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Continuing the recent trend of court decisions expanding jurisdiction over declaratory judgment challenges to patents, the Court of Appeals for the Federal Circuit (the 'Federal Circuit' or the 'court') opened the door to increased challenges to drug patents in Teva Pharms. USA Inc. v. Novartis Pharms. Corp., 482 F.3d 1330 (Fed. Cir. 2007). The Federal Circuit ruled that a generic drug company could, under the appropriate circumstances, pre-emptively seek a declaratory judgment that certain drug patents listed in the FDA's Orange Book are invalid or not infringed. Generic drug companies thus can have a court resolve patent infringement issues before undertaking the expense of launching a generic drug under the threat of patent litigation and any resulting injunction or treble damages for willful infringement. The Teva decision is expected to increase declaratory judgment challenges by generic drug companies and help speed generic drugs to market when those challenges are successful.
Background
Novartis filed with the Food and Drug Administration ('FDA') a New Drug Application for approval of the antiviral drug Famvir'. As part of the application process, Novartis listed five patents in the FDA's Orange Book, which catalogs patents for drugs evaluated by the FDA. One of the listed patents is directed to the active ingredient in Famvir and expires in 2010. The remaining four patents cover methods of using Famvir and do not expire until 2014-15.
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