On April 26, 2023, the Office of the United States Trade Representative (USTR) released its 2023 Special 301 Report on intellectual property. The report keeps Canada on a Watch List of 29 U.S. trading partners that “merit bilateral attention
Intellectual property
Federal Court of Appeal rejects elevated standard of proof for induced infringement in paliperidone case
The Federal Court of Appeal (FCA) has allowed an appeal concerning induced infringement in an action under the Patented Medicines (Notice of Compliance) Regulations (Regulations). The FCA found that the Federal Court (FC) had…
Federal Court launches IP Chamber pilot project
The Federal Court has created a new, specialized Chamber of judges to be used for assigning intellectual property and competition law hearings.
The Chamber formalizes the Court’s existing practice of endeavouring to assign judges with relevant IP expertise to preside…
Higher costs awards coming to the Federal Court, including for pharma regulatory and IP disputes
Higher costs awards for Federal Court litigation are on the horizon, with the Canadian government consulting on proposed amendments to the costs structure in the Federal Courts Rules (the Rules). The proposed amendments are intended to increase costs awards…
PMPRB Update: New Chairperson Appointed
The Governor in Council has appointed Thomas J. Digby as the new Chairperson of the Patented Medicine Prices Review Board (PMPRB).
According to the Government’s news release, “Mr. Digby is a lawyer with expertise in intellectual property…
Pharma in Brief: The 2022 Year in Review
Does 2022 already seem like a blur? The Pharma in Brief team is here for you with a summary of some of 2022’s most significant legal and regulatory developments in the Canadian pharmaceutical space. We also flag what to watch…
Federal Court of Appeal overturns judicial review decision in data protection dispute
The Federal Court of Appeal (FCA) has overturned a decision of the Federal Court (FC) that found the Minister of Health’s (Minister) analysis of the data protection provisions of the Food and Drug Regulations…
Federal Court of Appeal issues decision in industry challenge to the PMPRB Patented Medicines Regulations
On December 5, 2022, the Federal Court of Appeal (FCA) upheld the validity of changes to the list of countries used for international reference pricing by the Patented Medicine Prices Review Board (PMPRB). This new schedule…
PMPRB issues excessive price order on rare disease drug
The Patented Medicine Prices Review Board (PMPRB) has issued a decision that Procysbi (cysteamine bitartrate) is being sold at an “excessive” price. The PMPRB ordered the manufacturer, Horizon Pharma PLC (Horizon), to reduce its price and…
24-month stay extended under the PM(NOC) Regulations for late pleadings amendment
In a recent pleadings amendment motion under the Patented Medicines (Notice of Compliance) Regulations (the Regulations), the Federal Court gave the generic a choice: either (a) abandon proposed new grounds of invalidity or (b) accept that the scheduled trial…