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  1. Patented Medicines (Notice of Compliance) Regulations - SOR/93-133 (Section 5)
    Regulations Respecting a Notice of Compliance Pertaining to Patented Medicines
    • [...]

    • (2.1) The statements or allegations required for the submission or the supplement, as the case may be, are — with respect to each patent included on the register in respect of the other drug and with respect to each certificate of supplementary protection in which the patent is set out and that is included on the register in respect of the other drug — the following:

      • [...]

      • (b) a statement that the second person accepts that the notice of compliance will not issue until that patent or certificate of supplementary protection, as the case may be, expires; or

    • [...]

    • (3.1) A second person who makes an allegation that the patent or certificate of supplementary protection is invalid or void may, when the notice of allegation is served, request

      • (a) the name of and contact information for any inventor who might have information relevant to the allegation, along with an indication as to whether that inventor is an employee of the first person or of the patent owner; and

      • (b) any laboratory notebook, research report or other document that may be relevant to determine whether a particular property, advantage, or use asserted by the second person to be part of the invention was established as of the filing date of the application for the patent, if the second person identifies the specific allegation in the notice of allegation that is relevant to the request and the portion of the patent in which that property, advantage or use is set out.

    • [...]

    • (6) A second person who has served a notice of allegation on a first person under paragraph (3)(a) shall retract the notice of allegation and serve notice of the retraction on the first person within 90 days after either of the following dates:

      • (a) the date on which the Minister notifies the second person under paragraph C.08.004(3)(b) or C.08.004.01(3)(b), as the case may be, of the Food and Drug Regulations of their non-compliance with the requirements of section C.08.002, C.08.002.01, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1 of those Regulations; or

    [...]


  2. Patented Medicines (Notice of Compliance) Regulations - SOR/93-133 (Section 7)
    Regulations Respecting a Notice of Compliance Pertaining to Patented Medicines
    •  (1) The Minister shall not issue a notice of compliance to a second person before the latest of

      • [...]

      • (f) the day after the expiry of all of the certificates of supplementary protection, other than any that were held not to be infringed in an action referred to in paragraph (e), that

        • [...]

        • (iii) are included on the register in respect of the same submission or supplement as the patent.

    • [...]

    • (8) As long as the Federal Court has not made a declaration referred to in subsection 6(1), it may shorten or extend the 24-month period referred to in paragraph (1)(d) if it finds that a party has not acted diligently in carrying out their obligations under these Regulations or has not reasonably cooperated in expediting the action.

    [...]


  3. Patented Medicines (Notice of Compliance) Regulations - SOR/93-133 (Section 6.03)
    Regulations Respecting a Notice of Compliance Pertaining to Patented Medicines
    •  (1) If a second person makes a request under subsection 5(3.1), the person who brings the action must serve on the second person at the same time as their statement of claim,

      • [...]

      • (b) a document setting out an explanation of the steps that have been and are being taken to locate that information or those documents, along with a statement that they will be provided as soon as feasible; or

    [...]


  4. Patented Medicines (Notice of Compliance) Regulations - SOR/93-133 (Section 3)
    Regulations Respecting a Notice of Compliance Pertaining to Patented Medicines
    •  (1) The following definitions apply in this section and in section 4.

      new drug submission

      new drug submission  means a new drug submission or an extraordinary use new drug submission as those terms are used in Division 8 of Part C of the Food and Drug Regulations, but excludes such a submission that is based solely on the change of name of the manufacturer. (présentation de drogue nouvelle)

      supplement to a new drug submission

      supplement to a new drug submission  means a supplement to a new drug submission or a supplement to an extraordinary use new drug submission as those terms are used in Division 8 of Part C of the Food and Drug Regulations, but excludes such a supplement that is based solely on one or more of the matters mentioned in any of paragraphs C.08.003(2)(b) and (d) to (g) and subparagraphs C.08.003(2)(h)(iv) and (v) of those Regulations. (supplément à une présentation de drogue nouvelle)

    • [...]

    • (7) No patent on a patent list or certificate of supplementary protection shall be added to the register until after the Minister has issued a notice of compliance in respect of the new drug submission or the supplement to a new drug submission, as the case may be, to which the patent or certificate of supplementary protection relates.

    [...]


  5. Patented Medicines (Notice of Compliance) Regulations - SOR/93-133 (Section 6.13)
    Regulations Respecting a Notice of Compliance Pertaining to Patented Medicines

     The person who brings an action under subsection 6(1) shall provide to the Minister, as soon as feasible, a copy of the following documents in relation to the action:

    [...]



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