Patented Medicines (Notice of Compliance) Regulations

4 (1) A first person who files or who has filed a new drug submission or a supplement to a new drug submission may submit to the Minister a patent list in relation to the submission or supplement for addition to the register.

(1.1) The patent list may include a patent whose term under section 44 of the Patent Act, without taking into account section 46 of that Act, has expired and that is set out in a certificate of supplementary protection that has taken effect.

(2) A patent on a patent list in relation to a new drug submission is eligible to be added to the register if the patent contains

• (a) a claim for the medicinal ingredient and the medicinal ingredient has been approved through the issuance of a notice of compliance in respect of the submission;

• (b) a claim for the formulation that contains the medicinal ingredient and the formulation has been approved through the issuance of a notice of compliance in respect of the submission;

• (c) a claim for the dosage form and the dosage form has been approved through the issuance of a notice of compliance in respect of the submission; or

• (d) a claim for the use of the medicinal ingredient, and the use has been approved through the issuance of a notice of compliance in respect of the submission.

(2.1) The following rules apply when determining the eligibility of a patent to be added to the register under subsection (2):

• (a) for the purposes of paragraph (2)(a), a patent that contains a claim for the medicinal ingredient is eligible even if the submission includes, in addition to the medicinal ingredient claimed in the patent, other medicinal ingredients;

• (b) for the purposes of paragraph (2)(b), a patent that contains a claim for the formulation is eligible if the submission includes the non-medicinal ingredients specified in the claim, if any are specified, even if the submission contains any additional non-medicinal ingredients; and

• (c) for the purposes of paragraph (2)(d), a patent that contains a claim for the use of the medicinal ingredient is eligible if the submission includes the use claimed in the patent, even if

  • (i) the submission includes additional medicinal ingredients,

  • (ii) the submission includes other additional uses of the medicinal ingredient, or

  • (iii) the use that is included in the submission requires the use of the medicinal ingredient in combination with another drug.

(3) A patent on a patent list in relation to a supplement to a new drug submission is eligible to be added to the register if the supplement is for a change in formulation, a change in dosage form or a change in use of the medicinal ingredient, and

• (a) in the case of a change in formulation, the patent contains a claim for the changed formulation that has been approved through the issuance of a notice of compliance in respect of the supplement;

• (b) in the case of a change in dosage form, the patent contains a claim for the changed dosage form that has been approved through the issuance of a notice of compliance in respect of the supplement; or

• (c) in the case of a change in use of the medicinal ingredient, the patent contains a claim for the changed use of the medicinal ingredient that has been approved through the issuance of a notice of compliance in respect of the supplement.

(3.1) A certificate of supplementary protection is eligible to be added to the register in respect of a new drug submission or a supplement to a new drug submission if

• (a) the patent that is set out in the certificate of supplementary protection is included on the register in respect of that submission or supplement; and

• (b) the submission or supplement relates to a drug with respect to which the certificate of supplementary protection grants rights, privileges and liberties referred to in section 115 of the Patent Act.

(4) A patent list shall contain the following:

• (a) an identification of the new drug submission or the supplement to a new drug submission to which the list relates;

• (b) the medicinal ingredient, brand name, dosage form, strength, route of administration and use set out in the new drug submission or the supplement to a new drug submission to which the list relates;

• (c) for each patent on the list, the patent number, the filing date of the patent application in Canada, the date of grant of the patent and the date on which the term limited for the duration of the patent will expire under section 44 or 45 of the Patent Act;

• (d) for each patent on the list, a statement that the first person who filed the new drug submission or the supplement to a new drug submission to which the list relates

  • (i) is the owner of the patent,

  • (ii) has an exclusive licence to the patent or to a certificate of supplementary protection in which that patent is set out, or

  • (iii) has obtained the consent of the owner of the patent to its inclusion on the list;

• (e) the address in Canada for service, on the first person, of a notice of allegation referred to in paragraph 5(3)(a) or the name and address in Canada of another person on whom service may be made with the same effect as if service were made on the first person; and

• (f) a certification by the first person that the information submitted under this subsection is accurate and that each patent on the list meets the eligibility requirements of subsection (2) or (3).

(5) Subject to subsection (6), a first person who submits a patent list must do so at the time the person files the new drug submission or the supplement to a new drug submission to which the patent list relates.

(6) A first person may, after the date of filing of a new drug submission or a supplement to a new drug submission, and within 30 days after the issuance of a patent that was issued on the basis of an application that has a filing date in Canada that precedes the date of filing of the submission or supplement, submit a patent list, including the information referred to in subsection (4), in relation to the submission or supplement.

(7) A first person who has submitted a patent list must keep the information on the list up to date but, in so doing, may not add a patent to the list.

(8) The Minister shall insert on the patent list the date of filing and submission number of the new drug submission or the supplement to a new drug submission in relation to which the list was submitted.