Patented Medicines (Notice of Compliance) Regulations

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, in the submission, with respect to each patent on the register in respect of the other drug,

• (a) state that the second person accepts that the notice of compliance will not issue until the patent expires; or

• (b) allege that

  • (i) the statement made by the first person under paragraph 4(4)(d) is false,

  • (ii) the patent has expired,

  • (iii) the patent is not valid, or

  • (iv) no claim for the medicinal ingredient, no claim for the formulation, no claim for the dosage form and no claim for the use of the medicinal ingredient would be infringed by the second person making, constructing, using or selling the drug for which the submission is filed.

(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 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, in the supplement, with respect to each patent on the register in respect of the other drug,

• (a) state that the second person accepts that the notice of compliance will not issue until the patent expires; or

• (b) allege that

  • (i) the statement made by the first person under paragraph 4(4)(d) is false,

  • (ii) the patent has expired,

  • (iii) the patent is not valid, or

  • (iv) no claim for the medicinal ingredient, no claim for the formulation, no claim for the dosage form and no claim for the use of the medicinal ingredient would be infringed by the second person making, constructing, using or selling the drug for which the supplement is filed.

(3) A second person who makes an allegation under paragraph (1)(b) or (2)(b) 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 detailed statement of the legal and factual basis for the allegation;

• (c) include in the material served a certification by the Minister of the date of filing of the submission or supplement; and

• (d) serve proof of service of the documents and information referred to in paragraphs (a) to (c) on the Minister.

(4) A second person is not required to comply with

• (a) subsection (1) in respect of a patent 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 a patent added under subsection 3(5); and

• (b) subsection (2) in respect of a patent 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 a patent added under subsection 3(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.

(7) A first person who has applied for a prohibition order under subsection 6(1) in response to a notice of allegation shall, if the notice is retracted in accordance with subsection (6), apply without delay for a discontinuance of the proceedings.