Trends, analysis and insights in IP Law
On June 17, the 2022 Ministerial Conference of the World Trade Organization (“WTO”) issued a decision [PDF] pursuant to the Agreement on Trade-related Aspects of Intellectual Property Rights (“TRIPS Agreement”) and allowed certain members to use patented inventions for the production and supply of COVID-19 vaccines in specific circumstances (“Ministerial Decision”).
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UPDATE: On April 14, 2022, the Minister of Health announced that the federal government will not proceed with amendments to the Patented Medicines Regulations introducing new pharmacoeconomic factors and requiring that price and revenue information be reported net of all adjustments. The federal government will proceed with amendments establishing a new basket of comparator countries, with a coming-into-force date of July 1, 2022. For more information, see our Life Sciences Bulletin on the Minister’s announcement.
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This article provides an update on each of these cases and highlights the growing body of jurisprudence questioning the PMPRB’s price control reasoning.
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UPDATE: On April 14, 2022, the Minister of Health announced that the federal government will not proceed with amendments to the Patented Medicines Regulations introducing new pharmacoeconomic factors and requiring that price and revenue information be reported net of all adjustments. The federal government will proceed with amendments establishing a new basket of comparator countries, with a coming-into-force date of July 1, 2022. For more information, see our Life Sciences Bulletin on the Minister’s announcement.
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In December 2021, the Patented Medicine Prices Review Board (the “PMPRB”) and the Minister of Health issued two updates regarding the Regulations Amending the Patented Medicines Regulations (the “Amendments”) and the new PMPRB Guidelines (the “New Guidelines”). These notably include a further deferral of the coming-into-force date of the Amendments. The updates, along with the Federal Court of Appeal’s (“FCA”) July 2021 decision in Alexion Pharmaceuticals Inc v Canada (Attorney General), 2021 FCA 157 (“Alexion”), may have important implications for pharmaceutical patentees in Canada as they implement or revise their pricing strategy for 2022 and beyond.
On January 15, 2021, the Patented Medicines Prices Review Board (“PMPRB”) initiated a consultation on two proposed amendments to the new PMPRB Guidelines (“Guidelines”): (1) the definition of Gap medicines; and (2) the compliance timeline for Grandfathered and Gap medicines.
According to the PMPRB, the two amendments were required due to the change in the coming-into-force date of the Regulations Amending the Patented Medicines Regulations (“Regulations”), which was pushed from January 1, 2021 to July 1, 2021.
And so, on March 17th, the PMPRB rendered its decision.
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