On December 2, proposed Regulations Amending the Patented Medicines Regulations were published; the consultation period ends February 15, 2018, with a proposed coming into force date of January 1, 2019. If passed, they will significantly affect the Patented Medicine Prices Review Board (PMPRB)'s approach to drug price evaluation, including expanding the list of comparator countries to twelve, but excluding the US and Switzerland, and by taking into account the pharmacoeconomic value of patented products. On December 11, the PMPRB released a scoping paper with its preliminary thoughts on "how to best operationalize the proposed changes". A draft of the new Guidelines is expected in the spring of 2018.
Three decisions of note: On September 20, a PMPRB hearing panel decided that Alexion's SOLIRIS (eculizumab) was excessively priced as (i) its benchmark price exceeded the lowest international price (an approach outside the Guidelines) and (ii) the increases were beyond those permitted by the Guidelines (despite the increases resulting only from the appreciation of the Canadian dollar relative to foreign currencies). Alexion has sought judicial review. In a November 9 decision, the Federal Court overturned the PMPRB's finding that a patent 'pertained' to Galderma's DIFFERIN (0.1% adapalene), as the Board failed to consider the entire patent, including its claims. The PMPRB has appealed. Finally, on December 7, the FCA dismissed Alexion's appeal of a decision rejecting Alexion's arguments that the PMPRB provisions of the Patent Act are unconstitutional.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.
