Patented Medicines (Notice of Compliance) Regulations

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claim for the medicine itself[Repealed, SOR/2006-242, s. 1]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claim for the use of the medicine[Repealed, SOR/2006-242, s. 1]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court[Repealed, SOR/2017-166, s. 1]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medicine[Repealed, SOR/2006-242, s. 1]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.