The Federal Court (FC) has upheld the validity of a patent concerning a biologic drug used to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder, in an infringement action under section 6 of
Patent term adjustment: Canada consults on proposed regulatory framework
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
The Ontario Superior Court dismisses a generic manufacturer’s claim for damages under section 8 of the PM(NOC) Regulations
The Ontario Superior Court (ONSC) has dismissed a claim for damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations (the Regulations) brought by Apotex Inc. (Apotex) for lost sales of its Apo-Atomoxetine
Supreme Court denies leave to appeal in generic Statute of Monopolies case
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
Pharma in Brief: The 2022 Year in Review
Does 2022 already seem like a blur? The Pharma in Brief team is here for you with a summary of some of 2022’s most significant legal and regulatory developments in the Canadian pharmaceutical space. We also flag what to watch
Federal Court of Appeal overturns judicial review decision in data protection dispute
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
2022 Guide to Canada’s Pharmaceutical Intellectual Property Regime
Our 2022 Guide to Canada’s Pharmaceutical Intellectual Property Regime is a convenient all-in-one reference to the important legal and regulatory regimes governing pharmaceuticals in Canada.
The Guide provides a detailed review of the key regimes, including:
- Data protection market exclusivity;
Pharma in Brief: The 2021 Year in Review
In this article, the Pharma in Brief team has curated and provided updates on the most significant topics we covered in 2021.
Introduction
In 2021, governments advanced major policy initiatives aimed at the COVID-19 pandemic and broader health priorities. These
Federal Court quashes NOC in dispute over Data Protection Provisions
The Federal Court has quashed a notice of compliance (NOC) issued to Médunik Canada (Médunik) for its amifampridine product, RUZURGI, over an issue concerning data protection for another amifampridine product.
The Minister provided no reasons for
Data protection upheld for subsequently approved combination drugs containing new chemical entities: Federal Court finds Minister of Health’s decision to deny generic ANDS filing is reasonable
Summary
On July 24, 2020, the Federal Court dismissed an application for judicial review brought by Natco Pharma (Canada) Inc. (Natco) in respect of a July 26, 2019 decision (Decision) by the Minister of Health (