Sanofi-Synthelabo v. Apotex, Inc.
| Decision Date | 08 December 2006 |
| Docket Number | No. 06-1613.,06-1613. |
| Citation | 470 F.3d 1368 |
| Parties | SANOFI-SYNTHELABO, Sanofi-Synthelabo, Inc., and Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership, Plaintiffs-Appellees, v. APOTEX, INC. and Apotex Corp., Defendants-Appellants. |
| Court | U.S. Court of Appeals — Federal Circuit |
Evan R. Chesler, Cravath, Swaine & Moore, LLP, of New York, NY, argued for plaintiffs-appellees. With him on the brief were Richard J. Stark and David Greenwald. Of counsel on the brief were Robert L. Baechtold, John D. Murnane, and William E. Solander, Fitzpatrick, Cella, Harper & Scinto, of New York, NY.
Bruce J. Chasan, Caesar, Rivise, Bernstein, Cohen & Pokotilow, Ltd., of Philadelphia, PA, argued for defendants-appellants. With him on the brief were Robert S. Silver, Manny D. Pokotilow, Mona Gupta, and Lynn M. Terrebonne.
Anthony F. Lo Cicero, Amster, Rothstein & Ebenstein LLP, of New York, NY, for amicus curiae, Generic Pharmaceutical Association. With him on the brief was Richard S. Mandaro.
David H. Weinstein, Weinstein Kitchenoff & Asher LLC, of Philadelphia, PA, for amicus curiae, Medco Health Solutions, Inc.
Jeffrey Light, Patients Not Patents, Inc., of Washington, DC, for amicus curiae, Patients Not Patents, Inc.
Before LOURIE and BRYSON, Circuit Judges, CLEVENGER, Senior Circuit Judge.
Apotex, Inc. and Apotex Corp. (collectively referred to as "Apotex") appeal from the decision of the United States District Court for the Southern District of New York granting a preliminary injunction in favor of Sanofi-Synthelabo, Sanofi-Synthelabo, Inc., and Bristol-Myers Squibb ("BMS") Sanofi Pharmaceuticals Holding Partnership (collectively referred to as "Sanofi"). Because we conclude that the district court did not abuse its discretion in granting the preliminary injunction, we affirm.
Sanofi markets Plavix®, a platelet aggregation inhibiting agent used to reduce thrombotic events such as heart attacks and strokes. The active ingredient in Plavix® is clopidogrel bisulfate, which is covered by Sanofi's patent, U.S. Patent 4,847,265 ("the '265 patent"), which will expire on November 17, 2011.
To understand the issues presented in this appeal, it is necessary to have a generalized understanding of stereochemistry. Stereochemistry refers to the three-dimensional spatial arrangement of a molecule's constituent atoms. Molecules that have the same chemical substituents, but different spatial arrangements, are referred to as stereoisomers. If they contain an asymmetrical carbon atom, they exist as non-superimposable mirror images of each other and are referred to as enantiomers. Enantiomers are optically active because they are capable of rotating plane-polarized light; enantiomers that rotate polarized light to the right are referred to as dextrorotatory enantiomers, or d-enantiomers; enantiomers rotating polarized light to the left are referred to as levorotatory enantiomers, or l-enantiomers.1 A mixture of equal amounts of both types of enantiomers is referred to as a racemic mixture, or racemate, and it exhibits no optical activity. Clopidogrel is the dextrorotatory enantiomer of the free base methyl alpha-5-(4,5,6,7-tetrahydro(3,2-c)thienopyridyl)-(2-chlorophenyl) acetate, which the parties refer to as "MATTPCA." The active ingredient in Plavix® is the bisulfate salt of the d-enantiomer of MATTPCA, which is specifically recited in claim 3 of the '265 patent.
In November 2001, Apotex filed an Abbreviated New Drug Application ("ANDA") pursuant to the Hatch-Waxman Act seeking U.S. Food and Drug Administration ("FDA") approval to manufacture and sell a generic version of clopidogrel bisulfate. Apotex filed a Paragraph IV certification with its ANDA, pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), asserting that the '265 patent is invalid. In response, Sanofi sued Apotex on March 21, 2002, claiming that the filing of the ANDA infringed the '265 patent. Apotex counterclaimed, asserting that the patent is invalid and unenforceable. A thirty-month stay of FDA approval for the ANDA was triggered when the suit was filed in the district court, pursuant to 21 U.S.C. § 355(j)(5)(B)(iii). The stay expired May 17, 2005, and on January 20, 2006, the FDA approved the ANDA.
Several days before the ANDA was approved, Sanofi and Apotex began settlement negotiations in an effort to resolve the litigation. On March 17, 2006, the parties reached a first settlement agreement that was subject to the approval of the Federal Trade Commission and a consortium of state attorneys general pursuant to an order issued in another litigation involving BMS. In May 2006, the state attorneys general notified the parties that they would not approve the settlement. The parties negotiated a second agreement ("the May agreement"). The May agreement included provisions specifying, inter alia, actions that could be taken by the parties in the event that the settlement failed to receive regulatory approval. In July 2006, the state attorneys general again informed the parties that they would not approve the settlement. Apotex then declared "regulatory denial" on July 31, 2006, as permitted under the settlement agreement, which meant, inter alia, "a denial of approval by either the FTC or a state attorney general as to which neither party seeks further review." Under the agreement, litigation would resume in the event of "regulatory denial."
Pursuant to the aforementioned agreement, Apotex launched its generic clopidogrel bisulfate product on August 8, 2006. In accordance with the provisions in the settlement agreement, Sanofi notified Apotex of its intent to move for a preliminary injunction in the time frame permitted by the agreement, viz., five business days after the generic launch.2 Sanofi filed its motion for a preliminary injunction on August 15, 2006, and requested a recall of Apotex's products that were already distributed. After a two-day evidentiary hearing, the district court granted the motion for injunctive relief on August 31, 2006, but denied the request for recall. During the period between the generic launch and the entry of the preliminary injunction, Apotex shipped a six-month supply of its product to distributors in the United States.
In reaching its decision, the district court applied the established four-factor test for preliminary injunctive relief, and found that the factors weighed in favor of an injunction. Regarding the likelihood of success on the merits, the court noted that Apotex conceded that its accused products infringe claim 3 of the '265 patent. The court then found that Apotex failed to establish a likelihood of proving invalidity at trial—rejecting its anticipation, obviousness, and obviousness-type double patenting invalidity defenses. The court also determined that Apotex failed to raise a substantial question as to whether the '265 patent is unenforceable due to inequitable conduct. Additionally, the court found that the remaining three factors of the test favored issuance of a preliminary injunction. As for Apotex's other defenses, the court concluded that the doctrine of laches was inapplicable, and it rejected Apotex's unclean hands defense. The court set bond in the amount of $400 million. Trial is scheduled to commence on January 22, 2007.
Apotex moved for a stay of the injunction, which we denied on September 21, 2006, and it filed its appeal from the district court's grant of the preliminary injunction. An expedited briefing schedule was set, and oral argument was heard on October 31, 2006. We have jurisdiction pursuant to 28 U.S.C. § 1292(c) in view of §§ 1292(a) and 1295(a)(1).
A decision to grant or deny a preliminary injunction pursuant to 35 U.S.C. § 283 is within the sound discretion of the district court, and we review such a decision for an abuse of discretion. Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d 1343, 1350 (Fed.Cir.2001). Thus, a decision granting a preliminary injunction will be overturned on appeal only if it is established "that the court made a clear error of judgment in weighing relevant factors or exercised its discretion based upon an error of law or clearly erroneous factual findings." Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1364 (Fed.Cir. 1997). To the extent the court's decision is based upon an issue of law, we review that issue de novo. Tate Access Floors, Inc. v. Interface Architectural Res., Inc., 279 F.3d 1357, 1364 (Fed.Cir.2002).
Sanofi, as the moving party, may be entitled to a preliminary injunction if it establishes four factors: "(1) a reasonable likelihood of its success on the merits; (2) irreparable harm if an injunction is not granted; (3) a balance of hardships tipping in its favor; and (4) the injunction's . . . impact on the public interest." Amazon.com, 239 F.3d at 1350.
In order to satisfy the first element of the test, Sanofi must demonstrate that, "in light of the presumptions and burdens that will inhere at trial on the merits," Amazon.com, 239 F.3d at 1350, Sanofi will likely prove that Apotex's product infringes the '265 patent and that it will withstand Apotex's challenges to the validity and enforceability of the '265 patent. Because Apotex stipulated to infringement, only the second inquiry is at issue in this case. Thus, the first element was properly found satisfied if Apotex failed to raise a "substantial question" with regard to the validity or enforceability of the '265 patent—or, if it succeeded in doing so, Sanofi demonstrated that those defenses "lack substantial merit." Genentech, 108 F.3d at 1364. On appeal, Apotex challenges the district court's rulings with respect to anticipation, obviousness, obviousness-type double patenting, and enforceability.
We first consider whether the district court clearly erred in its...
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