The U.S. Court of Appeals for the Federal Circuit upheld a preliminary injunction finding that infringement is likely and that the harm and public interest favors enjoining a generic drug maker. Pfizer, Inc. v. Teva Pharmaceuticals, Case No. 05-1331 (Fed. Cir. Nov. 22, 2005) (Prost, J.).
Accupril is an angiotensin converting enzyme (ACE) inhibitor composed of the active ingredient quinapril and is used to treat hypertension or high blood pressure. Pfizer owned a patent containing claims to stabilized ACE inhibitor compositions such as quinapril and their methods of manufacture. (A metal-containing stabilizer and saccharide are used to reduce cyclization and degradation of the ACE inhibitors.)
Pfizer sued the generic drug makers of Accupril for infringing its patent claims. Rejecting a stipulated claim construction entered in a related case, the district court found Pfizer was likely to prove infringement under its construction, Pfizer would likely suffer irreparable harm, the harm to Teva did not outweigh the harm to Pfizer, and the issuance of an injunction was consistent with the public policy of enforcing the patent laws.
The Federal Circuit, agreeing with the district court's claim construction, affirmed. The Court found that the term "saccharide" encompassed both the polysaccharide microcrystalline cellulose found in the accused infringing product as well as sugars when read in context of the entire patent. It reasoned that a narrow construction was not supported by the claim language and would be inconsistent with the definition and use of the term as found in the specification. Based on this construction, the Court concluded Pfizer was likely to prevail on a literal infringement charge.
Addressing the tension between the disclosure/dedication rule and infringement under the doctrine of equivalents, the Court found that microcrystalline cellulose was a substantial equivalent of the claimed saccharide because unrefuted expert testimony showed it likely functioned in the same way. In clarifying the disclosure-dedication rule, the Court rejected Teva’s assertion that microcrystalline cellulose was dedicated to the public, stating "the public notice function of patents suggests that before unclaimed subject matter is deemed to have been dedicated to the public, that unclaimed subject matter must have been identified by the patentee as an alternative to a claim limitation." Microcrystalline cellulose was disclosed in the `450 patent as an optional excipient rather than as an alternative to the claimed saccharide.
The Court concluded Pfizer established a high likelihood of success on the merits and reaffirmed that a patentee is entitled to a presumption of irreparable harm upon a strong showing of likely infringement of a valid and enforceable patent. The Court noted that licensing the patent or delay in bringing suit could rebut this presumption, but it also reasoned that Pfizer’s activities in these areas were insufficient to warrant a finding that it was willing to forgo exclusivity. While Pfizer granted a narrow exclusive license in a product area other than Accupril, it did not engage in a pattern of licensing that would destroy its market exclusivity. Teva's argument on loss of market share that would be incurred by an injunction was summarily rejected for failure to outweigh the harm caused by Pfizer's loss of exclusivity. Also, the Court rejected Teva's argument on the availability of low cost drugs as a public policy excuse for infringement.
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