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ARTICLE · 25 JANUARY 2022

The 2022 PMPRB Outlook For Pharmaceutical Patentees In Canada

Fasken
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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").

CanadaIntellectual Property
Dara Jospé
Dara Jospé
Eric Saragosa
Eric Saragosa
Lina Bensaidane
Lina Bensaidane
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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.

December 2021 Updates

First, on December 17, 2021, the PMPRB announced that it had decided not to proceed with three amendments to the New Guidelines proposed in July 2021. The three proposed amendments were a change in the definition of "Gap medicines" to reflect the then-current coming-into-force date of the

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