Judge Andrews’ Claim Construction in ADHD Drug Generic Case

 

Judge Andrews recently issued a claim construction opinion in Shire LLC’s case against Teva Pharmaceuticals regarding a generic form of the pediatric ADHD drug Intuniv.  Shire LLC v. Teva Pharmaceuticals USA Inc., C.A. No. 10-329-RGA (March 22, 2012).  Judge Andrews construed the following terms of the three patents-in-suit:
-    “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”
-    “enteric agent”
-    “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”

Shire LLC v. Teva Pharmaceuticals USA Inc., C.A. No. 10-329-RGA (March 22, 2012).