As we reported last month, the Minister of Health launched a consultation on a proposed Ministerial Reliance Order that would permit Health Canada to complete the examination of certain parts of a drug submission for new...more
On December 19, 2025, the Minister of Health announced the launch of consultations on two key regulatory initiatives referenced in Health Canada’s Red Tape Review report: (i) the Ministerial Reliance Order and (ii) clinical...more
In 2025, the Rx IP Update team at Smart & Biggar reported on a number of developments in Canadian life sciences IP and regulatory law. Highlights from 2025 are below...more
As previously reported, in December 2024, Health Canada published its agile licensing amendments to the Food and Drug Regulations (FDRs). The amendments included authorities that will come into force on April 1, 2027,...more
On December 20, 2025, Health Canada launched a consultation on modernizing the framework for clinical trials involving drugs for human use, including pharmaceuticals, biologics, radiopharmaceuticals, and cannabis. This...more
On January 1, 2026, the Guidelines for PMPRB Staff will come into effect. In November, the Patented Medicine Prices Review Board (PMPRB) held information sessions on the Guidelines to share technical information. Slides from...more
Over ten years have passed since the Federal Court of Appeal (FCA) flagged the patentability of methods of medical treatment as being worthy of full consideration by the Supreme Court of Canada. This issue has finally come...more
September 21, 2025, marked the eighth anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the eighth year...more
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
This article provides an update on developments in the biosimilar space in Canada—regulatory, approvals, pending submissions, litigation, and market access—since our March 2024 update. Consultation on revised biosimilar...more
6/25/2025
/ Biosimilars ,
Canada ,
Competition ,
Drug Pricing ,
New Regulations ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Regulatory Reform ,
Regulatory Requirements
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
On December 3, 2024, the Federal Court of Appeal (FCA) set aside the order of the Patented Medicine Prices Review Board (PMPRB or Board) that had required Galderma to continue to provide information to the PMPRB in relation...more
September 21, 2024, marked the seventh anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the seventh year...more
Explore skinny labelling & obviousness in Canada and Australia -
If you are an intellectual property (IP) owner, a litigator or an in-house legal professional managing IP litigation in multiple jurisdictions, don’t miss...more
8/30/2024
/ Australia ,
Canada ,
Cross-Border ,
FDA Approval ,
Hatch-Waxman ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
Litigation Strategies ,
Obviousness ,
Patent Applications ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Webinars
Explore skinny labelling & obviousness in Canada and Australia -
If you are an intellectual property (IP) owner, a litigator or an in-house legal professional managing IP litigation in multiple jurisdictions, don’t miss...more
8/30/2024
/ Australia ,
Canada ,
Cross-Border ,
FDA Approval ,
Hatch-Waxman ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
Litigation Strategies ,
Obviousness ,
Patent Applications ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Webinars
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
In the first half of 2024, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. The Rx IP Update team at Smart & Biggar has collected the top stories from January to June and...more
In this article, we provide a further update on developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory, and market access) since our March 2023 update....more
3/27/2024
/ Biologics ,
Biosimilars ,
Compliance ,
Innovation ,
Life Sciences ,
Market Access Rule ,
Minister of Health ,
Patent Infringement ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Regulatory Agenda ,
Trademark Litigation
On January 11, 2024, the Federal Court released its decision concluding that the Patented Medicine Prices Review Board (PMPRB or Board) was reasonable in its redetermination that the invention of Patent No. 2,478,237 (the 237...more
Eli Lilly v Teva, Pharmascience, Riva, Apotex, Mylan (tadalafil, CIALIS) – Following a summary trial, Lilly’s infringement actions were dismissed: composition claims directed to “a physiologically acceptable salt” of...more
1/3/2024
/ Abuse of Process ,
Appeals ,
Biosimilars ,
CADTH ,
Canada ,
Compliance ,
Data Protection ,
Life Sciences ,
Medical Devices ,
Patent Act ,
Patent Infringement ,
Patent Term Adjustment ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Regulatory Agenda ,
Regulatory Standards ,
Statute of Monopolies ,
United States-Mexico-Canada Agreement (USMCA)
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
On October 25, 2023, the Patented Medicine Prices Review Board (PMPRB) announced that it will launch the first phase of consultations on new guidelines. The first phase will include a policy roundtable with stakeholders on...more
September 21, 2023, marked the sixth anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the sixth year...more