Budesonide - USA

On Oct. 27, 2017, Chief Judge Leonard P. Stark of district of Delaware issued an order granting Defendants' (Teva & Alvogen) motions for judgment of non-infringement of the US 8,784,888 patent in Uceris (Budesonide ER tablet) case. Claim 1 of US’888 patent reads:

“A controlled release oral pharmaceutical composition consisting essentially of: (1) a tablet core consisting essentially of: a) budesonide in an amount effective to treat intestinal inflammatory disease; and b) a macroscopically homogeneous composition comprising at least one lipophilic excipient, at least one amphiphilic excipient, and at least one hydrogel-forming hydrophilic excipient other than a gum, wherein said budesonide is dispersed in said macroscopically homogeneous composition; and (2) a coating on said tablet core, said coating consisting essentially of a gastro-resistant film”.

Cosmo filed suit against Actavis/ Teva and Alvogen in February 2015, after the companies sent notice with P-IV certification that their products would not infringe US’888 patent & other patents. Plaintiffs at one time asserted a number of patents and decided to drop patents at various stages of this litigation. Bench trial was completed on May 23, 2017. Court found that Plaintiffs did not meet the threshold to establish infringement. As the opinion was sealed, the court asked parties to sort out the final judgment, including other stipulations and orders about the other patents. Thereafter, the Court will issue a public version of its Memorandum Opinion.