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Patent Litigation PMNOC Regulations

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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 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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PM(NOC) Regulations: Five-year anniversary of major amendments

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September 21, 2022, marked the fifth anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the fifth year...more

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Sandoz granted leave to add new allegations on condition of trial adjournment and extension of 24-month stay

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In a decision rendered on August 17, 2022, the Federal Court granted Sandoz Canada Inc (Sandoz) leave to amend its Statement of Defence to add new allegations, contingent on an adjournment of the trial and an extension of a...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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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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2022 mid-year highlights in Canadian life sciences IP and regulatory law

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In the first half of 2022, 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 July and...more

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Janssen succeeds on infringement against Apotex in macitentan combination patent case

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In a public decision dated July 6, 2022 in an action under the Patented Medicines (Notice of Compliance) Regulations, Justice Pallotta of the Federal Court found that Apotex would infringe Janssen’s patent relating to...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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2021 Highlights in Canadian Life Sciences IP and Regulatory Law

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In the fall of 2021, the Rx IP Update team celebrated its 20thyear of monthly updates on Canadian life sciences IP and regulatory law. Below are highlights from our team’s 2021 updates...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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Supreme Court of Canada denies Amgen leave to appeal decision invalidating its filgrastim patent

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As previously reported, Amgen sought leave to appeal a decision of the Federal Court of Appeal (2020 FCA 188) affirming Justice Southcott’s decision that the relevant claims of its filgrastim (NEUPOGEN) patent were invalid...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 stays re-examination of glatiramer acetate patent pending appeal in PMNOC proceeding

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On April 26, 2021, the Federal Court granted Teva’s motion for a stay of the re-examination proceeding commenced by Pharmascience in respect of Canadian Patent No. 2,760,802 (802 patent) relating to glatiramer acetate (Teva’s...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 upholds Health Canada’s strict interpretation of patent listing deadline for KEYTRUDA formulation patent

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Update: Merck’s appeal was dismissed. The Federal Court recently dismissed Merck’s application for judicial review of Health Canada’s refusal to add Canadian Patent No. 2,830,806 (806 Patent) to the Patent Register, holding...more

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Federal Court of Appeal affirms prohibition order against Apotex regarding abiraterone

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As previously reported, in the final decision released under the pre-amended Patented Medicines (Notice of Compliance) Regulations (Regulations), the Federal Court granted a prohibition order relating to Canadian Patent No....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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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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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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