A US Court of Appeals for the Federal Circuit (CAFC) upheld a ruling which blocked sales of Ranbaxy’s generic alternative to Pfizer Inc’s Accupril blood pressure drug (Quinapril HCl), a generic equivalent of Pfizer’s (Parke Davis) anti-hypertensive agent Accupril Tablets. [Pfizer, Inc. and Warner-Lambert Company, LLC, v. Teva Pharmaceuticals USA, Inc., Ranbaxy Pharmaceuticals, Inc., and Ranbaxy Laboratories Limited, Fed. Cir. (05-1331, November 22, 2005)]

Teva and Ranbaxy appealed from the District Court order granting a motion for a preliminary injunction filed by Pfizer and Warner-Lambert to prevent Teva and Ranbaxy from infringing United States Patent No. 4,743,450 (“the ’450 patent”). The ’450 patent relates to pharmaceutical compositions containing angiotensin converting enzyme (“ACE”) inhibitors such as quinapril and their methods of manufacture. The ’450 patent discloses minimizing cyclization, hydrolysis, and discoloration by using formulations containing a metal-containing stabilizer and a saccharide.

The 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.

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.

Ranbaxy sought FDA approval to market its own generic version of Accupril® 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.

The district court eventually granted summary judgment against Teva, finding the ’450 patent not invalid for lack of enablement and infringed. In granting the motion for a preliminary injunction, the district 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 rejected both the stipulated construction previously entered in the separate case and Ranbaxy’s proposed construction of “sugars, including the lower molecular carbohydrates, specifically mono- and disaccharides.”

In upholding the preliminary injunction, the Fed. Circuit held that:

The claim language itself does not support Ranbaxy’s proposed construction.“[T]he claims themselves provide substantial guidance as to the meaning of particular claim terms.” Id. at 1314. Claim 1 includes “a suitable amount of a saccharide to inhibit hydrolysis,” and claim 16 includes “one or more saccharides.” It is important to note that the claims do not include the terms “sugar” or “sugars.” Neither do the claims distinguish between polysaccharides having ten or less monosaccharide units and polysaccharides having more than ten monosaccharide units.

This court has previously construed a disputed claim term by referencing use of “i.e.” in a patent specification. See Abbott Labs. v. Novopharm Ltd., 323 F.3d 1324, specification.” (emphasis added)). “[I]t is necessary to consider the specification as a whole, and to read all portions of the written description, if possible, in a manner that renders the 1327, 1330 (Fed. Cir. 2003). In that case, however, the court did not identify any support in the intrinsic evidence for a construction of the disputed claim term other than the construction linked to “i.e.” Id. at 1330. Indeed, the problem with Ranbaxy’s argument is that it ignores the fact that the person of ordinary skill in the art is deemed to have read the claim term in the context of the entire patent. Phillips, 415 F.3d at 1313. See also SanDisk Corp. v. Memorex Prods., Inc., 415 F.3d 1278, 1285 (Fed. Cir. 2005) (“The court must always read the claims in view of the full patent internally consistent.” Budde v. Harley-Davidson, Inc., 250 F.3d 1369, 1379–80 (Fed. Cir. 2001).

Ranbaxy admits that mannitol is not a sugar. It nevertheless argues that the patentee labeled mannitol as a sugar, and that we should respect the patentees’ decision to do so. Thus, according to Ranbaxy, “Mannitol, lactose, and other sugars are preferred” is, for the purpose of the patent, a list of like ingredients, “sugars.” We are not convinced that one of ordinary skill in the art would understand the patentee to have classified mannitol as a sugar in this sentence. As the district court found and Ranbaxy does not dispute on appeal, mannitol is not actually a sugar. On the other hand, lactose is a sugar. The reference to “other sugars” therefore appears to relate to the disclosure of lactose only. In short, the reference to “other sugars” does not mean that mannitol is a sugar or should be considered to be a sugar for purposes of the ’450 patent.

Extrinsic evidence in the form of technical dictionaries, treatises, and expert testimony supports the conclusion drawn from the ’450 patent that one of skill in the art would understand “saccharides” to encompass more than sugars. The district court reviewed the extrinsic evidence presented by the parties and found that one of skill in the art would understand “saccharides” to include polysaccharides. Ranbaxy, however, points to specific examples of references and testimony that allegedly support its view that “saccharides” means sugars.

The CAFC then went on to affirm the grant of the preliminary injunction stating that the district court’s claim construction was not erroneous; the district court did not abuse its discretion when it determined that Ranbaxy likely infringes the ’450 patent either literally or under the doctrine of equivalents; and the district court did not abuse its discretion when it found that the harm and public interest favors enjoining Ranbaxy.

Get the opinion here.

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