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ARTICLE · 24 NOVEMBER 2015

Federal Court Issues First Biologics Decision Under PM(NOC) Regulations

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Amgen Canada Inc v Apotex Inc (2015 FC 1261) is the first decision of the Federal Court under the Patented Medicines (Notice of Compliance) Regulations relating to a subsequent entry biologic.

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Amgen Canada Inc v Apotex Inc (2015 FC 1261) is the first decision of the Federal Court under the Patented Medicines (Notice of Compliance) Regulations relating to a subsequent entry biologic. Justice Hughes dismissed Amgen’s application for an order prohibiting the Minister of Health from issuing to Apotex a Notice of Compliance for a generic version of Amgen’s filgrastim product (NEUPOGEN®) until after expiry of Canadian Patent 1,341,537.

The only claim at issue before the Court was construed by the Court as covering a recombinant protein having an amino acid sequence beginning with Met (i.e. methionine), with the remainder of the sequence having some or all of the the sequence and some or all of the biological properties of the natural protein. 

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