On 12 June 2019 Justice Gleeson dismissed(1) Alexion's application for judicial review of a panel of the Patented Medicines Price Review Board's (PMPRB's) decision that Soliris (eculizumab) had been sold at an excessive price and its order fixing the amount of the payment to offset excess revenues (C$4.2 million).(2)

The PMPRB found that the guidelines were appropriate in assessing increases, but not appropriate in assessing the appropriate benchmark (instead, the lowest international price comparison test was applied) (for further details please see "Patented Medicine Prices Review Board Update"). The PMPRB rejected Alexion's argument that the guidelines were not appropriate regarding permitted increases, as the fluctuations in the exchange rates and the appreciation of the Canadian dollar resulted in the Canadian price appearing higher than the international comparators, while the Canadian price remained unchanged and, in fact, decreased based on changes in the consumer price index.

The Federal Court reviewed the PMPRB's decision on a reasonableness standard and dismissed the application on the grounds that the PMPRB had:

  • given due consideration to the guidelines before departing from the test and that the lowest international price comparison test was not contrary to the Patent Act and regulations "which cannot be read as excluding a particular test";
  • acknowledged that the price of Soliris after inflation had not increased and had undertaken a serious analysis with respect to this factor;
  • reasonably concluded that provincial rebates should not be considered in determining Soliris's average transaction price (as provinces are not customers) and had not erred in declining to take them into account in determining excess revenue for the same reason; and
  • not been unreasonable in ordering payment of excess revenues based on the highest international price comparison, including because it was a more conservative test that it might otherwise be entitled to pursue.

Alexion has appealed.(3)

For further information on this topic please contact Katie Lee at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email ([email protected]). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.


(1) For an update to this development, see "Federal Court of Appeal remits pricing decision on Alexion's Soliris to Patented Medicine Prices Review Board".

(2) Alexion Pharmaceuticals Inc v Canada (Attorney General), 2019 FC 734.

(3) Court File A-237-19.