Senju Pharm. Co. v. Apotex Inc.

746 F.3d 1344

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

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

No. 2013–1027.

United States Court of Appeals, Federal Circuit.

March 31, 2014.

Richard D. Kelly, Oblon, Spivak, McClelland, Maier, & Neustadt, L.L.P., of Alexandria, VA, argued for plaintiffs-appellants. With him on the brief were Stephen G. Baxter, Frank J. West, and Tia D. Fenton.

Hugh S. Balsam, Locke Lord LLP, of Chicago, IL, argued for defendants-appellees. With him on the brief were Scott B. Feder, David B. Abramowitz, Patrick C. Gallagher, of Chicago, IL, and Alan B. Clement, of New York, NY.

Before NEWMAN, PLAGER, and O'MALLEY, Circuit Judges.

Opinion for the court filed by Circuit Judge PLAGER. Dissenting opinion filed by Circuit Judge O'MALLEY.

PLAGER, Circuit Judge.

This is a patent case calling on us to consider the application of claim preclusion doctrine (res judicata) to a second suit on the same patent based on amended claims resulting from a re-examination of the patent. Plaintiffs–Appellants Senju Pharmaceutical Co., Ltd., Kyorin Pharmaceutical Co., Ltd., and Allergan, Inc. (collectively referred to as “Senju”) filed suit in the United States District Court for the District of Delaware against Defendants–Appellees Apotex Inc. and Apotex Corp. (“Apotex”). Plaintiffs alleged infringement of certain claims of Senju's reexamined U.S. Patent No. 6,333,045 (the '045 patent).

In response, Apotex filed a motion to dismiss Senju's lawsuit. Apotex argued that Senju had asserted the same '045 patent against Apotex in a previous infringement action (the “first action”) prior to the '045 patent's reexamination, and therefore Senju's subsequent action for infringement of the reexamined '045 patent (the “second action”) was barred by the doctrine of claim preclusion. The district court agreed and granted Apotex's motion to dismiss. Senju now appeals.

For the reasons that follow, we conclude that Senju's action for infringement was properly dismissed as barred by claim preclusion, and therefore affirm the district court's ruling.

I. Background

The '045 patent relates to an ophthalmic solution for eye drops that contains the drug Gatifloxacin. Gatifloxacin is an antimicrobial agent used to kill various types of bacteria. When treating the eye with Gatifloxacin, tear dilution and the outer layer of the eye, the cornea, can prevent the Gatifloxacin from passing into and treating the space between the cornea and the lens of the eye, the aqueous humor. '045 patent col.1 ll.27–34.

The '045 patent discloses a pharmaceutical solution that resolves this problem by combining the Gatifloxacin with disodium edetate (“EDTA”). Id. col.1 ll.54–61. EDTA helps expand the intercellular spaces of the cornea, accelerating the passage of Gatifloxacin solution into the eye. Id. The '045 patent as originally issued in December 2001 claimed this combination of Gatifloxacin and EDTA.

Pursuant to the terms of the Hatch–Waxman Act (Pub.L. No. 98–417, 98 Stat. 1585) (“the Act”), Apotex in July 2007 filed an Abbreviated New Drug Application (“ANDA”) (No. 79–084) with the Food and Drug Administration (“FDA”). The application requested approval to manufacture, market, and sell a generic version of the Gatifloxacin ophthalmic solution covered by the '045 patent. Apotex filed the Paragraph IV notice specified by the Act, which places the patent-holder on notice of the application. In response, in November 2007 Senju filed its first action against Apotex, arguing that Apotex's ANDA and any manufacture of Gatifloxacin ophthalmic solution were acts of infringement of the '045 patent claims 1–3 and 6–9 under the Act.

The district court held a bench trial, and in June 2010 the district court issued findings of fact and conclusions of law under Rule 52(a). At that time the court held that, though the ANDA product infringed claims 1–3, 6, 7, and 9 of the '045 patent, claims 1–3 and 6–9 were invalid as obvious. Senju Pharm. Co. v. Apotex Inc., 717 F.Supp.2d 404, 433 (D.Del.2010). Senju then filed a motion for a new trial or to amend the district court's judgment and findings, specifically regarding the validity of claim 7.

Over one year passed while the district court addressed this and other issues. In December 2011 the district court again concluded that claim 7 was invalid on the ground of obviousness, and it entered final judgment in the case. Senju Pharm. Co. v. Apotex Inc., 836 F.Supp.2d 196 (D.Del.2011). In due course, the judgment was affirmed by this court. See485 Fed.Appx. 433 (Fed.Cir.2012).

In the gap between the district court's issuance in June 2010 of its findings of fact and conclusions of law under Rule 52(a), and its entry of final judgment in the case in December 2011, the patentee Senju filed, in February 2011, with the U.S. Patent and Trademark Office (“PTO”) a request for reexamination of claims 1–3, 6, 8, and 9 of the '045 patent. The PTO granted reexamination in April 2011. In response to an initial rejection on the ground of obviousness, Senju amended claim 6 to include several additional limitations, including the amount of Gatifloxacin, the amount of EDTA, and the pH. Senju also added new independent claim 12 with similar limitations. In October 2011, the PTO issued a reexamination certificate cancelling claims 1–3 and 8–11, and certifying amended claim 6, new independent claim 12, and new dependent claims 13–16 as patentable.

On November 28, 2011, still in the gap prior to the entry of final judgment in the first action, Senju filed a new action against Apotex, seeking a declaratory judgment that Apotex's manufacture, use, or sale of Gatifloxacin ophthalmic solution infringed claims 6 and 12–16 set forth in the reexamination certificate of the '045 patent.

In January 2012, several weeks after the district court issued its final judgment in the first case, Apotex filed a Rule 12(b)(6) motion to dismiss this second suit, arguing that Senju was precluded from asserting the reexamined ' 045 patent in the second action under the doctrine of claim preclusion. Apotex argued that Senju's second action involved the same cause of action that Senju asserted in its first action.

The district court agreed that Senju had asserted the same cause of action in its second action that it had asserted in its first action. The district court reached this conclusion because “none of the claims [that Senju] added or amended during reexamination were broader than their predecessors,” and the reexamined claims “[did] not create any new cause of action that plaintiffs lacked under the original version of the patent.” Senju Pharm. Co. v. Apotex Inc., 891 F.Supp.2d 656, 662 (D.Del.2012). The district court therefore granted Apotex's motion to dismiss the second action, rendering final judgment for Apotex. Id. This appeal by the patentee Senju of the dismissal of its suit followed.

We have jurisdiction to decide Senju's appeal based upon 28 U.S.C. § 1295(a).

II. Discussion

A. Principles of Claim Preclusion

Senju's appeal requires us to decide whether Senju's second action is barred by the judicial doctrine now generally known as claim preclusion, earlier known as res judicata and still referred to by that name. “[U]nder the doctrine of res judicata, a judgment ‘on the merits' in a prior suit involving the same parties or their privies bars a second suit based on the same cause of action.” Lawlor v. Nat'l Screen Serv. Corp., 349 U.S. 322, 326, 75 S.Ct. 865, 99 L.Ed. 1122 (1955).

The underlying policies that the doctrine of claim preclusion is designed to further are considerations of efficiency and finality:

The general rule of res judicata applies to repetitious suits involving the same cause of action. It rests upon considerations of economy of judicial time and public policy favoring the establishment of certainty in legal relations. The rule provides that when a court of competent jurisdiction has entered a final judgment on the merits of a cause of action, the parties to the suit and their privies are thereafter bound “not only as to every matter which was offered and received to sustain or defeat the claim or demand, but as to any other admissible matter which might have been offered for that purpose.”

C.I.R. v. Sunnen, 333 U.S. 591, 597, 68 S.Ct. 715, 92 L.Ed. 898 (1948) (quoting Cromwell v. Sac Cnty., 94 U.S. 351, 352, 24 L.Ed. 195 (1876)).

Whether a cause of action is barred by claim preclusion is a question of law that we review without deference. Acumed LLC v. Stryker Corp., 525 F.3d 1319, 1323 (Fed.Cir.2008). We look to the law of the regional circuit in which the district court sits for guidance regarding the principles of claim preclusion; however, whether a particular cause of action in a patent case is the same as or different from another cause of action has special application to patent cases, and we therefore apply our own law to that issue. Id. at 1323.

Under Third Circuit law, the home circuit of the district court in this case, claim preclusion principles require: “(1) a final judgment on the merits in a prior suit involving[ ](2) the same parties or their [privies]; and (3) a subsequent suit based on the same cause of action.” CoreStates Bank, N.A. v. Huls Am., Inc., 176 F.3d 187, 194 (3d Cir.1999). In this case, both parties agree that Senju meets the first two of the three requirements for claim preclusion—that is, Senju's first action resulted in a final judgment on the merits, and both the first and second actions involved the same parties.

The parties disagree, however, regarding the third requirement—whether Senju's first and second actions were based on the same cause of action. That is the central issue of this appeal.

In applying the policies expressed by the doctrine of claim preclusion, our court has identified certain significant factors to be considered in determining when a cause of action is the same. In Acumed, we...