Patented Medicines (Notice of Compliance) Regulations
7 (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
- Date modified: