Alexion Pharmaceuticals Inc. v. Canada (Attorney General), 2021 FCA 157

Justice Stratas; Justice Webb; Justice Rennie - 2021-07-29

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The Patented Medicine Prices Review Board started proceedings into whether Alexion priced Soliris excessively contrary to the Patent Act. It found that it did. It ordered Alexion to forfeit excess revenues earned between 2009 and 2017. ... However, Vavilov did change the law substantially by requiring that reviewing courts be able to discern a reasoned explanation for administrators’ decisions. This change in the law affects the outcome of this appeal. ... In particular, certain words the Board used suggest that it went beyond its permissible statutory mandate by regulating the reasonableness of pricing, rather than preventing abusive pricing, i.e., excessive pricing made possible by the abuse of the monopoly power given by a patent. ... As well, the Board’s departure from the Guidelines and its imposition of a requirement that the medicine be lower than all seven comparator countries was unprecedented. It was a marked departure from its own authorities. In the circumstances of this case, a coherent, relatively detailed explanation is called for. ... For the foregoing reasons, the Board’s decision cannot stand. It must be quashed and remitted to the Board for re-determination.

Decision relates to:


Canadian Intellectual Property