Patent Act (R.S.C., 1985, c. P-4)

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Act current to 2019-06-20 and last amended on 2018-12-13. Previous Versions

Supplementary Protection for Inventions — Medicinal Ingredients (continued)

Application for Certificate of Supplementary Protection

Marginal note:Application

  •  (1) On the payment of the prescribed fee, a patentee may apply to the Minister for a certificate of supplementary protection for a patented invention if all of the following conditions are met:

    • (a) the patent is not void and it meets any prescribed requirements;

    • (b) the filing date for the application for the patent is on or after October 1, 1989;

    • (c) the patent pertains in the prescribed manner to a medicinal ingredient, or combination of medicinal ingredients, contained in a drug for which an authorization for sale of the prescribed kind was issued on or after the day on which this section comes into force;

    • (d) the authorization for sale is the first authorization for sale that has been issued with respect to the medicinal ingredient or the combination of medicinal ingredients, as the case may be;

    • (e) no other certificate of supplementary protection has been issued with respect to the medicinal ingredient or the combination of medicinal ingredients, as the case may be;

    • (f) if an application for a marketing approval, equivalent to an authorization for sale, was submitted in a prescribed country with respect to the medicinal ingredient or combination of medicinal ingredients, as the case may be, before the application for the authorization for sale was filed with the Minister, the application for the authorization for sale was filed before the end of the prescribed period that begins on the day on which the first such application for a marketing approval was submitted.

  • Marginal note:Issuance — paragraph (1)(e)

    (2) Another certificate of supplementary protection is considered to have been issued for the purposes of paragraph (1)(e) even if that other certificate is subsequently held to be invalid or void or it never takes effect or ceases to have effect.

  • Marginal note:When application to be filed

    (3) An application for a certificate of supplementary protection shall be filed with the Minister before the end of the prescribed period that begins on

    • (a) the day on which the authorization for sale is issued, if the patent is granted on or before that day; or

    • (b) the day on which the patent is granted, if the patent is granted after the day on which the authorization for sale is issued.

  • Marginal note:Exception

    (4) Despite subsection (3), no application shall be filed within the prescribed period preceding the expiry of the term of the patent under section 44 without taking into account section 46.

  • Marginal note:Contents of application

    (5) An application for a certificate of supplementary protection shall

    • (a) set out the number, as recorded in the Patent Office, of the patent — as well as the medicinal ingredient or combination of medicinal ingredients and the number of the authorization for sale — in relation to which the certificate is sought;

    • (b) if paragraph (1)(f) applies with respect to the application, specify the day on which the first application for a marketing approval that is equivalent to an authorization for sale was made and the country in which that application was made; and

    • (c) set out any prescribed information.

  • Marginal note:One patent per application

    (6) Each application is permitted to set out only one patent.

  • 2017, c. 6, s. 59

Marginal note:Information to be provided

  •  (1) An applicant shall provide the Minister with any additional information that the Minister considers necessary.

  • Marginal note:Refusal

    (2) Whenever the Minister is satisfied that any of the requirements set out in section 106 are not met with respect to an application for a certificate of supplementary protection, the Minister may refuse the application. The Minister shall notify the applicant of a refusal and of the grounds for it.

  • 2017, c. 6, s. 59

Marginal note:Order of priority — same authorization for sale

  •  (1) Subsections (2) to (4) apply in determining the priority of applications for a certificate of supplementary protection that set out the same authorization for sale.

  • Marginal note:Patents granted on or before authorization for sale

    (2) An application setting out a patent that was granted on or before the day on which the authorization for sale was issued has the same priority as every other such application.

  • Marginal note:Priority over patents granted after authorization for sale

    (3) An application setting out a patent that was granted on or before the day on which the authorization for sale was issued has priority over an application setting out a patent that is granted after that date.

  • Marginal note:Patents granted after authorization for sale — priority

    (4) Priority among applications setting out patents that were granted after the day on which the authorization for sale was issued is established according to the date on which the patent was granted, with an earlier date having priority over a later date and patents granted on the same date having the same priority.

  • 2017, c. 6, s. 59

Marginal note:Applications with same authorization for sale and priority

 If two or more pending applications set out the same authorization for sale and have the same priority, the Minister shall provide each applicant with a written notice setting out the name and contact information of all the applicants, as well as the number, as recorded in the Patent Office, of the patent set out in each application.

  • 2017, c. 6, s. 59

Marginal note:Declaration of non-compliance

  •  (1) A pending application for a certificate of supplementary protection may be declared invalid or void by the Federal Court for non-compliance with section 106 at the instance of another applicant whose application for a certificate sets out the same authorization for sale and the same priority.

  • Marginal note:Limitation

    (2) A proceeding to obtain a declaration under subsection (1) shall be commenced before the end of the prescribed period that begins on the day that is specified by the Minister in the written notice sent under section 109.

  • Marginal note:Copy to Minister

    (3) Anyone who commences such a proceeding, or an appeal or application for leave to appeal with respect to such a proceeding, shall provide the Minister with a copy of

    • (a) any document that commences the proceeding, appeal or application, immediately after the document is filed with the court; and

    • (b) any document that marks the end of the proceeding, appeal or application, immediately after the document is issued by or filed with the court.

  • 2017, c. 6, s. 59

Marginal note:Expiry of pending applications

  •  (1) If two or more applications that set out the same authorization for sale and have the same priority are still pending at the end of the prescribed period that begins on the day specified in the written notice sent under section 109, all of those applications expire at that end of that period. However, if any proceedings are brought under section 110 with respect to any of those applications, all of those applications — if two or more are still pending — expire at the end of the prescribed period that begins on the day on which the last of any of the proceedings to be completed is finally disposed of.

  • Marginal note:Expiry of application with lower priority

    (2) A pending application that sets out the same authorization for sale as another application of higher priority expires on the day on which the Minister issues a certificate of supplementary protection in respect of that other application.

  • 2017, c. 6, s. 59

Marginal note:Withdrawal

 An applicant for a certificate of supplementary protection may withdraw their application in accordance with the regulations.

  • 2017, c. 6, s. 59

Certificate of Supplementary Protection

Marginal note:Issue of certificate

 The Minister shall issue, to the patentee, a certificate of supplementary protection for the patented invention set out in the patentee’s application if, on the day of issuance,

  • (a) the Minister is satisfied that all requirements set out in section 106 are met;

  • (b) the applicable period referred to in subsection 106(3) for filing the application has ended;

  • (c) there is no other pending application that sets out the same authorization for sale and that has priority over, or the same priority as, the application; and

  • (d) any court proceedings, brought under section 110 with respect to the application or to another pending application that sets out the same authorization for sale and that has priority over, or the same priority as, the application, have been finally disposed of.

  • 2017, c. 6, s. 59
 
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