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Patent Validity PMNOC Regulations

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Boehringer Ingelheim succeeds in nintedanib PMNOC action against JAMP

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In a public decision dated August 8, 2024, Justice Furlanetto of the Federal Court found Boehringer Ingelheim’s Canadian Patent No. 2,591,083 (the 083 patent) valid and infringed by JAMP in an action under the Patented...more

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Federal Court upholds validity of patent relating to paliperidone palmitate

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On August 23, 2022, the Federal Court issued its public judgment and reasons in two actions under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (the “Regulations”) relating to paliperidone...more

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Federal Court finds Janssen’s macitentan combination therapy patent valid

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On May 31, 2022, the Federal Court released a decision by Justice Pallotta in a patent infringement action pursuant to subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations in relation to macitentan...more

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PM(NOC) Regulations: Fourth year following major amendments

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September 21, 2021 marked the fourth anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the fourth year...more

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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

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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

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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

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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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Amended PMNOC Regulations: First Anniversary Update

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As previously reported, the amended Patented Medicines (Notice of Compliance) Regulations (“Regulations”) came into force on September 21, 2017, heralding significant changes to the landscape for pharmaceutical companies in...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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New Use Patent for Janssen’s REMICADE valid and infringed by Hospira’s biosimilar INFLECTRA

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On March 7, 2018, the Federal Court upheld the validity of Kennedy’s patent for a use of infliximab (Janssen’s REMICADE) (Patent No. 2,261,630 [the “630 patent”]), and granted Kennedy’s counterclaim that Hospira’s biosimilar...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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