Patented Medicines (Notice of Compliance) Regulations — 5
5 (1) If a second person files a submission for a notice of compliance in respect of a drug and the submission directly or indirectly compares the drug with, or makes reference to, another drug marketed in Canada under a notice of compliance issued to a first person and in respect of which a patent list has been submitted, the second person shall include in the submission the required statements or allegations set out in subsection (2.1). (2) If a second person files a supplement to a submission referred to in subsection (1) seeking a notice of compliance for a change in formulation, a change in dosage form or a change in use of the medicinal ingredient and the supplement directly or indirectly compares the drug for which the supplement is filed with, or makes reference to, another drug that has been marketed in Canada under a notice of compliance issued to a first person and in respect of which a patent list has been submitted, the second person shall include in the supplement the required statements or allegations set out in subsection (2.1). (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: (a) a statement that the owner of that patent has consented to the making, constructing, using or selling in Canada of the drug for which the submission or supplement is filed by the second person; (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 (c) an allegation that (i) the statement made by the first person under paragraph 4(4)(d) is false, (ii) that patent or certificate of supplementary protection is invalid or void, (iii) that patent or certificate of supplementary protection is ineligible for inclusion on the register, (iv) that patent or certificate of supplementary protection would not be infringed by the second person making, constructing, using or selling the drug for which the submission or the supplement is filed, (v) that patent or certificate of supplementary protection has expired, or (vi) in the case of a certificate of supplementary protection, that certificate of supplementary protection cannot take effect. (3) A second person who makes an allegation referred to in paragraph (2.1)(c) shall (a) serve on the first person a notice of allegation relating to the submission or supplement filed under subsection (1) or (2) on or after its date of filing; (b) include in the notice of allegation (i) a description of the medicinal ingredient, dosage form, strength, route of administration and use of the drug in respect of which the submission or supplement has been filed, and (ii) a statement of the legal and factual basis for the allegation, which statement must be detailed in the case of an allegation that the patent or certificate of supplementary protection is invalid or void; (c) serve the following documents with the notice: (i) a certification by the Minister of the date of filing of the submission or supplement, (ii) a document setting out the second person’s address for service for the purpose of any action that may be brought against them under subsection 6 (1), along with the names of and contact information for their anticipated solicitors of record if that action is brought, (iii) a searchable electronic copy of the portions of the submission or supplement that are under the control of the second person and relevant to determine if any patent or certificate of supplementary protection referred to in the allegation would be infringed, and (iv) if the second person is alleging that the patent or certificate of supplementary protection is invalid or void, an electronic c