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

Short Title

1 These Regulations may be cited as the Patented Medicines (Notice of Compliance) Regulations.

Interpretation

• 2 (1) In these Regulations,

  claim for the dosage form

  claim for the dosage form means a claim for a delivery system for administering a medicinal ingredient in a drug or a formulation of a drug that includes within its scope that medicinal ingredient or formulation; (revendication de la forme posologique)

  claim for the formulation

  claim for the formulation means a claim for a mixture that is composed of medicinal and non-medicinal ingredients, that is contained in a drug and that is administered to a patient in a particular dosage form; (revendication de la formulation)

  claim for the medicinal ingredient

  claim for the medicinal ingredient includes a claim in the patent for the medicinal ingredient, whether chemical or biological in nature, when prepared or produced by the methods or processes of manufacture particularly described and claimed in the patent, or by their obvious chemical equivalents, and also includes a claim for different polymorphs of the medicinal ingredient, but does not include different chemical forms of the medicinal ingredient; (revendication de l’ingrédient médicinal)

  claim for the medicine itself

  claim for the medicine itself[Repealed, SOR/2006-242, s. 1]

  claim for the use of the medicinal ingredient

  claim for the use of the medicinal ingredient means a claim for the use of the medicinal ingredient for the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms; (revendication de l’utilisation de l’ingrédient médicinal)

  claim for the use of the medicine

  claim for the use of the medicine[Repealed, SOR/2006-242, s. 1]

  court

  court[Repealed, SOR/2017-166, s. 1]

  expire

  expire means

  • (a) in relation to a patent, expire, lapse or terminate by operation of law; and

  • (b) in relation to a certificate of supplementary protection, expire or terminate by operation of law; (expiré)

  first person

  first person means the person referred to in subsection 4(1); (première personne)

  medicine

  medicine[Repealed, SOR/2006-242, s. 1]

  Minister

  Minister means the Minister of Health; (ministre)

  notice of compliance

  notice of compliance means a notice issued under section C.08.004 or C.08.004.01 of the Food and Drug Regulations; (avis de conformité)

  patent list

  patent list means a list submitted under subsection 4(1); (liste de brevets)

  register

  register means the register maintained by the Minister in accordance with subsection 3(2); (registre)

  second person

  second person means the person referred to in subsection 5(1) or (2) who files a submission or supplement referred to in those subsections. (seconde personne)

• (2) For the purposes of the definition claim for the formulation in subsection (1), the claim for the formulation need not specify the non-medicinal ingredients contained in the drug.

• (3) In these Regulations, a reference to the owner of a patent includes the owner of a patent set out in a certificate of supplementary protection.

Register and Patent List

• 3 (1) The following definitions apply in this section and in section 4.

  identification number

  identification number means a number, preceded by the letters “DIN”, that is assigned for a drug in accordance with subsection C.01.014.2(1) of the Food and Drug Regulations. (identification numérique)

  new drug submission

  new drug submission means a new drug submission or an extraordinary use new drug submission as those terms are used in Division 8 of Part C of the Food and Drug Regulations, but excludes such a submission that is based solely on the change of name of the manufacturer. (présentation de drogue nouvelle)

  supplement to a new drug submission

  supplement to a new drug submission means a supplement to a new drug submission or a supplement to an extraordinary use new drug submission as those terms are used in Division 8 of Part C of the Food and Drug Regulations, but excludes such a supplement that is based solely on one or more of the matters mentioned in any of paragraphs C.08.003(2)(b) and (d) to (g) and subparagraphs C.08.003(2)(h)(iv) and (v) of those Regulations. (supplément à une présentation de drogue nouvelle)

• (2) The Minister shall maintain a register of patents that have been submitted for addition to the register and certificates of supplementary protection in which any of those patents are set out

  • (a) by adding any patent on a patent list or certificate of supplementary protection that meets the requirements for addition to the register;

  • (b) by refusing to add any patent or certificate of supplementary protection that does not meet the requirements for addition to the register;

  • (c) by deleting any patent or certificate of supplementary protection

    • (i) that was added to the register due to an administrative error,

    • (ii) that has, under subsection 60(1) or 125(1) of the Patent Act, been declared to be invalid or void,

    • (iii) that has, under subsection 6.07(1), been declared to be ineligible for inclusion on the register, or

    • (iv) the deletion of which was requested by the first person in respect of the patent list that includes that patent;

  • (d) by deleting, in respect of a new drug submission or a supplement to a new drug submission, any patent that has expired, unless a certificate of supplementary protection in which the patent is set out is included on the register in respect of that submission or supplement; and

  • (e) by deleting any certificate of supplementary protection that has expired.

• (2.1) The Minister is not permitted to make a deletion referred to in subparagraph (2)(c)(iii) based on a decision by the Federal Court before the later of the day on which the period for appealing that decision to the Federal Court of Appeal ends and the day on which any appeal of that decision to the Federal Court of Appeal is discontinued or dismissed.

• (2.2) The Minister shall add any patent or certificate of supplementary protection to the register that has been deleted under subparagraph (2)(c)(ii) or (iii) based on a decision that subsequently is reversed or set aside on appeal.

• (2.3) The Minister may review the register to determine whether any patents or certificates of supplementary protection do not meet the requirements for inclusion on the register and, if the Minister conducts that review, shall delete any patent or certificate of supplementary protection that is determined not to meet those requirements.

• (3) If a patent is listed on the register in respect of a new drug submission or supplement to a new drug submission for a drug for which the identification number has been cancelled under paragraph C.01.014.6(1)(a) of the Food and Drug Regulations, the Minister shall delete the patent from the register 90 days after the date of cancellation.

• (4) Subsection (3) does not apply if the identification number is cancelled under paragraph C.01.014.6(1)(a) of the Food and Drug Regulations because of a change in manufacturer.

• (5) If, after an identification number is cancelled under paragraph C.01.014.6(1)(a) of the Food and Drug Regulations, an identification number is assigned for the same drug, the Minister shall add to the register the patent that was deleted under subsection (3) when the Minister receives the document required by section C.01.014.3 of the Food and Drug Regulations in respect of the drug.

• (6) The register shall be open to public inspection during business hours.

• (7) No patent on a patent list or certificate of supplementary protection shall be added to the register until after the Minister has issued a notice of compliance in respect of the new drug submission or the supplement to a new drug submission, as the case may be, to which the patent or certificate of supplementary protection relates.

• (8) For the purpose of determining whether a patent or certificate of supplementary protection is to be added to or deleted from the register, the Minister may consult with officers or employees of the Patent Office.

• 3.1 (1) The Minister shall not delete from the register a patent on a patent list that was submitted before June 17, 2006, unless

  • (a) the patent has expired;

  • (b) a court has, under subsection 60(1) of the Patent Act, declared that the patent is invalid or void;

  • (c) the identification number assigned to the drug in respect of which the patent is listed is cancelled under paragraph C.01.014.6(1)(a) of the Food and Drug Regulations; or

  • (d) the first person in respect of that patent list requests the Minister to delete the patent.

• (2) The Minister shall not refuse to add to the register a patent on a patent list that was submitted before June 17, 2006 solely on the basis that the patent is not relevant to the submission for a notice of compliance to which the patent list relates.

3.2 [Repealed, SOR/2017-166, s. 4]

• 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.