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Federal Circuit Rules for Apotex in Paxil Suit
In Smithkline Beecham Corp. v. Apotex Corp., Nos. 03-1285, 03-1313, 2005 U.S. App. LEXIS 5671 (Fed. Cir. Apr. 8, 2005), the Federal Circuit granted a rehearing en banc for the limited purpose of vacating the original panel's opinion that concerned the issue of experimental use. The Federal Circuit then remanded the case to the original panel, which issued a new decision invalidating GlaxoSmithKline's (“GSK”) patent covering the antidepressant Paxil due to “inherent anticipation.”
In March 2003, the U.S. District Court of the Northern District of Illinois found that Apotex's generic drug did not violate GSK's patents. On appeal, the Federal Circuit affirmed the district court's decision, but on different grounds. While the Federal Circuit found that the district court's claim construction of claim 1 of U.S. Patent No. 4,721,723 (“the '723 patent”) was erroneous (and therefore Apotex's drug did infringe claim 1 of the '723 patent), it ruled that this claim was invalid because of “public use” more than 1 year prior to the filing of the application. GSK had admitted that its clinical trials were public, but argued that such trials constituted an “experimental use.”
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