In re Rosuvastatin Calcium Patent Litigation

An unsuccessful filing of an ANDA is a statutory act of infringement.

Opinion (Newman): The cholesterol lowering drug “rosuvastatin” was the #314 patent issued to Shionogi Seiyaku Kabushiki Kaisha (“Shionogi”), and was licensed to Astrazeneca UK and its United States subsidiary IPR Pharmaceuticals Inc. (collectively “Plaintiffs”). Plaintiffs alleged infringement of the #314 patent against several generic producers, including Apotex U.S. (collectively “Defendants”), when they filed an Abbreviated New Drug Application (ANDA) under the Hatch-Waxman Act. The trial court held for the Plaintiffs, ruling the #314 patent valid, enforceable, and infringed. All Defendants appealed the rulings of validity and enforceability, and defendant Apotex U.S. claimed that it was not a proper defendant because their agency for Apotex Canada did not qualify them as a legal “submitter” of an ANDA. The Court affirmed that patent invalidity based on obviousness had not been shown, affirmed that unenforceability based on inequitable conduct was not established, and affirmed that the reissue was available and its scope was in accordance with the law. The Court also affirmed that Apotex U.S. was properly named as a defendant. The judgment of infringement against all Defendants was AFFIRMED.