The Patented Medicine Prices Review Board (PMPRB) has launched a consultation on proposed changes to its new Guidelines (the New Guidelines). These changes include revisions to the price tests for some medicines marketed prior to the anticipated
2021
Certain COVID-19 medical devices no longer hold urgent public health need status under Interim Order No. 2



Health Canada has issued a notice explaining a policy change to the review of applications for COVID-19 medical devices. As of July 16, 2021, Health Canada is no longer accepting applications for certain categories of medical devices under Interim Order …
Consultation on proposed amendments to Patent Rules
The Government of Canada has proposed a series of amendments to the Patent Rules intended to keep Canada compliant with its obligations under the Canada-United States-Mexico Agreement (CUSMA) and the Patent Cooperation Treaty (PCT). As part…
PMPRB Update: delayed implementation of Patented Medicines Regulations amendments and new Guidelines
Changes to the Patented Medicine Prices Review Board (PMPRB) regime, contained in pending amendments to the Patented Medicines Regulations, have been delayed until January 1, 2022. These amendments form the basis for new PMPRB Guidelines, which…
Amendments to the Federal Courts Rules



On June 17, 2021, a series of amendments to the Federal Courts Rules (the Amended Rules), were registered and came into force. On July 7, 2021, the Amended Rules were officially published in the Canada Gazette Part II.…
Generic allowed to plead new grounds of invalidity not raised in the Notice of Allegation


The Federal Court of Appeal (FCA) has confirmed that in an infringement action under the Patented Medicines (Notice of Compliance) Regulations, the “second person” (i.e., generic/biosimilar) is not precluded from pleading invalidity allegations in its…
CSP Amendments to the PMPRB Regime: Jurisdiction of Patented Medicine Prices Review Board to Include Medicines Protected by Certificates of Supplementary Protection
A suite of amendments to the Patent Act and the Patented Medicines Regulations (the Regulations) will soon require holders of Certificates of Supplementary Protection (CSPs) to report information to the Patented Medicine Prices Review Board (PMPRB…
Federal Court of Appeal Gradually Phases Out Suspension Period


The Federal Court of Appeal (FCA) has begun to gradually restore filing deadlines in appeals before the Court that were subject to the Court’s Suspension Period.
Under the Suspension Period system, the progress of individual appeals has been…
Federal Court quashes NOC in dispute over Data Protection Provisions
The Federal Court has quashed a notice of compliance (NOC) issued to Médunik Canada (Médunik) for its amifampridine product, RUZURGI, over an issue concerning data protection for another amifampridine product.
The Minister provided no reasons for…
Overview of IP Law In Canada – The Intellectual Property Review, 10th Edition


The recently published Tenth Edition of the Intellectual Property Review (the Review) includes a Canadian chapter. Readers are invited to learn more on the various forms of IP protection available in Canada, and highlights of important changes in…