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
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
Generic not required to address Patent Register when reference innovator drug is no longer marketed in Canada
On August 17, 2022, the Federal Court dismissed applications for judicial review regarding the product-specificity requirements for addressing patents listed on the Patent Register under the Patented Medicines (Notice of Compliance) Regulations (the Regulations).
Background
This case concerns biosimilar
PMPRB round-up: report on current reforms
In this post, we summarize the current status of reforms to the Patented Medicine Prices Review Board (PMPRB). These reforms commenced with August 2019 amendments to the Patented Medicines Regulations (the Amendments) and accompanying changes to the