Patent Act (R.S.C., 1985, c. P-4)

Act current to 2016-04-12 and last amended on 2015-06-17. Previous Versions

Marginal note:Disclosure of information on website
  •  (1) Before exporting a product manufactured under an authorization, the holder of the authorization must establish a website on which is disclosed the prescribed information respecting the name of the product, the name of the country or WTO Member to which it is to be exported, the quantity that is authorized to be manufactured and sold for export and the distinguishing features of the product, and of its label and packaging, as required by regulations made under the Food and Drugs Act, as well as information identifying every known party that will be handling the product while it is in transit from Canada to the country or WTO Member to which it is to be exported.

  • Marginal note:Obligation to maintain

    (2) The holder must maintain the website during the entire period during which the authorization is valid.

  • Marginal note:Links to other websites

    (3) The Commissioner shall post and maintain on the website of the Canadian Intellectual Property Office a link to each website required to be maintained by the holder of an authorization under subsection (1).

  • Marginal note:Posting on the website

    (4) The Commissioner shall, within seven days of receipt, post on the website of the Canadian Intellectual Property Office each application for authorization filed under subsection 21.04(1).

  • 2004, c. 23, s. 1.
Marginal note:Export notice

 Before each shipment of any quantity of a product manufactured under an authorization, the holder of the authorization must, within fifteen days before the product is exported, provide to each of the following a notice, by certified or registered mail, specifying the quantity to be exported, as well as every known party that will be handling the product while it is in transit from Canada to the country or WTO Member to which it is to be exported:

  • (a) the patentee or each of the patentees, as the case may be;

  • (b) the country or WTO Member named in the authorization; and

  • (c) the person or entity that purchased the product to which the authorization relates.

  • 2004, c. 23, s. 1.
Marginal note:Royalty
  •  (1) Subject to subsections (3) and (4), on the occurrence of a prescribed event, the holder of an authorization is required to pay to the patentee or each patentee, as the case may be, a royalty determined in the prescribed manner.

  • Marginal note:Factors to consider when making regulations

    (2) In making regulations for the purposes of subsection (1), the Governor in Council must consider the humanitarian and non-commercial reasons underlying the issuance of authorizations under subsection 21.04(1).

  • Marginal note:Time for payment

    (3) The royalties payable under this section must be paid within the prescribed time.

  • Marginal note:Federal Court may determine royalty

    (4) The Federal Court may, in relation to any authorization, make an order providing for the payment of a royalty that is greater than the royalty that would otherwise be required to be paid under subsection (1).

  • Marginal note:Application and notice

    (5) An order may be made only on the application of the patentee, or one of the patentees, as the case may be, and on notice of the application being given by the applicant to the holder of the authorization.

  • Marginal note:Contents of order

    (6) An order may provide for a royalty of a fixed amount or for a royalty to be determined as specified in the order, and the order may be subject to any terms that the Federal Court considers appropriate.

  • Marginal note:Conditions for making of order

    (7) The Federal Court may make an order only if it is satisfied that the royalty otherwise required to be paid is not adequate remuneration for the use of the invention or inventions to which the authorization relates, taking into account

    • (a) the humanitarian and non-commercial reasons underlying the issuance of the authorization; and

    • (b) the economic value of the use of the invention or inventions to the country or WTO Member.

  • 2004, c. 23, s. 1.
Marginal note:Duration

 An authorization granted under subsection 21.04(1) is valid for a period of two years beginning on the day on which the authorization is granted.

  • 2004, c. 23, s. 1.
Marginal note:Use is non-exclusive

 The use of a patented invention under an authorization is non-exclusive.

  • 2004, c. 23, s. 1.
Marginal note:Authorization is non-transferable

 An authorization is non-transferable, other than where the authorization is an asset of a corporation or enterprise and the part of the corporation or enterprise that enjoys the use of the authorization is sold, assigned or otherwise transferred.

  • 2004, c. 23, s. 1.
Marginal note:Renewal
  •  (1) The Commissioner shall, on the application of the person to whom an authorization was granted and on the payment of the prescribed fee, renew the authorization if the person certifies under oath in the renewal application that the quantities of the pharmaceutical product authorized to be exported were not exported before the authorization ceases to be valid and that the person has complied with the terms of the authorization and the requirements of sections 21.06 to 21.08.

  • Marginal note:One renewal

    (2) An authorization may be renewed only once.

  • Marginal note:When application must be made

    (3) The application for renewal must be made within the 30 days immediately before the authorization ceases to be valid.

  • Marginal note:Duration

    (4) An authorization that is renewed is valid for a period of two years beginning on the day immediately following the day of the expiry of the period referred to in section 21.09 in respect of the authorization.

  • Marginal note:Prescribed form

    (5) Applications for renewal and renewed authorizations issued under subsection (1) must be in the prescribed form.

  • 2004, c. 23, s. 1.
Marginal note:Termination

 Subject to section 21.14, an authorization ceases to be valid on the earliest of

  • (a) the expiry of the period referred to in section 21.09 in respect of the authorization, or the expiry of the period referred to in subsection 21.12(4) if the authorization has been renewed, as the case may be,

  • (b) the day on which the Commissioner sends, by registered mail, to the holder of the authorization a copy of a notice sent by the Minister of Health notifying the Commissioner that the Minister of Health is of the opinion that the pharmaceutical product referred to in paragraph 21. 04(3)(b) has ceased to meet the requirements of the Food and Drugs Act and its regulations,

  • (c) the day on which the last of the pharmaceutical product authorized by the authorization to be exported is actually exported,

  • (d) thirty days after the day on which

    • (i) the name of the pharmaceutical product authorized to be exported by the authorization is removed from Schedule 1, or

    • (ii) the name of the country or WTO Member to which the pharmaceutical product was, or is to be, exported is removed from Schedule 2, 3 or 4, as the case may be, and not added to any other of those Schedules, and

  • (e) on any other day that is prescribed.

  • 2004, c. 23, s. 1.
Marginal note:Termination by Federal Court

 On the application of a patentee, and on notice given by the patentee to the person to whom an authorization was granted, the Federal Court may make an order, on any terms that it considers appropriate, terminating the authorization if the patentee establishes that

  • (a) the application for the authorization or any of the documents provided to the Commissioner in relation to the application contained any material information that is inaccurate;

  • (b) the holder of the authorization has failed to establish a website as required by section 21.06, has failed to disclose on that website the information required to be disclosed by that section or has failed to maintain the website as required by that section;

  • (c) the holder of the authorization has failed to provide a notice required to be given under section 21.07;

  • (d) the holder of the authorization has failed to pay, within the required time, any royalty required to be paid as a result of the authorization;

  • (e) the holder of the authorization has failed to comply with subsection 21.16(2);

  • (f) the product exported to the country or WTO Member, as the case may be, under the authorization has been, with the knowledge of the holder of the authorization, re-exported in a manner that is contrary to the General Council Decision;

  • (g) the product was exported, other than in the normal course of transit, to a country or WTO Member other than the country or WTO Member named in the authorization;

  • (h) the product was exported in a quantity greater than the quantity authorized to be manufactured; or

  • (i) if the product was exported to a country that is not a WTO Member, the country has permitted the product to be used for commercial purposes or has failed to adopt the measures referred to in Article 4 of the General Council Decision.

  • 2004, c. 23, s. 1.
 
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