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Canada Pharmaceutical Industry Appeals

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Supreme Court of Canada to hear method of medical treatment appeal

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On September 19, 2024, the Supreme Court of Canada granted Pharmascience leave to appeal a Federal Court of Appeal decision affirming a trial decision that upheld the validity of Janssen’s patent relating to paliperidone...more

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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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Dechert Re:Torts - Issue 14

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A Prescription for Liability: Michigan Repeals Flagship Drug Immunity Law - Michigan’s recent repeal of immunity provisions under its Product Liability Act has potentially significant implications for pharmaceutical...more

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BYOOVIZ is confusing with BEOVU: Federal Court finds violation of Novartis’ trademark rights

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In a decision dated January 24, 2024, Justice Pallotta allowed Novartis’ application, finding that Biogen and Samsung’s use of the trademark BYOOVIZ in association with an ophthalmologic drug violates Novartis’ rights in its...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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LUMIGAN RC formulation patent found valid and infringed

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In a patent infringement action brought by Allergan and AbbVie under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (Regulations), in relation to 0.01% w/v bimatoprost solution for ophthalmic...more

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Federal Court finds PMPRB reasonably concluded Galderma’s patent claiming 0.3% adapalene “pertained to” 0.1% adapalene DIFFERIN

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On January 11, 2024, the Federal Court released its decision concluding that the Patented Medicine Prices Review Board (PMPRB or Board) was reasonable in its redetermination that the invention of Patent No. 2,478,237 (the 237...more

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2023 Highlights in Canadian Life Sciences IP and Regulatory Law

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Eli Lilly v Teva, Pharmascience, Riva, Apotex, Mylan (tadalafil, CIALIS) – Following a summary trial, Lilly’s infringement actions were dismissed: composition claims directed to “a physiologically acceptable salt” of...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 upholds Health Canada’s decision to designate Lifestyle Patch a Natural Health Product

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In Le-Vel Brands, LLC v The Attorney General Of Canada, 2023 FCA 177, the Federal Court of Appeal (FCA) held that the Federal Court properly determined that Health Canada reasonably decided that Le-Vel Brands (L-Vel)’s Thrive...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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FCA remits pricing decision on ALEXION’S SOLIRIS to PMPRB

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Update: On September 29, 2021, Canada applied to the Supreme Court of Canada for leave to appeal (Docket No. 39858). In September 2017, the Patented Medicine Prices Review Board (PMPRB or Board) decided (see article here)...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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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 of Appeal finds Minister of Health’s refusal to grant a CSP for SHINGRIX is reasonable

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In the first appellate decision relating to Certificates of Supplementary Protection (CSPs), the Federal Court of Appeal has allowed the appeal of the Minister of Health (the Minister), setting aside the lower court judgment....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 of Appeal refuses to grant stay of Federal Court decision remanding Health Canada’s refusal of SHINGRIX CSP

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The Federal Court of Appeal recently dismissed a motion brought by the Minister of Health (the Minister) for stay of a judgment of the Federal Court that held Health Canada’s refusal to issue a Certificate of Supplementary...more

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Federal Court of Appeal sets aside Order for common trial across multiple actions under PMNOC Regulations

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An interesting procedural question under the amended Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) is the extent to which separate actions against multiple generic manufacturers can proceed...more

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COVID-19 Update: CIPO, Federal Courts, Health Canada

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This article was last updated on June 26, 2020. In view of COVID-19, we have compiled a list of important updates as it relates to the pandemic and its impact on Life Sciences. We will continue to update this page as new...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 - March 2019

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Federal Court finds invalidity allegations relating to patent for metformin formulations not justified - On March 8, 2019, Justice Fothergill granted Valeant Canada’s application for an order prohibiting the Minister of...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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