We provide an update of developments in recent PMPRB cases below. Notably, the PMPRB has ordered Alexion Pharmaceuticals Inc. to pay $4,245,329.60 in excess revenues earned on sales of SOLIRIS (eculizumab) to Her Majesty in right of Canada and has also appealed the Federal Court’s judgment against it in the Galderma case regarding DIFFERIN.
Updates in the SOLIRIS case
Background. As we reported, a PMPRB panel found Alexion liable for excessive pricing on SOLIRIS and ordered the parties to submit their calculations by October 20, 2017, on the amount of excess revenues owed to the Crown in accordance with the highest international price comparison (HIPC) test.Submissions and decision. Alexion and the board staff disagreed regarding the amount owed by Alexion to the Crown because of differing assumptions about which international prices were relevant to the analysis. Following a clarification issued by the panel on October 25, the parties agreed to a calculation of Alexion’s liability made using the median international price comparison test for 2009 and the HIPC test for 2010–2017, using Alexion’s final revised Block 5 reported prices. The panel approved this amount on November 8 and required Alexion to pay the balance ($4,245,329.60) on or before December 8, 2017.
Alexion’s judicial review. On October 20, 2017, Alexion filed an application for judicial review of the panel’s decision on the merits in Federal Court File No. T-1596-17. We will monitor the proceeding and report on developments as they arise.
Updates in the DIFFERIN case
Background. As we reported, the Federal Court found that the PMPRB wrongly asserted jurisdiction over Differin® pricing based on an incorrect application of the patent-pertaining analysis. The court allowed a judicial review application from the PMPRB’s failure-to-file decision, holding that the PMPRB had failed to consider the entirety of Galderma Canada Inc.’s patent when determining whether it pertained to Differin®.
PMPRB’s appeal. On November 21, 2017, the PMPRB filed an appeal from the Federal Court’s judgment in Court File No A-385-17. The PMPRB alleged the Federal Court committed a range of factual and legal errors, including:
- finding that the “medicines” at issue were the consumer end products — Differin® and Differin XP® — rather than adapalene (the same, sole active ingredient of both end products);
- misapplying the ICN test and elevating the very low threshold necessary for the board’s jurisdiction under the “merest slender thread” test;
- interpreting the relevant provisions of the Patent Act with a focus on those in a position to cause mischief rather than those in need of protection from such mischief, i.e., consumers;
- failing to properly apply the “reasonableness” standard of review; and
- conflating the concepts of “claim” and “pertain.”
We will monitor the proceeding and report on developments as they arise.