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ANDA Filing is not per se willful patent infringement July 29, 2004

Posted by mais in Litigation, Litigations, Patent, Patent infringement.
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Patently Obvious: MBHB Patent Law Blog: “ANDA Filing is not per se willful patent infringement

Glaxo v. Apotex (Fed. Cir. July 27, 2004)
Apotex appealed the district court judgment, which found that Apotex’s filing of an Abbreviated New Drug Application (ANDA) for a generic version of the antibiotic Ceftin� willfully infringed Glaxo and SmithKline Beecham’s patents. (U.S. Patents 4,562,181 and 4,820,833).
On appeal, the Federal Circuit (GAJARSA) affirmed the infringement holding, but refersed the the district court’s finding of willful infringement.
We hold that the mere filing of an ANDA cannot constitute an act of willful infringement compensable by attorney�s fees under the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act.
Because, the ANDA filing did not constitute an ‘exceptional case,’ the willfulness holding was reversed
In dissent, DYK argued that the case was moot and thus should not be decided.
The questions of infringement and invalidity are moot since, as the parties conceded at oral argument, there are no past damages being sought for infringement, and the patents have expired. I dissent from the majority�s decision to address the issues of infringement and invalidity in the absence of a live case or controversy.”

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