- Application for Prohibition Granted for Generic Version of Concerta
- January 30, 2017 | Authors: Jillian Brenner; Adrian J. Howard; Beverley Moore; Chantal Saunders
- Law Firm: Borden Ladner Gervais LLP - Ottawa Office
- Janssen Inc. v. Actavis Pharma Company, 2016 FC 1361
The Court granted Janssen's application prohibiting the Minister of Health from issuing an NOC to Actavis for its generic version of Concerta. The patent at issue does not relate to the active ingredient in Concerta, but rather, to the use of compositions that release the active ingredient in a "sustained-ascending dose over time". The active ingredient, methylphenidate, had been used in other products (Ritalin IR and SR), but both products were problematic. The ascending dosage in the patent was shown to achieve equivalent behavioural improvements to Ritalin IR, with no significant elevation of side effects.
Actavis submitted that the patent at issue should be construed as claiming dosage form and a method of administering a drug that involves providing an increasing rate of release throughout the entire extended dosing period, not just some portion of it. The Court disagreed. The Court found that the skilled person would not interpret the words "over time" and "sustained" to mean an entire dosing period. Therefore, a drug that had a sustained-ascending release profile over a few hours (and not the entire dosing period) could continue to be effective for a few hours after the drug stopped releasing the active ingredient into the plasma.
The Court found Actavis' allegations of invalidity were unjustified. The Court also concluded that Actavis' allegations of non-infringement were not justified. Actavis' expert erroneously relied on Actavis' construction to conclude that since the Actavis tablets did not provide a sustained-ascending dose over an entire dosing period, they would not infringe the patent. Further, Actavis' expert relied on mean data, not the results from analyzing individual Actavis tablets. The Court noted that this approach told us only whether a batch of tablets might infringe, and therefore, could permit a large quantity of infringing material to enter the market.