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• (a) [Repealed, SOR/98-166, s. 6]

• (b) the day on which the second person complies with section 5,

• (c) subject to subsection (3), the expiration of any patent on the register that is not the subject of an allegation,

• (d) subject to subsection (3), the expiration of 45 days after the receipt of proof of service of a notice of allegation under paragraph 5(3)(a) in respect of any patent on the register,

• (e) subject to subsections (2), (3) and (4), the expiration of 24 months after the receipt of proof of the making of any application under subsection 6(1), and

• (f) the expiration of any patent that is the subject of an order pursuant to subsection 6(1).

(2) Paragraph (1)(e) does not apply if at any time, in respect of each patent that is the subject of an application pursuant to subsection 6(1),

• (a) the patent has expired; or

• (b) the court has declared that the patent is not valid or that 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.

(3) Paragraphs (1)(c), (d) and (e) do not apply in respect of a patent if the owner of the patent has consented to the making, constructing, using or selling of the drug in Canada by the second person.

(4) Paragraph (1)(e) ceases to apply in respect of an application under subsection 6(1) if the application is withdrawn or discontinued by the first person or is dismissed by the court hearing the application.

(5) If the court has not yet made an order under subsection 6(1) in respect of an application, the court may

• (a) shorten the time limit referred to in paragraph (1)(e) if the first and second persons consent to it or if the court finds that the first person has failed, at any time during the proceeding, to reasonably cooperate in expediting the application; or

• (b) extend the time limit referred to in paragraph (1)(e) if the first and second persons consent to it or if the court finds that the second person has failed, at any time during the proceeding, to reasonably cooperate in expediting the application.