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

Short Title

1 These Regulations may be cited as the Patented Medicines (Notice of Compliance) Regulations.

Interpretation

• 2 (1) In these Regulations,

  claim for the dosage form

  claim for the dosage form means a claim for a delivery system for administering a medicinal ingredient in a drug or a formulation of a drug that includes within its scope that medicinal ingredient or formulation; (revendication de la forme posologique)

  claim for the formulation

  claim for the formulation means a claim for a mixture that is composed of medicinal and non-medicinal ingredients, that is contained in a drug and that is administered to a patient in a particular dosage form; (revendication de la formulation)

  claim for the medicinal ingredient

  claim for the medicinal ingredient includes a claim in the patent for the medicinal ingredient, whether chemical or biological in nature, when prepared or produced by the methods or processes of manufacture particularly described and claimed in the patent, or by their obvious chemical equivalents, and also includes a claim for different polymorphs of the medicinal ingredient, but does not include different chemical forms of the medicinal ingredient; (revendication de l’ingrédient médicinal)

  claim for the medicine itself

  claim for the medicine itself[Repealed, SOR/2006-242, s. 1]

  claim for the use of the medicinal ingredient

  claim for the use of the medicinal ingredient means a claim for the use of the medicinal ingredient for the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms; (revendication de l’utilisation de l’ingrédient médicinal)

  claim for the use of the medicine

  claim for the use of the medicine[Repealed, SOR/2006-242, s. 1]

  court

  court[Repealed, SOR/2017-166, s. 1]

  expire

  expire means

  • (a) in relation to a patent, expire, lapse or terminate by operation of law; and

  • (b) in relation to a certificate of supplementary protection, expire or terminate by operation of law; (expiré)

  first person

  first person means the person referred to in subsection 4(1); (première personne)

  medicine

  medicine[Repealed, SOR/2006-242, s. 1]

  Minister

  Minister means the Minister of Health; (ministre)

  notice of compliance

  notice of compliance means a notice issued under section C.08.004 or C.08.004.01 of the Food and Drug Regulations; (avis de conformité)

  patent list

  patent list means a list submitted under subsection 4(1); (liste de brevets)

  register

  register means the register maintained by the Minister in accordance with subsection 3(2); (registre)

  second person

  second person means the person referred to in subsection 5(1) or (2) who files a submission or supplement referred to in those subsections. (seconde personne)

• (2) For the purposes of the definition claim for the formulation in subsection (1), the claim for the formulation need not specify the non-medicinal ingredients contained in the drug.

• (3) In these Regulations, a reference to the owner of a patent includes the owner of a patent set out in a certificate of supplementary protection.

Register and Patent List

• 3 (1) The following definitions apply in this section and in section 4.

  identification number

  identification number means a number, preceded by the letters “DIN”, that is assigned for a drug in accordance with subsection C.01.014.2(1) of the Food and Drug Regulations. (identification numérique)

  new drug submission

  new drug submission means a new drug submission or an extraordinary use new drug submission as those terms are used in Division 8 of Part C of the Food and Drug Regulations, but excludes such a submission that is based solely on the change of name of the manufacturer. (présentation de drogue nouvelle)

  supplement to a new drug submission

  supplement to a new drug submission means a supplement to a new drug submission or a supplement to an extraordinary use new drug submission as those terms are used in Division 8 of Part C of the Food and Drug Regulations, but excludes such a supplement that is based solely on one or more of the matters mentioned in any of paragraphs C.08.003(2)(b) and (d) to (g) and subparagraphs C.08.003(2)(h)(iv) and (v) of those Regulations. (supplément à une présentation de drogue nouvelle)

• (2) The Minister shall maintain a register of patents that have been submitted for addition to the register and certificates of supplementary protection in which any of those patents are set out

  • (a) by adding any patent on a patent list or certificate of supplementary protection that meets the requirements for addition to the register;

  • (b) by refusing to add any patent or certificate of supplementary protection that does not meet the requirements for addition to the register;

  • (c) by deleting any patent or certificate of supplementary protection

    • (i) that was added to the register due to an administrative error,

    • (ii) that has, under subsection 60(1) or 125(1) of the Patent Act, been declared to be invalid or void,

    • (iii) that has, under subsection 6.07(1), been declared to be ineligible for inclusion on the register, or

    • (iv) the deletion of which was requested by the first person in respect of the patent list that includes that patent;

  • (d) by deleting, in respect of a new drug submission or a supplement to a new drug submission, any patent that has expired, unless a certificate of supplementary protection in which the patent is set out is included on the register in respect of that submission or supplement; and

  • (e) by deleting any certificate of supplementary protection that has expired.

• (2.1) The Minister is not permitted to make a deletion referred to in subparagraph (2)(c)(iii) based on a decision by the Federal Court before the later of the day on which the period for appealing that decision to the Federal Court of Appeal ends and the day on which any appeal of that decision to the Federal Court of Appeal is discontinued or dismissed.

• (2.2) The Minister shall add any patent or certificate of supplementary protection to the register that has been deleted under subparagraph (2)(c)(ii) or (iii) based on a decision that subsequently is reversed or set aside on appeal.

• (2.3) The Minister may review the register to determine whether any patents or certificates of supplementary protection do not meet the requirements for inclusion on the register and, if the Minister conducts that review, shall delete any patent or certificate of supplementary protection that is determined not to meet those requirements.

• (3) If a patent is listed on the register in respect of a new drug submission or supplement to a new drug submission for a drug for which the identification number has been cancelled under paragraph C.01.014.6(1)(a) of the Food and Drug Regulations, the Minister shall delete the patent from the register 90 days after the date of cancellation.

• (4) Subsection (3) does not apply if the identification number is cancelled under paragraph C.01.014.6(1)(a) of the Food and Drug Regulations because of a change in manufacturer.

• (5) If, after an identification number is cancelled under paragraph C.01.014.6(1)(a) of the Food and Drug Regulations, an identification number is assigned for the same drug, the Minister shall add to the register the patent that was deleted under subsection (3) when the Minister receives the document required by section C.01.014.3 of the Food and Drug Regulations in respect of the drug.

• (6) The register shall be open to public inspection during business hours.

• (7) No patent on a patent list or certificate of supplementary protection shall be added to the register until after the Minister has issued a notice of compliance in respect of the new drug submission or the supplement to a new drug submission, as the case may be, to which the patent or certificate of supplementary protection relates.

• (8) For the purpose of determining whether a patent or certificate of supplementary protection is to be added to or deleted from the register, the Minister may consult with officers or employees of the Patent Office.

• 3.1 (1) The Minister shall not delete from the register a patent on a patent list that was submitted before June 17, 2006, unless

  • (a) the patent has expired;

  • (b) a court has, under subsection 60(1) of the Patent Act, declared that the patent is invalid or void;

  • (c) the identification number assigned to the drug in respect of which the patent is listed is cancelled under paragraph C.01.014.6(1)(a) of the Food and Drug Regulations; or

  • (d) the first person in respect of that patent list requests the Minister to delete the patent.

• (2) The Minister shall not refuse to add to the register a patent on a patent list that was submitted before June 17, 2006 solely on the basis that the patent is not relevant to the submission for a notice of compliance to which the patent list relates.

3.2 [Repealed, SOR/2017-166, s. 4]

• 4 (1) A first person who files or who has filed a new drug submission or a supplement to a new drug submission may submit to the Minister a patent list in relation to the submission or supplement for addition to the register.

• (1.1) The patent list may include a patent whose term under section 44 of the Patent Act, without taking into account section 46 of that Act, has expired and that is set out in a certificate of supplementary protection that has taken effect.

• (2) A patent on a patent list in relation to a new drug submission is eligible to be added to the register if the patent contains

  • (a) a claim for the medicinal ingredient and the medicinal ingredient has been approved through the issuance of a notice of compliance in respect of the submission;

  • (b) a claim for the formulation that contains the medicinal ingredient and the formulation has been approved through the issuance of a notice of compliance in respect of the submission;

  • (c) a claim for the dosage form and the dosage form has been approved through the issuance of a notice of compliance in respect of the submission; or

  • (d) a claim for the use of the medicinal ingredient, and the use has been approved through the issuance of a notice of compliance in respect of the submission.

• (2.1) The following rules apply when determining the eligibility of a patent to be added to the register under subsection (2):

  • (a) for the purposes of paragraph (2)(a), a patent that contains a claim for the medicinal ingredient is eligible even if the submission includes, in addition to the medicinal ingredient claimed in the patent, other medicinal ingredients;

  • (b) for the purposes of paragraph (2)(b), a patent that contains a claim for the formulation is eligible if the submission includes the non-medicinal ingredients specified in the claim, if any are specified, even if the submission contains any additional non-medicinal ingredients; and

  • (c) for the purposes of paragraph (2)(d), a patent that contains a claim for the use of the medicinal ingredient is eligible if the submission includes the use claimed in the patent, even if

    • (i) the submission includes additional medicinal ingredients,

    • (ii) the submission includes other additional uses of the medicinal ingredient, or

    • (iii) the use that is included in the submission requires the use of the medicinal ingredient in combination with another drug.

• (3) A patent on a patent list in relation to a supplement to a new drug submission is eligible to be added to the register if the supplement is for a change in formulation, a change in dosage form or a change in use of the medicinal ingredient, and

  • (a) in the case of a change in formulation, the patent contains a claim for the changed formulation that has been approved through the issuance of a notice of compliance in respect of the supplement;

  • (b) in the case of a change in dosage form, the patent contains a claim for the changed dosage form that has been approved through the issuance of a notice of compliance in respect of the supplement; or

  • (c) in the case of a change in use of the medicinal ingredient, the patent contains a claim for the changed use of the medicinal ingredient that has been approved through the issuance of a notice of compliance in respect of the supplement.

• (3.1) A certificate of supplementary protection is eligible to be added to the register in respect of a new drug submission or a supplement to a new drug submission if

  • (a) the patent that is set out in the certificate of supplementary protection is included on the register in respect of that submission or supplement; and

  • (b) the submission or supplement relates to a drug with respect to which the certificate of supplementary protection grants rights, privileges and liberties referred to in section 115 of the Patent Act.

• (4) A patent list shall contain the following:

  • (a) an identification of the new drug submission or the supplement to a new drug submission to which the list relates;

  • (b) the medicinal ingredient, brand name, dosage form, strength, route of administration and use set out in the new drug submission or the supplement to a new drug submission to which the list relates;

  • (c) for each patent on the list, the patent number, the filing date of the patent application in Canada, the date of grant of the patent and the date on which the term limited for the duration of the patent will expire under section 44 or 45 of the Patent Act;

  • (d) for each patent on the list, a statement that the first person who filed the new drug submission or the supplement to a new drug submission to which the list relates

    • (i) is the owner of the patent,

    • (ii) has an exclusive licence to the patent or to a certificate of supplementary protection in which that patent is set out, or

    • (iii) has obtained the consent of the owner of the patent to its inclusion on the list;

  • (e) the address in Canada for service, on the first person, of a notice of allegation referred to in paragraph 5(3)(a) or the name and address in Canada of another person on whom service may be made with the same effect as if service were made on the first person; and

  • (f) a certification by the first person that the information submitted under this subsection is accurate and that each patent on the list meets the eligibility requirements of subsection (2) or (3).

• (5) Subject to subsection (6), a first person who submits a patent list must do so at the time the person files the new drug submission or the supplement to a new drug submission to which the patent list relates.

• (6) A first person may, after the date of filing of a new drug submission or a supplement to a new drug submission, and within 30 days after the issuance of a patent that was issued on the basis of an application that has a filing date in Canada that precedes the date of filing of the submission or supplement, submit a patent list, including the information referred to in subsection (4), in relation to the submission or supplement.

• (7) A first person who has submitted a patent list must keep the information on the list up to date but, in so doing, may not add a patent to the list.

• (8) The Minister shall insert on the patent list the date of filing and submission number of the new drug submission or the supplement to a new drug submission in relation to which the list was submitted.

• 4.1 (1) In this section, supplement to the new drug submission means a supplement to a new drug submission or a supplement to an extraordinary use new drug submission as those terms are used in Division 8 of Part C of the Food and Drug Regulations.

• (2) A first person who submits a patent list in relation to a new drug submission referred to in subsection 4(2) may, if the list is added to the register, resubmit the same list in relation to a supplement to the new drug submission, but may not submit a new patent list in relation to a supplement except in accordance with subsection 4(3).

• 5 (1) If a second person files a submission for a notice of compliance in respect of a drug and the submission directly or indirectly compares the drug with, or makes reference to, another drug marketed in Canada under a notice of compliance issued to a first person and in respect of which a patent list has been submitted, the second person shall include in the submission the required statements or allegations set out in subsection (2.1).

• (2) If a second person files a supplement to a submission referred to in subsection (1) seeking a notice of compliance for a change in formulation, a change in dosage form or a change in use of the medicinal ingredient and the supplement directly or indirectly compares the drug for which the supplement is filed with, or makes reference to, another drug that has been marketed in Canada under a notice of compliance issued to a first person and in respect of which a patent list has been submitted, the second person shall include in the supplement the required statements or allegations set out in subsection (2.1).

• (2.1) The statements or allegations required for the submission or the supplement, as the case may be, are — with respect to each patent included on the register in respect of the other drug and with respect to each certificate of supplementary protection in which the patent is set out and that is included on the register in respect of the other drug — the following:

  • (a) a statement that the owner of that patent has consented to the making, constructing, using or selling in Canada of the drug for which the submission or supplement is filed by the second person;

  • (b) a statement that the second person accepts that the notice of compliance will not issue until that patent or certificate of supplementary protection, as the case may be, expires; or

  • (c) an allegation that

    • (i) the statement made by the first person under paragraph 4(4)(d) is false,

    • (ii) that patent or certificate of supplementary protection is invalid or void,

    • (iii) that patent or certificate of supplementary protection is ineligible for inclusion on the register,

    • (iv) that patent or certificate of supplementary protection would not be infringed by the second person making, constructing, using or selling the drug for which the submission or the supplement is filed,

    • (v) that patent or certificate of supplementary protection has expired, or

    • (vi) in the case of a certificate of supplementary protection, that certificate of supplementary protection cannot take effect.

• (3) A second person who makes an allegation referred to in paragraph (2.1)(c) shall

  • (a) serve on the first person a notice of allegation relating to the submission or supplement filed under subsection (1) or (2) on or after its date of filing;

  • (b) include in the notice of allegation

    • (i) a description of the medicinal ingredient, dosage form, strength, route of administration and use of the drug in respect of which the submission or supplement has been filed, and

    • (ii) a statement of the legal and factual basis for the allegation, which statement must be detailed in the case of an allegation that the patent or certificate of supplementary protection is invalid or void;

  • (c) serve the following documents with the notice:

    • (i) a certification by the Minister of the date of filing of the submission or supplement,

    • (ii) a document setting out the second person’s address for service for the purpose of any action that may be brought against them under subsection 6(1), along with the names of and contact information for their anticipated solicitors of record if that action is brought,

    • (iii) a searchable electronic copy of the portions of the submission or supplement that are under the control of the second person and relevant to determine if any patent or certificate of supplementary protection referred to in the allegation would be infringed, and

    • (iv) if the second person is alleging that the patent or certificate of supplementary protection is invalid or void, an electronic copy of any document — along with an electronic copy of it in English or French if available — on which the person is relying in support of the allegation;

  • (d) provide, without delay, to the first person any portion of a submission or supplement referred to in subparagraph (c)(iii) that is changed on or before the later of the 45th day after the day on which the notice of allegation is served and the day of the disposition of any action that has been brought under subsection 6(1); and

  • (e) provide to the Minister proof of service of the documents referred to in paragraphs (a) and (b), along with a copy of the notice of allegation.

• (3.1) A second person who makes an allegation that the patent or certificate of supplementary protection is invalid or void may, when the notice of allegation is served, request

  • (a) the name of and contact information for any inventor who might have information relevant to the allegation, along with an indication as to whether that inventor is an employee of the first person or of the patent owner; and

  • (b) 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, if the second person identifies the specific allegation in the notice of allegation that is relevant to the request and the portion of the patent in which that property, advantage or use is set out.

• (3.2) A document referred to in paragraph (3.1)(b) must be provided in a searchable electronic format but, if it is not available in that format, in an electronic format. In addition, if the document provided is not already in English or French, it must also be provided, if available, in English or French and be in a searchable electronic format but, if it is not available in that format, in an electronic format.

• (3.3) Within five days after the day on which the first person is served with any notice or document under subsection (3), they shall forward a copy of it, along with any request made under subsection (3.1) when the notice was served and an indication of the date of the service,

  • (a) to the owner of each patent in respect of which an allegation is made in that notice; and

  • (b) to the owner of a patent that is set out in each certificate of supplementary protection in respect of which an allegation is made in that notice.

• (3.4) The first person shall, without delay, notify the second person that they forwarded the copy under subsection (3.3) and, if they are owner of any patent referred to in that subsection, that they are its owner.

• (3.5) The second person may impose on the first person referred to in paragraph (3)(a) and any owner of a patent to whom a document is forwarded under subsection (3.3) any reasonable rules for maintaining the confidentiality of any portion of a submission or supplement referred to in subparagraph (3)(c)(iii).

• (3.6) 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.

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

• (3.8) A second person who is, under subparagraph (3)(c)(iii) or paragraph (3)(d), required to serve or provide a document may — if there is reason to believe that the intended recipient of the document is not in Canada — refuse to do so unless that recipient attorns to the jurisdiction of the Federal Court with respect to the confidentiality of the information set out in the document.

• (3.9) A second person who is, under subparagraph (3)(c)(iii) or paragraph (3)(d), required to serve or provide a document to a first person referred to in paragraph (3)(a) may — if there is reason to believe that the first person is required to forward the document to the owner of a patent who is not in Canada — require that the first person forward it only if that owner attorns to the jurisdiction of the Federal Court with respect to the confidentiality of the information set out in the document.

• (4) A second person is not required to comply with

  • (a) subsection (1) in respect of a patent, or a certificate of supplementary protection that sets out the patent, that is added to the register in respect of the other drug on or after the date of filing of the submission referred to in that subsection, including one added under subsection 3(2.2) or (5); and

  • (b) subsection (2) in respect of a patent, or a certificate of supplementary protection that sets out the patent, that is added to the register in respect of the other drug on or after the date of filing of the supplement referred to in that subsection, including one added under subsection 3(2.2) or (5).

• (5) For the purposes of subsections (3) and (4), if subsection (1) or (2) applies to a submission or supplement referred to in paragraph C.07.003(b) of the Food and Drug Regulations, if the drug to which the comparison or reference is made is an innovative drug within the meaning of subsection C.08.004.1(1) of those Regulations and if the date of filing of the submission or supplement is less than six years from the day on which the first notice of compliance was issued in respect of the innovative drug, the deemed date of filing of the submission or supplement is six years after the date of issuance of the notice of compliance.

• (6) A second person who has served a notice of allegation on a first person under paragraph (3)(a) shall retract the notice of allegation and serve notice of the retraction on the first person within 90 days after either of the following dates:

  • (a) the date on which the Minister notifies the second person under paragraph C.08.004(3)(b) or C.08.004.01(3)(b), as the case may be, of the Food and Drug Regulations of their non-compliance with the requirements of section C.08.002, C.08.002.01, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1 of those Regulations; or

  • (b) the date of the cancellation by the second person of the submission or supplement to which the allegation relates.

• (6.1) Within five days after the day on which the first person is served under subsection (6), they shall, if they are not the owner of any patent to which the notice of allegation relates, forward to the owner of that patent a copy of the notice of retraction.

• (7) A person who brings an action under subsection 6(1) in response to a notice of allegation shall, if the notice is retracted in accordance with subsection (6), file without delay a notice of discontinuance.

Right of Action

• 6 (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.

6.01 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.

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).

8.1 A person who files a submission for a notice of compliance or a supplement to a submission for a notice of compliance in respect of a drug and who has reasonable grounds to believe that the making, constructing, using or selling of the drug might be alleged to infringe a patent or a certificate of supplementary protection is, if the submission or supplement directly or indirectly compares the drug with, or makes reference to, another drug marketed in Canada, an interested person

• (a) for the purpose of subsection 60(1) of the Patent Act with respect to bringing an action for a declaration that the patent or any claim in the patent is invalid or void; or

• (b) for the purpose of subsection 125(1) of that Act with respect to bringing an action for a declaration that the certificate of supplementary protection or any claim in the patent set out in it is invalid or void.

8.2 On receipt of a notice of allegation relating to a submission or supplement, a first person or owner of a patent may, under subsection 54(1) or 124(1) of the Patent Act, bring an action for infringement of a patent or certificate of supplementary protection — other than one that is the subject of an allegation set out in that notice — that could result from the making, constructing, using or selling of the drug in accordance with the submission or supplement.

Service

• 9 (1) Service of any document referred to in these Regulations shall be effected personally or by registered mail.

• (2) Service by registered mail shall be deemed to be effected on the addressee five days after mailing.