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.
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 application of a Lowest International Price Comparison (LIPC) test. In public reasons issued September 27, 2017, the PMPRB ordered Alexion to: (i) repay excess revenues to the Crown from the date of introduction through the date of the decision; and (ii) lower its prices to match the lowest international price going forward. As we also reported, Alexion commenced an application for judicial review of the PMPRB’s decision on the merits in late 2017.
Updates in the file. Since we last reported, there have been a number of developments in Alexion’s judicial review application concerning the Board’s decision on the merits:
- Intervention by the Minister of Health for British Columbia. On March 19, 2018, the Minister of Health for British Columbia moved to be added as a respondent to the application. This motion was initially contested. The parties subsequently submitted a consent Order that resulted in the Minister being added as an intervener with the right to make limited written submissions and oral submissions at the discretion of the application judge.
- On April 23, 2018, the matter was consolidated with Alexion’s earlier application for judicial review in Court File No. T-1855-15, by which it seeks to quash the PMPRB’s decision dismissing Alexion’s motion to quash the Notice of Hearing and Statement of Allegations in the proceeding and disqualify Ms. Isabel Raasch from having future involvement in the proceeding. That application was previously stayed pending disposition of the PMPRB’s decision on the merits of the excessive pricing hearing giving rise to the main application.
- Motion to stay PMPRB’s Order. On July 6, 2018, the Court vacated the hearing of Alexion’s motion to stay the effect of the PMPRB’s Price-Reduction Order and granted a stay in part, pending disposition of the application and subject to a number of conditions. This motion was initially contested; subsequently, an Order issued on consent.
- Hearing date. The hearing of the application on the merits was originally scheduled for September 17-18, 2018. On July 6, 2018, Alexion wrote to the Court seeking to adjourn the hearing to November 8–9, 14–15, or 15–16, subject to the Court’s availability.
- Constitutionality proceedings:
- Supreme Court of Canada: Alexion Pharmaceuticals Inc. v Canada (Attorney General), SCC Case No. 37949
- Federal Court of Appeal:Alexion Pharmaceuticals Inc. v Canada (Attorney General), 2017 FCA 241
- Federal Court (Appeal Judge):Alexion Pharmaceuticals Inc. v Canada (Attorney General), 2017 FC 22
- Federal Court (Prothonotary):Alexion Pharmaceuticals Inc. v Canada (Attorney General), 2016 FC 716
- SandozFederal Court of Appeal: Canada (Attorney General) v Sandoz Canada Inc., 2015 FCA 249
- Excessive pricing proceedings: The PMPRB’s decision on the merits can be found here.