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Dismissals Canada Pharmaceutical Industry

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Federal Court of Appeal dismisses appeal of SPRAVATO “innovative drug” decision

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On November 10, 2021, the Minister of Health refused to reassess its decision that Janssen’s esketamine hydrochloride product (SPRAVATO) was not an “innovative drug” and therefore not entitled to data protection. As...more

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Twice is not nice – second notice of allegation may be abusive

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On December 23, 2023, the Federal Court of Appeal (FCA) held that it was an abuse of process for Apotex to raise invalidity in defending actions under the Patented Medicines (Notice of Compliance) Regulations (Regulations)...more

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Federal Court of Appeal dismisses appeal relating to Minister of Health’s decision to disclose records pursuant to Access to...

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On November 1, 2023, the Federal Court of Appeal (FCA) dismissed Actial’s appeal from an application for judicial review of the Minister of Health’s decision to disclose records pursuant to a request under the Access to...more

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Federal Court of Appeal dismisses appeal challenging amended basket of comparator countries in PMPRB Regulations

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On December 5, 2022, the Federal Court of Appeal (FCA) dismissed Innovative Medicines Canada (IMC) and sixteen innovative pharmaceutical companies’ appeal regarding the validity of the amended basket of comparator countries...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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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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Federal Court of Appeal upholds decision finding Seedlings' LifeCard patent invalid and not infringed by Pfizer’s EpiPen

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On July 28, 2021, the Federal Court of Appeal (FCA) dismissed Seedling’s appeal from the Federal Court decision of Justice Grammond (2020 FC 1, previously reported), which concluded that certain claims of Seedlings' LifeCard...more

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Federal Court of Appeal confirms Janssen’s SPRAVATO not eligible for data protection

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Update: On November 10, 2021, the Minister rejected Janssen’s second request for data protection for SPRAVATO, which was submitted following the coming into force of the Canada-United States-Mexico Agreement (CUSMA). The...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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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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Federal Court denies stay of decision issuing NOC for RUZURGI

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On September 30, 2020, the Federal Court dismissed an application by Catalyst Pharmaceuticals Inc (Catalyst) and KYE Pharmaceuticals Inc (KYE) (collectively, the applicants) for an interlocutory injunction to stay the...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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Federal Court finds reasonable Health Canada’s decision that enantiomer of previously approved drug not entitled to data...

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Update: On July 12, 2021, the Federal Court of Appeal dismissed Janssen’s appeal from Zinn J.’s decision: Janssen Inc v Attorney General of Canada (Minister of Health), 2021 FCA 137 (see article here). On September 18,...more

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Orders of prohibition relating to polymorphic form patent for PRISTIQ upheld on appeal

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As previously reported, the Federal Court, in a pair of decisions, granted orders prohibiting Apotex and Teva from marketing their generic o-desmethyl-venlafaxine (ODV) succinate products (Pfizer’s PRISTIQ) until expiry of...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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Federal Court of Appeal dismisses Teva’s appeal relating to utility and sufficiency

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On March 14, 2017, the Federal Court of Appeal (FCA) dismissed Teva’s appeal of Locke J.’s Order prohibiting the Minister of Health from issuing a notice of compliance (NOC) to Teva in respect of its calcipotriol and...more

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Rx IP Update - March 2017

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Tribunal dismisses Eli Lilly’s NAFTA challenge on promise utility doctrine - As previously reported, Eli Lilly submitted claims to international arbitration under the North American Free Trade Agreement (NAFTA) seeking...more

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