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

Regulations are current to 2017-11-06 and last amended on 2017-09-21. Previous Versions

Patented Medicines (Notice of Compliance) Regulations

SOR/93-133

PATENT ACT

Registration 1993-03-12

Regulations Respecting a Notice of Compliance Pertaining to Patented Medicines

P.C. 1993-502 1993-03-12

His Excellency the Governor General in Council, on the recommendation of the Minister of Consumer and Corporate Affairs, pursuant to subsection 55.2(4)Footnote * of the Patent Act, is pleased hereby to make the annexed Regulations respecting a notice of compliance pertaining to patented medicines.

Short Title

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

Interpretation

[SOR/2015-169, s. 1(F)]
  •  (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    claim for the medicine itself[Repealed, SOR/2006-242, s. 1]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    claim for the use of the medicine[Repealed, SOR/2006-242, s. 1]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.

  • SOR/98-166, s. 1;
  • SOR/99-379, s. 1;
  • SOR/2006-242, s. 1;
  • err. (E), Vol. 140, No. 23;
  • SOR/2008-211, s. 1;
  • SOR/2011-89, s. 1;
  • SOR/2015-169, s. 2;
  • SOR/2017-166, s. 1.

Register and Patent List

  •  (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.

  • SOR/98-166, s. 2;
  • SOR/2006-242, s. 2;
  • SOR/2011-89, s. 2;
  • SOR/2017-166, s. 2.
 
Date modified: