Application for judicial review; September 22, 2008; ramipril

The Federal Court dismissed Sanofi-Aventis’ application under the NOC Regulations.

Sanofi-Aventis was successful in obtaining prohibition against Pharmascience in an application in response to an NOA. In an application in response to a later sent NOA from Apotex, Sanofi-Aventis was unsuccessful. Riva then sent a NOA, alleging the same grounds on which Apotex had succeeded. Riva had cross-referenced its ANDS to that of Pharmascience. Furthermore, in another previous NOC proceeding relating to ramipril, the Federal Court found that Pharmascience and Riva were not privies on the evidence in that proceeding.

Initially, the Minister of Health had refused to grant regulatory approval to Riva because it had cross-referenced to Pharmascience and Pharmascience was prohibited from obtaining regulatory approval. Before the hearing of the application, the Minister changed its view and granted the NOC.

The Court decided to hear the within application, despite aspects of the relief being sought being moot due to the issuance of an NOC to Riva. However, the Court found that in the within proceeding, there was little evidence as to the relationship between Pharmascience and Riva. Combined with the previous decision of the Court that they were not privies under the evidence in that proceeding, the Court held that there was not enough evidence to establish that one party is a privy of the other. The mere fact that one party has cross-referenced a drug application to another party’s drug application is not enough. The application was dismissed. This decision is under appeal.

Full text of the decision can be found at:

http://decisions.fct-cf.gc.ca/en/2008/2008fc1062/2008fc1062.html