Patented Medicines (Notice of Compliance) Regulations (SOR/93-133)

8.1 A person who files a submission for a notice of compliance or a supplement to a submission for a notice of compliance in respect of a drug and who has reasonable grounds to believe that the making, constructing, using or selling of the drug might be alleged to infringe a patent or a certificate of supplementary protection is, if the submission or supplement directly or indirectly compares the drug with, or makes reference to, another drug marketed in Canada, an interested person

• (a) for the purpose of subsection 60(1) of the Patent Act with respect to bringing an action for a declaration that the patent or any claim in the patent is invalid or void; or

• (b) for the purpose of subsection 125(1) of that Act with respect to bringing an action for a declaration that the certificate of supplementary protection or any claim in the patent set out in it is invalid or void.

8.2 On receipt of a notice of allegation relating to a submission or supplement, a first person or owner of a patent may, under subsection 54(1) or 124(1) of the Patent Act, bring an action for infringement of a patent or certificate of supplementary protection — other than one that is the subject of an allegation set out in that notice — that could result from the making, constructing, using or selling of the drug in accordance with the submission or supplement.

Service

• 9 (1) Service of any document referred to in these Regulations shall be effected personally or by registered mail.

• (2) Service by registered mail shall be deemed to be effected on the addressee five days after mailing.