Alza Corporation and McNeil-PPC, Inc. vs. Andrx Pharmaceuticals, LLC and Andrx Corporation
Economic Advice in Litigation
The Situation
Alza and McNeil-PPC manufacture and sell CONCERTA®, which contains the active ingredient methylphenidate in a specific sustained release dosage form and treats Attention Deficit Hyperactivity Disorder (ADHD). Research scientists at Alza discovered and patented the invention to treat ADHD with methylphenidate in an oral sustained-release dosage that provides an ascending rate of release for the product over an extended period of time. Subsequently, several companies, including Andrx, sought approval from the US Food and Drug Administration to market a generic version of CONCERTA® by filing an Abbreviated New Drug Application asserting the associated patents were invalid or not infringed. In response, Alza and McNeil-PPC filed a patent infringement suit in the US District Court for the District of Delaware (Civil Action No. 305-642-JJF).
NERA's Role
Counsel for Alza and McNeil-PPC retained NERA Special Consultant Dr. Richard Rozek to analyze whether CONCERTA® is a commercial success, a factor in assessing the non-obviousness of the invention embodied in the patents. Dr. Rozek prepared an expert report and testified at trial on the commercial success of CONCERTA®.
The Result
On 30 March 2009, the Court cited Dr. Rozek's trial testimony in finding "that the '373 patent is not invalid as obvious."
