Norton Rose Fulbright (LexBlog Canada)

In a world where generative AI is driving innovation and technology is outpacing legislation, there’s a lot for companies to consider to maintain operational effectiveness and minimize risk. To help provide some guidance, Norton Rose Fulbright Canada hosted its 2023 technology, privacy and cybersecurity virtual summit. Our leading lawyers were joined by prominent industry leaders...

In Sharp v. Autorité des marchés financiers, 2023 SCC 29, the Supreme Court of Canada recognized the transnational nature of modern securities regulation in holding there was a “real and substantial connection” between alleged perpetrators of a “pump-and-dump” scheme and Québec. This connection allowed the province’s Financial Markets Administrative Tribunal (FMAT) to assume jurisdiction over...

In recent months, the Federal Courts have twice upheld Health Canada’s findings as to what is, and is not, a natural health product. The Courts’ decisions provide insight into how natural health products are distinguished, under federal law, from cosmetics and from drugs subject to the Food and Drug Regulations.  These distinctions are important as...

On October 5, the Minister of Innovation, Science and Industry (ISED) wrote a letter to the Standing Committee on Industry and Technology proposing amendments to Artificial Intelligence and Data Act (AIDA), which was introduced as part of Bill C-27 in June 2022. Further information on AIDA can be found in our previous update. The letter...

On September 27, the Minister of Innovation, Science and Industry released a voluntary code of conduct specific to generative AI. This GenAI code follows the proposed Artificial Intelligence and Data Act (AIDA), which was introduced as part of Bill C-27 in June 2022 but will not likely be in force until 2025. Beyond risk mitigation,...

Canada’s Drug and Health Technology Agency (CADTH) has published its procedures for a new time-limited reimbursement recommendation category. This recommendation category is intended to help provide earlier access to new therapies for severe, rare, or debilitating conditions where there is an unmet medical need. The pathway includes mechanisms to revisit the clinical and economic evidence...

Norton Rose Fulbright Canada invites you to our annual technology, privacy and cybersecurity virtual summit. Navigating the evolving world of technology is not easy for companies today. From AI to effective company records management, privacy considerations, and cybersecurity breaches, there’s a lot to consider as businesses work to maximize operational effectiveness and minimize risk. Join...

The Federal Court has upheld a decision of the Minister of Health (Minister) that the new owner of a biosimilar new drug submission (NDS) could adopt the notice of allegation (NOA) served by its predecessor.  Consequently, the new owner was properly added as a defendant to an on-going action under subsection 6(1) of the Patented...

In a previous blog post, we covered the impact of Bill C-11 and how the proposed legislation would regulate social media and streaming companies in Canada. In spring 2023, Bill C-11 received Royal Assent, becoming the Online Streaming Act, and began amending the Broadcasting Act. This included the Canadian Radio-television and Telecommunications Commission (CRTC) developing...

On August 8, 2023, the Federal Court overturned Health Canada’s decision that a cannabis product, Edison Jolts, was to be classified as edible cannabis and not cannabis extract.   The Court found that Health Canada had breached the duty of procedural fairness by relying on a product classification factor in an internal guidance document that Health...

Beginning January 1, 2024, the Canadian Intellectual Property Office (CIPO) will implement the first substantial increases to its service fees since 2004. Many fees will increase by 25% of more, though some “low materiality fees” will remain capped at $150. Meanwhile, an increase to the employee cap for “small entity” status will increase the number...

On August 7, 2023, the Canadian Intellectual Property Office (CIPO) launched a consultation on proposed features of regulations on patent term adjustment (PTA) in Canada (the Consultation). The PTA system is intended to compensate patentees for “unreasonable delays” by CIPO in issuing a patent. The Consultation seeks feedback on proposals that would impact the length of...

On July 31, 2023, Health Canada published its updated Guidance on distinction between advertising and other activities for health products (the Distinction Guidance). The Distinction Guidance outlines the factors that contribute to rendering a message or activity promotional in nature. Promotional messages and activities are subject to the advertising provisions of the Food and Drugs...

The pan-Canadian Pharmaceutical Alliance (pCPA) has recently published a set of principles and conditions for a pCPA Temporary Access Process (pTAP) which will inform the negotiation process and potential product listing agreements (PLAs) for drug products following the Canada Drug and Health Technology Agency (CADTH) time-limited recommendation pathway.  CADTH Time-Limited Reimbursement...

On June 22, 2023, Canada’s federal government passed legislation (Bill C-47) introducing a system of general patent term adjustment (PTA). The provisions amending the Patent Act to introduce PTA passed without substantive amendment and are scheduled to come into force no later than January 1, 2025. Canada’s new PTA system is intended to compensate patentees...

On May 12, 2023, Health Canada announced the release of an updated version of the Guidance Document: Certificates of Supplementary Protection (CSP Guidance).  The CSP Guidance was revised to reflect amendments to the definition of “authorization for sale” in the Certificate of Supplementary Protection Regulations (CSP Regulations) and to reflect changes to Health Canada’s administrative...

Government institutions and businesses in Canada must soon comply with new legislation aimed at combatting forced labour and child labour or “modern slavery”. Bill S-211, an Act to enact the Fighting Against Forced Labour and Child Labour in Supply Chains Act and to amend the Customs Tariff (the Act), passed its third reading by the...

On April 27, 2023, the Supreme Court of Canada dismissed an application by Apotex Inc. and Apotex Pharmachem Inc. (Apotex) for leave to appeal from a decision of the Ontario Court of Appeal (ONCA), dismissing its claim for damages in the Ontario courts under the Statutes of Monopolies and other novel causes of action. In the Courts below, Apotex...

Children are generally recognized by both industry and government to be a vulnerable or special audience when it comes to advertising. On June 28, 2023, a new advertising code will be coming into effect as released by Ad Standards Canada. It is intended to expand upon legislative, regulatory, and self-regulatory regimes that already exist in...

On April 20, 2023, the federal government tabled legislation (Bill C-47) that would amend the Patent Act to bring, for the first time, a system of general patent term adjustment (PTA) into Canada. Canada is required under the Canada-United States-Mexico Agreement (CUSMA) to adopt a PTA system by 2025. The PTA system is intended to...

On April 26, 2023, the Office of the United States Trade Representative (USTR) released its 2023 Special 301 Report on intellectual property. The report keeps Canada on a Watch List of 29 U.S. trading partners that “merit bilateral attention to address underlying IP problems”.  The report is the USTR’s annual review of the global state of...

The Federal Court of Appeal (FCA) has allowed an appeal concerning induced infringement in an action under the Patented Medicines (Notice of Compliance) Regulations (Regulations). The FCA found that the Federal Court (FC) had erred by applying an elevated causation requirement. The FCA also rejected an appeal by the generic from the finding that the patent was...

On March 22, 2023, Canada’s federal government announced its first-ever National Strategy for Drugs for Rare Diseases, including an investment of up to $1.5 billion over three years to help increase drug access and affordability.  Investments made as part of the National Strategy The lion’s share of the federal government’s investment – up to $1.4...

In our previous update, we summarized key operational elements that businesses should be aware of under the proposed Consumer Privacy Protection Act (CPPA), and provided practical tips to help businesses comply with these new requirements. As currently drafted, the CPPA codifies a number of best practices and recommendations issued by the Office of the Privacy Commissioner of Canada...

When faced with a cross-border or multi-jurisdictional filing, it is important to understand the key attributes of the restructuring legislation in all applicable jurisdictions. Where Canadian assets, creditors and/or operations are involved, the Canadian Companies’ Creditors Arrangement Act (CCAA) provides a restructuring regime that can be beneficial to debtors and creditors. Below are a few...

Across the globe, the race is already underway among vehicle manufacturers to develop fully autonomous vehicles (AVs). AVs currently under development make sense of their surroundings and control vehicle operation through data gathered about the outside world.  Like other connected vehicles, AVs can also collect and use specific personal information about a driver (e.g., through...

The threshold for certain pre-closing net benefit reviews under the Investment Canada Act (ICA) and the threshold for a pre-closing merger notification under the Competition Act have been updated for 2023. For the second year in a row, the Minister of Innovation, Science and Economic Development has announced that the threshold for pre-closing merger notifications...

Our global restructuring team has released its quarterly International Restructuring Newswire. Our new issue features articles from Canada, Germany, the US, France and China/Hong Kong to help you stay current on recent developments in restructurings in various jurisdictions around the globe.

Health Canada has launched a consultation on proposed amendments to the Food and Drug Regulations and Medical Devices Regulations (the Regulatory Amendments). Consultation on the Regulatory Amendments, which have been published in the Canada Gazette, Part 1, is open until March 27, 2023. The Regulatory Amendments build upon the regulatory flexibilities introduced in the Interim...

The Federal Court of Appeal (FCA) has overturned a decision of the Federal Court (FC) that found the Minister of Health’s (Minister) analysis of the data protection provisions of the Food and Drug Regulations unreasonable. The FCA restored the Minister’s decision granting an NOC to Médunik Canada (Médunik) for its amifampridine product, RUZURGI. Background Catalyst...