Markwell Clarizio LLP

pharmaceuticals

FCA Reaffirms Strict Rules for Patent Lists Under the PMNOC Regulations

Federal Court of Appeal (Locke JA writing) holds that PMNOC Regulations do not allow a first person to amend an existing patent list to create a new patent linkage. Janssen Inc. v. Canada (Health) – Federal Court of Appeal (fca-caf.ca) Janssen Inc. v. Canada (Health) – Federal Court (fct-cf.gc.ca) This decision concerns the arcane timing […]

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Sandoz v. Janssen 2023 FCA 221: Threshold for Sound Prediction

The Federal Court of Appeal (Locke JA writing for the Court) recently confirmed the threshold for establishing a sound prediction of utility. Sandoz v Janssen 2023 FCA 221 Canadian patent law requires that, to prevent the filing of patent applications based on speculation, utility must be either demonstrated or the requirements for a sound prediction

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Inducing Infringement with a Skinny Label: FCA Weighs-In

The Federal Court of Appeal (Locke JA writing for the Court) held that Apotex will induce infringement of patent claims to a combination of two active ingredients to treat a condition even though Apotex is seeking approval to market only one of the active ingredients as a monotherapy for the same condition. https://lnkd.in/gkb9faVi Janssen is the

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