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Launch of pCPA temporary access process

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On April 5, 2024, the pan-Canadian Pharmaceutical Alliance (pCPA) announced that it was ready to accept drugs through the pCPA Temporary Access Process (pTAP) (see our previous article regarding the consultation)....more

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CADTH proposals to enhance drug review processes

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The Canadian Agency for Drugs and Technologies in Health (CADTH) held consultations which ended April 14, 2022 on two new proposals: (1) a proposed process for non-sponsored reimbursement reviews and (2) a streamlined process...more

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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

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New CADTH Report on Health Technology Trends in 2021

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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

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CADTH harmonizes Drug Reimbursement Review Process

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On September 30, 2020, the Canadian Agency for Drugs and Technologies in Health (CADTH) announced the launch of new Procedures for CADTH Drug Reimbursement Reviews (updated October 29, 2020), which harmonize procedures under...more

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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

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Update on biosimilars in Canada – October 2019

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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 June 2018....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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Rx IP Update - June 2019

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National Pharmacare Update: Publication of the final report of the Advisory Council - On June 12, 2019, the Minister of Health tabled the final report, A Prescription for Canada: Achieving Pharmacare for All, from the...more

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Rx IP Update - March 2019

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Federal Court finds invalidity allegations relating to patent for metformin formulations not justified - On March 8, 2019, Justice Fothergill granted Valeant Canada’s application for an order prohibiting the Minister of...more

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Health Canada and CADTH launch new initiative to provide early parallel scientific advice

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On February 28, 2019, Health Canada released a Notice to Industry announcing the Early Parallel Scientific Advice initiative. Currently, Health Canada and the Canadian Agency for Drugs and Technologies in Health (CADTH) offer...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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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

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Rx IP Update - July 2018

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IN THIS ISSUE: - Shire’s VYVANSE patent valid, prohibition order issued - First judicial consideration of Vanessa’s Law: Health Canada must disclose requested clinical trial data - PMPRB News - Patented Medicine...more

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Rx IP Update - 2018 Mid-Year Highlights in Canadian Life Sciences IP

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In this special mid-year edition, we take a look at the major highlights in Canadian life sciences and intellectual property law that we have reported on over the last six months, starting with one of the most closely-watched...more

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Update on biosimilars - June 2018

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Further to our update in December 2017, here, below is a mid-year update on biosimilar approvals, litigation and other news. Approvals of biosimilars: In the first half of 2018, Health Canada approved three biosimilars...more

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Rx IP Update - April 2018

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Standing Committee on Health proposes National Pharmacare program, modifications to prescription and generic drug pricing - While common among member countries of the Organisation for Economic Co-operation and Development...more

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Rx IP Update - February 2018

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Federal Court of Appeal dismisses Teva’s levofloxacin damages appeal - On February 8, 2018, the Federal Court of Appeal issued public reasons for its decision dismissing Teva’s appeal relating to the damages and costs...more

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Rx IP Update - July 2017

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Supreme Court of Canada strikes down "promise doctrine", upholds AstraZeneca’s NEXIUM patent as useful - As previously reported, on June 30, 2017, the Supreme Court of Canada granted AstraZeneca’s appeal in the NEXIUM...more

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Rx IP Update - December 2016

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Janssen seeks leave to appeal to SCC regarding FCA decision upholding Minister of Health’s decisions relating to administrative drug submissions - As reported previously, on October 12, 2016, the Federal Court of Appeal...more

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