Federal Court of Appeal Rules on Abuse of Process and the PM(NOC) Regulations

In Sanofi-Aventis Canada Inc v Novopharm Limited (2007 FCA 163), a three-judge panel of the Federal Court of Appeal held by a 2-1 majority that it was an abuse of process for the holder of a pharmaceutical patent to defend an allegation by a generic manufacturer after the same allegation, made by a different generic manufacturer in an earlier proceeding, had been found to be justified. Sanofi-Aventis Canada Inc (S-A Inc) had been previously involved in a proceeding under the PM(NOC)Regulations involving the same patent and the same allegation, specifically, lack of sound prediction. In that first proceeding, which involved Apotex Inc (Apotex), Apotex's allegation was held to be justified. Although in the second proceeding S-A Inc planned to introduce new evidence on the sound prediction issue that was not available in the first proceeding, the Court held that the new evidence was irrelevant because it was an abuse of process for a party to hold back evidence in one case and then rely on it as a ground for allowing a subsequent application to proceed. Rather, said the Court, all parties must be held to the same standard. They must put forward their entire case, complete with all relevant evidence, at the first instance. Otherwise, the likelihood of inconsistent results would be increased, threatening the integrity and efficacy of the judicial system. In support of this position, the majority of the Court noted that a generic manufacturer is generally not permitted to serve multiple NOAs relating to a particular drug and alleging invalidity of a particular patent, even if different grounds for establishing invalidity are put forward in each NOA. However, while it may lead to an inconsistent result, the Court also noted that a second ge neric manufacturer is not prevented from making the same allegation as a first generic manufacturer because they may have additional evidence or more appropriate legal arguments to make. For the full reasons for judgment, see: http://decisions.fca-caf.gc.ca/en/2007/2007fca163/2007fca163.html Summary by: Katharine McGinnis