Patent Act (R.S.C., 1985, c. P-4)

Act current to 2016-11-21 and last amended on 2016-06-24. Previous Versions

Marginal note:Notice to patentee

 The Commissioner shall, without delay, notify the patentee, or each of the patentees, as the case may be, in writing of any authorization granted in respect of the patentee’s invention.

  • 2004, c. 23, s. 1.
Marginal note:Obligation to provide copy of agreement
  •  (1) Within fifteen days after the later of the day on which the authorization was granted and the day on which the agreement for the sale of the product to which the authorization relates was entered into, the holder of an authorization must provide by certified or registered mail, the Commissioner and the patentee, or each patentee, as the case may be, with

    • (a) a copy of the agreement it has reached with the person or entity referred to in paragraph 21.04(2)(f) for the supply of the product authorized to be manufactured and sold, which agreement must incorporate information that is in all material respects identical to the information referred to in paragraphs 21.04(2)(a), (b), (e) and (f); and

    • (b) a solemn or statutory declaration in the prescribed form setting out

      • (i) the total monetary value of the agreement as it relates to the product authorized to be manufactured and sold, expressed in Canadian currency, and

      • (ii) the number of units of the product to be sold under the terms of the agreement.

  • Marginal note:Prohibition

    (2) The holder of an authorization may not export any product to which the authorization relates until after the holder has complied with subsection (1).

  • 2004, c. 23, s. 1.
Marginal note:Application when agreement is commercial in nature
  •  (1) If the average price of the product to be manufactured under an authorization is equal to or greater than 25 per cent of the average price in Canada of the equivalent product sold by or with the consent of the patentee, the patentee may, on notice given by the patentee to the person to whom an authorization was granted, apply to the Federal Court for an order under subsection (3) on the grounds that the essence of the agreement under which the product is to be sold is commercial in nature.

  • Marginal note:Factors for determining whether agreement is commercial in nature

    (2) In determining whether the agreement is commercial in nature, the Federal Court must take into account

    • (a) the need for the holder of the authorization to make a reasonable return sufficient to sustain a continued participation in humanitarian initiatives;

    • (b) the ordinary levels of profitability, in Canada, of commercial agreements involving pharmaceutical products, as defined in paragraph 1(a) of the General Council Decision; and

    • (c) international trends in prices as reported by the United Nations for the supply of such products for humanitarian purposes.

  • Marginal note:Order

    (3) If the Federal Court determines that the agreement is commercial in nature, it may make an order, on any terms that it considers appropriate,

    • (a) terminating the authorization; or

    • (b) requiring the holder to pay, in addition to the royalty otherwise required to be paid, an amount that the Federal Court considers adequate to compensate the patentee for the commercial use of the patent.

  • Marginal note:Additional order

    (4) If the Federal Court makes an order terminating the authorization, the Federal Court may also, if it considers it appropriate to do so, make an order, on any terms that it considers appropriate,

    • (a) requiring the holder to deliver to the patentee any of the product to which the authorization relates remaining in the holder’s possession as though the holder had been determined to have been infringing a patent; or

    • (b) with the consent of the patentee, requiring the holder to export any of the product to which the authorization relates remaining in the holder’s possession to the country or WTO Member named in the authorization.

  • Marginal note:Restriction

    (5) The Federal Court may not make an order under subsection (3) if, under the protection of a confidentiality order made by the Court, the holder of the authorization submits to a Court-supervised audit and that audit establishes that the average price of the product manufactured under the authorization does not exceed an amount equal to the direct supply cost of the product plus 15 per cent of that direct supply cost.

  • Marginal note:Definitions

    (6) The following definitions apply in this section.

    average price

    prix moyen

    average price means

    • (a) in relation to a product to be manufactured under an authorization, the total monetary value of the agreement under which the product is to be sold, expressed in Canadian currency, divided by the number of units of the product to be sold under the terms of the agreement; and

    • (b) in relation to an equivalent product sold by or with the consent of the patentee, the average of the prices in Canada of that product as those prices are reported in prescribed publications on the day on which the application for the authorization was filed. (prix moyen)

    direct supply cost

    coût direct de fourniture

    direct supply cost, in relation to a product to be manufactured under an authorization, means the cost of the materials and of the labour, and any other manufacturing costs, directly related to the production of the quantity of the product that is to be manufactured under the authorization. (coût direct de fourniture)

    unit

    unité

    unit, in relation to any product, means a single tablet, capsule or other individual dosage form of the product, and if applicable, in a particular strength. (unité)

  • 2004, c. 23, s. 1.
Marginal note:Advisory committee
  •  (1) The Minister and the Minister of Health shall establish, within three years after the day this section comes into force, an advisory committee to advise them on the recommendations that they may make to the Governor in Council respecting the amendment of Schedule 1.

  • Marginal note:Standing committee

    (2) The standing committee of each House of Parliament that normally considers matters related to industry shall assess all candidates for appointment to the advisory committee and make recommendations to the Minister and the Minister of Health on the eligibility and qualifications of those candidates.

  • 2004, c. 23, s. 1;
  • 2005, c. 18, s. 1.
Marginal note:Website for notices to Canada

 The person designated by the Governor in Council for the purpose of this section must maintain a website on which is set out a copy of every notice referred to in subparagraphs 21.04(3)(d)(ii) and (v) that is provided to the Government of Canada through diplomatic channels by a country that is not a WTO Member. The copy must be added to the website as soon as possible after the notice has been provided to the Government of Canada.

  • 2004, c. 23, s. 1.
Marginal note:Review
  •  (1) A review of sections 21.01 to 21.19 and their application must be completed by the Minister two years after this section comes into force.

  • Marginal note:Tabling of report

    (2) The Minister must cause a report of the results of the review to be laid before each House of Parliament on any of the first fifteen days on which that House is sitting after the report has been completed.

  • 2004, c. 23, s. 1.

Patents Relating to Nuclear Energy

Marginal note:Communication to Canadian Nuclear Safety Commission

 Any application for a patent for an invention that, in the opinion of the Commissioner, relates to the production, application or use of nuclear energy shall, before it is dealt with by an examiner appointed pursuant to section 6 or is open to inspection by the public under section 10, be communicated by the Commissioner to the Canadian Nuclear Safety Commission.

  • R.S., 1985, c. P-4, s. 22;
  • R.S., 1985, c. 33 (3rd Supp.), s. 5;
  • 1997, c. 9, s. 111.

General

Marginal note:Patented invention in vessels, aircraft, etc., of any country

 No patent shall extend to prevent the use of any invention in any ship, vessel, aircraft or land vehicle of any country entering Canada temporarily or accidentally, if the invention is employed exclusively for the needs of the ship, vessel, aircraft or land vehicle, and not so used for the manufacture of any goods to be sold within or exported from Canada.

  • R.S., c. P-4, s. 23.

 [Repealed, R.S., 1985, c. 33 (3rd Supp.), s. 6]

Marginal note:Cost of proceedings before the court

 In all proceedings before any court under this Act, the costs of the Commissioner are in the discretion of the court, but the Commissioner shall not be ordered to pay the costs of any other of the parties.

  • R.S., c. P-4, s. 25.
 
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