Shire Dev., LLC v. Watson Pharma., Inc., No. 13-1409 (Fed. Cir. 2015)Annotate this Case
Shire markets oral pharmaceuticals under the brand name LIALDA®. Its patent, entitled “Mesalazine Controlled Release Oral Pharmaceutical Composition,” concerns controlled-release compositions for treating inflammatory bowel diseases, such as Crohn’s and ulcerative colitis by direct contact with the intestinal mucosal tissue. It must pass through the stomach and small intestine without being absorbed into the bloodstream and must be administered throughout the entire length of the colon so that mesalamine contacts all affected tissues. The oral composition must, therefore, contain a high percentage of mesalamine. The patent teaches an inner lipophilic matrix and an outer hydrophilic matrix to address the limitations of prior art; the combination is advantageous because the inner-outer matrix properties cause the mesalamine to be released in a sustained and uniform manner. Watson submitted an Abbreviated New Drug Application seeking approval to sell generic LIALDA®. Shire sued. The district court found infringement. The Federal Circuit reversed. The district court’s constructions of “inner lipophilic matrix” and “outer hydrophilic matrix” impermissibly broadened the ordinary meaning of the terms. On remand, following the Supreme Court decision, Teva Pharmaceuticals v. Sandoz (2015), the Federal Circuit again reversed the district court’s constructions of the disputed claim terms and subsequent findings of infringement, and remanded.
This opinion or order relates to an opinion or order originally issued on March 28, 2014.