Patent Act (R.S.C., 1985, c. P-4)

Marginal note:Interpretation

• 105 (1) For the purposes of this section and sections 106 to 134, if a patent is reissued under section 47, it is deemed to have been granted on the day on which the original patent was granted and its application filing date is deemed to be the day on which the application for the original patent was filed.

• Marginal note:Human and veterinary uses

  (2) For the purposes of this section and sections 106 to 134, a medicinal ingredient or combination of medicinal ingredients contained in a drug authorized for human use and a medicinal ingredient or combination of medicinal ingredients contained in a drug authorized for veterinary use are to be treated as different medicinal ingredients or different combinations of medicinal ingredients, as the case may be.

• Marginal note:Same medicinal ingredient — human use

  (3) If medicinal ingredients contained in drugs authorized for human use differ from each other only with respect to a prescribed variation, they are to be treated as the same medicinal ingredient for the purposes of this section and sections 106 to 134.

• Marginal note:Same medicinal ingredient — veterinary use

  (4) If medicinal ingredients contained in drugs authorized for veterinary use differ from each other only with respect to a prescribed variation, they are to be treated as the same medicinal ingredient for the purposes of this section and sections 106 to 134.

• Marginal note:Same combination — human use

  (5) If combinations of medicinal ingredients contained in drugs authorized for human use differ from each other only with respect to a variation in the ratio between those ingredients, they are to be treated as the same combination of medicinal ingredients for the purposes of this section and sections 106 to 134.

• Marginal note:Same combination — veterinary use

  (6) If combinations of medicinal ingredients contained in drugs authorized for veterinary use differ from each other only with respect to a variation in the ratio between those ingredients, they are to be treated as the same combination of medicinal ingredients for the purposes of this section and sections 106 to 134.

Application for Certificate of Supplementary Protection

Marginal note:Application

• 106 (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 referred to in 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.

Marginal note:Information to be provided

• 107 (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.

Marginal note:Order of priority — same authorization for sale

• 108 (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.

Marginal note:Applications with same authorization for sale and priority

109 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.

Marginal note:Declaration of non-compliance

• 110 (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.

Marginal note:Expiry of pending applications

• 111 (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.

Marginal note:Withdrawal

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

Certificate of Supplementary Protection

Marginal note:Issue of certificate

113 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.

Marginal note:Contents of certificate

114 A certificate of supplementary protection shall set out

• (a) the number, as recorded in the Patent Office, of the patent set out in the application;

• (b) the medicinal ingredient or combination of medicinal ingredients set out in the application;

• (c) a statement as to whether the certificate relates to use in humans or to veterinary use;

• (d) the number of the authorization for sale set out in the application; and

• (e) the day on which the certificate’s term begins and the day on which the term ends, as determined under section 116.

Marginal note:Scope of supplementary protection

• 115 (1) The issuance of a certificate of supplementary protection grants the certificate’s holder and their legal representatives, during the certificate’s term, the same rights, privileges and liberties that are granted by the patent set out in the certificate, but only with respect to the making, constructing, using and selling of any drug that contains the medicinal ingredient, or combination of medicinal ingredients, set out in the certificate, by itself or in addition to any other medicinal ingredient.

• Marginal note:No infringement — export

  (2) Despite subsection (1), it is not an infringement of the certificate of supplementary protection for any person to make, construct, use or sell the medicinal ingredient or combination of medicinal ingredients for the purpose of export from Canada.

Marginal note:Validity

• 116 (1) After the certificate is issued, it shall, in the absence of any evidence to the contrary, be valid and avail the holder and the holder’s legal representatives for its term.

• Marginal note:Taking effect

  (2) A certificate of supplementary protection takes effect on the expiry of the term referred to in section 44, without taking into account section 46, of the patent set out in the certificate, but the certificate takes effect only if the patent remains valid until, and is not void before, the expiry of that term.

• Marginal note:Calculation of term

  (3) The certificate’s term is calculated by subtracting five years from the period beginning on the filing date of the application for the patent and ending on the day on which the authorization for sale set out in the certificate is issued, but in any event is for a maximum of two years.

• Marginal note:Reduction in period

  (4) Despite subsection (3), if the person to whom the authorization for sale set out in the certificate is issued is also the patentee, the Minister may, if he or she is of the opinion that that person’s failure to act resulted in a period of unjustified delay in the process of obtaining the authorization for sale, reduce the term of the certificate when issuing it by the amount of that period.

• Marginal note:Never takes effect

  (5) A certificate of supplementary protection that has been issued never takes effect if the calculation of its term, including any reduction under subsection (3), produces a result of zero or a negative value.

• Marginal note:For greater certainty

  (6) For greater certainty, the certificate’s term runs concurrently with any additional term granted under section 46.1.

Marginal note:Revocation of certificate

117 The Minister shall revoke a certificate of supplementary protection in the prescribed circumstances.

Transfer

Marginal note:Transfer of patent

• 118 (1) Despite subsection 49(1), a certificate of supplementary protection, or an application for one, is not transferable other than by the transfer of the patent, or part of the patent, that is set out in the certificate or application.

• Marginal note:Whole of patent

  (2) If the whole of the patent is transferred, the certificate or application is transferred accordingly.

• Marginal note:Part of patent

  (3) If part of the patent is transferred, any part of the certificate or application — including, as the case may be, the whole of it — that corresponds to the transferred part of the patent is transferred accordingly.

• Marginal note:For greater certainty

  (4) For greater certainty, the transfer of part of an application for a certificate of supplementary protection does not result in its division into more than one application.