another lawsuit before this court, Civ. No. 07–779 (“the prior litigation”). In an opinion in that case dated June 14, 2010, the court found claims 1–3 and 6–9 of the '045 patent invalid as obvious.⁴Senju Pharm. Co. v. Apotex Inc., 717 F.Supp.2d 404, 433 (D.Del.2010).

On February 25, 2011, before final judgment was entered in the prior litigation, Senju Pharma and Kyorin filed a 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 ¶ 26) The request was granted on April 28, 2011. ( Id.) 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 ¶ 27)

C. Apotex's Counterclaims and Affirmative Defenses

Apotex's second and fourth affirmative defenses aver that the asserted claims of the patents-at-issue “are invalid for failure to comply with one or more of the provisions of Title 35 of the United States Code, including, but not limited to Sections 101, 102, 103 and/or 112.” (D.I. 9 at 13–14) Counts II and IV of Apotex's counterclaims repeat these allegations using the same language. ( Id., counterclaims at ¶¶ 11, 13) The counterclaims do not recite any factual allegations, except for party background and jurisdictional statements. ( Id., counterclaims at ¶¶ 1–9)

Apotex's fifth affirmative defense cross-references count V, which claims that the '045 patent is unenforceable due to inequitable conduct during reexamination of the '045 patent. ( Id. at 14, counterclaims at ¶¶ 14–36) Apotex alleges that “but for” material omissions and misrepresentations made by “Senju [Pharma], Kyorin, the inventors, and/or those acting on their behalf” ⁵ with an intent to deceive the PTO, the reexamined claims of the ' 045 patent would not have issued. ( Id., counterclaims at ¶¶ 14–36) Specifically, the pleadings allege that the following materials were withheld: (1) portions of the trial record and expert reports from the prior litigation disclosing that Kyorin's researchers had been the first to make and test gatifloxacin ophthalmic formulations covered by the ' 045 patent claims ( id., counterclaims at ¶¶ 20, 22); (2) evidence showing that the formulations as claimed by the ' 045 patent did not exhibit unexpected results ( id., counterclaims at ¶¶ 20, 30, 33); and (3) deposition testimony of Senju's expert from the prior litigation allegedly conceding the obviousness of preparing aqueous liquid compositions containing 0.3 w/v% gaitfloxacin and 0.01 w/v% of disodium edetate, based on the well-known use of disodium edetate to prevent coloration. ( Id., counterclaims at ¶¶ 21, 29) Apotex further alleges that “Senju [Pharma] and Kyorin ... amended reexamination claim 6 knowing that the added limitations to the claimed methods were not supported by the written description of the ' 045 patent specification, and thus reexamined claim 6 was invalid.” ( Id., counterclaims at ¶¶ 25–26)

III. STANDARD OF REVIEWA. Motion to Dismiss

In reviewing a motion filed under Federal Rule of Civil Procedure 12(b)(6), the court must accept all factual allegations in a complaint as true and take them in the light most favorable to the pleader. See Erickson v. Pardus, 551 U.S. 89, 94, 127 S.Ct. 2197, 167 L.Ed.2d 1081 (2007); Christopher v. Harbury, 536 U.S. 403, 406, 122 S.Ct. 2179, 153 L.Ed.2d 413 (2002). A court may consider the pleadings, public record, orders, exhibits attached to the complaint, and documents incorporated into the complaint by reference. Tellabs, Inc. v. Makor Issues & Rights, Ltd., 551 U.S. 308, 322, 127 S.Ct. 2499, 168 L.Ed.2d 179 (2007); Oshiver v. Levin, Fishbein, Sedran & Berman, 38 F.3d 1380, 1384–85 n. 2 (3d Cir.1994). A complaint must contain “a short and plain statement of the claim showing that the pleader is entitled to relief, in order to give the defendant fair notice of what the ... claim is and the grounds upon which it rests.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) (internal quotation marks omitted) (interpreting Fed.R.Civ.P. 8(a)). A complaint does not need detailed factual allegations; however, “a [pleader's] obligation to provide the grounds of his entitle[ment] to relief requires more than labels and conclusions, and a formulaic recitation of a cause of action's elements will not do.” Id. (alteration in original) (citation omitted). The “[f]actual allegations must be enough to raise a right to relief above the speculative level on the assumption that all the allegations in the complaint are true....” Id. (citations omitted) Furthermore, “[w]hen there are well-ple[d] factual allegations, a court should assume their veracity and then determine whether they plausibly give rise to an entitlement to relief.” Ashcroft v. Iqbal, 556 U.S. 662, 129 S.Ct. 1937, 1950, 173 L.Ed.2d 868 (2009). Such a determination is a context-specific task requiring the court “to draw on its judicial experience and common sense.” Id.

B. Motion to Strike

Fed.R.Civ.P. 12(b)(6) does not offer a mechanism for dismissing affirmative defenses because it refers only to “claim[s].” See Wyeth Holdings Corp. v. Sandoz, Inc., Civ. No. 0–955, 2012 WL 600715, at *4 (D.Del. Feb. 3, 2012). However, Fed.R.Civ.P. 12(f) provides: “The court may strike from a pleading an insufficient defense or any redundant, immaterial, impertinent, or scandalous matter.” “When ruling on a motion to strike, the [c]ourt must construe all facts in favor of the nonmoving party and deny the motion if the defense is sufficient under law. Further, a court should not grant a motion to strike a defense unless the insufficiency of the defense is clearly apparent.” Symbol Techs., Inc. v. Aruba Networks, Inc., 609 F.Supp.2d 353, 356 (D.Del.2009) (alteration in original) (citations omitted) (internal quotation marks omitted). “As a general matter, motions to strike under Rule 12(f) are disfavored.” Fesnak & Assocs., LLP v. U.S. Bank Nat'l Ass'n, 722 F.Supp.2d 496, 502 (D.Del.2010).

IV. DISCUSSION

Senju moves to dismiss counts II, IV, and V of the counterclaims and to strike the second, fourth, and fifth affirmative defenses. (D.I. 20) Counts II and IV of the counterclaims, as well as the second and fourth affirmative defenses, allege that the patents-in-suit are invalid.⁶ Count V of the counterclaims and the fifth affirmative defense assert unenforceability of the ' 045 patent for inequitable conduct.⁷

A. Apotex's Invalidity Defense

Senju asserts that Apotex's invalidity defense is deficient because the counterclaims and affirmative defenses recite legal conclusions without factual support and, as such, do not comply with Fed.R.Civ.P. 8, as interpreted by the Supreme Court in Twombly and Iqbal. (D.I. 20 at 2–4) Apotex does not attempt to argue that its invalidity defense lays out sufficient...