PMPRB Update: SCC Dismisses Appeal Regarding Constitutional Issues Concerning The PMPRB In Eculizumab Case

The Supreme Court of Canada has denied leave to appeal on a question regarding the constitutionality of the Patented Medicine Prices Review Board (PMPRB) raised in Alexion's ongoing dispute with the Board regarding prices of SOLIRIS (eculizumab). In addition, we report on a number of updates in Alexion's challenge of the Board's excessive-pricing order in respect of SOLIRIS.

Background

Alexion has marketed SOLIRIS in Canada since June 2009. SOLIRIS is indicated for the treatment of paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uremic syndrome (aHUS). The Board described SOLIRIS as a "breakthrough drug", with no other medicines in the same therapeutic class. The PMPRB first advised Alexion that it was investigating the price of SOLIRIS in June 2010 and several related legal proceedings have been commenced since that time, including those discussed below.

Constitutionality proceedings (Court Files No. T-1537-15, A-51-17, and 37949 (SCC))

Context. As we reported, Alexion challenged the constitutionality of sections 80 through 86 of the Patent Act, as well as the words "in any proceeding under section 83" in subsection 87(1) (the Impugned Provisions) on the basis that they are ultra vires the federal powers granted to Parliament. Alexion also sought an order prohibiting the PMPRB from continuing the proceeding against it. Subsequently:

Canada moved successfully before Aalto P. to strike the constitutionality judicial review on the basis that the issue had been decided, including by the Federal Court of Appeal (FCA) in Attorney General (Canada) v. Sandoz Canada Inc., 2015 FCA 249 (Sandoz). On appeal to the Federal Court, Simpson J. agreed that the Court was bound as a matter of stare decisis by the Sandoz case As we reported, on further appeal in the SOLIRIS case, the FCA held that Alexion was not entitled to bring the underlying application as it had not first raised the constitutionality issue before the PMPRB and, in any event, agreed with the lower courts that the constitutionality issue had already been decided. The FCA therefore dismissed the appeal. Leave application dismissed. On June 28, 2018, the SCC dismissed Alexion's application for leave to appeal from the FCA's decision. As is customary, the SCC did not provide reasons.

Excessive price proceedings (Court Files No. T-1596-17 and T-1855-15)

Context. As we reported, the PMPRB issued an excessive-pricing order against Alexion in respect of SOLIRIS based on the...