Friday, April 6, 2018

Mesalamine – USA


On Apr. 06, 2018, in one liner decision, Federal Circuit affirmed Florida district court’s non-infringement finding in favor of Mylan in Lialda® Hatch-Waxman litigation.

Previously following a four-day bench trial, U.S. District Judge Charlene Edwards Honeywell in January 2017 concluded that the ANDA from Mylan infringes the US 6,773,720 patent. Mylan appealed but it was deactivated. Mylan then returned to the Florida Middle court & asked to re-consider its decision. The Court agreed, and in Jun 2017 it vacated the prior decision and entered non-infringement judgment in favor of Mylan. This judgment was appealed by Shire. Federal circuit then heard oral argument in Apr 2018 & affirmed the non-infringement decision of Florida court by way of Rule 36 judgment.


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