Patented Medicines (Notice of Compliance) Regulations (SOR/93-133)

Regulations are current to 2017-11-06 and last amended on 2017-09-21. Previous Versions

 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:

  • (a) the statement of claim, including any amendments to it;

  • (b) any order made under subsection 6.04(1) or 7(8);

  • (c) any declaration referred to in subsection 6(1) or (3) or 6.07(1);

  • (d) the notice of motion and the motion record in respect of any motion referred to in subsection 6.07(1);

  • (e) any document discontinuing or dismissing the action, in whole or in part;

  • (f) any notice of appeal, including a motion or application for leave to appeal, in relation to any document referred to in paragraph (b), (c) or (e); and

  • (g) any judgment or order in an appeal, or a motion or application for leave to appeal, in relation to any document referred to in paragraph (b), (c) or (e).

  • SOR/2017-166, s. 7.

Notice of Compliance

  •  (1) The Minister shall not issue a notice of compliance to a second person before the latest of

    • (a) the day after the expiry of all of the patents and certificates of supplementary protection in respect of which the second person is required to make a statement or allegation under subsection 5(1) or (2) and that are not the subject of an allegation;

    • (b) the day on which the second person complies with paragraph 5(3)(e);

    • (c) the 46th day after the day on which a notice of allegation under paragraph 5(3)(a) is served;

    • (d) the day after the expiry of the 24-month period that begins on the day on which an action is brought under subsection 6(1);

    • (e) the day after the expiry of all of the patents and certificates of supplementary protection in respect of which a declaration of infringement has been made in an action brought under subsection 6(1); and

    • (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

      • (i) set out a patent referred to in paragraph (a) or (e),

      • (ii) are not the subject of a statement or allegation made under subsection 5(1) or (2), and

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

  • (2) Subsection (1) does not apply in respect of a patent or a certificate of supplementary protection if the Minister has been provided with evidence from the owner of the patent of their consent to the making, constructing, using or selling of the drug in Canada by the second person.

  • (3) Paragraphs (1)(a) to (d) do not apply in respect of a patent or certificate of supplementary protection if it is deleted from the register under any of paragraphs 3(2)(c) to (e) or subsection 3(2.3) or (3).

  • (4) Paragraph (1)(d) does not apply in respect of a patent or a certificate of supplementary protection that has been declared in the action referred to in that paragraph by the Federal Court to be ineligible for inclusion on the register.

  • (5) Paragraph (1)(d) does not apply if

    • (a) the action referred to in that paragraph is discontinued or dismissed; or

    • (b) each of the parties who brings an action referred to in subsection 6(1) in relation to a given notice of allegation provides, when they bring the action, a notice to the second person and the Minister that they renounce the application of that paragraph.

  • (6) A party may make the renouncement referred to in paragraph (5)(b) without prejudice to their right to proceed with the action or any other action for patent infringement or their entitlement to any remedy from the Federal Court or another court.

  • (7) A second person, or a first person or owner of a patent who receives a notice of allegation, shall, on request of the Minister, provide to the Minister without delay any information or document that the Minister requires to maintain the register in accordance with subsection 3(2), to determine the latest of the days referred to in subsection (1) and to determine whether any of subsections (2) to (5) apply.

  • (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.

  • SOR/98-166, ss. 6, 9;
  • SOR/2006-242, s. 4;
  • SOR/2010-212, s. 1;
  • SOR/2017-166, s. 8.
  •  (1) A second person may apply to the Federal Court or another superior court of competent jurisdiction for an order requiring all plaintiffs in an action brought under subsection 6(1) to compensate the second person for the loss referred to in subsection (2).

  • (2) Subject to subsection (3), if an action brought under subsection 6(1) is discontinued or dismissed or if a declaration referred to in subsection 6(1) is reversed on appeal, all plaintiffs in the action are jointly and severally, or solidarily, liable to the second person for any loss suffered after the later of the day on which the notice of allegation was served, the service of which allowed that action to be brought, and of the day, as certified by the Minister, on which a notice of compliance would have been issued in the absence of these Regulations.

  • (3) The Federal Court or the other superior court may specify another day for the purpose of subsection (2) if it concludes that the other day is more appropriate, including being more appropriate because the certified day was, by the operation of An Act to amend the Patent Act and the Food and Drugs Act (The Jean Chrétien Pledge to Africa), chapter 23 of the Statutes of Canada, 2004, earlier than it would otherwise have been.

  • (4) Subsections (1) to (3) do not apply if paragraph 7(1)(d) has no application because its application has been renounced under paragraph 7(5)(b).

  • (5) If the Federal Court or the other superior court orders a second person to be compensated for a loss referred to in subsection (2), the court may, in respect of that loss, make any order for relief by way of damages that the circumstances require.

  • (6) In assessing the amount of compensation — including any apportionment of that amount between the plaintiffs who are liable under subsection (2) — the court shall take into account all matters that it considers relevant to the assessment of the amount or the apportionment, including any conduct of the parties that contributed to delay the disposition of the action.

  • (7) No action or proceeding lies against Her Majesty in right of Canada in respect of any loss referred to in subsection (2).

  • SOR/98-166, ss. 8, 9;
  • SOR/2006-242, s. 5;
  • SOR/2010-212, s. 2(F);
  • SOR/2017-166, s. 8.

 A person who files a submission for a notice of compliance or a supplement to a submission for a notice of compliance in respect of a drug and who has reasonable grounds to believe that the making, constructing, using or selling of the drug might be alleged to infringe a patent or a certificate of supplementary protection is, if the submission or supplement directly or indirectly compares the drug with, or makes reference to, another drug marketed in Canada, an interested person

  • (a) for the purpose of subsection 60(1) of the Patent Act with respect to bringing an action for a declaration that the patent or any claim in the patent is invalid or void; or

  • (b) for the purpose of subsection 125(1) of that Act with respect to bringing an action for a declaration that the certificate of supplementary protection or any claim in the patent set out in it is invalid or void.

  • SOR/2017-166, s. 8.

 On receipt of a notice of allegation relating to a submission or supplement, a first person or owner of a patent may, under subsection 54(1) or 124(1) of the Patent Act, bring an action for infringement of a patent or certificate of supplementary protection — other than one that is the subject of an allegation set out in that notice — that could result from the making, constructing, using or selling of the drug in accordance with the submission or supplement.

  • SOR/2017-166, s. 8.

Service

  •  (1) Service of any document referred to in these Regulations shall be effected personally or by registered mail.

  • (2) Service by registered mail shall be deemed to be effected on the addressee five days after mailing.

 
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