Regulatory Ramblings: Episode 72 - Cultural Roots, Belonging, and the Fear of Change: What’s Next for Inclusion?
Daily Compliance News: June 24, 2025, The Questions, Questions, and More Questions Edition
Hot Topics in International Trade - Tariff Mitigation Strategies
Everything Compliance, Shout Outs and Rants: Episode 151, The What is Illegal DEI Edition
Adapting to Tariffs and Other Trade Policy Shifts Under the Trump Administration
A Brief Primer on Tariffs Under the Trump Administration
Protect, Prepare, Prevail: Navigating a Complex Cybersecurity World
Private M&A 2024: Key Trends and Forecasts
Patent Considerations in View of the Nearshoring Trends to the Americas
Examining E-Discovery in Competition Law
No Password Required: Education Lead at Semgrep and Former Czar for Canada’s Election Security
Shifting Dynamics in Private Equity
4 Key Takeaways | Major U.S. Supreme Court Trademark & Copyright Decisions
Hidden Traffic : New Human Trafficking and Child Labor Regulation in Canada with Sean Stephenson
[Podcast] Catching Up on Canadian Environmental Regulation
[Podcast] USMCA in Review, with C.J. Mahoney, Former Deputy U.S. Trade Representative
Episode 4 - USMCA and the trade relationship between the U.S.A, Mexico, & China
Five Questions, Five Answers: Electric Mobility Canada on Its Promises for a Cleaner Economy
Five Questions, Five Answers: The Voice of Canadian Automotive Parts Manufacturers
The Great Green North: A Discussion on Canada’s Environmental Regulations
On June 10, 2025, Health Canada initiated a public consultation on proposed revisions to its Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs. A notable update is the proposal to remove...more
On June 10, 2025, Health Canada launched a consultation on its Draft Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs which includes numerous proposed revisions to the current guidance...more
In Bayer Inc v Amgen Canada Inc, 2024 FC 1849, the Court granted a motion brought by Amgen for a declaration that Canadian Patent No. 3,007,276 (276 patent) was ineligible for inclusion on the Patent Register and that the...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
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
In the first half of 2023, 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
On May 12, 2023, Health Canada announced the fifth version of the Guidance Document: Certificates of Supplementary Protection. The changes are described as being made to reflect current administrative practices, and to...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
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
Below are highlights from the Rx IP’s team’s 2022 updates (see also our Top 10 Rx IP Update Reads of 2022): Contents: 1. Patent decisions on the merits 2. PMNOC Regulations: Fifth-year anniversary of major amendments,...more
In the first half of 2022, 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 July and...more
In the fall of 2021, the Rx IP Update team celebrated its 20thyear of monthly updates on Canadian life sciences IP and regulatory law. Below are highlights from our team’s 2021 updates...more
Mid-year update: Health products approved in 2021 – In October 2021, Health Canada published a “Mid-year update: Health products approved in 2021”, which provides an update on the drugs, medical devices, over-the-counter...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
In the first half of 2021, 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
On May 4, 2021, Amgen Canada announced the launch of their adalimumab biosimilar AMGEVITA (reference drug HUMIRA) for the treatment of 11 chronic inflammatory conditions. AMGEVITA is available as a prefilled syringe and a...more
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 August...more
In 2020, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: Table of Contents 1. COVID-19: CIPO, Federal Courts, Health Canada 2. PMPRB:...more
In 2019, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: 1) PMPRB: Amendments to Regulations will come into force July 1, 2020, court...more
Below are the major highlights in Canadian life sciences intellectual property and regulatory law that we have reported on in the first half of 2019....more
In 2018 we reported on a number of developments in life sciences IP and regulatory law. Our most-read articles were: #1 a June update on biosimilars (authored by Urszula Wojtyra); #2 a “live” summary chart of Vanessa’s Law...more
In This Issue: Ontario Court of Appeal allows Sanofi and Schering to plead that Federal Court ramipril patent invalidity decision was flawed due to “promise doctrine” - In an action by Apotex for compensation from...more
In this special mid-year edition, we take a look at the major highlights in Canadian life sciences and intellectual property law that we have reported on over the last six months, starting with one of the most closely-watched...more
The year 2017 was one of the most significant years for Canadian Life Sciences IP and Regulatory Law in Canada’s history. The year saw major developments in patent linkage, patent term, and substantive patent issues. As we...more
While the patent eligibility of diagnostic method claims remains questionable in the United States, the Canadian Intellectual Property Office has issued updated guidance on the types of diagnostic method claims that can–and...more