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ANDA filing doesn’t constitute Willful patent infringement August 16, 2004

Posted by mais in Drugs, Litigation, Patent, USA.
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Glaxo Group Limited v. Apotex, Inc., 2004 U.S. App. LEXIS 15489 (Fed. Cir., July 27, 2004)
Apotex, Inc. (‘Apotex’) appeals the judgment of the United States District Court for the Northern District of Illinois, which found that Apotex’s filing of an Abbreviated New Drug Application (‘ANDA’) for a generic version of the antibiotic CEFTIN willfully infringed U.S. Patent No. 4,562,181 (the ”181 patent’) and U.S. Patent No. 4,820,833 (the ”833 patent’) owned by Glaxo Group Limited and SmithKline Beecham Corp. (collectively ‘Glaxo’). The Federal Circuit affirmed the district court’s determination that Apotex’s ANDA infringes both the ‘181 and ‘833 patents pursuant to 35 U.S.C. � 271(e)(2), and also affirmed that the patents at issue are not invalid. The Federal Circuit, however, reversed the district court’s finding that Apotex’s ANDA filing constituted willful infringement. The Federal Circuit held 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. The Federal Circuit explained that 35 U.S.C. � 271(e)(2) and 35 U.S.C. � 271(e)(4) create only an ‘artificial’ act of infringement for a ‘very limited and technical purpose that relates only to certain drug applications.’ This purpose is to permit patent holders to bring suit against generic companies despite the fact that the generic companies have not yet infringed the patents at issue. The Federal Circuit eloquently wrapped up its analysis by saying: ‘[t]he district court therefore erred in hanging a finding of willfulness on such a special-purpose peg.'”

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