News & Analysis as of

Canada Data Protection Pharmaceutical Industry

Smart & Biggar

Federal Court of Appeal dismisses appeal of SPRAVATO “innovative drug” decision

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On November 10, 2021, the Minister of Health refused to reassess its decision that Janssen’s esketamine hydrochloride product (SPRAVATO) was not an “innovative drug” and therefore not entitled to data protection. As...more

Smart & Biggar

2023 Highlights in Canadian Life Sciences IP and Regulatory Law

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Eli Lilly v Teva, Pharmascience, Riva, Apotex, Mylan (tadalafil, CIALIS) – Following a summary trial, Lilly’s infringement actions were dismissed: composition claims directed to “a physiologically acceptable salt” of...more

Smart & Biggar

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

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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

Smart & Biggar

Federal Court of Appeal restores Minister of Health’s decision to grant RUZURGI NOC despite FIRDAPSE data protection

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As previously reported, the Federal Court quashed a second decision by the Minister of Health (Minister) to issue a Notice of Compliance (NOC) to Médunik Canada (Médunik) for its amifampridine product, RUZURGI, following the...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 sets aside decision by the Minister of Health to issue RUZURGI NOC for the second time

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On March 10, 2022, for the second time, the Federal Court set aside a decision by the Minister of Health (Minister) to issue Médunik Canada (Médunik) a Notice of Compliance (NOC) for its amifampridine product, RUZURGI,...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

Federal Court of Appeal confirms Janssen’s SPRAVATO not eligible for data protection

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Update: On November 10, 2021, the Minister rejected Janssen’s second request for data protection for SPRAVATO, which was submitted following the coming into force of the Canada-United States-Mexico Agreement (CUSMA). The...more

Smart & Biggar

2021 Mid-Year Highlights in Canadian Life Sciences IP and Regulatory Law

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In the first half of 2021, 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

Smart & Biggar

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 denies stay of decision issuing NOC for RUZURGI

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On September 30, 2020, the Federal Court dismissed an application by Catalyst Pharmaceuticals Inc (Catalyst) and KYE Pharmaceuticals Inc (KYE) (collectively, the applicants) for an interlocutory injunction to stay the...more

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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 reasonable Health Canada’s decision that enantiomer of previously approved drug not entitled to data...

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Update: On July 12, 2021, the Federal Court of Appeal dismissed Janssen’s appeal from Zinn J.’s decision: Janssen Inc v Attorney General of Canada (Minister of Health), 2021 FCA 137 (see article here). On September 18,...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

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

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Rx IP Update - August 2018

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Teva succeeds in section 8 bortezomib action; infringement counterclaim dismissed - On July 18, 2018, Justice Locke of the Federal Court granted Teva’s claim for compensation under section 8 of the Patented Medicines...more

Blake, Cassels & Graydon LLP

Trends in Life Sciences: From Data Protection to Drug Pricing

As part of our series on current trends across different industries, we explore current changes taking place in the life sciences field. Privacy & Data Protection - Personal information protection and compliance...more

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