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A. Chandimal Nicholas
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Cassels Brock
Tel: +1 416 8695300
Fax: +1 416 3608877
Suite 2100, Scotia Plaza
40 King Street West
Toronto
Ontario M5H 3C2
Canada
Health Canada is soliciting input on possible changes to the Food and Drug Regulations regarding establishing pharmaceutical equivalence between a proposed generic drug product and the Canadian Reference Product.
The new CSP system provides an additional period of patent-like protection for patentees after the date of expiry of certain eligible pharmaceutical patents.
The Supreme Court of Canada's (the "Court" or the "SCC") recent judgment in AstraZeneca Canada Inc. v Apotex Inc., released on June 30, 2017, constitutes an important paradigm shift in Canadian patent law.
On May 16, 2017, the Federal Minister of Health, the Hon. Jane Philpott announced a number of proposed regulatory changes to the Patented Medicines Regulations (the "Regulations").
Under the Patent Act in Canada, an invention must be new and useful to be patentable.
In Apotex Inc. v Canada (Minister of Health) ("Apotex"), the Federal Court (the "Court") provided some guidance with respect to the procedure pharmaceutical companies should undertake...
The Federal Court has reaffirmed and clarified how a pharmaceutical brand company should respond to a generic company's motion to strike an application for abuse of process...
With Emily Larose
Health Canada has recently released the revised Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs, replacing the March 2010 Guidance for Sponsors...
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