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ARTICLE · 12 JUNE 2014

Generic Drug Company Licensees Avoid Patented Medicines Price Oversight

The Federal Court of Canada held that some licensees of patents relating to medicines are not subject to the jurisdiction of the Patented Medicines Prices Review Board.

CanadaIntellectual Property

In nearly identical decisions released on May 27, 2014, Sandoz Canada Inc v Canada, 2014 FC 501 (Sandoz) and ratiopharm Inc v Canada, 2014 FC 502 (ratiopharm), the Federal Court of Canada held that some licensees of patents relating to medicines are not subject to the jurisdiction of the Patented Medicines Prices Review Board (PMPRB or Board), including its powers to regulate drug prices. These decisions, which may be appealed to the Federal Court of Appeal, mark a retreat from the courts' expansive views about the jurisdiction of the PMPRB.

Background

The PMPRB is the quasi-judicial body established by Parliament to monitor and control the price of patented medicines in Canada. In 2008, it initiated a proceeding against ratiopharm, alleging that it sold an authorized generic salbutamol drug product (ratio HFA) at excessive prices. Separately, in 2010, the PMPRB started a proceeding against Sandoz, a wholly-owned subsidiary of a well-known pharmaceutical patentee

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