Senju Pharm. Co. v. Apotex Inc.

• Decision Date: 17 September 2012
• Docket Number: Civil No. 11–1171–SLR.
• Citation: 891 F.Supp.2d 656
• 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

891 F.Supp.2d 656

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

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

Civil No. 11–1171–SLR.

United States District Court,

D. Delaware.

Sept. 17, 2012.

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, and Frank J. West, Esquire of Oblon, Spivak, McClelland, Maier & Neustadt, LLP.

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 Bissell & Liddell LLP.

MEMORANDUM OPINION

SUE L. ROBINSON, District Judge.

I. INTRODUCTION

Senju Pharmaceutical Co., Ltd. (“Senju”) and Kyorin Pharmaceutical Co., Ltd. (“Kyorin”) are co-owners of United States Patent No. 6,333,045 (“the ' 045 patent”), which is directed to aqueous liquid pharmaceutical compositions comprising gatifloxacin and disodium edetate, as well as various methods utilizing these compositions. Allergan, Inc. (“Allergan”) is the exclusive licensee of the '045 patent for ophthalmic uses and the holder of two New Drug Applications (“NDAs”) that cover gatifloxacin ophthalmic solutions. (D.I. 1 at ¶¶ 16, 26)

The current case is related to prior litigation (“the first litigation”) over the '045 patent in this court between Senju, Kyorin, and Allergan (collectively, “plaintiffs”) and Apotex Inc. and Apotex Corp. (collectively, “the Apotex entities” or “defendants”) that was based on defendants' Abbreviated New Drug Application (“ANDA”) for an allegedly infringing product. (D.I. 1 at ¶ 30) The court entered final judgment in that case against plaintiffs on December 20, 2011. See Senju Pharma. Co. v. Apotex Corp., 836 F.Supp.2d 196 (D.Del.2011).

Plaintiffs, meanwhile, were engaged in reexamination proceedings for the ' 045 patent with the United States Patent and Trademark Office (“PTO”) without the court's knowledge. (D.I. 13 at 1) Following reexam, plaintiffs filed the instant action against the same defendants on November 28, 2011. (D.I. 1) Plaintiffs seek a declaratory judgment of infringement based on the same ANDA filing at issue in the first litigation. ( Id. at ¶¶ 18, 36–37, 45–46) However, plaintiffs are now alleging infringement of the claims that were added or amended during the reexamination of the '045 patent, namely claims 6 and 12–16. ( Id. at ¶¶ 36, 39, 46–47)

The court has jurisdiction over this matter pursuant to 28 U.S.C. §§ 1331 and 1338(a). Presently before the court is defendants' motion to dismiss for failure to state a claim upon which relief can be granted, filed on January 9, 2012. (D.I. 8) For the reasons that follow, the court grants defendants' motion to dismiss.

II. BACKGROUNDA. The Parties

Senju and Kyorin are corporations organized under the laws of Japan and having principal places of business in Japan. (D.I. 1 ¶¶ 2–3) Allergan is a Delaware corporation with its principal place of business in California. ( Id. at ¶ 4)

Apotex Corp. is a Delaware corporation, having its principal place of business in Florida. ( Id. at ¶ 5) Apotex Inc. is a corporation formed under the laws of Canada, having its principal place of business in Ontario, Canada. ( Id. at ¶ 7)

B. The First Litigation

Apotex Inc. is allegedly formulating or planning to formulate gatifloxacin ophthalmicsolution to be marketed and sold in the United States by Apotex Corp. ( Id. at ¶ 9) In connection with this product, the Apotex entities filed ANDA No. 79–084 on July 19, 2007. ( Id. at ¶ 28) The Apotex entities notified plaintiffs of their ANDA filing on October 17, 2007. ( Id. at ¶ 29) Pursuant to the Hatch–Waxman Act, plaintiffs then commenced the first litigation, asserting that the product in the ANDA filing would infringe claims 1–3, 6, 7, and 9 of the '045 patent. ( Id. at ¶¶ 29–30)

Following a bench trial, the court entered judgment on June 21, 2010 that claims 1–3 and 6–9 of the '045 patent were invalid as obvious. Senju Pharma., 717 F.Supp.2d 404, 433 (D.Del.2010). Plaintiffs filed a post-trial motion for a new trial, which was denied without prejudice, but the court reopened the judgment on claim 7 of the '045 patent to allow for further submission of evidence. Senju Pharma., 2010 WL 4538265 (D.Del. Nov. 3, 2010). On December 20, 2011, after reviewing the additional evidence, the court issued a final judgment confirming the invalidity of claim 7, thereby closing the case. See Senju Pharma., 836 F.Supp.2d at 210–11.¹

C. Reexamination of the '045 Patent

On February 25, 2011, before final judgment was entered in the first litigation, Senju and Kyorin filed a request for reexamination of claims 1–3, 6, 8, and 9 of the '045 patent with the PTO. (D.I. 1 at ¶ 23) The request was granted on April 28, 2011. ( Id.) Plaintiffs did not inform defendants about the reexamination proceedings at the time and waited until they received a notice of intent to issue a reexamination certificate from the PTO before informing the court about the reexamination. (D.I. 9 at 4; D.I. 13 at 1) During the reexamination prosecution, plaintiffs submitted the prior art, the arguments relied upon by the court and defendants in the first litigation, and the court's opinion in that case. ( Id. at ¶ 24) On October 25, 2011, the PTO issued a reexamination certificate for the '045 patent, which canceled claims 1–3 and 8–11, allowed amended claim 6, and added claims 12–16. ( Id. at ¶ 25)

Claim 1 of the '045 patent, as originally issued, claimed an aqueous liquid pharmaceutical composition which comprises gatifloxacin or its salt and disodium edetate (“EDTA”). Claim 2 limited claim 1 to a composition with a pH within the range of 5 to 8, and claims 3 and 9 taught the eye drop form of the compositions taught by claims 1 and 2, respectively. New reexamined claim 12 incorporates claims 1, 2, 3, and 9 and adds further limitations, teaching “[a]n aqueous liquid pharmaceutical eye drop composition which comprises from about 0.3 to about 0.8 w/v% gatifloxacin or its salt, about 0.01 w/n% disodium edetate, and wherein the aqueous liquid pharmaceutical composition has a pH of from about 5 to about 6.”

New reexamined claims 13 and 14 are dependent on claim 12 and further specify particular concentrations of gatifloxacin or its salt.² Claim 15 teaches an aqueous liquid pharmaceutical eye drop composition according to claim 12, “comprising at least one isotonic agent selected from the group consisting of sodium chloride, potassium chloride, glycerin, mannitol and glucose.” Claim 16 teaches an aqueous liquid pharmaceutical eye drop composition according to claim 14, “wherein the at least one isotonic agent is sodium chloride.”

Finally, claim 6 was amended to include limitations that were not in any of the original claims. These limitations relate to the amount of gatifloxacin or its salt, a new range of pH, and the amount of EDTA. (D.I. 13 at App'x A1)

III. STANDARD OF REVIEW

In reviewing a motion to dismiss 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 plaintiff. 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, 545, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) (interpreting Fed.R.Civ.P. 8(a)) (internal quotations omitted). A complaint does not need detailed factual allegations; however, “a plaintiff's obligation to provide the ‘grounds' of his entitle[ment] to relief requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do.” Id. at 545, 127 S.Ct. 1955 (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 of the complaint's allegations are true.” Id. 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.

IV. DISCUSSION

Defendants seek dismissal of the current infringement action based on the doctrine of res judicata, or claim preclusion. (D.I. 8) Their motion to dismiss argues that dismissal is proper because the claims of the current lawsuit are precluded by the judgment in plaintiffs' first litigation against them. (D.I. 9 at 5–8)

A. Applicable Law

The issue of claim preclusion in the context of patent infringement cases requires the application of both regional circuit and Federal Circuit law. “Because the general principles of res judicata are not unique to patent law,” the court looks “to regional circuit law for guidance applying those principles.” Aspex Eyewear, Inc. v. Marchon Eyewear, Inc., 672 F.3d 1335, 1341 n. 1 (Fed.Cir.2012) (citing Acumed LLC v. Stryker Corp., 525 F.3d 1319, 1323 (Fed.Cir.2008)). However, the more particular question of whether...