Certificate of Supplementary Protection Regulations (SOR/2017-165)

Regulations are current to 2019-06-20 and last amended on 2017-09-21. Previous Versions

Marginal note:Countries and period

  •  (1) For the purpose of paragraph 106(1)(f) of the Act,

    • (a) the prescribed countries are

      • (i) the European Union and any country that is a member of the European Union,

      • (ii) the United States of America,

      • (iii) Australia,

      • (iv) Switzerland, and

      • (v) Japan; and

    • (b) the prescribed period for filing the application for the authorization for sale is

  • Marginal note:Period — filing application for certificate

    (2) For the purpose of subsection 106(3) of the Act, the prescribed period for filing the application for a certificate of supplementary protection is 120 days.

  • Marginal note:Content of application

    (3) An application for a certificate of supplementary protection must contain

    • (a) the applicant’s name and contact information in Canada, including their complete address;

    • (b) the filing date of the application for the patent, the date on which the patent was granted and the date on which the term of the patent will expire;

    • (c) the applicant’s attestation, as the case may be, that the applicant is the patentee and is recorded as an owner of the patent in the Patent Office or that they are the manufacturer who is authorized under section 8 to file the application;

    • (d) the applicant’s attestation that

      • (i) when the application was filed for the authorization for sale referred to in paragraph 106(1)(c) of the Act, no application for a marketing approval, equivalent to an authorization for sale, with respect to the medicinal ingredient or combination of medicinal ingredients, as the case may be, set out in the application for the certificate of supplementary protection had been submitted in a country prescribed by paragraph (1)(a), or

      • (ii) if one or more of those applications for a marketing approval had been submitted in one or more of those countries, the application for the authorization for sale referred to in paragraph 106(1)(c) of the Act was filed before the end of the prescribed period referred to in paragraph (1)(b) that begins on the day of submission of the first of those marketing approval applications; and

    • (e) a description of the method of payment used to pay the fee prescribed under subsection 9(1).

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