Certificate of Supplementary Protection Regulations

Certificate of Supplementary Protection Regulations His Excellency the Governor General in Council, on the recommendation of the Minister of Industry, pursuant to paragraphs 12(1)(g)a, (h)b and (k)b and subsection 134(1)c of the Patent Actd, makes the annexed Certificate of Supplementary Protection Regulations. S.C. 2017, c. 6, s. 34(2) R.S., c. 33 (3rd Supp.), s. 3 S.C. 2017, c. 6, s. 59 R.S., c. P-4 Definition of Act In these Regulations, Act means the Patent Act. Definition of authorization for sale In these Regulations and for the purposes of section 104 of the Act, authorization for sale means an authorization under the Food and Drugs Act, or any predecessor enactment relating to the same subject matter, that permits the sale of a drug in Canada, but does not include an interim order permitting the sale of a drug under section 30.1 of that Act, a certificate issued under section C.08.015 of the Food and Drug Regulations, an exemption under subsection C.10.002(1) or C.10.008(1) of those Regulations or an authorization under section C.05.006, C.05.008 or C.08.010 or subsection C.11.003(1) or C.11.014(1) of those Regulations, section 67 or 71 of the Natural Health Products Regulations or section 21 or subsection 24(2) of the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations. Variations For the purposes of subsections 105(3) and (4) of the Act, the prescribed variations are a variation in any appendage within the molecular structure of a medicinal ingredient that causes it to be an ester, salt, complex, chelate, clathrate or any non-covalent derivative; a variation that is an enantiomer, or a mixture of enantiomers, of a medicinal ingredient; a variation that is a solvate or polymorph of a medicinal ingredient; an in vivo or in vitro post-translational modification of a medicinal ingredient; and any combination of the variations set out in paragraphs (a) to (d). Eligible patents — requirement For the purpose of paragraph 106(1)(a) of the Act, the prescribed requirement is that the patent must be in force. Eligible patents — manners of pertinence to medicinal ingredients For the purpose of paragraph 106(1)(c) of the Act, the prescribed manners in which a patent may pertain to a medicinal ingredient or combination of medicinal ingredients are the following: the patent contains a claim for the medicinal ingredient or combination of all the medicinal ingredients contained in a drug for which the authorization for sale set out in the application for a certificate of supplementary protection was issued; the patent contains a claim for the medicinal ingredient or combination of all the medicinal ingredients as obtained by a specified process and contained in a drug for which the authorization for sale set out in the application for a certificate of supplementary protection was issued; and the patent contains a claim for a use of the medicinal ingredient or combination of all the medicinal ingredients contained in a drug for which the authorization for sale set out in the application for a certificate of supplementary protection was issued. Authorization for sale For the purpose of paragraph 106(1)(c) of the Act, the prescribed kind of authorization for sale is a notice of compliance issued under section C.08.004 or C.08.004.01 of the Food and Drug Regulations. Consultation with Patent Office The Minister may consult with the officers or employees of the Patent Office about any matter relating to a patent that is set out in a certificate of supplementary protection or in an application for a certificate of supplementary protection. Countries and period For the purpose of paragraph 106(1)(f) of the Act, the prescribed countries are the European Union and any country that is a member of the European Union, the United States of America, Australia, Switzerland, Japan, and the United Kingdom; and the prescribed period for filing the application for the authorization for sale is 24 months, if the application for a certificate of supplementary protection was filed no later than the first anniversary of the day on which section 59 of the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act comes into force, and 12 months, in any other case. Period — filing application for certificate For the purpose of subsection 106(3) of the Act, the prescribed period for filing the application for a certificate of supplementary protection is 120 days. Content of application An application for a certificate of supplementary protection must contain the applicant’s name and contact information in Canada, including their complete address; the filing date of the application for the patent, the date on which the patent was granted and the date on which the term referred to in section 44 of the Act will expire; the applicant’s attestation, as the case may be, that the applicant is the patentee and is recorded as an owner of the patent in the Patent Office or that they are the manufacturer who is authorized under section 8 to file the application; the applicant’s attestation that when the application was filed for the authorization for sale referred to in paragraph 106(1)(c) of the Act, no application for a marketing approval, equivalent to an authorization for sale, with respect to the medicinal ingredient or combination of medicinal ingredients, as the case may be, set out in the application for the certificate of supplementary protection had been submitted in a country prescribed by paragraph (1)(a), or if one or more of those applications for a marketing approval had been submitted in one or more of those countries, the application for the authorization for sale referred to in paragraph 106(1)(c) of the Act was filed before the end of the prescribed period referred to in paragraph (1)(b) that begins on the day of submission of the first of those marketing approval applications; and a description of the method of payment used to pay the fee prescribed under subsection 9(1). Filing date The filing date of an application for a certificate of supplementary protection is the date on which the information required by paragraphs 106(5)(a) and (b) of the Act and the content required by subsection 6(3) of these Regulations are received by the Minister. Application by manufacturer A person recorded in the Patent Office as the owner of a patent may authorize a manufacturer to file on their behalf an application for a certificate of supplementary protection that sets out the patent if the authorization for sale in relation to which the certificate of supplementary protection is sought was issued to that manufacturer. Fee — application for certificate The fee payable on filing an application for a certificate of supplementary protection is $9,011. Beginning on April 1, 2018, the fee increases annually by an amount equal to 2% of the fee payable in the previous year, rounded up to the nearest dollar. Manner of payment The fee must be paid in Canadian currency to the account of the Receiver General for Canada. Period — commencement of proceeding For the purpose of subsection 110(2) of the Act, the prescribed period for commencing a proceeding referred to in that subsection is 90 days. Period — expiry of pending applications For the purpose of subsection 111(1) of the Act, the prescribed period for the expiry of pending applications for a certificate of supplementary protection is 90 days. However, if any proceedings have been commenced under section 110 of the Act and two or more applications are pending at the end of the 90-day period, the prescribed period for the expiry of all of the pending applications is 30 days after the day on which the last of those proceedings has been finally disposed of. Withdrawal of application An application for a certificate of supplementary protection is withdrawn on the day on which the Minister receives a notice of withdrawal from the applicant. Register The Minister must maintain an electronic register of applications for certificates of supplementary protection and certificates of supplementary protection that contains the following information: in the case of an application, the number of the patent as recorded in the Patent Office, the date on which the term referred to in section 44 of the Act expires, the medicinal ingredient or combination of medicinal ingredients and the number of the authorization for sale set out in the application, along with an indication of whether the authorization for sale relates to human use or veterinary use; and in the case of a certificate of supplementary protection, the number of the patent as recorded in the Patent Office, the medicinal ingredient or combination of medicinal ingredients and the number of the authorization for sale set out in the certificate of supplementary protection, the number of the certificate of supplementary protection, the day on which its term begins and on which its term ends, along with an indication of whether it relates to human use or veterinary use. Period — new patent notice For the purpose of subsection 122(1) of the Act, the prescribed period that begins on the day on which a new patent is issued under section 47 of the Act is 30 days. Correction of errors — application On the request of an applicant for a certificate of supplementary protection or with their consent, the Minister may, before the certificate of supplementary protection is issued, amend the application to correct any obvious error, including an obvious omission. However, after the expiry of the period prescribed by section 10, the Minister must not correct an error in the patent number that is set out in the application. Correction of errors — certificate The Minister may correct any obvious error, including an obvious omission, in a certificate of supplementary protection, on the basis of information that the Minister had, or could have obtained, on the day of its issuance. However, the Minister may also correct such an error that concerns how a medicinal ingredient, or a combination of medicinal ingredients, is set out on the basis of information that the Minister obtains after that day. Effect of correction A corrected application or certificate of supplementary protection has the same effect as if it were originally filed or issued in its corrected form. Coming into force These Regulations come into force on the day on which section 59 of the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act, chapter 6 of the Statutes of Canada, 2017, comes into force but, if they are registered after that day, they come into force on the day on which they are registered. [Note: Regulations in force September 21, 2017, see SI/2017-47.] In this section and in sections 11 to 15, Exceptional Importation and Shortages Interim Order No. 2 means the Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19, made by the Minister of Health on March 1, 2021 and published in Part I of the Canada Gazette on March 20, 2021. In sections 11 to 15, designated biocide, designated drug, designated food for a special dietary purpose, designated hand sanitizer and designated medical device have the same meaning as in the Exceptional Importation and Shortages Interim Order No. 2. A person who, immediately before the Exceptional Importation and Shortages Interim Order No. 2 ceased to have effect, was permitted, under subsection 30(2) of that Interim Order, to conduct an activity in respect of a designated hand sanitizer may continue to do so without holding an establishment licence that authorizes them to do so until the earliest of the occurrence of one of the circumstances referred to in paragraphs 30(2)(a) to (c) of that Interim Order, and September 1, 2023. In this section, new Regulations means the Food and Drug Regulations as they read on the day on which these Regulations come into force. A letter of authorization that was issued under subsection C.08.010(1) of the Food and Drug Regulations before the day on which these Regulations come into force is deemed to be an authorization issued under subsection C.11.003(1) of the new Regulations, if the medical emergency in respect of which the letter was issued is a public or Canadian Armed Forces health emergency.