429 F.3d 1364 (Fed. Cir. 2005), 05-1331, Pfizer, Inc. v. Teva Pharmaceuticals, USA, Inc.

Docket Nº:05-1331.
Citation:429 F.3d 1364
Party Name:77 U.S.P.Q.2d 1257 PFIZER, INC. and Warner-Lambert Company, LLC, Plaintiffs-Appellees, v. TEVA PHARMACEUTICALS USA, INC., Defendant-Appellant, Ranbaxy Pharmaceuticals, Inc. and Ranbaxy Laboratories Limited, Defendants-Appellants.
Case Date:November 22, 2005
Court:United States Courts of Appeals, Court of Appeals for the Federal Circuit

Page 1364

429 F.3d 1364 (Fed. Cir. 2005)

77 U.S.P.Q.2d 1257

PFIZER, INC. and Warner-Lambert Company, LLC, Plaintiffs-Appellees,



Ranbaxy Pharmaceuticals, Inc. and Ranbaxy Laboratories Limited, Defendants-Appellants.

No. 05-1331.

United States Court of Appeals, Federal Circuit.

Nov. 22, 2005

Appealed from: United States District Court for the District of New Jersey Senior Judge Dickinson R. Debevoise.

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Joseph M. O'Malley, Jr., Fitzpatrick, Cella, Harper & Scinto, of New York, New York, argued for plaintiffs-appellees. With him on the brief were Bruce M. Wexler, Christopher L. Limpus, and John C. Heuton . Of counsel was Herbert W. Rea.

William R. Zimmerman, Knobbe, Martens, Olson & Bear, LLP, of Irvine, California, argued for defendants-appellants. With him on the brief for Ranbaxy Pharmaceuticals, Inc. were Darrell L. Olson, James F. Lesniak, Craig S. Summers, Payson J. LeMeilleur, and Christy G. Lea . Of counsel on the brief were David M. Hashmall and Dominique T. Hussey, Goodwin Procter LLP, of New York, New York, for Teva Pharmaceuticals USA, Inc.

Before NEWMAN, RADER, and PROST, Circuit Judges.

PROST, Circuit Judge.

Teva Pharmaceuticals USA, Inc. ("Teva") along with Ranbaxy Pharmaceuticals, Inc. and Ranbaxy Laboratories Limited (collectively, "Ranbaxy") appeal from the order of the United States District Court for the District of New Jersey granting a motion for a preliminary injunction filed by Pfizer, Inc. ("Pfizer") and Warner-Lambert Company, L.L.C. ("Warner-Lambert") to prevent Teva and Ranbaxy from infringing United States Patent No. 4,743,450 ("the '450 patent"). Pfizer, Inc. v.

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Teva Pharms. USA, Inc., No. 05-CV-620 (D.N.J. Mar. 31, 2005) (" Preliminary Injunction Order "); Pfizer, Inc. v. Teva Pharms. USA, Inc., No. 05-CV-620 (D.N.J. Mar. 29, 2005) (" Bench Decision "). At this preliminary stage in the proceedings, we neither find error in the district court's claim construction, nor do we conclude that the district court abused its discretion in determining that infringement is likely and that the harm and public interest favors enjoining Teva and Ranbaxy. We therefore affirm the grant of the preliminary injunction.



The '450 patent relates to pharmaceutical compositions containing angiotensin converting enzyme ("ACE") inhibitors such as quinapril and their methods of manufacture. Quinapril and other ACE inhibitors can be used to treat hypertension, commonly known as high blood pressure. According to the '450 patent, however, many ACE inhibitors including quinapril are susceptible to degradation due to cyclization, hydrolysis, and oxidation. Cyclization occurs when one part of an ACE inhibitor compound reacts with a different part of the same compound to form a degraded, inactive "cyclized" compound. Hydrolysis and oxidation involve reactions with water and oxygen, respectively. Hydrolysis results in a degraded compound, and oxidation causes discoloration.

The '450 patent discloses minimizing cyclization, hydrolysis, and discoloration by using formulations containing a metal-containing stabilizer and a saccharide. According to the '450 patent, the metal-containing stabilizer prevents both cyclization and discoloration, while the saccharide prevents hydrolysis. A contemporaneous report, summarizing the research by the inventors eventually named on the '450 patent, describes how the inventors came to these conclusions. The report explains that the inventors initially attempted to prevent quinapril drug formulations from decomposing due to cyclization and discoloration. The inventors first suspected that moisture caused these problems and so developed a dry formulation. They chose excipients known to have low moisture content, employing anhydrous lactose as a "filler" and microcrystalline cellulose as a "dry binder." The formulation continued to degrade, however. Eventually the inventors discovered that the two problems, cyclization and discoloration, could be prevented by including magnesium carbonate in the formulations. Use of magnesium carbonate, however, resulted in a new, third problem: hydrolysis. To reduce hydrolysis successfully, the inventors added various proportions of an "inert diluent," lactose. The resulting composition thus eliminated all three problems: cyclization, discoloration, and hydrolysis. Warner-Lambert, which owns the '450 patent, now markets the resulting quinapril formulation as Accupril TM.1

This appeal involves the '450 patent's independent claims 1 and 16. Claim 1 is a composition claim:

A pharmaceutical composition which contains:

(a) a drug component which comprises a suitable amount of an ACE inhibitor which is susceptible to cyclization, hydrolysis, and discoloration,

(b) a suitable amount of an alkali or alkaline earth metal carbonate to inhibit cyclization and discoloration, and

(c) a suitable amount of a saccharide to inhibit hydrolysis.

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'450 patent, col. 5, l. 52 - col. 6, l. 2. Claim 16 is a process claim:

A process for stabilizing an ACE inhibitor drug against cyclization which comprises the step of contacting the drug with:

(a) a suitable amount of an alkali or alkaline earth-metal carbonate and,

(b) one or more saccharides.

Id. at col. 6, ll. 54-63.



On January 15, 1999, Teva sought approval from the Food and Drug Administration ("FDA") to market a generic version of Accupril TM by filing an Abbreviated New Drug Application ("ANDA") pursuant to the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act.2 Because Teva was the first company to file an ANDA for the generic version of Accupril TM, Teva was entitled to a 180-day generic market exclusivity period pursuant to 21 U.S.C. § 355(j)(5)(B)(iv). As this court recently explained:

The 180-day exclusivity period typically begins on the date of the first commercial marketing of the drug by the first applicant. 21 U.S.C. § 355(j)(5)(B)(iv). The original Hatch-Waxman Amendments provided that the commencement of the 180-day exclusivity period could also be triggered by "the date of a decision of a court . . . holding the patent which is the subject of the certification to be invalid or not infringed." Id.

Teva Pharms. USA, Inc. v. Pfizer, Inc., 395 F.3d 1324, 1328 (Fed. Cir. 2005).3 Along with the ANDA, Teva simultaneously filed a paragraph IV certification pursuant to the requirements of 21 U.S.C. § 355(j)(2)(A)(vii)(IV), asserting that the '450 patent is invalid under 35 U.S.C. §§ 102 and 103.

On March 2, 1999, Warner-Lambert responded by suing Teva in the District of New Jersey for infringement of the '450 patent under 35 U.S.C. § 271(e)(2)(A). During the course of those proceedings, Teva and Warner-Lambert initially presented diverging claim construction arguments to the district court. In particular, with respect to the claim terms "saccharide" and "saccharides," Teva advocated a construction that would encompass carbohydrates, including polysaccharides and sugars, as well as compounds derived from carbohydrates. For its part, Warner-Lambert simply argued that a "saccharide" is a sugar.4 Later, however, Teva and Warner-Lambert stipulated to the following claim construction:

The word "saccharide" in Claims 1 and 16 of the '450 patent means "a sugar, and specifically includes only lower molecular weight carbohydrates, specifically, mono- and disaccharides and their simple derivatives, including such substances

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as lactose, sucrose, mannitol and sorbitol."

The district court entered this stipulation in an order dated May 7, 2002. The ultimate resolution of that separate case is not at issue in this appeal.5


On December 27, 2002, in what would eventually lead to the instant action, Ranbaxy sought FDA approval to market its own generic version of Accupril TM by filing its own ANDA and certifying that its product would not infringe the '450 patent. Ranbaxy sent Warner-Lambert a paragraph IV certification letter on April 7, 2003, explaining why Ranbaxy believed its product would not infringe the '450 patent. Ranbaxy's letter indicated that it had adopted and relied upon the construction of "saccharide" Warner-Lambert had previously stipulated to in its case against Teva. Warner-Lambert did not respond to Ranbaxy's letter or sue Ranbaxy within forty-five days of receiving the letter, which would have triggered a thirty-month stay of approval of Ranbaxy's ANDA. See 21 U.S.C. § 355(j)(5)(B)(iii) (2000).

Ranbaxy eventually approached Teva to solicit Teva's assistance in marketing Ranbaxy's product, and on August 26, 2004, the two entered into a Distribution and Supply Agreement. Later, on December 15, 2004, Teva relinquished its potential 180-day generic market exclusivity period, resulting in final FDA approval of Ranbaxy's ANDA. The next day, Teva began marketing Ranbaxy's product.

In response, Pfizer, the corporate parent of Warner-Lambert, and Warner-Lambert (hereinafter, collectively "Warner-Lambert") sued Ranbaxy and Teva (hereinafter, collectively "Ranbaxy") on January 28, 2005 for infringement of the '450 patent. Shortly thereafter, Warner-Lambert filed a motion for a preliminary injunction. The district court granted the motion on March 29, 2005, and issued a detailed explanation of the reasons for granting the motion on March 31, 2005. See Bench Decision ; Preliminary Injunction Order .

The court construed "saccharide," as the term is used in claim 1, and "saccharides," as the term is used in claim 16, to include "mono-, di--, tri--, and polysaccharides." In doing so, the court simultaneously...

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