USA: Shire Development, LLC v. Watson Pharmaceuticals, Inc., United States Court of Appeals, Federal Circuit, No. 2016-1785, 10 February 2017

Pharmaceuticals company Watson’s proposed generic version of competitor Shire’s brand-name mesalamine LIALDA® did not satisfy the requirements for a Markush group claimed by a Shire patent, the U.S. Court of Appeals for the Federal Circuit has held. A compound contained in the ANDA product—which was not present in the patent claim’s Markush group—structurally and functionally related to the invention, meaning that the ANDA product did not meet the claim limitations. Therefore, Watson was entitled to judgment of noninfringement. The Federal Circuit reversed a decision of a Florida district court finding that Watson had infringed the patent by filing an Abbreviated New Drug Application (ANDA) seeking approval to market its generic mesalamine product (Shire Development, LLC v. Watson Pharmaceuticals, Inc., February 10, 2017, Hughes, T.).

A full summary of this case has been published on Kluwer IP Law