Apotex Inc. v. Shire LLC, 2018 FC 1106 (Lisdexamfetamine*)

Justice Fothergill - 2018-11-02

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On June 21, 2018, this Court ruled (see 2018 FC 637) that specified claims of Canadian Patent 2,527,646, “Abuse Resistant Amphetamine Compounds” [646 Patent], are not invalid on any of the asserted grounds of anticipation, obviousness, overbreadth, or insufficiency of specification. This Court also ruled that Apotex Inc [Apotex] did not infringe the 646 Patent by manufacturing and retaining its generic product for experimental or regulatory use. Finally, this Court prohibited the Minister of Health from issuing a Notice of Compliance [NOC] to Apotex for its generic product under the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 [PM(NOC) Regulations] promulgated under the Patent Act, RSC 1985, c P-4. Shire LLC and Shire Pharma Canada ULC [collectively Shire] seek costs of the impeachment action and the application brought under the PM(NOC) Regulations. For the reasons that follow, costs are awarded to Shire in the amount of $1,600,000.00, inclusive of legal fees and disbursements.

Decision relates to:


Canadian Intellectual Property