Budesonide - USA

On Jan. 14, 2019, Federal Circuit upheld (Rule 36 Judgment) a lower court ruling that found Teva and Alvogen’s ANDA non-infringing which were filed to market generic version of Uceris®. 

Previously on 10/27/17, Delaware Court issued Order that US 8,784,888 patent not infringed by Actavis and Alvogen (reported here on this blog). In summary, Court concluded that Plaintiff failed to prove that Actavis infringes claim 9 & Alvogen infringes claim 6 of US’888 patent. The only claim limitation at issue was whether Defendant’s ANDA products have “macroscopically homogenous composition”. Court found that Defendants tablets do not appear of uniform structure throughout. Actavis tablets have some yellow dots & Alvogen tablets have some holes or bumps which were not uniformly distributed throughout the bisected tablet. Therefore court held that Defendants tablets are not macroscopically homogenous.