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

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