Claim construction issues in ANDA case
Shire LLC, et al. v. Teva Pharmaceuticals USA, et al., Civil Action No. 10-329 RGA, March 22, 2012.
Andrews, J. The court rules on seven disputed terms after Markman hearing.
The three patents-in-suit relate to Intuniv®, a drug used to treat pediatric ADHD. The terms considered include:
Without inducing excessive sedation
Readministering the dose at an interval required to obtain a desired level and duration of behavioral inhibition
Non-pH dependent sustained release agent
pH dependent agent that increases the rate of release of said at least one pharmaceutically active agent from the tablet at a pH in excess of 5.5
polymer that swells at a pH in excess of 5.5
Agent that increases the solubility of said at least one pharmaceutically active agent at a pH of greater than 5.5
Agent that maintains an acidic microenvironment in the composition
Reducing the likelihood of side effects associated with the administration of guanfacine
