In the first half of 2025, the Rx IP Update team reported on a number of developments in Canadian life sciences IP and regulatory law. Below are our top stories....more
In 2024, the Rx IP Update team at Smart & Biggar reported on a number of developments in Canadian life sciences IP and regulatory law. Highlights from 2024 are below; see also our top ten Rx IP Update reads of 2024....more
1/8/2025
/ Biosimilars ,
Data Protection ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent Term Adjustment ,
Patents ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs
Following consultation starting in 2022, on November 29, 2024, Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing) were registered. These Regulations amend the Food and Drug...more
Following consultation starting in 2022, on November 29, 2024, Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing) were registered. These Regulations amend the Food and Drug...more
12/20/2024
/ Clinical Trials ,
Food and Drug Act ,
Innovation ,
Labeling ,
Licensing Rules ,
Medical Devices ,
New Amendments ,
Prescription Drugs ,
Product Packaging ,
Regulatory Requirements ,
Risk Management ,
Terms and Conditions
Manitoba has implemented a Biosimilars Initiative effective August 1, 2024. Manitoba is the last province in Canada to implement a biosimilar policy that requires patients receiving funding under the Manitoba Pharmacare...more
As we have previously reported, the Patented Medicine Prices Review Board (PMPRB) announced that it will launch the first phase of consultations on new guidelines. On November 10, 2023, the PMPRB published its Scoping Paper...more
11/15/2023
/ Canada ,
Compliance ,
Consultation ,
Filing Deadlines ,
Health Care Providers ,
Life Sciences ,
Patented Medicine Prices Review Board (PMPRB) ,
Patients ,
Pharmacies ,
Prescription Drugs ,
Regulatory Requirements ,
Shareholders
As previously reported, in the spring, the Canadian Agency for Drugs and Technologies in Health (CADTH) consulted on a process for time-limited reimbursement recommendations. The pan-Canadian Pharmaceutical Alliance (pCPA)...more
The Canadian Agency for Drugs and Technologies in Health (CADTH) has released a consultation document for a Proposed Process for Time-limited Reimbursement Recommendations. The time-limited reimbursement recommendations would...more
Update: Health Canada has prepared an overview of its special access programs, and has finalized the Guidance Document: Sale of Drugs - Public or Canadian Armed Forces Health Emergencies.
On February 15, 2023, Regulations...more
In this article, we provide a further update on developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory, market access and competition) since our last update in June 2022....more
On October 20, 2022, Saskatchewan announced it is introducing a biosimilars initiative.
For any new patients starting a biologic drug, the Saskatchewan Drug Plan will only offer coverage for the listed biosimilar version....more
Health Canada released a number of reports over the summer:
- Annual Health Product Highlights for 2021, which provides an overview of new health products, including drugs and medical devices, that Health Canada approved...more
We provide a further update on developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory, market access and competition) since our last update in October 2021....more
6/30/2022
/ Biosimilars ,
Canada ,
Drug Approvals ,
Health Canada ,
Health Care Providers ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Update: Health Canada’s “ Forward Regulatory Plan: 2023-2025” no longer lists some of the below initiatives, including the 2019 proposed amendments to the Food and Drug Regulations, “Regulations amending the Food and Drug...more
6/29/2022
/ Artificial Intelligence ,
Canada ,
Exports ,
Fees ,
Food & Drug Regulations ,
Generic Drugs ,
Health Canada ,
Machine Learning ,
Medical Devices ,
Natural Products ,
Pharmaceutical Industry ,
Prescription Drugs
As we have previously reported, in response to the COVID-19 pandemic, the Minister of Health had made interim orders pursuant to the Food and Drugs Act to address the significant risk to health posed by shortages in 2020 and...more
3/30/2022
/ Amended Regulation ,
Canada ,
Certificates of Supplementary Protection (CSPs) ,
Coronavirus/COVID-19 ,
Health Canada ,
Medical Devices ,
Minister of Health ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs ,
Reporting Requirements ,
Supply Shortages
As previously reported, the Canadian Agency for Drugs and Technologies in Health (CADTH) and the Pan-Canadian Formulary Advisory Panel (Panel) held an information session on January 18 about a potential pan-Canadian...more
The Patented Medicine Prices Review Board (PMPRB) has released its 7th edition CompassRX report, Annual Public Drug Plan Expenditure Report for 2019/20. The report was prepared as part of the National Prescription Drug...more
Since our last update in April 2021, there have been many developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory and market access).
Biosimilars approved in Canada -
Health...more
10/27/2021
/ Biologics ,
Biosimilars ,
Canada ,
Drug Approvals ,
Drug Pricing ,
Health Canada ,
Intellectual Property Protection ,
Life Sciences ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
September 21, 2021 marked the fourth anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the fourth year...more
9/28/2021
/ Amended Regulation ,
Apotex ,
Appeals ,
Canada ,
Dismissals ,
Judgment on the Merits ,
Patent Infringement ,
Patent Litigation ,
Patent Validity ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drugs ,
Sandoz ,
Teva Pharmaceuticals
As previously reported, British Columbia, Alberta, and New Brunswick have all launched biosimilar initiatives which require that patients switch from certain reference biologics to biosimilars for certain indications. On May...more
The Federal Government has published the following proposed amending regulations in Part 1 of the Canada Gazette:
- Regulations Amending the Food and Drug Regulations (Exports and Transhipments of Drugs): The amendments...more
7/2/2021
/ Canada ,
Dietary Supplements ,
Exports ,
Food and Drug Act ,
Health Canada ,
Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Product Labels ,
Proposed Amendments ,
Proposed Regulation
The following provides an overview of the many developments regarding biosimilars in Canada (approvals, pending submissions, regulatory, litigation and market access) that have taken place since our last update in October...more
8/27/2020
/ Biosimilars ,
CADTH ,
Canada ,
Drug Approvals ,
Drug Pricing ,
Health Canada ,
Patent Infringement ,
Patented Medicine Prices Review Board (PMPRB) ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Popular ,
Prescription Drugs ,
United States-Mexico-Canada Agreement (USMCA)
On June 3, 2020, a proposed class action was commenced against over 50 generic drug manufacturers... The claim alleges that the generic drug manufacturers violated the Competition Act by conspiring to allocate the market, fix...more
6/29/2020
/ Antitrust Conspiracies ,
Antitrust Investigations ,
Antitrust Litigation ,
Bid Rigging ,
Class Action ,
Competition Act ,
Generic Drugs ,
Generic Marks ,
Market Allocation Scheme ,
Pharmaceutical Industry ,
Prescription Drugs ,
Price-Fixing
As part of the National Prescription Drug Utilization Information System (NPDUIS) initiative, the Patented Medicine Prices Review Board (PMPRB) has released three reports:
1) Market Intelligence Report: Combination...more
September 21, 2019 was the second anniversary of the coming into force of the amended Patented Medicines (Notice of Compliance) Regulations (Regulations) heralding significant changes to the landscape for pharmaceutical...more
10/3/2019
/ Allergan Inc ,
Amended Regulation ,
Amgen ,
Apotex ,
Bristol-Myers Squibb ,
Canada ,
Certificates of Supplementary Protection (CSPs) ,
Hatch-Waxman ,
Health Canada ,
Janssen Pharmaceuticals ,
Joinder ,
Leave to Appeal ,
Notice of Compliance ,
Patent Infringement ,
Patented Medicines ,
Pfizer ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drugs ,
Sandoz ,
Teva Pharmaceuticals ,
Trial Plan