Sanofi-Synthelabo v. Apotex Inc.
Decision Date | 31 August 2006 |
Docket Number | No. 02 Civ. 2255(SHS).,02 Civ. 2255(SHS). |
Citation | 488 F.Supp.2d 317 |
Parties | SANOFI-SYNTHELABO; Sanofi-Synthelabo, Inc.; and Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership, Plaintiffs, v. APOTEX INC.; and Apotex Corp., Defendants. |
Court | U.S. District Court — Southern District of New York |
Evan R. Chesler, Richard J. Stark and David Greenwald, Cravath Swaine Moore LLP, New York, NY, for Plaintiffs.
Allan H. Fried, Caesar, Rivise, Bernstein, Cohen & Pokotilow, Ltd., New York, NY, Bruce J. Chasan, Kevin A. Keeling, Mona Gupta, Caesar, Rivise, Bernstein, Cohen & Pokotilow, Ltd., Philadelphia, PA, Karen J. Bernstein, Pryor Cashman Sherman & Fynn LLP, New York, NY, for Defendants.
Plavix, the most widely prescribed prescription blood-thinning agent in the world, prevents platelets in blood from aggregating around obstructions — such as metal stents or cholesterol deposits — in arterial passageways. Forty-eight million Americans take Plavix daily to prevent potentially fatal blood clots. This action arose between Sanofi-Aventis, Sanofi-Synthelabo, Inc. and Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership (collectively, "Sanofi") — those entities that invested in the research and development to patent this drug and bring it to market — on the one hand, and Apotex, Inc. and Apotex Corporation (collectively, "Apotex") — which seeks to market the generic equivalent of Plavix — on the other. Before the Court is a motion by Sanofi to preliminarily enjoin Apotex from distributing its generic version of Plavix in the United States after an at-risk launch of that drug by Apotex approximately three weeks ago, on August 8, 2006. Sanofi seeks to enjoin Apotex from any further distribution of the generic drug pending an ultimate decision on the merits of this action and has also requested that the Court order a recall of the product already distributed.
In this action, the parties have agreed and stipulated that Apotex's generic product in fact infringes Sanofi's patent. Apotex does not dispute that but rather claims that Sanofi's patent is invalid and unenforceable. Because Sanofi has adequately demonstrated that the questions Apotex raises as to the validity and enforceability of Sanofi's '265 patent are without substantial merit based on the evidence adduced to date, Sanofi has demonstrated a likelihood of success on the merits at trial. Further, Sanofi will suffer irreparable harm due to Apotex's continued distribution of the infringing pharmaceutical, and Apotex's hardships primarily arise from the company's own calculated risk-taking. Finally, although there are competing — and substantial — public interests at stake on both sides of this litigation, the balance of those competing public interests slightly favors Sanofi. For these reasons, and because the Court finds Apotex's laches and unclean hands defenses to be without merit, Sanofi's motion is granted insofar as Apotex is enjoined from further distribution of its generic product. Sanofi's motion is denied insofar as it requests a recall of the product Apotex has already distributed.
In the context of the Court's consideration of a motion for a preliminary injunction, "all findings of fact and conclusions of law ... are subject to change upon the ultimate trial on the merits." Purdue Pharma L.P. v. Boehringer Ingelheim GmbH, 237 F.3d 1359, 1363 (Fed.Cir.2001) (citing Illinois Tool Works, Inc. v. Grip-Pak, Inc., 906 F.2d 679, 681 (Fed.Cir. 1990)); University of Texas v. Camenisch, 451 U.S. 390, 395, 101 S.Ct. 1830, 1834, 68 L.Ed.2d 175 (1981). The Court finds the following facts for the purposes of this Opinion.
Plavix, approved for sale in the United States by the U.S. Food and Drug Administration ("FDA") in November 1997, is prescribed for the reduction of thrombotic events, such as heart attacks and strokes, for patients who have recently suffered such events or who have arterial disease or acute coronary syndrome. The active ingredient of Plavix is clopidogrel bisulfate. (Id.) Sanofi obtained a patent claiming clopidogrel bisulfate on July 11, 1989, naming Sanofi employees Alain Badorc and Daniel Fréhel as inventors. (Id. at ¶¶ 8-9.) That patent, U.S. patent number 4,847,265 ("the '265 patent"), claims clopidogrel bisulfate by its chemical name in claim three: "hydrogen sulfate of the dextrorotatory isomer of methyl alpha 5(4,5,6,7-tetrahydro(3,2-c)thieno pyridyl)(2-chlorophenyl)-acetate substantially separated from the levo-rotatory isomer." (Id. at ¶¶ 9-10.) The '265 patent is exclusively licensed to the Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership and expires on November 17, 2011. (Id. at ¶ 9.)
Apotex sought approval from the FDA to manufacture and sell clopidogrel bisulfate tablets before the expiration of Sanofi's '265 patent by filing an Abbreviated New Drug Application ("ANDA") with the FDA in November 2001. (Fact Stmt at ¶¶ 14-15.) In the ANDA, Apotex certified that it believed the '265 patent to be invalid, pursuant to the requirements of 21 U.S.C. § 355(j)(2)(vii)(IV). (Id. at ¶ 16; see Glaxo Group Ltd. v. Apotex, Inc., 376 F.3d 1339, 1344 (Fed.Cir.2004) ( ).) Apotex was the first to file an ANDA for clopidogrel bisulfate (Decl. of Dr. Bernard Sherman, dated Aug. 16, 2006 ("Sherman Decl.") at ¶ 17), thereby securing the right to 180 days of market exclusivity provided by the Hatch-Waxman Act to the first ANDA filer to challenge a patent. See 21 U.S.C. § 355(j)(5)(B)(iv); see also In re Tamoxifen Citrate Antitrust Litig., 429 F.3d 370, 376 (2d Cir.2005).
In response to that ANDA filing by Apotex, Sanofi filed this suit against Apotex on March 21, 2002 pursuant to 35 U.S.C. § 271(e), on the ground that Apotex's filing of the ANDA constituted infringement of the '265 patent. Section 271(e)(2)(A) provides that "it shall be an act of infringement to submit (A) an application ... for a drug claimed in a patent or the use of which is claimed in such a patent, ... if the purpose of such submission is to obtain approval ... to engage in the commercial manufacture, use, or sale" of the drug before the expiration of the patent. See also Glaxo Group, 376 F.3d at 1344 (); Glaxo, Inc. v. Novopharm Ltd., 110 F.3d 1562, 1569 (Fed.Cir.1997) (...
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