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  • Article

    Health Canada TPD, BRDD And NNHPD Annual Performance Reports Released

    The Therapeutic Products Directorate (TPD), the Biologic and Radiopharmaceutical Drugs Directorate (BRDD), and the Natural and Non-Prescription Health Products Directorate (NNHPD) ...
    CanadaFood, Drugs, Healthcare, Life Sciences
    Smart & Biggar
    Smart & Biggar
  • Article

    Market Access: National Pharmacare, OHIP+, Costco Rebates

    On June 12, the Advisory Council on the Implementation of National Pharmacare released its final report which recommends that Canada implement a universa
    CanadaFood, Drugs, Healthcare, Life Sciences
    Smart & Biggar
    Smart & Biggar
  • Article

    Minister Of Health Announces Advisory Group And Three-Year Consultation Period For The National Strategy For Drugs For Rare Diseases

    In March 2023, the Minister of Health announced the National Strategy for Drugs for Rare Diseases, which has as its objective to increase access to, and affordability of, effective drugs for rare diseases...
    CanadaFood, Drugs, Healthcare, Life Sciences
    Smart & Biggar
    Smart & Biggar
  • Article

    New Guidance Document On Administrative Processing Of Submissions And Applications

    On December 11, 2017, Health Canada announced a guidance document clarifying the requirements for drug submissions and applications to be processed under the administrative pathway.
    CanadaFood, Drugs, Healthcare, Life Sciences
    Smart & Biggar
    Smart & Biggar
  • Article

    New PMPRB Guidelines Will Not Be Implemented January 1, 2023

    The Patented Medicine Prices Review Board (PMPRB) has advised that the new Guidelines will not be implemented on January 1, 2023, and that the Interim Guidance issued by the...
    CanadaFood, Drugs, Healthcare, Life Sciences
    Smart & Biggar
    Smart & Biggar
  • Article

    PMPRB News: "Significant Changes" To Be Made To Draft Pricing Guidelines

    On April 2, 2020, the Patented Medicine Prices Review Board (PMPRB) published a message from the Chairperson regarding the results of its consultation on the draft Guidelines operationalizing the...
    CanadaFood, Drugs, Healthcare, Life Sciences
    Smart & Biggar
    Smart & Biggar
  • Article

    PMPRB Releases New Draft Guidelines For Comment

    Following its Phase 2 Consultations, on December 19, 2025, the Patented Medicine Prices Review Board (PMPRB) released its new Draft Guidelines and accompanying Overview.
    CanadaFood, Drugs, Healthcare, Life Sciences
    Smart & Biggar
    Smart & Biggar
  • Article

    PMPRB Releases Report Analyzing Generic Drug Pricing In Canada

    On February 6, 2018, the Patented Medicine Prices Review Board (PMPRB) announced the publication of the most recent edition of its series of reports on generic drug pricing.
    CanadaFood, Drugs, Healthcare, Life Sciences
    Smart & Biggar
    Smart & Biggar
  • Article

    Restricted Drugs Now Possible Through The Special Access Program

    On January 5, 2022, amendments came into force amending the Food and Drug Regulations to allow practitioners to request access to restricted drugs through the Special Access Program (SAP)...
    CanadaFood, Drugs, Healthcare, Life Sciences
    Smart & Biggar
    Smart & Biggar
  • Article

    Supreme Court Of Canada Denies Apotex Leave To Appeal Federal Court Of Appeal's Rejection Of Judicial Review Of Health Canada Decision Regarding India Facilities

    As previously reported, the Federal Court of Appeal (FCA) dismissed Apotex's appeal of a judicial review decision of the Therapeutic Products Directorate (TPD) ...
    CanadaFood, Drugs, Healthcare, Life Sciences
    Smart & Biggar
    Smart & Biggar
  • Article

    CIPO Will Not Issue Patents On July 9 Or July 16

    The Canadian Intellectual Property Office (CIPO) will be launching a new online portal for patent services, MyCIPO Patents, on July 15, 2024.
    CanadaIntellectual Property
    Smart & Biggar
    Smart & Biggar
  • Article

    Federal Court Of Appeal Confirms Patent Infringer Not Entitled To Dictate Appropriate Remedy

    The Federal Court of Appeal affirmed that, under the Patent Act, a successful patentee always has a right to its damages, and only it has the right to elect an accounting of profits, subject to the court's discretion.
    CanadaIntellectual Property
    Smart & Biggar
    Smart & Biggar
  • Article

    Government Introduces Bill C-4 To Implement Changes Required Under USMCA

    On January 29, 2020, Bill C-4, which addresses some of the changes required under the Agreement between Canada, the U.S. and Mexico (USMCA), was introduced in the House of...
    CanadaIntellectual Property
    Smart & Biggar
    Smart & Biggar
  • Article

    Mark Your Calendar: Three Ways To Save On Official Fees At The Canadian Patent Office Before January 1, 2024

    Earlier this year, the Canadian Patent Office announced that it will increase its official fees on January 1, 2024, in some cases by as much as 36%.
    CanadaIntellectual Property
    Smart & Biggar
    Smart & Biggar
  • Article

    Ontario Court Of Appeal Dismisses Summary Judgment Appeal In Section 8 Case

    The appellants argued that Apo-Lansoprazole could not and would not have received regulatory approval in April 2007 and Apotex was not entitled to damages.
    CanadaIntellectual Property
    Smart & Biggar
    Smart & Biggar
  • Article

    Patent Protection For Stem Cells - Expanding Opportunities

    Therapeutic applications of stem cells are central to the promise of regenerative medicine. An increasing number of stem cell therapies are being approved for clinical use and by some estimates
    CanadaIntellectual Property
    Smart & Biggar
    Smart & Biggar
  • Article

    Podcast Series With Louis-Pierre Gravelle In Collaboration With ISEQ

    We are proud to announce a new podcast series with Louis-Pierre Gravelle of B&P in collaboration with ISEQ to demystify and explore the intellectual property (IP)...
    CanadaIntellectual Property
    Smart & Biggar
    Smart & Biggar
  • Article

    Supreme Court Of Canada Denies Pharmascience Leave To Appeal Decision Upholding The Validity Of Two Patents Relating To ELIQUIS

    On March 30, 2023, the Supreme Court of Canada dismissed Pharmascience's application for leave to appeal (Docket No. 40400) a decision of the Federal Court of Appeal (FCA) upholding the validity...
    CanadaIntellectual Property
    Smart & Biggar
    Smart & Biggar
  • Article

    Canada Signs New Trade Agreement With United States And Mexico

    On November 30, 2018, Global Affairs Canada issued a news release announcing the signing of the Canada-United States-Mexico Agreement (CUSMA or USMCA) ...
    CanadaInternational Law
    Smart & Biggar
    Smart & Biggar
  • Article

    Government Of Canada Announces Suspension Of IP Provisions Under The Comprehensive And Progressive Partnership For Trans-Pacific Partnership (CPTPP)

    On January 30, 2018, the Government of Canada posted the Comprehensive and Progressive Partnership for Trans-Pacific Partnership (CPTPP) - Backgrounder.
    CanadaInternational Law
    Smart & Biggar
    Smart & Biggar

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