Hot Topics in International Trade - Wood Chucks Chuck Canadian Lumber tariffs
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
Daily Compliance News: March 7, 2025, The No Jail Time 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
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
The Bloom Burton & Co. Healthcare Investor Conference (BBHIC), held in Toronto this week, drew over 1,500 global participants to one of Canada's leading events for healthcare investment and innovation. The conference brought...more
Canada’s Bill C-64, An Act respecting pharmacare (the “Pharmacare Act”) received royal assent on October 10, 2024 and established a framework for national pharmacare. On February 27, 2025, the Hon. Mark Holland, Canada’s...more
We previously reported on Canada’s first-ever National Strategy for Drugs for Rare Diseases, which included up to $1.4 billion in funding for provinces and territories, to be negotiated through bilateral agreements. This...more
Health Canada is proposing to amend the Food and Drug Regulations, C.R.C., c.870 (the FDRs) and the Medical Device Regulations, SOR/98-282 (the MDRs) in an effort to avoid pharmaceutical and medical device shortages and...more
On December 28, 2024, Health Canada published a regulatory proposal in the Canada Gazette, Part I, Volume 158, Number 52, introducing amendments to the Food and Drug Regulations, CRC, c 870 and the Medical Devices...more
On October 10, 2024, Canada’s Bill C-64, An Act respecting pharmacare (the “Pharmacare Act”) received Royal Assent. This legislation establishes a framework for a national universal pharmacare system, aiming to enhance the...more
On September 19, 2024, the Supreme Court of Canada granted Pharmascience leave to appeal a Federal Court of Appeal decision affirming a trial decision that upheld the validity of Janssen’s patent relating to paliperidone...more
On December 17, 2024, recent amendments to the Food and Drug Regulations (FDR) and the Medical Devices Regulations (MDR) relating to the recall of drugs and medical devices will come into force....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
CADTH is now known as Canada’s Drug Agency (CDA-AMC or CDA). Its mandate extends beyond CADTH’s mandate to include: improving the appropriate prescribing and use of medications; increasing pan-Canadian data collection and...more
On April 5, 2024, the pan-Canadian Pharmaceutical Alliance (pCPA) announced that it was ready to accept drugs through the pCPA Temporary Access Process (pTAP) (see our previous article regarding the consultation)....more
In Palmer v. Teva Canada Limited, the Ontario Court of Appeal upheld the lower court’s decision to deny certification of a proposed product liability class action seeking damages for the alleged increased risk of being...more
On May 26, 2023, the Minister of Health determined that Biosimilar Collaborations Ireland Limited was entitled to the benefit of section 5 of the Patented Medicines (Notice of Compliance) Regulations (Regulations), including...more
In a decision dated January 24, 2024, Justice Pallotta allowed Novartis’ application, finding that Biogen and Samsung’s use of the trademark BYOOVIZ in association with an ophthalmologic drug violates Novartis’ rights in its...more
A recent development with the Food and Drug Administration made us think of a song lyric from Florida native and Rock and Roll Hall of Famer, Tom Petty, “What lies ahead, [we] have no way of knowing.” As a kick-off to 2024,...more
On January 5, 2024 the Food and Drug Administration (FDA) issued its approval of the State of Florida’s proposal to import certain prescription drugs from Canada under the Section 804 Importation Program (SIP). This approval...more
On Jan. 5, the FDA authorized Florida’s Section 804 Implementation program (SIP), making Florida the first state to secure such approval. Generally, there are three pathways to importing a prescription drug into the United...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
On November 1, 2023, the Federal Court of Appeal (FCA) dismissed Actial’s appeal from an application for judicial review of the Minister of Health’s decision to disclose records pursuant to a request under the Access to...more
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
On September 28, 2023, the Canadian Agency for Drugs and Technologies in Health (CADTH) introduced the time-limited reimbursement recommendation category, which aims to provide early access to promising new drugs that target...more
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
On July 17, 2023, Justice Aylen of the Federal Court dismissed Janssen’s application for judicial review of the decision of the Office of Submissions and Intellectual Property (OSIP) refusing to list Canadian Patent 3,113,837...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