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Federal Circuit Rules That Filing an ANDA Is Not Willful Infringement
In Glaxo Group, Ltd. v. Apotex, Inc., No. 03-1575, 2004 U.S. App. LEXIS 15489 (Fed Cir. 2004), the Federal Circuit held that the act of merely filing an Abbreviated New Drug Application (ANDA) could not constitute willful infringement and reversed the attorneys' fees that were awarded by the district court.
Apotex, a generic drug manufacturer, filed an ANDA to receive approval to manufacture the generic version of the drug Ceftin', a patented antibiotic produced by Glaxo. However, Apotex did not begin manufacture of the drug or offer certification that the patent protecting Ceftin' was invalid or non-infringed, as is common in the ANDA application process. The Federal Circuit cited 35 U.S.C '271(e)(2), calling the act of filing an ANDA a “highly artificial act of infringement.” Further, the court noted that the only remedies to a patentee against an ANDA filer were moving the effective date of ANDA approval to a date after the patent expired, obtaining an injunction against the manufacture and use of the drug, and monetary damages only in the event the infringer manufactured or used the drug in the United States. The court stressed that without manufacture of the drug, the only monetary damages it would award were attorneys' fees.
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