On March 22, 2023, Canada’s federal government announced its first-ever National Strategy for Drugs for Rare Diseases, including an investment of up to $1.5 billion over three years to help increase drug access and affordability.
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
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
Health Canada consulting on wide-ranging regulatory amendments for drugs and medical devices
Health Canada has launched a consultation on proposed amendments to the Food and Drug Regulations and Medical Devices Regulations (the Regulatory Amendments). Consultation on the Regulatory Amendments, which have been published in the Canada Gazette, Part 1, is
Ontario introduces biosimilar transition policy
Federal Court of Appeal upholds decision invalidating claims to multiple sclerosis treatment regimen
The Federal Court of Appeal (FCA) has dismissed appeals concerning two actions brought under the Patented Medicines (Notice of Compliance) Regulations (Regulations), confirming the Federal Court (FC) holding that claims to uses of the
CADTH advisory panel consults on framework for pan-Canadian formulary
In a recently published discussion paper, an Advisory Panel (the Panel) convened by the Canadian Agency for Drugs and Technologies in Health (CADTH) presents a proposed framework for a potential pan-Canadian formulary. The Panel is asking
Federal Court of Appeal provides guidance on the “inventive concept”
The Federal Court of Appeal (FCA) has held that the “inventive concept” can go beyond the essential elements of the claim and may include advantageous properties stated in the patent’s description. The FCA confirmed that the inventive concept
Federal Court finds 45-day limitation period does not apply to s 8.2 PM(NOC) related rights of action for unlisted patents
Summary
The Federal Court has held that the “related right of action” for infringement of unlisted patents under section 8.2 of the Patented Medicines (Notice of Compliance) Regulations (Regulations) is not subject to the 45-day limitation period familiar
Federal Court of Appeal Upholds First Trial Judgment under New PM(NOC) Regulations
The Federal Court of Appeal has upheld the first trial judgment under the new Patented Medicines (Notice of Compliance) Regulations. In Amgen Inc v Pfizer Canada ULC, 2020 FCA 188, the Court dismissed Amgen’s appeal from the