NEW YORK, August 25, 2008 – On August 20,2008 the Federal Circuit affirmed a district court judgment finding two generic pharmaceutical companies, Apotex and Impax, infringed two AstraZeneca patents covering formulations embodied in the blockbuster proton-pump inhibitor Prilosec®. The Federal Circuit determined the district court properly found that Apotex had failed to prove AstraZeneca’s patents were invalid for anticipation or obviousness and Impax failed to prove AstraZeneca’s patents violated the public-use bar of 35 U.S.C. § 102(b). The Federal Circuit also rejected Apotex’s and Impax’s challenges to the district court’s infringement findings.
The decision comes after approximately ten years of litigation, during which time both Apotex and Impax began marketing at-risk. The actions now return to the district court for further proceedings, including resolution of AstraZeneca’s willful infringement, exceptional case, and damages claims against Apotex and willful infringement and exceptional case claims against Impax. In addition, the Federal Circuit decision opens the way for AstraZeneca to pursue damages from Impax's marketing partner Teva.
The Federal Circuit addressed several additional issues in its thirty-six page precedential opinion. The Federal Circuit rejected an obviousness challenge based on the Supreme Court's seminal KSR Int'l Co. v. Teleflex, Inc. decision. The Federal Circuit also declined to overturn the district court’s order striking Impax’s jury demand. The district court’s order had held that AstraZeneca’s voluntary dismissal with prejudice of its damages claims left only equitable § 271(e) claims, thereby extinguishing Impax’s right to a jury trial. The Federal Circuit further found jurisdiction existed even though the district court’s opinion was entered after patent expiration, affirming that § 271(e)(4)(A) and exceptional case claims under § 285 provide post-expiration remedies sufficient to maintain jurisdiction. The Federal Circuit rejected an attempt to apply 35 U.S.C. § 102(b) to Phase III clinical trials, finding that in this case the clinical trials were necessary to determine if the claimed inventions worked for their intended purposes, such that the inventions were not reduced to practice before the critical date.
AstraZeneca AB, Aktiebolaget Hässle, KBI-E Inc., KBI, Inc. and AstraZeneca LP are represented in this matter by Milbank, led by partner Errol B. Taylor. Partners Fredrick Zullow, John M. Griem, Jr., and Lawrence Kass also led Milbank's representation of AstraZeneca in this matter, which included associates Marc McKithen, Emily Kunz, Dana Weir, and Anna Brook. Milbank attorneys Robert Koch, Jay Alexander, Chris Holm, Enrique Longton, and Yomi Ayandipo, also worked on the matter, with support from Lisa Coward, Marie Kenny, Richard Rose, Nga Phan, Justin Coates, David McCracken, Peter Delfausse, Benjamin Harris, Kurt Maitland, Shota Milrova, and David Starr.
Click here to view the decision.