sanofi-aventis v. Laboratoire Riva; appeal of an application to quash an NOC; 2009 FCA 169; ramipril; May 26, 2009

The Court of Appeal upheld the decision of the Trial Division refusing to quash the decision of the Minister of Health to issue a Notice of Compliance. The underlying decision is summarized here.

Pharmascience was prohibited from bringing its generic ramipril product to market under the NOC Regulations. Riva cross-referenced Pharmascience's submission. However, after the Pharmascience proceeding, another generic company was successful in alleging the invalidity of the patent at issue. Thus, Riva was able to follow that Notice of Allegation and obtain an NOC. sanofi sought to quash that NOC on the basis of the cross-reference.

The Court of Appeal found that Riva's ANDS was not so linked to that of Pharmascience that the Pharmascience Prohibition Order should also bar Riva. Furthermore, the Court of Appeal held that Riva did not circumvent the NOC Regulations as it was required to engage them with a Notice of Allegation. Thus, Riva should not be prohibited from coming to market.

The full text of the decision can be found at:

http://decisions.fca-caf.gc.ca/en/2009/2009fca169/2009fca169.html

The full text of the Trial Division decision can be found at:

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