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Smart & Biggar

Update on biosimilars in Canada – June 2025

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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

Smart & Biggar

2022 Highlights in Canadian Life Sciences IP and Regulatory Law

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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

Smart & Biggar

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

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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

Smart & Biggar

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

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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

Smart & Biggar

2020 Highlights in Canadian Life Sciences IP and Regulatory Law

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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

Smart & Biggar

Federal Court finds Eli Lilly’s tadalafil dosage form and process patents invalid

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UPDATE: On September 30, 2020, Eli Lilly appealed both decisions by Justice St-Louis: Eli Lilly v Apotex (A-234-20 and A-239-20); Eli Lilly v Pharmascience and Riva (A-236-20); Eli Lilly v Mylan (A-237-20); and Eli Lilly v...more

Smart & Biggar

Health Canada reasonable in finding Natco’s indirect comparison to GENVOYA triggered data protection

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On July 24, 2020, Justice McHaffie of the Federal Court dismissed Natco’s application for judicial review, finding that Health Canada’s refusal to accept Natco’s Abbreviated New Drug Submission (ANDS) for its tenofovir...more

Smart & Biggar

Update on biosimilars in Canada – August 2020

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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

Smart & Biggar

Federal Court dismisses ViiV’s action for patent infringement re: Gilead’s BIKTARVY following summary trial on claim construction

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Update: see our article here regarding the dismissal of ViiV’s appeal. On April 6, 2020, the Federal Court granted Gilead’s motion for summary trial and dismissed ViiV’s action: ViiV Healthcare Company v Gilead Sciences...more

Smart & Biggar

First decision under amended PMNOC Regulations: Federal Court finds Amgen’s filgrastim patent obvious

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UPDATE: On November 3, 2020, the Federal Court of Appeal dismissed Amgen’s appeal. See our article here. On April 16, 2020, Justice Southcott of the Federal Court issued the first decision under the amended Patented...more

Smart & Biggar

Federal Court of Appeal dismisses Pfizer’s appeal of interlocutory decision in pregabalin section 8 case: infringement not a...

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UPDATE: On December 10, 2020, the Supreme Court of Canada dismissed Pfizer’s application for leave to appeal (Docket No. 39150)... As previously reported, Justice O’Reilly of the Federal Court granted Pharmascience’s...more

International Lawyers Network

Pandemics And Emergency Access To Patented Technology In Canada

Canada’s COVID-19 Emergency Response Act came into force on March 25, 2020. Perhaps overlooked amongst emergency relief, health care and financial effects is Part 12 of the Act which makes changes to the Patent Act. Why...more

Smart & Biggar

Federal Court maintains $100M+ award in cefaclor infringement damages reconsideration decision

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On November 20, 2019, the Federal Court (FC) issued its reconsideration decision on the quantum of damages owed by Apotex for its infringement of eight Eli Lilly process patents related to the antibiotic cefaclor:  Eli Lilly...more

Smart & Biggar

2019 Highlights in Canadian Life Sciences IP and Regulatory Law

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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

Smart & Biggar

Federal Court of Appeal confirms obviousness finding in section 8 bortezomib action against Teva

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As previously reported, the Federal Court granted Teva’s claim for compensation under section 8 of the Patented Medicines (Notice of Compliance) Regulations relating to Teva’s bortezomib product (Janssen markets bortezomib as...more

Smart & Biggar

Amgen not precluded by invalidity decision under pre-amended PMNOC Regulations from litigating same patent under amended...

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On October 4, 2019, the Federal Court of Appeal dismissed Pfizer’s appeal of its failed motion to dismiss Amgen’s action under section 6 of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) for a...more

Fenwick & West LLP

Key IP Takeaways from the United States-Mexico-Canada Agreement

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On September 30, 2018, the United States, Mexico and Canada reached a trade agreement to supersede the North American Free Trade Agreement. The aptly named United States-Mexico-Canada Agreement includes intellectual property...more

Smart & Biggar

Supreme Court of Canada strikes down "promise doctrine", upholds AstraZeneca’s NEXIUM patent as useful

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The Supreme Court of Canada today delivered an important and highly anticipated decision, AstraZeneca Canada Inc v Apotex Inc (2017 SCC 36), by rejecting the “promise doctrine” and clarifying the requirement for patent...more

Blake, Cassels & Graydon LLP

More Than a Pinky Promise: Recent Developments to the Promise Doctrine in Patent Law

Don’t want your patent invalidated? Then you should diligently vet any promissory language in that patent because, as the following cases illustrate, such language raises significant risks of patent invalidation on the basis...more

Bennett Jones LLP

The Top 5 Trends in Canadian Intellectual Property Law for 2015

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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

McDonnell Boehnen Hulbert & Berghoff LLP

How the Kirtsaeng Decision Could Ruin the U.S. Branded Drug Industry

The Constitution gives Congress the power to grant copyright and patent protection in the same part of Article I, specifically in Section 8, Clause 8...more

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