News & Analysis as of

Drug Approvals PMNOC Regulations

Smart & Biggar

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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Biosimilars: Comparison chart between Canada, US and Europe

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As more biosimilars continue to be approved across the world, it is helpful to compare the applicable regimes across major jurisdictions. We have collaborated with Brian Coggio of Fish & Richardson, and Mary Foord-Weston and...more

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Rx IP Update - January 2019

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IN THIS ISSUE: -Abbott/Takeda permitted to plead that a third party’s patent would be infringed by alleged non-infringing alternative - PMPRB News: **PMPRB issues a Notice of Hearing for allegations of excessive...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 - 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 - January 2018

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Apotex granted damages from contract research organization for delayed FDA approval of two products - Appeal of summary dismissal under PMNOC Regulations: dismissal order stayed...more

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Rx IP Update - December 2017

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PMPRB News - PMPRB releases scoping paper relating to proposed amended Regulations - As previously reported, on December 2, 2017, Canada’s Governor-in-Council published proposed Regulations Amending the Patented...more

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Rx IP Update - November 2017

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Canada’s new linkage litigation scheme: A comparison to Hatch-Waxman - The September 21, 2017 amendments to the Patented Medicines (Notice of Compliance) Regulations (see our article here) introduced a new scheme for...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 - May 2017

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Federal Court of Appeal finds that Apotex did not fail to mitigate its damages in relation to Apo-Trazodone drug submission - On April 6, 2017, the Federal Court of Appeal overturned the Federal Court’s finding that...more

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Rx IP Update - April 2017

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Teva awarded section 8 damages regarding pregabalin and olanzapine - On March 30 and April 4, 2017, the Federal Court released two decisions on the merits under section 8 of the Patented Medicines (Notice of...more

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