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Pfizer, Inc. v. Teva Pharms. USA, Inc.

United States Court of Appeals for the Federal Circuit

November 22, 2005, Decided

05-1331

Opinion

 [***1258]  [*1368]   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")  [**2]  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. Teva Pharms. USA, Inc., 2005 U.S. Dist. LEXIS 29050, No. 05-CV-620 (D.N.J. Mar. 31, 2005) ("Preliminary Injunction Order"); Pfizer, Inc. v.  [*1369]  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  [***1259]  is likely and that the harm and public interest favors enjoining Teva and Ranbaxy. We therefore affirm the grant of the preliminary injunction.

BACKGROUND

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 [**3]  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 [**4]  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(R). 1

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429 F.3d 1364 *; 2005 U.S. App. LEXIS 25123 **; 77 U.S.P.Q.2D (BNA) 1257 ***

PFIZER, INC. and WARNER-LAMBERT COMPANY, LLC, Plaintiffs-Appellees, v. TEVA PHARMACEUTICALS USA, INC., Defendant-Appellant, and RANBAXY PHARMACEUTICALS, INC. and RANBAXY LABORATORIES LIMITED, Defendants-Appellants.

Subsequent History: Motion granted by, Summary judgment denied by Pfizer Inc. v. Teva Pharms. USA, Inc., 2007 U.S. Dist. LEXIS 70896 (D.N.J., Sept. 25, 2007)

Prior History:  [**1]  Appealed from: United States District Court for the District of New Jersey. Senior Judge Dickinson R. Debevoise.

Pfizer, Inc. v. Teva Pharms. USA, Inc., 2005 U.S. Dist. LEXIS 29050 (D.N.J., Mar. 31, 2005)

Disposition: AFFIRMED.

CORE TERMS

patent, saccharides, district court, infringement, sugars, hydrolysis, cellulose, microcrystalline, preliminary injunction, polysaccharides, irreparable harm, inhibit, mannitol, patentee, generic, cyclization, injunction, products, lactose, doctrine of equivalents, subject matter, carbohydrates, inventors, literally, license, dedicate, argues, skill, pharmaceutical, discoloration

Patent Law, Remedies, Equitable Relief, Injunctions, Jurisdiction & Review, Standards of Review, Abuse of Discretion, Infringement Actions, Burdens of Proof, General Overview, De Novo Review, Claim Interpretation, Aids & Extrinsic Evidence, Construction Preferences, Civil Procedure, Judgments, Entry of Judgments, Consent Decrees, Claims & Specifications, Doctrine of Equivalents, Equivalence Limits