Generic Drug Manufacturer Properly Shut Down by Preliminary Injunction

Case: Pfizer v. Teva Pharmaceuticals USA, Inc., No. 05-1331 (Fed Cir. 11/22/05)

The One Sentence Summary: A preliminary injunction against a generic drug manufacturer was affirmed after consideration of issues of claim construction, issue estoppel, doctrine of equivalents, vitiation and weighing of the harms.


What They Were Fighting About: Pfizer had sued Teva and Ranbaxy for infringement of its patent on stabilizing a hypertension drug. Teva and Ranbaxy had been manufacturing a generic version. The district court granted a preliminary injunction against defendants, and the Federal Circuit panel affirmed.

Federal Circuit Holdings:

• The district court properly construed claim language providing for stabilization of the compound with “saccharides.” This claim language was interpreted to include polysaccharides, and not just sugars as defendants claimed. The claim language did not use the narrower term “sugars.”
• The claim was not narrowed due to the phrase “saccharides (i.e., sugars)" in the specification. The claim language should be read in the context of the entire specification, and broader language existed in other sections.
• Extrinsic evidence from technical dictionaries, treatises and expert testimony supported the conclusion that "saccharides" was broader than the term "sugars."
• A stipulated construction of the term "saccharides" from earlier litigation between Teva and Warner Lambert did not control the interpretation of the term here. There was no issue preclusion where the stipulation clearly stated that its effect was limited to the earlier litigation.
• The district court properly found that plaintiffs were likely to prevail in showing infringement. Plaintiffs need not have tested the accused product in order to prevail in a preliminary injunction.
• In applying the doctrine of equivalents, the disclosure-dedication rule did not apply. The patents did not dedicate the stabilizing agent to the public domain by listing it as a disintegrating agent. Disclosure-dedication requires disclosure as an alternative to the relevant claim limitation. There was no disclosure of microcrystalline cellulose as an alternative to "saccharides."
• The "all limitations" rule did not preclude application of the doctrine of equivalents because holding microcrystalline cellulose was equivalent to a "saccharide" did not vitiate the claim limitation and render it meaningless.
• The district court properly presumed irreparable harm to the patentee absent an injunction. Defendants failed to rebut the presumption. A narrow license granted by patentee to one generic manufacturer did not show that there was no harm.
• An injunction's harm to the defendant in loss of market share and customer relationships was outweighed by the harm to the patentee in loss of exclusivity due to infringement.
• The policy of ANDA in encouraging low priced generics was not a public interest that prevented issuance of an injunction.