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  • Article

    Santé Canada et la Food and Drug Administration des États-Unis conviennent de mettre en place un programme de partage d'informations pour l'examen des médicaments génériques

    Santé Canada et la Food and Drug Administration des États-Unis (la « FDA ») ont créé un programme visant à soutenir la mise en place d'un programme de Demande de partage d'informations (« DPI »)...
    CanadaFood, Drugs, Healthcare, Life Sciences
    Smart & Biggar
    Smart & Biggar
  • Article

    Saskatchewan Launches Biosimilars Initiative

    On October 20, 2022, Saskatchewan announced it is introducing a biosimilars initiative.
    CanadaFood, Drugs, Healthcare, Life Sciences
    Smart & Biggar
    Smart & Biggar
  • Article

    Strict 45-Day Time Limit For Starting PMNOC Action Was Suspended By COVID-19 Federal Legislation

    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...
    CanadaFood, Drugs, Healthcare, Life Sciences
    Smart & Biggar
    Smart & Biggar
  • Article

    Update On Amended Patented Medicines Regulations

    Both the applicants and the respondent have appealed the June 29, 2020 decision striking subsection 3(4) of the Regulations Amending the Patented Medicines Regulations...
    CanadaFood, Drugs, Healthcare, Life Sciences
    Smart & Biggar
    Smart & Biggar
  • Article

    Update On Proposed Ministerial Reliance Order

    As we reported last month, the Minister of Health launched a consultation on a proposed Ministerial Reliance Order that would permit Health Canada to complete the examination of certain parts...
    CanadaFood, Drugs, Healthcare, Life Sciences
    Smart & Biggar
    Smart & Biggar
  • Article

    Canada Finalizes Patent Term Adjustment Rules

    On January 1, 2025, Canada will implement a patent term adjustment (PTA) system to account for unreasonable delays by the Canadian Intellectual Property Office (CIPO) in issuing a patent.
    CanadaIntellectual Property
    Smart & Biggar
    Smart & Biggar
  • Article

    Christian Bolduc On Bill 96 In World Trademark Review

    In a recent interview with the World Trademark Review (WTR), Principal Christian Bolduc discusses Bill 96 and its Regulations, and the implications for those doing business in Québec. On June 1, 2022, the Québec...
    CanadaIntellectual Property
    Smart & Biggar
    Smart & Biggar
  • Article

    Confirmed: Delays In First Examination Of Canadian Trademark Applications To Be Reduced Substantially

    During a recent meeting, the Canadian Intellectual Property Office (CIPO) revealed plans for a significant reduction in the first examination of Canadian trademark applications not using the pre-approved list of goods...
    CanadaIntellectual Property
    Smart & Biggar
    Smart & Biggar
  • Article

    Court Permits Addition Of Inventor To A Patent That Is Subject Of Ongoing Litigation

    In Regeneron Pharmaceuticals, Inc v Canada (AG), 2023 FC 768, the Federal Court granted Regeneron's application to add an inventor to its issued patent, which was the subject of pending...
    CanadaIntellectual Property
    Smart & Biggar
    Smart & Biggar
  • Article

    Defeat Of The Knight: No Moral Rights Infringement For Discounted Sales Of Popular Series Of Books

    In an interesting factual situation concerning the scope of moral rights, the Quebec Court of Appeal, in 91439 Canada ltée (Éditions de Mortagne) c. Robillard, 2022 QCCA 76...
    CanadaIntellectual Property
    Smart & Biggar
    Smart & Biggar
  • Article

    Diagnostic Test Kit: Integration Of Patented Technologies

    Since the beginning of the pandemic, the Food and Drug Administration (FDA) has been at a rapid pace in evaluating COVID-19 related diagnostic tests, amongst which include those that utilize patented technologies.
    CanadaIntellectual Property
    Smart & Biggar
    Smart & Biggar
  • Article

    FCA Dismisses Appeal, Patent Not Listable Against STELARA SNDS

    As previously reported, the Federal Court (FC) dismissed Janssen's application for judicial review of the decision of the Office of Submissions and Intellectual Property (OSIP) refusing to list...
    CanadaIntellectual Property
    Smart & Biggar
    Smart & Biggar
  • Article

    Government Of Canada Launches Consultation On Expanding The Geographical Indications Regime

    On May 28, 2026, the Government of Canada launched a public consultation on the scope of the geographical indications (GIs) regime under the Trademarks Act. The consultation seeks stakeholders' views on how Canada's GI regime could be strengthened and modernized, including whether its scope should be expanded beyond its current categories of protected products.
    CanadaIntellectual Property
    Smart & Biggar
    Smart & Biggar
  • Article

    Inuit-Inspired Products Raise Cultural Appropriation Concerns: Meika Ellis In CBC News

    In a recent interview with CBC News on the cultural appropriation of Inuit designs, Associate Meika Ellis emphasizes the importance of respecting the Inuit community and their cultural heritage.
    CanadaIntellectual Property
    Smart & Biggar
    Smart & Biggar
  • Article

    Janssen's Abiraterone Acetate And Prednisone Combination Therapy Patent Found Invalid

    On January 14, 2020, the Federal Court released a decision by Phelan J. in patent infringement actions pursuant to subsection 6(1) of the Patented Medicines
    CanadaIntellectual Property
    Smart & Biggar
    Smart & Biggar
  • Article

    Quebec To Bolster French Language Requirements

    Bill 96 was tabled today by the Government of Quebec proposing sweeping revisions to the Quebec's Charter of the French Language
    CanadaIntellectual Property
    Smart & Biggar
    Smart & Biggar
  • Article

    SOLIRIS PMPRB Redetermination Proceeding Resolved On Consent

    In September 2017, the Patented Medicine Prices Review Board (PMPRB) decided that Alexion's SOLIRIS (eculizumab) was sold at an excessive price. In doing so, the Board departed from the Guidelines...
    CanadaIntellectual Property
    Smart & Biggar
    Smart & Biggar
  • Article

    Supreme Court Of Canada Denies Amgen Leave To Appeal Decision Invalidating Its Filgrastim Patent

    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)
    CanadaIntellectual Property
    Smart & Biggar
    Smart & Biggar
  • Article

    Supreme Court Of Canada Dismisses Apotex's Application For Leave To Appeal Macitentan Inducing Infringement Decision

    As previously reported, the Federal Court of Appeal dismissed Apotex's appeal of a decision relating to macitentan (Janssen's OPSUMIT), which found that Apotex would induce infringement of Janssen's patent.
    CanadaIntellectual Property
    Smart & Biggar
    Smart & Biggar
  • Article

    New Court Proceedings - December 2020

    REVLIMID (lenalidomide): Celgene v Taro.
    CanadaLitigation, Mediation & Arbitration
    Smart & Biggar
    Smart & Biggar

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