Smart & Biggar

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40 King Street West
Toronto, ON M5H 3Y2, Canada
Phone: 416.593.5514
Fax: 416.591.1690
Areas Of Practice
  • Agriculture
  • Art, Entertainment, & Sports Law
  • Communications & Media Law
  • Intellectual Property
  • Litigation
  • Science, Computers, & Tech
Locations
Other Countries
  • Canada
Number of Attorneys
100+ Attorneys

Updated PMPRB Guidelines expected in summer 2025 and NPDUIS releases ninth edition of the Meds Entry Watch Report

In the Patented Medicine Prices Review Board (PMPRB)’s June 2025 NEWSletter, Acting Chairperson Anie Perrault confirms that the PMPRB plans on publishing its final Guidelines in summer 2025. This will mark the completion of the…more
 /  Administrative Law, Health, Intellectual Property

Health Canada must redetermine exemption requests for psilocybin (magic mushroom)-assisted psychotherapy training

TheraPsil, a patient advocacy organization, and 73 healthcare practitioners (HCPs) have succeeded in the Federal Court of Appeal (FCA) to overturn the refusal of the Minister of Mental Health and Addictions and Associate…more
 /  Administrative Law, Constitutional Law, Health

Update on biosimilars in Canada – June 2025

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
 /  Antitrust & Trade Regulation, Health, Intellectual Property

What the Canuck?! Understanding scandalous, obscene and immoral marks in Canada

“Scandalous, obscene or immoral” trademarks are not only unregistrable in Canada, but they are also unlawful to adopt in connection with a business “as a trademark or otherwise.” While similar prohibitions have been deemed…more
 /  Administrative Law, Constitutional Law, Intellectual Property

Health Canada consultation on revised biosimilar guidance: no requirement for comparative clinical efficacy and safety trials

On June 10, 2025, Health Canada launched a consultation on its Draft Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs which includes numerous proposed revisions to the current guidance…more
 /  Administrative Law, Health

Canadian Intellectual Property Office “Next Generation Patents” update and status as of June 17, 2025

On July 17, 2024, the Canadian Intellectual Property Office (CIPO) launched a new electronic system and portal, MyCIPO Patents, as part of its Next Generation Patents initiative. The launch has been fraught with difficulties,…more
 /  Administrative Law, Intellectual Property, Science, Computers, & Technology

CDA update: new five-year strategic plan and position statement on using AI in health technology assessments

On April 15, 2025, Canada’s Drug Agency (CDA) released its new five-year strategic plan, Insight to Impact 2025-2030. Formerly the Canadian Agency for Drugs and Technologies in Health (CADTH), this is the CDA’s first strategic…more
 /  Health, Science, Computers, & Technology

Alexion awarded injunction against Amgen in SOLIRIS patent action; Court considers anticipation by incorporation by reference

The Federal Court has granted Alexion a declaration of infringement and an injunction preventing Amgen from manufacturing, using, and selling its proposed biosimilar eculizumab product, BEKEMV, in Canada until the expiration of…more
 /  Health, Intellectual Property

Quebec’s French language requirements for commerce and business: reform of the Charter of the French language

This article provides an overview of French language requirements in Quebec for commerce and business under the Charter of the French language (RLRQ c. C-11) (the French Charter) and the Regulation respecting the language of…more
 /  Administrative Law, Commercial Law & Contracts

Canadian Intellectual Property Office “Next Generation Patents” update and status as of May 13, 2025

On July 17, 2024, the Canadian Intellectual Property Office (CIPO) launched a new electronic system and portal, MyCIPO Patents, as part of its Next Generation Patents initiative. The launch has been fraught with difficulties,…more
 /  Administrative Law, Intellectual Property, Science, Computers, & Technology

Health Canada publishes Guide to the precision regulating authorities under the Food and Drugs Act

In March 2025,  Health Canada published a Guide to the precision regulating authorities under the Food and Drugs Act. The Guide sets out the principles, policies, considerations and standards that Health Canada should follow in…more
 /  Administrative Law, Health

Canadian Intellectual Property Office “Next Generation Patents” update and status as of April 10, 2025

On July 17, 2024, the Canadian Intellectual Property Office (CIPO) launched a new electronic system and portal, MyCIPO Patents, as part of its Next Generation Patents initiative. The launch has been fraught with difficulties,…more
 /  Administrative Law, Intellectual Property, Science, Computers, & Technology

Accelerating Canadian Plant Breeders’ Rights (PBR) applications with foreign Distinctness, Uniformity and Stability (DUS) test results

In Canada, Plant Breeders’ Rights (PBRs) provide breeders exclusive rights for up to 25 years for tree and vine varieties and 20 years for all other plant varieties, ensuring breeders can benefit from their innovations. To…more
 /  Agriculture, Intellectual Property, International Law & Trade

PMPRB announces Anie Perrault as acting Chairperson and releases latest expenditure report on private drug plan costs and utilization

On March 6, 2025, the Patented Medicine Prices Review Board (PMPRB) announced that Thomas Digby stepped down from his role as Chairperson of the PMPRB. Vice-Chairperson Anie Perrault is now serving as acting Chairperson until…more
 /  Administrative Law, Finance & Banking, Health

SCC to revisit “method of medical treatment” patent claims

This spring, the Supreme Court of Canada (SCC) will consider the scope of patentable subject-matter as it relates to “methods of medical treatment”…more
 /  Civil Procedure, Health, Intellectual Property
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