News & Analysis as of

Dismissals PMNOC Regulations

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Ontario Court of Appeal affirms dismissal of Apotex’s Statutes of Monopolies and Trademarks Act claims regarding olanzapine

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On March 8, 2021, the Ontario Superior Court of Justice dismissed Apotex’s claims against Eli Lilly (Lilly) under the Statute of Monopolies, Trademarks Act, and common law conspiracy relating to Canadian Patent No. 2,041,113...more

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Federal Court finds Minister of Health reasonable in concluding JAMP not a ‘second person’ for its SIMLANDI biosimilar

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On August 17, 2022, the Federal Court, per Justice Fothergill, dismissed AbbVie’s applications for judicial review of the Minister of Health’s decisions that (1) JAMP was not a “second person” and therefore it was not...more

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Federal Court of Appeal upholds invalidity of fampridine patent

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The Federal Court of Appeal (FCA) dismissed an appeal by Biogen and a cross-appeal by Taro from a decision of the Federal Court... dismissing two actions by Biogen under the Patented Medicines (Notice of Compliance)...more

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Federal Court of Appeal dismisses appeal, upholds strict interpretation of patent listing deadline for KEYTRUDA formulation patent

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The Federal Court of Appeal (FCA) dismissed an appeal by Merck from a decision of the Federal Court... dismissing Merck’s application for judicial review of Health Canada’s refusal to add Canadian Patent No. 2,830,806 (806...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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2021 Mid-Year Highlights in Canadian Life Sciences IP and Regulatory Law

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In the first half of 2021, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. The Rx IP Update team at Smart & Biggar has collected the top stories from January to June and...more

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Federal Court dismisses Roche’s PMNOC Regulations actions against Sandoz re: pirfenidone

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By judgment dated May 12, 2021, the Federal Court dismissed patent infringement actions related to Sandoz’s pirfenidone capsules and tablets for the treatment of idiopathic pulmonary fibrosis (IPF) (Roche’s ESBRIET):...more

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Plaintiff cannot amend Statement of Claim more than 45 days after receipt of NOAs to plead infringement of further patents.

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On May 5, 2021, the Federal Court dismissed a motion by Biomarin Pharmaceutical Inc (Biomarin) to amend its Statement of Claim to allege infringement of two patents that had not been asserted within the 45-day deadline...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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Ontario Superior Court dismisses Apotex’s Statutes of Monopolies and Trademarks Act claims regarding olanzapine

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Update: Apotex has appealed. On March 8, 2021, the Ontario Superior Court of Justice granted Eli Lilly’s (Lilly) motion for summary judgment and dismissed Apotex’s claims under the Statutes of Monopolies, Trademarks Act, and...more

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Federal Court holds section 8.2 of the PMNOC Regulations does not impose a limitation period

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On December 22, 2020, the Federal Court issued its decision holding that section 8.2 of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) does not impose a limitation period either the same as or...more

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Strict 45-day time limit for starting PMNOC action was suspended by COVID-19 Federal legislation

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The Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) require that any section 6(1) action be brought within 45 days after the day on which the first person is served with a notice of allegation (NOA)....more

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Federal Court of Appeal dismisses appeal of first trial decision under the amended PMNOC Regulations

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UPDATE: On July 9, 2021, the Supreme Court of Canada denied Amgen’s leave to appeal (see article here). On November 3, 2020, the Federal Court of Appeal heard and dismissed the appeal of the first trial decision under the...more

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Federal Court dismisses Biogen’s actions under PMNOC Regulations against Taro and Pharmascience re: FAMPYRA

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On May 15, 2020, Manson J. of the Federal Court dismissed two actions brought by Biogen under the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) alleging infringement of Patent No. 2,562,277 (277...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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Court declines to direct preliminary determination on interpretation of subsection 6(1) of PMNOC Regulations

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On November 7, 2019, Prothonotary Tabib dismissed Pharmascience’s motion for an order directing a preliminary determination of a question of law in the context of a patent infringement action brought by Teva pursuant to the...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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Rx IP Update - July 2019

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Federal Court of Appeal requires PMPRB to re-determine whether patent ‘pertains to’ Galderma’s DIFFERIN - On June 28, 2019, the Federal Court of Appeal granted the appeal of the Patented Medicine Prices Review Board (PMPRB...more

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Rx IP Update - May 2019

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IN THIS ISSUE: - Federal Court dismisses Servier's application for order of prohibition regarding salt patent for perindopril arginine - FCA upholds issuance of NON-W letter and cancellation of reconsideration process...more

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Rx IP Update - February 2019

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Orders of prohibition relating to polymorphic form patent for PRISTIQ upheld on appeal - As previously reported, the Federal Court, in a pair of decisions, granted orders prohibiting Apotex and Teva from marketing their...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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Shire’s VYVANSE patent valid, prohibition order issued

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On June 29, 2018, Justice Fothergill of the Federal Court granted Shire’s application under the pre-amended Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) for an order prohibiting the Minister of...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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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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