Patented Medicines (Notice of Compliance) Regulations

6 (1) The first person or an owner of a patent who receives a notice of allegation referred to in paragraph 5(3)(a) may, within 45 days after the day on which the first person is served with the notice, bring an action against the second person in the Federal Court for a declaration that the making, constructing, using or selling of a drug in accordance with the submission or supplement referred to in subsection 5(1) or (2) would infringe any patent or certificate of supplementary protection that is the subject of an allegation set out in that notice.

(2) If the person who brings an action under subsection (1) is not the owner of each patent — or of a patent that is set out in each certificate of supplementary protection — that is the subject of the action, the owner of each of those patents shall be or be made a party to the action.

(3) The second person may bring a counterclaim for a declaration

• (a) under subsection 60(1) or (2) of the Patent Act in respect of any patent claim asserted in the action brought under subsection (1); or

• (b) under 125(1) or (2) of that Act in respect of any claim, asserted in the action brought under subsection (1), in the patent set out in the certificate of supplementary protection in question in that action.

(4) If the Federal Court makes a declaration referred to in subsection (1), it may order any other remedy that is available under the Patent Act, or at law or in equity, in respect of infringement of a patent or a certificate of supplementary protection.