Attempt to Re-litigate is Ruled an Abuse of Process in NOC Proceedings

By a 2-1 majority decision (Sanofi-Aventis Canada Inc v Novopharm Limited et al, 2007 FCA 163), the Federal Court of Appeal has ruled that it is an abuse of process under section 6(5)(b) of the Patented Medicines (NOC) Regulations for a holder of a pharmaceutical patent to attempt to re-litigate an allegation of invalidity made by a generic manufacturer, when that same allegation of invalidity has been found to be justified in a previous prohibition proceeding against another generic manufacturer. In this case (Sanofi case), the patent in question was the "˜206 Patent for the drug ramipril. An allegation that the "˜206 Patent was invalid for lack of sound prediction had been upheld in an earlier prohibition proceeding brought against Apotex Inc (see Aventis Pharma Inc v Apotex Inc et al, 2005 FC 1283) (Apotex case). At trial in the Sanofi case, an application against Novopharm Limited (Novopharm) in respect of its NOA was dismissed under section 6(5)(b) because the Federal Court held that the decision in the Apotex case was binding and the allegations made by both Apotex and Novopharm in their respective NOAs were the same in material respects. Section 6(5)(b) allows for dismissal if the application is "redundant, scandalous, frivolous or vexatious or is otherwise an abuse of process". However, on appeal to the Federal Court of Appeal, both the majority and dissenting decisions held that the Apotex case was not a binding authority, because the question of sound prediction was one of fact and factual questions must be resolved by each trier of fact on the information put before it. The majority further commented that it was not clear that Sanofi's application was "clearly futile" or that it was "plain and obvious" that it would not succeed. Despite these comments, after examining the Supreme Court of Canada's discussion of abuse of process in Toronto (City) v CUPE, Local 79, 2003 SCC 63, the majority went on to conclude that the application against Novopharm was an abuse of process. In reaching this conclusion, the majority decision noted that re-litigation may in itself constitute an abuse of process. There is no requirement that there be something more, such as dishonesty or unjust harassment. In the Sanofi case, the abuse of process was substantiated by the chance that the re-litigation could lead to inconsistent judicial results that would threaten the credibility of the adjudicative process. If re-litigation were allowed, it would be possible that one generic manufacturer could receive an NOC, while another could be prohibited, even though the same allegation of invalidity was raised. In his dissenting opinion, Justice Nadon held that something more than mere re-litigation was required to support a claim of abuse of process since if simple re-litigation were sufficient, one justified allegation of invalidity would effectively de-list the patent from the register. Full reasons for judgment Summary by: Michael Migus