A design-around solution for a MMX-based tablet drug comprising mesalazine-A lesson from shire development, LLC v. Watson pharmaceuticals, Inc.

Abstract

This article explores Shire Development, LLC v. Watson Pharmaceuticals, Inc., 848 F.3d 981 (Fed. Cir. 2017) and illustrates some implications for designing around aMMX-based tablet drug, Lialda. TheMMXtechnology is known for its lipophilic matrix and hydrophilic matrix in a tablet, while the former matrix is dispersed within the latter one. In Shire Development, LLC, the disputed claim recited a Markush limitation for the hydrophilic matrix and excludes unlisted materials from the hydrophilic matrix. On the other hand, the accused generic drug included magnesium stearate, a lipophilic material, in its hydrophilic matrix and, therefore, did not infringe the disputed patent. The case opens a door for generic drug companies to design around the patented MMX technology underlying Lialda.