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.
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