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

Regulations are current to 2019-05-22 and last amended on 2017-09-21. Previous Versions

Register and Patent List (continued)

  •  (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.

  • SOR/2008-211, s. 2
  • SOR/2017-166, s. 3

 [Repealed, SOR/2017-166, s. 4]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.

  • SOR/98-166, s. 3
  • SOR/2006-242, s. 2
  • err. (E), Vol. 140, No. 23
  • SOR/2015-169, s. 4
  • SOR/2017-166, s. 5
  •  (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).

  • SOR/2006-242, s. 2
  • SOR/2011-89, s. 3
  •  (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.

  • SOR/98-166, ss. 4, 9
  • SOR/99-379, s. 2
  • SOR/2006-242, s. 2
  • err. (E), Vol. 140, No. 23
  • SOR/2011-89, s. 4
  • SOR/2017-166, s. 6
 
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