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

6.02 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.

• 6.03 (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.

• 6.04 (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.

6.05 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.

6.06 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.

• 6.07 (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.

6.08 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.

6.09 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.

• 6.1 (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.

• 6.11 (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.

• 6.12 (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).

6.13 The person who brings an action under subsection 6(1) shall provide to the Minister, as soon as feasible, a copy of the following documents in relation to the action:

• (a) the statement of claim, including any amendments to it;

• (b) any order made under subsection 6.04(1) or 7(8);

• (c) any declaration referred to in subsection 6(1) or (3) or 6.07(1);

• (d) the notice of motion and the motion record in respect of any motion referred to in subsection 6.07(1);

• (e) any document discontinuing or dismissing the action, in whole or in part;

• (f) any notice of appeal, including a motion or application for leave to appeal, in relation to any document referred to in paragraph (b), (c) or (e); and

• (g) any judgment or order in an appeal, or a motion or application for leave to appeal, in relation to any document referred to in paragraph (b), (c) or (e).

Notice of Compliance

• 7 (1) The Minister shall not issue a notice of compliance to a second person before the latest of

  • (a) the day after the expiry of all of the patents and certificates of supplementary protection in respect of which the second person is required to make a statement or allegation under subsection 5(1) or (2) and that are not the subject of an allegation;

  • (b) the day on which the second person complies with paragraph 5(3)(e);

  • (c) the 46th day after the day on which a notice of allegation under paragraph 5(3)(a) is served;

  • (d) the day after the expiry of the 24-month period that begins on the day on which an action is brought under subsection 6(1);

  • (e) the day after the expiry of all of the patents and certificates of supplementary protection in respect of which a declaration of infringement has been made in an action brought under subsection 6(1); and

  • (f) the day after the expiry of all of the certificates of supplementary protection, other than any that were held not to be infringed in an action referred to in paragraph (e), that

    • (i) set out a patent referred to in paragraph (a) or (e),

    • (ii) are not the subject of a statement or allegation made under subsection 5(1) or (2), and

    • (iii) are included on the register in respect of the same submission or supplement as the patent.

• (2) Subsection (1) does not apply in respect of a patent or a certificate of supplementary protection if the Minister has been provided with evidence from the owner of the patent of their consent to the making, constructing, using or selling of the drug in Canada by the second person.

• (3) Paragraphs (1)(a) to (d) do not apply in respect of a patent or certificate of supplementary protection if it is deleted from the register under any of paragraphs 3(2)(c) to (e) or subsection 3(2.3) or (3).

• (4) Paragraph (1)(d) does not apply in respect of a patent or a certificate of supplementary protection that has been declared in the action referred to in that paragraph by the Federal Court to be ineligible for inclusion on the register.

• (5) Paragraph (1)(d) does not apply if

  • (a) the action referred to in that paragraph is discontinued or dismissed; or

  • (b) each of the parties who brings an action referred to in subsection 6(1) in relation to a given notice of allegation provides, when they bring the action, a notice to the second person and the Minister that they renounce the application of that paragraph.

• (6) A party may make the renouncement referred to in paragraph (5)(b) without prejudice to their right to proceed with the action or any other action for patent infringement or their entitlement to any remedy from the Federal Court or another court.

• (7) A second person, or a first person or owner of a patent who receives a notice of allegation, shall, on request of the Minister, provide to the Minister without delay any information or document that the Minister requires to maintain the register in accordance with subsection 3(2), to determine the latest of the days referred to in subsection (1) and to determine whether any of subsections (2) to (5) apply.

• (8) As long as the Federal Court has not made a declaration referred to in subsection 6(1), it may shorten or extend the 24-month period referred to in paragraph (1)(d) if it finds that a party has not acted diligently in carrying out their obligations under these Regulations or has not reasonably cooperated in expediting the action.

• 8 (1) A second person may apply to the Federal Court or another superior court of competent jurisdiction for an order requiring all plaintiffs in an action brought under subsection 6(1) to compensate the second person for the loss referred to in subsection (2).

• (2) Subject to subsection (3), if an action brought under subsection 6(1) is discontinued or dismissed or if a declaration referred to in subsection 6(1) is reversed on appeal, all plaintiffs in the action are jointly and severally, or solidarily, liable to the second person for any loss suffered after the later of the day on which the notice of allegation was served, the service of which allowed that action to be brought, and of the day, as certified by the Minister, on which a notice of compliance would have been issued in the absence of these Regulations.

• (3) The Federal Court or the other superior court may specify another day for the purpose of subsection (2) if it concludes that the other day is more appropriate, including being more appropriate because the certified day was, by the operation of An Act to amend the Patent Act and the Food and Drugs Act (The Jean Chrétien Pledge to Africa), chapter 23 of the Statutes of Canada, 2004, earlier than it would otherwise have been.

• (4) Subsections (1) to (3) do not apply if paragraph 7(1)(d) has no application because its application has been renounced under paragraph 7(5)(b).

• (5) If the Federal Court or the other superior court orders a second person to be compensated for a loss referred to in subsection (2), the court may, in respect of that loss, make any order for relief by way of damages that the circumstances require.

• (6) In assessing the amount of compensation — including any apportionment of that amount between the plaintiffs who are liable under subsection (2) — the court shall take into account all matters that it considers relevant to the assessment of the amount or the apportionment, including any conduct of the parties that contributed to delay the disposition of the action.

• (7) No action or proceeding lies against Her Majesty in right of Canada in respect of any loss referred to in subsection (2).