Patented Medicines (Notice of Compliance) Regulations (SOR/93-133)

Regulations are current to 2017-10-13 and last amended on 2017-09-21. Previous Versions

Right of Action

  •  (1) The first person or an owner of a patent who receives a notice of allegation referred to in paragraph 5(3)(a) may, within 45 days after the day on which the first person is served with the notice, bring an action against the second person in the Federal Court for a declaration that the making, constructing, using or selling of a drug in accordance with the submission or supplement referred to in subsection 5(1) or (2) would infringe any patent or certificate of supplementary protection that is the subject of an allegation set out in that notice.

  • (2) If the person who brings an action under subsection (1) is not the owner of each patent — or of a patent that is set out in each certificate of supplementary protection — that is the subject of the action, the owner of each of those patents shall be or be made a party to the action.

  • (3) The second person may bring a counterclaim for a declaration

    • (a) under subsection 60(1) or (2) of the Patent Act in respect of any patent claim asserted in the action brought under subsection (1); or

    • (b) under 125(1) or (2) of that Act in respect of any claim, asserted in the action brought under subsection (1), in the patent set out in the certificate of supplementary protection in question in that action.

  • (4) If the Federal Court makes a declaration referred to in subsection (1), it may order any other remedy that is available under the Patent Act, or at law or in equity, in respect of infringement of a patent or a certificate of supplementary protection.

  • SOR/98-166, ss. 5, 9;
  • SOR/99-379, s. 3;
  • SOR/2006-242, s. 3;
  • err. (E), Vol. 140, No. 23;
  • SOR/2008-211, s. 3;
  • SOR/2017-166, s. 7.

 No action, other than one brought under subsection 6(1), may be brought against the second person for infringement of a patent or a certificate of supplementary protection that is the subject of a notice of allegation served under paragraph 5(3)(a) in relation to the making, constructing, using or selling of a drug in accordance with the submission or supplement referred to in subsection 5(1) or (2) unless the first person or the owner of the patent did not, within the 45-day period referred to in subsection 6(1), have a reasonable basis for bringing an action under that subsection.

  • SOR/2017-166, s. 7.

 No action may be joined to a given action brought under subsection 6(1) during any period during which the Minister shall not issue a notice of compliance because of paragraph 7(1)(d) other than

  • (a) another action brought under that subsection in relation to the submission or supplement in that given action; and

  • (b) an action brought in relation to a certificate of supplementary protection that is added to the register after the filing of the submission or supplement in that given action, if the patent that is set out in that certificate of supplementary protection is at issue in that given action.

  • SOR/2017-166, s. 7.
  •  (1) If a second person makes a request under subsection 5(3.1), the person who brings the action must serve on the second person at the same time as their statement of claim,

    • (a) a document setting out the information referred to in paragraph (3.1)(a) and the documents referred to in paragraph (3.1)(b);

    • (b) a document setting out an explanation of the steps that have been and are being taken to locate that information or those documents, along with a statement that they will be provided as soon as feasible; or

    • (c) a document setting out the reasons for not providing them, if applicable.

  • (2) The person bringing the action may impose on the second person any reasonable rules for maintaining the confidentiality of the information set out in any document provided under paragraph (1)(a).

  • (3) Those confidentiality rules are binding and enforceable by the Federal Court, which may award any remedy that it considers just if they are not respected.

  • (4) On motion of the second person or on its own initiative, after giving an opportunity to be heard to the parties to the action, the Federal Court may set aside or vary any or all of those confidentiality rules in any manner that it considers just.

  • (5) Any person who is, under paragraph (1)(a), required to provide a document may — if there is reason to believe that the intended recipient of the document is not in Canada — refuse to provide it unless the recipient attorns to the jurisdiction of the Federal Court with respect to the confidentiality of the information set out in the document.

  • SOR/2017-166, s. 7.
  •  (1) On the motion of a first person or owner of a patent who is a party to an action brought under subsection 6(1) or a counterclaim brought under subsection 6(3), the Federal Court may, at any time during the proceeding, order that the second person produce any portion of the submission or supplement that is relevant to determine if any patent or certificate of supplementary protection at issue would be infringed and any such portion that is changed.

  • (2) On the motion of a second person who is party to an action brought under subsection 6(1) or a counterclaim brought under subsection 6(3), the Federal Court may, at any time during the proceeding, order that the first person or owner of a patent produce a document setting out any information referred to in paragraph 5(3.1)(a) or any laboratory notebook, research report or other document that may be relevant to determine whether a particular property, advantage, or use asserted by the second person to be part of the invention was established as of the filing date of the application for the patent.

  • (3) The information set out in any document produced under subsection (1) or (2) shall be treated confidentially by the Federal Court subject to any conditions that it considers just.

  • SOR/2017-166, s. 7.

 The Minister shall, on the request of any party, verify that any portion of a submission or supplement that is referred to in subparagraph 5(3)(c)(iii) or paragraph 5(3)(d) or produced as a result of an order made under subsection 6.04(1) corresponds to the submission or supplement filed.

  • SOR/2017-166, s. 7.

 On the request, made by way of a motion, of a person who imposed rules referred to in subsection 5(3.5) or 6.03(2) for maintaining the confidentiality of the information set out in any document, the Federal Court shall treat that information confidentially subject to any conditions that it considers just.

  • SOR/2017-166, s. 7.
  •  (1) In an action brought under subsection 6(1), the Federal Court may, on the motion of the second person, declare that a patent or certificate of supplementary protection is ineligible for inclusion on the register.

  • (2) The Minister may intervene as of right in the motion and make representations and call evidence that are relevant to any issue in the motion or to the factors that the Federal Court is entitled to take into consideration in determining the issue. The Minister may intervene as of right in any appeal arising from the decision made on the motion, whether the Minister intervened at the Federal Court or not.

  • (3) The Federal Court shall not, in whole or in part, dismiss the action solely on the basis that a patent or certificate of supplementary protection is ineligible for inclusion on the register.

  • (4) Subsection (1) does not apply in respect of a patent on a patent list that was submitted before June 17, 2006.

  • SOR/2017-166, s. 7.

 An action brought under subsection 6(1) may, on the motion of a second person, be dismissed, in whole or in part, on the ground that it is redundant, scandalous, frivolous or vexatious or is otherwise an abuse of process in respect of one or more patents or certificates of supplementary protection.

  • SOR/2017-166, s. 7.

 Every first person, second person and owner of a patent shall act diligently in carrying out their obligations under these Regulations and shall reasonably cooperate in expediting any action brought under subsection 6(1) or a counterclaim brought under subsection 6(3) to which they are a party.

  • SOR/2017-166, s. 7.
  •  (1) An action brought under subsection 6(1) shall be a specially managed proceeding in accordance with the Federal Courts Rules.

  • (2) The case management judge who is assigned the specially managed proceeding shall conduct a case management conference as soon as feasible after the 10th day after proof of service of the statement of claim in the action is filed.

  • SOR/2017-166, s. 7.
  •  (1) Any interlocutory order made in an action brought under subsection 6(1) or a counterclaim brought under subsection 6(3), including one that, in whole or in part, disposes of the action or counterclaim, may be appealed to the Federal Court of Appeal, with leave of that Court, and not to the Federal Court.

  • (2) The motion for leave to appeal shall be filed no later than 10 days after the day on which that interlocutory order is made.

  • SOR/2017-166, s. 7.
  •  (1) In an action brought under subsection 6(1) or a counterclaim brought under subsection 6(3), the Federal Court may make any order in respect of costs, including on a solicitor-and-client basis, in accordance with the Federal Courts Rules.

  • (2) In addition to any other factor that the Federal Court may take into account in making an order in respect of costs, it may consider

    • (a) the diligence with which the parties have pursued the action;

    • (b) the extent to which they have reasonably cooperated in expediting the action;

    • (c) the certification of a patent list that includes a patent that should not have been included under section 4; and

    • (d) the failure of the first person to keep a patent list up to date in accordance with subsection 4(7).

  • SOR/2017-166, s. 7.
 
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