Federal Court Prohibits Approval Of Generic ADHD Drug

In Janssen Inc. v. Actavis Pharma Company, 2016 FC 1361, Janssen sought an order prohibiting the Minister of Health from issuing a Notice of Compliance to Actavis for a generic version of the ADHD drug CONCERTA. Justice O'Reilly held that Actavis's allegations of invalidity and non-infringement of Canadian Patent No 2,264,852 were not justified.

The 852 Patent is generally directed to the use of methylphenidate (MP) using a novel dosage form and a novel method for administering it producing a therapeutic effect. The prior art taught that methylphenidate had issues in maintaining sufficient plasma concentrations. Dr. Saneel Gupta, a named inventor of the 852 Patent, discovered  that the issue with prior art formulations of  methylphenidate was acute tolerance (tolerance to a drug over a single dosing period), which lead to the invention described in the 852 Patent.