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Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
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IS THE A IN ANDA BEGINNING TO MEAN ANTITRUST?
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
The Federal Court of Appeal recently affirmed a trial decision relating to two competing patents over Gilead’s SOVALDI (sofosbuvir). In the trial decision, as previously reported, the Court declared Idenix’s Patent No....more
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
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