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Canada
Torys LLP
In Palmer v. Teva Canada Limited1, the Ontario Court of Appeal dismissed the plaintiffs' appeal from the lower court's decision denying certification of a proposed product liability class action that claimed damages...
Goodwin Procter LLP
On March 18, 2024, Fresenius Kabi ("Fresenius") and Formycon announced a settlement agreement with Johnson & Johnson regarding FYB202, a proposed ustekinumab biosimilar to STELARA in Europe and Canada.
Smart & Biggar
On February 16, 2024, the Minister of Health tabled the 2022 Annual Report of the Patented Medicine Prices Review Board (PMPRB).
Smart & Biggar
On February 29, 2024, the Minister of Health announced the introduction of Bill C-64, An Act respecting pharmacare (Pharmacare Act), which "proposes the foundational principles...
Smart & Biggar
On February 23, 2024, Health Canada announced that it will expand the information available on the Generic Submissions Under Review (GSUR) list to include the following...
Smart & Biggar
In this article, we provide a further update on developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory, and market access) since our March 2023 update.
Smart & Biggar
On March 7, 2024, Health Canada published a Memorandum of Understanding (MOU) with the Competition Bureau (together, Participants) to advance their mutual interests and develop a framework...
Oyen Wiggs Green & Mutala LLP
An application for leave to appeal the decision in Apotex Inc. v. Janssen Inc., 2024 FCA 9 has been filed by Apotex in the Supreme Court of Canada (SCC).
Blake, Cassels & Graydon LLP
Welcome to the March edition of Blakes upRound, a regular publication from the Blakes Emerging Companies & Venture Capital (EC&VC) group...
Fasken
On January 26, Health Canada issued a notice clarifying how a drug's "dormant" status on the drug product database may affect whether that drug...
Fasken
The federal Parliament tabled Bill C-64, An Act respecting pharmacare (the "Bill"), on February 29, 2024. The Bill outlines the first phase of the federal government's...
Fasken (French)
Le 26 janvier, Santé Canada a publié un avis précisant comment l'état « dormant » d'un médicament dans la base de données sur les produits pharmaceutiques...
Cassels
The Patented Medicine Prices Review Board Canada (PMPRB) published its "What We Learned Report" (Report) on February 15, 2024...
Aird & Berlis LLP
For many Canadians, pharmaceutical names are an alphabet soup. Biogen's BYOOVIZ and Novartis's BEOVU trademarks are classic examples of drug brand names comprised of coined words.
Gowling WLG
Once you decide to file a patent, you must determine what it will cover. Obviously, you need to protect your invention, but to reduce the risk of others designing around your patent in the future...
Smart & Biggar
We previously reported amendments to Part 1.1 of the Medical Devices Regulations that created a permanent regulatory framework for expediting access to COVID-19 medical devices.
Smart & Biggar
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...
Fasken
This bulletin provides an update on the most recent decision of the Federal Court in the ongoing saga concerning Galderma's dermatology medicine...
Worldwide
Bennett Jones LLP
The Canadian Venture Capital Association (CVCA) released its annual look at the state of venture capital (VC) funding in Canada in their 2023 Market Overview.
Fasken
On January 5, 2024, the U.S. Food and Drug Administration (FDA) signed off on Florida's request to import prescription drugs from Canada under the Section 804 State Importation Program (SIP).
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