Addressing the issue of artificial infringement under the Hatch-Waxman (H-W) Act, the U.S. Court of Appeals for the Federal Circuit held that filing an Abbreviated New Drug Application (ANDA) cannot constitute willful infringement. Glaxo Group Ltd. v. Apotex, Inc., Case No. 03-1575 (Fed. Cir. July 27, 2004) (Gajarsa, J.) (Dyk, J., concurring-in-part, dissenting-in-part).
Ceftin is an antibiotic having the active ingredient cefuroxime axetil (CA), and is the subject of two now expired Glaxo Group Ltd. (Glaxo) patents. U.S. Patent No. 4,562,181 (the `181 patent) claims amorphous CA having a purity of at least 95 percent and pharmaceutical compositions. U.S. Patent No. 4,820,833 (the `833 patent) claims a method of preparing a highly pure amorphous CA.
Apotex, Inc. (Apotex) filed an ANDA for a generic version of Ceftin containing 90 percent amorphous CA with 10 percent excipients. Because CA was approved under a now repealed provision exempting antibiotic manufacturers from listing relevant patents with the FDA, Glaxo did not list its patents, and Apotex did not file a certification in its ANDA application. Glaxo sued Apotex under the H-W Act, which provides an infringement cause of action against generic manufacturers filing for FDA market approval. Construing the 95 percent purity limitation of the `181 patent claims to exclude excipients, the district court found Apotex infringed because its ANDA stated its product did not contain more than 1 percent impurities, excluding excipients. Infringement of the `833 patent was based on a similar rationale. The district court also concluded that Apotex failed to exercise due care in its ANDA filing, holding willful infringement and awarding attorney’s fees.
The Federal Circuit affirmed the district court’s claim construction, concluding that Apotex’s construction, requiring the purity limitation to include added excipients, would: conflict with the term’s ordinary meaning; exclude preferred embodiments; and conflict with the specification. Relying on Apotex’s ANDA admission as to purity level, the Court upheld infringement of both the `181 and `833 patents. Construing remedies available under the H-W Act, the Court noted that filing an ANDA gives rise to only three statutory remedies: delay of product approval; injunctive relief; and damages when actual commercial activity has occurred. Addressing the issue of willfulness, the Court indicated that the mere filing of an ANDA or certification does not justify elevation to willful infringement. The Court reasoned that the statutory scheme creates a "highly artificial" act of infringement with specific remedies for the limited and technical purpose of conferring jurisdiction to enable adjudication of generic drug manufacturers before actual infringement of a patent. Apotex did not engage in any litigation misconduct; therefore, the award of attorney’s fees was reversed.
Concurring on willful infringement, Judge Dyk dissented on the issues of infringement and invalidity, concluding an absence of a case or controversy since no past damages were sought and the patents had expired.
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