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Canada Patent Validity Patent Litigation

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Federal Court of Appeal affirms paliperidone palmitate claims are not unpatentable methods of medical treatment

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In a 2022 decision involving Janssen and Pharmascience, the Federal Court found that the claims of Canadian Patent No. 2,655,335 (335 patent, relating to paliperidone palmitate (Janssen’s INVEGA SUSTENNA)) were not invalid...more

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Supreme Court of Canada denies Pharmascience leave to appeal decision upholding the validity of two patents relating to ELIQUIS

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On March 30, 2023, the Supreme Court of Canada dismissed Pharmascience’s application for leave to appeal (Docket No. 40400) a decision of the Federal Court of Appeal (FCA) upholding the validity of two patents relating to...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 of Appeal upholds validity of two patents relating to ELIQUIS

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On August 4, 2022, the Federal Court of Appeal (FCA) dismissed Pharmascience’s appeal of a Federal Court decision upholding the validity of Canadian Patent Nos. 2,461,202 (the 202 patent) and 2,791,171 (the 171 patent)...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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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

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Federal Court of Appeal upholds validity of glatiramer acetate patent

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The Federal Court of Appeal (FCA) dismissed an appeal by Pharmascience from a decision of the Federal Court... which found Canadian Patent No. 2,760,802 (802 Patent) valid and infringed by Pharmascience’s proposed glatiramer...more

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Supreme Court of Canada denies leave regarding lisdexamfetamine patent decision

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As previously reported, Apotex sought leave to appeal a decision of the Federal Court of Appeal (2021 FCA 52) affirming a Federal Court decision finding that the claims of a patent relating to lisdexamfetamine (Shire’s...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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Apotex seeks leave to appeal lisdexamfetamine patent decision

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As previously reported, the Federal Court of Appeal dismissed Apotex’s appeal from a decision holding that the claims of a patent relating to lisdexamfetamine (Shire’s VYVANSE) were valid and prohibiting the Minister of...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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Federal Court of Appeal upholds Federal Court decision finding Shire’s VYVANSE patent valid

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Update: On October 7, 2021, the Supreme Court of Canada denied Apotex’s leave to appeal (Apotex v Shire, Docket No. 39662). The Federal Court of Appeal (FCA) recently dismissed an appeal by Apotex from a decision of the...more

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Protecting innovations through patent due diligence and FTO analysis

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Innovations that arise in competitive markets with a well-developed and rapidly evolving intellectual property space often integrate several pre-existing technologies from various scientific and engineering disciplines. If...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 finds Eli Lilly’s tadalafil dosage form and process patents invalid

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UPDATE: On September 30, 2020, Eli Lilly appealed both decisions by Justice St-Louis: Eli Lilly v Apotex (A-234-20 and A-239-20); Eli Lilly v Pharmascience and Riva (A-236-20); Eli Lilly v Mylan (A-237-20); and Eli Lilly v...more

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Double Patenting: A comparative guide between U.S. & Canadian practice

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Double patenting has become a common challenge to patent validity in Canada since the decision rendered by the Supreme Court of Canada in Whirlpool Corp. v Camco Inc in 2000. The Canadian double patenting doctrine is similar...more

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Federal Court upholds validity of Janssen’s paliperidone palmitate patent

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On May 5, 2020, Manson J. of the Federal Court issued the second decision on the merits under the amended Patented Medicines (Notice of Compliance Regulations). The Court upheld the validity of Janssen’s patent for...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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Year-end Round-up: Notable Canadian Patent Cases of 2018

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Earlier this month we published an exhaustive review of the life sciences and regulatory cases in the Canadian courts, and decisions on the merits for the year are summarized in our in our Rx IP Update 2018 Highlights in...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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Top 5 reasons to consider patent litigation in Canada now

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Canada has historically been a much less active jurisdiction for patent litigation compared to the United States, which can be explained in part by the simple fact that the United States’ market is almost 10 times the size of...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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Apotex’s Infringement of AstraZeneca’s Omeprazole Formulation Patent Upheld

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The Federal Court of Appeal, in a unanimous decision released on January 12, 2017 (2017 FCA 9), has affirmed the validity of AstraZeneca’s Patent No. 1,292,693. The patent covered AstraZeneca’s successful product, LOSEC, for...more

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