Patented Medicines (Notice of Compliance) Regulations — 5
reason to believe that the intended recipient of the document is not in Canada — refuse to do so unless that recipient attorns to the jurisdiction of the Federal Court with respect to the confidentiality of the information set out in the document. (3.9) A second person who is, under subparagraph (3)(c)(iii) or paragraph (3)(d), required to serve or provide a document to a first person referred to in paragraph (3)(a) may — if there is reason to believe that the first person is required to forward the document to the owner of a patent who is not in Canada — require that the first person forward it only if that owner attorns to the jurisdiction of the Federal Court with respect to the confidentiality of the information set out in the document. (4) A second person is not required to comply with (a) subsection (1) in respect of a patent, or a certificate of supplementary protection that sets out the patent, that is added to the register in respect of the other drug on or after the date of filing of the submission referred to in that subsection, including one added under subsection 3(2.2) or (5); and (b) subsection (2) in respect of a patent, or a certificate of supplementary protection that sets out the patent, that is added to the register in respect of the other drug on or after the date of filing of the supplement referred to in that subsection, including one added under subsection 3(2.2) or (5). (5) For the purposes of subsections (3) and (4), if subsection (1) or (2) applies to a submission or supplement referred to in paragraph C.07.003(b) of the Food and Drug Regulations , if the drug to which the comparison or reference is made is an innovative drug within the meaning of subsection C.08.004.1(1) of those Regulations and if the date of filing of the submission or supplement is less than six years from the day on which the first notice of compliance was issued in respect of the innovative drug, the deemed date of filing of the submission or supplement is six years after the date of issuance of the notice of compliance. (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 (b) the date of the cancellation by the second person of the submission or supplement to which the allegation relates. (6.1) Within five days after the day on which the first person is served under subsection (6), they shall, if they are not the owner of any patent to which the notice of allegation relates, forward to the owner of that patent a copy of the notice of retraction. (7) A person who brings an action under subsection 6 (1) in response to a notice of allegation shall, if the notice is retracted in accordance with subsection (6), file without delay a notice of discontinuance. SOR/98-166, ss. 4, 9; SOR/99-379, s. 2; SOR/2006-242, s. 2; err. (E), Vol. 140, No. 23; SOR/2011-89, s. 4; SOR/2017-166, s. 6