2015 FCA 249 Attorney General of Canada v Sandoz (A-302-14) & v ratiopharm (now Teva) (A-303-14).
The central issue in both appeals is whether the Federal Court judge properly held that Sandoz and ratiopharm (collectively the respondents) fell outside of the jurisdiction of the Board as they were not “patentees” within the meaning of subsection 79(1) of the Patent Act. In a unanimous decision, the appeal court allowed the appeals and reversed the federal court decision. The appeal court decision concludes that the generic products in question fall within the jurisdiction of the PMPRB. This decision (subject to possible leave for appeal to the Supreme Court) removes uncertainty and confirms PMPRB’s jurisdiction over prices of patented multi-source drug products. In the case of ratiopharm (now Teva), with the jurisdiction question addressed, the appeal of the PMPRB’s initial decision of excessive pricing (and excess revenues of $65M) will be returned to the Federal Court for disposition.