In Pharmascience Inc. v. Sanofi-Aventis Canada Inc. (2006 FCA 229), an appeal from an Order of prohibition (2005 FC 340) regarding ramipril (ALTACE), the Federal Court of Appeal considered the infringement of a use patent. The Court ruled that the Patented Medicines (Notice of Compliance) Regulations (“Regulations”) are intended to prevent infringement by generic drug manufacturers, rather than infringement generally, such as by patients. Two previous Court of Appeal decisions provided arguably conflicting guidance on the issue: AB Hassle v. Minister of Health (2002 FCA 421) and Procter & Gamble v. Minister of Health and Genpharm (2002 FCA 290). Given that it was not established that Pharmascience would infringe or would induce or procure infringement, the allegation was found to be justified. The Court also overruled the Applications Judge’s finding that the allegation was insufficient.
In the same ruling, the Court considered whether a patent covering ramipril, owned by Schering and listed on the Patent Register by Sanofi-Aventis, was invalid for double patenting. Pharmascience relied on two Sanofi-Aventis patents that were applied for after the Schering patent, but which issued earlier.
The Court found that there was not sufficient evidence on whether the Schering patent would have been obvious in view of the Sanofi-Aventis patents. While this finding was sufficient to uphold the Order of prohibition, the Court offered some guidance on double patenting, noting that double patenting is devised to prevent evergreening. The Court agreed that applying double patenting in this case would have been inconsistent with the provision of the relevant Patent Act, which granted a patent on the basis of first to invent rather than first to file. As the inventors of the later Sanofi-Aventis patents and the Schering patent worked independently, the filing of the Schering patent was not an attempt to unduly extend the terms of the other two patents. The application of double patenting would have unfairly deprived Schering of patent rights merely because of delay beyond its control in the issuance of the Schering patent.
The Court expressly declined to adopt the proposition that double patenting applies only where there is common inventorship, although it noted that it was difficult to envisage a case involving more than one inventor that is or should be vulnerable to double patenting.