Mesalamine – USA

On Dec 12, 2018, Federal Circuit affirmed (Rule 36 judgment) Texas district court’s decision which granted summary judgment of non-infringement to ANDA filers in Delzicol® Hatch-Waxman case.

Previously on Oct 24, 2017, District Judge R. Gilstrap accepted Magistrate Judge Payne’s report & recommendations (Sep 28, 2017) regarding claim construction & summary judgment of non-infringement to Teva & Mylan. Allergan objected to the report and recommendation on a number of grounds. Allergan argued that the Magistrate Judge re-construed the term “gelling agent” to a “substance that gels the film composition, but which cannot be water or heated water” in US 6,649,180 & thus excluded the accused product. However, court found no error in this construction. Court said that Allergan’s infringement theory, its expert’s opinion, and the literature upon which it relies all recognize that water merely plays a passive role in the gelling process. This evidence, as the Magistrate Judge correctly concluded, establishes that a person of ordinary skill in the art would not recognize water as a “gelling agent” in the context of the ’180 patent because water at most permits the hydroxypropyl methyl cellulose (HPMC) to gel on its own when an aqueous solution of HPMC is heated. Similarly, in citing the inventor’s admission that water is not a “gelling agent,” the Magistrate Judge did not improperly rely on the inventor’s subjective intent regarding the meaning of a claim term. More importantly, the Magistrate Judge’s clarified claim construction was one of two alternative grounds for recommending summary judgment. The second basis relied on the original claim construction to conclude that, even when all disputed facts are construed in Allergan’s favor, no evidence could support a finding that water gels the film composition in the accused products. Thus, court granted Teva and Mylan’s motions for summary judgment.