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Patent Act (R.S.C., 1985, c. P-4)

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Act current to 2022-07-25 and last amended on 2021-06-30. Previous Versions

Supplementary Protection for Inventions — Medicinal Ingredients (continued)

Application for Certificate of Supplementary Protection (continued)

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

Marginal note:Contents of certificate

 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.

  • 2017, c. 6, s. 59

Marginal note:Scope of supplementary protection

  •  (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.

  • 2017, c. 6, s. 59

Marginal note:Validity

  •  (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 under 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 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.

  • 2017, c. 6, s. 59

Marginal note:Revocation of certificate

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

  • 2017, c. 6, s. 59

Transfer

Marginal note:Transfer of patent

  •  (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.

  • 2017, c. 6, ss. 59, 135

Administrative Matters

Marginal note:Applications, fees and documents

 Applications, fees and documents relating to certificates of supplementary protection shall be submitted to the Minister.

  • 2017, c. 6, s. 59

Marginal note:Inspection by public

  •  (1) The Minister shall ensure that the prescribed contents of all certificates of supplementary protection and applications for a certificate are made available for public inspection under the conditions that may be prescribed.

  • Marginal note:Non-application

    (2) Subsection (1) does not apply with respect to the contents of applications for a certificate that are refused, declared invalid or void, expired or withdrawn.

  • 2017, c. 6, s. 59

Marginal note:Copy in case of loss or destruction

 The Minister may issue a certified copy of a certificate of supplementary protection to replace one that is lost or destroyed.

  • 2017, c. 6, s. 59

Marginal note:Issuance of patent under section 47

  •  (1) If a patent set out in a certificate of supplementary protection or in a pending application for such a certificate is surrendered, and a new patent is issued, under section 47, the holder of the certificate or the applicant shall, before the end of the prescribed period that begins on the day on which the new patent is issued, provide the Minister with written notice of the number, as recorded in the Patent Office, of the new patent to which the certificate or application relates.

  • Marginal note:One patent

    (2) If more than one new patent is issued under section 47, the holder of the certificate or the applicant shall provide the number for only one of the new patents.

  • Marginal note:New certificate

    (3) If notice is provided under subsection (1) by a holder of a certificate, the Minister shall issue a new certificate of supplementary protection, setting out the new patent number, to replace the original certificate. The new certificate’s term is the then unexpired term of the original certificate.

  • Marginal note:Effect of new certificate

    (4) The new certificate is deemed to have been issued on the day on which the new patent is issued. The original certificate and the new certificate have the same effect in law, in any action commenced after the issuance of the new certificate for any cause accruing after that issuance, as if the new patent had been set out in the original certificate; however, insofar as the claims of the new patent and the original patent are identical, the issuance of the new certificate does not affect any action pending at the time of the issuance of the new certificate or abate any cause of action that existed at that time and the new certificate constitutes a continuation of the original certificate and has effect accordingly.

  • Marginal note:Application

    (5) If notice is provided under subsection (1) by an applicant for a pending application, the Minister shall

    • (a) amend the application to set out the new patent number; and

    • (b) provide written notice of the amendment to any other applicant referred to in section 109 with respect to the application.

  • Marginal note:Effect of amendment to application

    (6) The amended application has the same effect, for the purposes of sections 106 to 113, as if the pending application had been originally filed in its amended form.

  • 2017, c. 6, s. 59

Use of Certificates of Supplementary Protection by Government

Marginal note:Application

 Sections 19 to 19.2 apply with respect to certificates of supplementary protection, with

  • (a) any reference to “patented invention” to be read, with any grammatical adaptations, as a reference to “invention protected by a certificate of supplementary protection”; and

  • (b) any reference to “patentee” to be read as a reference to “holder of the certificate of supplementary protection”.

  • 2017, c. 6, s. 59

Legal Proceedings in Respect of Certificates of Supplementary Protection

Marginal note:Admissible in evidence

 A written communication, or any part of such a communication, that is admissible under section 53.1 in respect of a patent set out in a certificate of supplementary protection may be admitted into evidence to any action or proceeding respecting the certificate of supplementary protection to rebut any representation made by the holder of the certificate of supplementary protection in the action or proceeding as to the construction of a claim in the patent set out in the certificate of supplementary protection.

  • 2018, c. 27, s. 197

Infringement and Impeachment

Marginal note:Action for infringement

  •  (1) An action for the infringement of a certificate of supplementary protection may be brought in the same manner as an action for the infringement of a patent, and the following provisions apply to the action:

    • (a) sections 54, 57 and 59, with any reference to “patent” to be read as a reference to “certificate of supplementary protection”;

    • (b) subsection 55(1), and subsection 55(3) as it applies to that subsection (1), with any reference to “patent” to be read as a reference to “certificate of supplementary protection”, any reference to “patentee” to be read as a reference to “holder of the certificate of supplementary protection” and any reference to “grant” to be read as a reference to “taking of effect”;

    • (c) section 55.01;

    • (d) section 55.1, with any reference to “patent” to be read as a reference to “certificate of supplementary protection” and any reference to “patented process” to be read as a reference to “process protected by the certificate of supplementary protection”;

    • (e) subsections 55.2(1) and (6), with any reference to “patent” to be read as a reference to “certificate of supplementary protection” and any reference to “patented invention” to be read as a reference to “invention protected by the certificate of supplementary protection”;

    • (f) subsection 55.3(1), with any reference to “patent” to be read as a reference to “certificate of supplementary protection”;

    • (g) section 58, with the reference to “a patent that contains two or more claims” to be read as a reference to a “two or more claims in a patent that is set out in a certificate of supplementary protection” and with the reference to “the patent as if it” to be read as a reference to “the certificate as if the patent set out in it”.

  • Marginal note:Regulations — subsection 55.2(4)

    (2) The Governor in Council may make regulations respecting the infringement of any certificate of supplementary protection that, directly or indirectly, could result or results from the making, construction, use or sale of a patented invention or invention protected by a certificate of supplementary protection in accordance with subsection 55.2(1), including regulations described in paragraphs 55.2(4)(a) to (k), with

    • (a) any reference in those paragraphs to a “patent” to be read as a reference to a “certificate of supplementary protection”; and

    • (b) the reference in paragraph 55.2(4)(k) to “subsection 60(1)” to be read as a reference to “subsection 125(1)”.

  • Marginal note:Regulations

    (2.1) The Governor in Council may make regulations respecting

    • (a) factors that the court may consider, must consider or is not permitted to consider in determining whether an act is, or is not, committed for the purpose of experimentation relating to the subject-matter of the certificate of supplementary protection; and

    • (b) circumstances in which an act is, or is not, committed for the purpose of experimentation relating to the subject-matter of the certificate of supplementary protection.

  • Marginal note:Inconsistency or conflict

    (3) In the event of an inconsistency or conflict between regulations made under subsection (2) and any Act of Parliament or regulations made under such an Act, the regulations made under subsection (2) prevail to the extent of the inconsistency or conflict.

  • 2017, c. 6, s. 59
  • 2018, c. 27, s. 198
 
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