Popular, Canada, Pharmaceutical Industry

Update on biosimilars in Canada – June 2025

Smart & Biggar on 6/25/2025

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

Supreme Court Approves Constitutionality of Multi-Crown Class Action

Bennett Jones LLP on 5/23/2025

The Supreme Court of Canada (SCC) has endorsed the constitutionality of British Columbia (BC) legislation empowering the province to seek recovery of opioid epidemic healthcare costs in a proposed class action brought on...more

2024 mid-year highlights in Canadian life sciences IP and regulatory law

Smart & Biggar on 7/10/2024

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

2023 Mid-Year Highlights in Canadian Life Sciences IP and Regulatory Law

Smart & Biggar on 7/18/2023

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

2022 Highlights in Canadian Life Sciences IP and Regulatory Law

Smart & Biggar on 1/5/2023

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

2022 mid-year highlights in Canadian life sciences IP and regulatory law

Smart & Biggar on 7/25/2022

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

Quarterly Cartel Catch-Up: Recent Developments in Criminal Antitrust for Busy Corporate Counsel - Q1 2022

Morrison & Foerster LLP on 5/10/2022

Since the last edition of the QCC, there has been a series of dramatic developments in the criminal antitrust enforcement space in the U.S. from the Department of Justice’s Antitrust Division (Division)....more

Federal Court upholds Health Canada’s strict interpretation of patent listing deadline for KEYTRUDA formulation patent

Smart & Biggar on 4/28/2021

Update: Merck’s appeal was dismissed. The Federal Court recently dismissed Merck’s application for judicial review of Health Canada’s refusal to add Canadian Patent No. 2,830,806 (806 Patent) to the Patent Register, holding...more

New CADTH Report on Health Technology Trends in 2021

Smart & Biggar on 3/30/2021

The Canadian Agency for Drugs and Technologies in Health (CADTH) published an interesting new report on January 29, 2021 about Health Technology Trends to Watch. The report identifies the following list of emerging trends...more

2020 Highlights in Canadian Life Sciences IP and Regulatory Law

Smart & Biggar on 1/5/2021

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

Update on biosimilars in Canada – August 2020

Smart & Biggar on 8/27/2020

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 October...more

Biosimilars Approvals: Nepexto Receives European Marketing Authorization, Ziextenzo and Riximyo Receive Health Canada Approval

Goodwin on 6/10/2020

Last week, Lupin and Mylan announced that the European Commission had granted marketing authorization for their biosimilar Nepexto (etanercept) for all indications of the reference product. The marketing authorization follows...more

Seedlings’ LifeCard patent found invalid and not infringed by Pfizer’s EpiPen

Smart & Biggar on 2/6/2020

Update: On July 28, 2021, the Federal Court of Appeal dismissed Seedling’s appeal from Justice Grammond’s decision: Seedlings Life Science Ventures, LLC v Pfizer Canada ULC, 2021 FCA 154 (see article here). On January 2,...more

2019 Highlights in Canadian Life Sciences IP and Regulatory Law

Smart & Biggar on 1/10/2020

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

FDA Issues Proposed Rule and Draft Guidance on Drug Importation

King & Spalding on 1/7/2020

In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more

Project Orbis enables concurrent regulatory approval of LENVIMA and KEYTRUDA combination therapy in Canada, U.S. and Australia

Smart & Biggar on 11/8/2019

On September 17, 2019, the combination therapy of Eisai’s LENVIMA (lenvatinib) and Merck’s KEYTRUDA (pembrolizumab) for the treatment of advanced endometrial carcinoma received simultaneous approvals by Health Canada, the...more

Data Privacy + Cybersecurity Insider - July 2019

Robinson & Cole LLP on 7/5/2019

DHS Warns Businesses of Risk of Iranian-Backed Wiper Malware Attacks - The tension with Iran has generally increased, and it has been reported that the U.S. has launched a cyber-attack against Iran. In retaliation, the risk...more

Biosimilar Regulatory Submission Updates: Europe, U.S., Japan, Canada

Goodwin on 6/6/2018

Several biopharmaceutical developers recently announced significant regulatory submission activity in connection with biosimilar products in their pipelines. In addition to yesterday’s news about the U.S. FDA’s approval of...more

The World in US Courts: Orrick's Quarterly Review of Decisions Applying US Law to Global Business and Cross-Border Activities

Orrick, Herrington & Sutcliffe LLP on 11/25/2016

Alien Tort Statute (ATS)/Torture Victims Protection Act (TVPA)/Anti-Terrorism Act (ATA) - District Court Dismisses ATS Claim Where Alleged Conduct in US Was Not Directly Linked to Injuries Claimed in Other Countries - ...more

The Top 5 Trends in Canadian Intellectual Property Law for 2015

Bennett Jones LLP on 3/4/2015

Last year promised significant changes in Canadian IP law; some of which will be realized in 2015. As the first quarter draws to a close, this year’s trends in IP law are emerging. Canada’s international trade negotiations...more

Today's Popular Updates › Canada › Pharmaceutical Industry

"My best business intelligence, in one easy email…"