News & Analysis as of

Health Canada Pharmaceutical Patents Patent Act

Smart & Biggar

PMPRB update: Revised compliance timelines for grandfathered and gap medicines and proposed regulatory amendments directed to CSPs

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Revised compliance timelines for Grandfathered and Gap medicines - On April 16, 2021, in view of COVID-19, the Patented Medicine Prices Review Board (PMPRB) reversed its position on compliance timelines for Grandfathered...more

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Federal Court of Appeal finds Minister of Health’s refusal to grant a CSP for SHINGRIX is reasonable

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In the first appellate decision relating to Certificates of Supplementary Protection (CSPs), the Federal Court of Appeal has allowed the appeal of the Minister of Health (the Minister), setting aside the lower court judgment....more

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Innovators challenge final PMPRB Guidelines in new Federal Court application

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On November 23, 2020, Innovative Medicines Canada (IMC) and a number of research-based pharmaceutical companies commenced an application for judicial review (T-1419-20) of the final Patented Medicine Prices Review Board...more

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Federal Court releases decision on validity of the Amending Regulations of the Patented Medicines Regulations

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UPDATE: See July 15, 2020 article here describing the decision in more detail. On September 10, 2020, the applicants (Innovative Medicines Canada and the company applicants) appealed Justice Manson’s decision (A-215-20). On...more

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Action under amended PMNOC Regulations not rendered moot by patent expiry

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On May 22, 2020, the Federal Court held that an action under the amended Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) relating to saxagliptin (ONGLYZA) would not be rendered moot by the relevant...more

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Rx IP Update - July 2019

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Federal Court of Appeal requires PMPRB to re-determine whether patent ‘pertains to’ Galderma’s DIFFERIN - On June 28, 2019, the Federal Court of Appeal granted the appeal of the Patented Medicine Prices Review Board (PMPRB...more

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2018 Highlights in Canadian Life Sciences IP

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In 2018 we reported on a number of developments in life sciences IP and regulatory law. Our most-read articles were: #1 a June update on biosimilars (authored by Urszula Wojtyra); #2 a “live” summary chart of Vanessa’s Law...more

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Standing Committee on Health proposes National Pharmacare program, modifications to prescription and generic drug pricing

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While common among member countries of the Organisation for Economic Co-operation and Development (OECD), Canada does not have a national pharmacare program, i.e. a single system of public insurance coverage for prescription...more

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