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Canada Intellectual Property Protection Pharmaceutical Industry

Smart & Biggar

2025 mid-year highlights in Canadian life sciences IP and regulatory law

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In the first half of 2025, the Rx IP Update team reported on a number of developments in Canadian life sciences IP and regulatory law. Below are our top stories....more

Smart & Biggar

SCC to revisit “method of medical treatment” patent claims

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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

Smart & Biggar

Canadian patent law 2024: a year in review

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2024 was an active year in Canadian patent law, with the Federal Court issuing several decisions on the merits regarding invalidity and/or infringement. The courts also considered issues of the regulation of patent agents,...more

Bennett Jones LLP

Competition Tribunal Issues First-of-Its-Kind Decision in Private Abuse of Dominance Case Against Major Pharma Manufacturer

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On December 17, 2024, the Competition Tribunal (the Tribunal) issued reasons for its decision to dismiss an application for leave to bring a private abuse of dominance action against a major pharmaceutical manufacturer. JAMP...more

Smart & Biggar

[Webinar] Cross-border IP strategies for IP owners and litigators - September 18th, 2:00 pm PDT

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Explore skinny labelling & obviousness in Canada and Australia - If you are an intellectual property (IP) owner, a litigator or an in-house legal professional managing IP litigation in multiple jurisdictions, don’t miss...more

Smart & Biggar

[Webinar] Cross-border IP strategies for IP owners and litigators - September 12th, 12:00 pm GMT

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Explore skinny labelling & obviousness in Canada and Australia - If you are an intellectual property (IP) owner, a litigator or an in-house legal professional managing IP litigation in multiple jurisdictions, don’t miss...more

Jones Day

Canadian Drug Importation May Undermine Intellectual Property Protection

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The Situation: Earlier this year, Florida became the first state to receive authorization for its Section 804 Importation Program ("SIP") from the U.S. Food and Drug Administration ("FDA"). This initial step toward the legal...more

Smart & Biggar

BYOOVIZ is confusing with BEOVU: Federal Court finds violation of Novartis’ trademark rights

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In a decision dated January 24, 2024, Justice Pallotta allowed Novartis’ application, finding that Biogen and Samsung’s use of the trademark BYOOVIZ in association with an ophthalmologic drug violates Novartis’ rights in its...more

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Obviousness of Lilly’s tadalafil (CIALIS) dosage form patent stands

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The Federal Court of Appeal has dismissed Lilly’s appeals of judgments that held Canadian Patent No. 2,371,684 (the 684 patent) claims invalid. The decision, Eli Lilly v Apotex, 2023 FCA 125, was issued on June 2, 2023....more

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Update on biosimilars in Canada – March 2023

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In this article, we provide a further update on developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory, market access and competition) since our last update in June 2022....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

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Health Canada releases its Health Product Highlights, Annual Drug Submission Performance Reports and OPML Statistical Report

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Health Canada released a number of reports over the summer: - Annual Health Product Highlights for 2021, which provides an overview of new health products, including drugs and medical devices, that Health Canada approved...more

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Merck’s JANUVIA crystalline monohydrate DHP salt patent found valid

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In a patent infringement action brought under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations, in relation to sitagliptin phosphate monohydrate (Merck’s JANUVIA), Justice Furlanetto of the Federal...more

Smart & Biggar

2021 Highlights in Canadian Life Sciences IP and Regulatory Law

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In the fall of 2021, the Rx IP Update team celebrated its 20thyear of monthly updates on Canadian life sciences IP and regulatory law. Below are highlights from our team’s 2021 updates...more

Smart & Biggar

Update on biosimilars in Canada - October 2021

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Since our last update in April 2021, there have been many developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory and market access). Biosimilars approved in Canada - Health...more

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Plaintiff cannot amend Statement of Claim more than 45 days after receipt of NOAs to plead infringement of further patents.

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On May 5, 2021, the Federal Court dismissed a motion by Biomarin Pharmaceutical Inc (Biomarin) to amend its Statement of Claim to allege infringement of two patents that had not been asserted within the 45-day deadline...more

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Federal Court quashes RUZURGI NOC and returns matter to the Minister of Health for redetermination

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Update: On redetermination, Health Canada issued a new notice of compliance for RUZURGI on June 24, 2021. Catalyst and Kye have sought judicial review (Court File No T-1047-21). On May 31, 2021, the Federal Court quashed a...more

Smart & Biggar

Federal Court of Appeal Upholds Decision Allowing Taro to Plead Validity Attacks beyond Notice of Allegation

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On June 9, 2021, the Federal Court of Appeal (FCA), following grant of leave to hear Sunovion’s appeal, dismissed Sunovion’s appeal from a Federal Court (FC) decision of Furlanetto J. (2021 FC 37) granting Taro leave to amend...more

Smart & Biggar

Update on biosimilars in Canada - April 2021

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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 August...more

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Transition measures released for Interim Order for COVID-19 drugs

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As previously reported... on September 16, 2020, Canada’s Minister of Health approved an Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (the ISAD Interim Order), which...more

Smart & Biggar

COVID-19 Update: Further extension of Canadian Intellectual Property Office deadlines to August 31, 2020

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We recently reported that, in view of the ongoing COVID-19 disruption, the Canadian Intellectual Property Office (CIPO) has further extended patent, trademark, and industrial design deadlines until Monday August 24, 2020, and...more

Smart & Biggar

Federal Court of Appeal sets aside Order for common trial across multiple actions under PMNOC Regulations

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An interesting procedural question under the amended Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) is the extent to which separate actions against multiple generic manufacturers can proceed...more

Herbert Smith Freehills Kramer

USMCA: Implications for Biologics and Innovation

On Wednesday, President Donald Trump signed the United States-Mexico-Canada Agreement (USMCA) into law. The USMCA contains a number of key and last-minute revisions that implicate biologic medicines and patent obligations. ...more

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Amendments to USMCA remove 10-year data protection requirement for biologics

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On December 10, 2019, the parties to the Canada-United States-Mexico Agreement (commonly referred to as USMCA, or the new NAFTA) signed amendments (see summary of revised outcomes) to the Agreement. The original USMCA was...more

Goodwin

10-Year Data Exclusivity for Biologics Removed from Final USMCA Agreement

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On December 10, 2019, the House Democrats and Trump administration reached an agreement on the United States-Mexico-Canada Agreement (USMCA), which would replace the North American Free Trade Agreement (NAFTA) of 1994....more

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