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Canada Section 8

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Apotex’s section 8 claim for Apo-Atomoxetine dismissed

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On March 30, 2023, the Ontario Superior Court of Justice dismissed Apotex’s claim under section 8 of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) relating to Apo-Atomoxetine (Lilly’s...more

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2022 Highlights in Canadian Life Sciences IP and Regulatory Law

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Below are highlights from the Rx IP’s team’s 2022 updates (see also our Top 10 Rx IP Update Reads of 2022): Contents: 1. Patent decisions on the merits 2. PMNOC Regulations: Fifth-year anniversary of major amendments,...more

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Federal Court rejects pre-trial determination of a question of law about the nature of the section 8 but-for world

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As previously reported, the Federal Court found Janssen’s Canadian Patent No. 2,661,422 (422 patent) – which relates to treatment of prostate cancer in humans by co-administration of abiraterone acetate (Janssen’s ZYTIGA) and...more

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Federal Court rejects trial of common issues and allows pleadings amendment re: supply disruptions in abiraterone acetate amended...

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As previously reported, the Federal Court found Janssen’s Canadian Patent No. 2,661,422 (“422 patent”) – which relates to treatment of prostate cancer in humans by co-administration of abiraterone acetate (marketed by Janssen...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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Supreme Court denies leave of interlocutory decision in pregabalin section 8 case

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On December 10, 2020, the Supreme Court of Canada dismissed Pfizer’s application for leave to appeal (Docket No. 39150) a decision upholding an interlocutory decision on a question relevant to the assessment of section 8...more

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2020 Mid-Year Highlights in Canadian Life Sciences IP and Regulatory Law

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In the first half of 2020, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review the following top developments...more

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Supreme Court of Canada Leave Applications - May 2020

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UPDATE: UPDATE: On December 10, 2020, the Supreme Court of Canada dismissed Pfizer’s application for leave to appeal (Docket No. 39150) (see article here). Pfizer seeks leave in pregabalin section 8 case As previously...more

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Federal Court of Appeal dismisses Pfizer’s appeal of interlocutory decision in pregabalin section 8 case: infringement not a...

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UPDATE: On December 10, 2020, the Supreme Court of Canada dismissed Pfizer’s application for leave to appeal (Docket No. 39150)... As previously reported, Justice O’Reilly of the Federal Court granted Pharmascience’s...more

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Millennium and Janssen seek leave from Supreme Court of Canada in section 8 bortezomib case

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As previously reported, the Federal Court of Appeal (FCA) dismissed Millennium Pharmaceuticals and Janssen’s appeal from a decision granting Teva’s claim for compensation under section 8 of the Patented Medicines (Notice of...more

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2019 Highlights in Canadian Life Sciences IP and Regulatory Law

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In 2019, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: 1) PMPRB: Amendments to Regulations will come into force July 1, 2020, court...more

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Federal Court of Appeal confirms obviousness finding in section 8 bortezomib action against Teva

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As previously reported, the Federal Court granted Teva’s claim for compensation under section 8 of the Patented Medicines (Notice of Compliance) Regulations relating to Teva’s bortezomib product (Janssen markets bortezomib as...more

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Federal Court issues two interlocutory decisions in section 8 pregabalin case

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On October 10, 2019, Justice O’Reilly of the Federal Court issued two decisions relating to Pharmascience’s claim for section 8 damages under the pre-amended Patented Medicines (Notice of Compliance) Regulations for its...more

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2019 Mid-Year Highlights in Canadian Life Sciences IP

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Below are the major highlights in Canadian life sciences intellectual property and regulatory law that we have reported on in the first half of 2019....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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Abbott/Takeda permitted to plead that a third party’s patent would be infringed by alleged non-infringing alternative

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On the eve of a section 8 trial, the Ontario Superior Court granted Abbott and Takeda leave to amend their pleadings to assert that Apotex’s purported non-infringing alternative (NIA) was unlawful as it would have infringed a...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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Ontario Court of Appeal allows Sanofi and Schering to plead that Federal Court ramipril patent invalidity decision was flawed due...

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In an action by Apotex for compensation from Sanofi and Schering under the Ontario Statute of Monopolies, U.K. Statute of Monopolies and the Trade-marks Act, the Ontario Court of Appeal has overturned a motion judge’s...more

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Apotex not permitted to plead promise-based invalidity grounds in Ontario section 8 lansoprazole action

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This motion arose in the context of a section 8 action in which Apotex claims damages for delay in the issuance of its notice of compliance for its generic lansoprazole product (Takeda's PREVACID), due to prohibition...more

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Teva succeeds in section 8 bortezomib action; infringement counterclaim dismissed

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On July 18, 2018, Justice Locke of the Federal Court granted Teva’s claim for compensation under section 8 of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) for losses suffered while market...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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Rx IP Update - May 2018

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An Update on Vanessa’s Law - This is a special update on the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) which was approved on November 6, 2014 (as previously reported), amending the Food and Drugs Act...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 - March 2018

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No Section 8 Liability for Valid and Infringed Patent in NEXIUM Proceeding - What happens when a patentee is unsuccessful in a prohibition application under the Patented Medicines (Notice of Compliance) (PMNOC)...more

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