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

Regulations are current to 2017-04-12 and last amended on 2015-06-19. Previous Versions

Right of Action

  •  (1) A first person may, within 45 days after being served with a notice of allegation under paragraph 5(3)(a), apply to a court for an order prohibiting the Minister from issuing a notice of compliance until after the expiration of a patent that is the subject of the notice of allegation.

  • (2) The court shall make an order pursuant to subsection (1) in respect of a patent that is the subject of one or more allegations if it finds that none of those allegations is justified.

  • (3) The first person shall, within the 45 days referred to in subsection (1), serve the Minister with proof that an application referred to in that subsection has been made.

  • (4) Where the first person is not the owner of each patent that is the subject of an application referred to in subsection (1), the owner of each such patent shall be made a party to the application.

  • (5) Subject to subsection (5.1), in a proceeding in respect of an application under subsection (1), the court may, on the motion of a second person, dismiss the application in whole or in part

    • (a) in respect of those patents that are not eligible for inclusion on the register; or

    • (b) 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.

  • (5.1) In a proceeding in respect of an application under subsection (1), the court shall not dismiss an application in whole or in part solely on the basis that a patent on a patent list that was submitted before June 17, 2006 is not eligible for inclusion on the register.

  • (6) For the purposes of an application referred to in subsection (1), if a second person has made an allegation under subparagraph 5(1)(b)(iv) or (2)(b)(iv) in respect of a patent and the patent was granted for the medicinal ingredient when prepared or produced by the methods or processes of manufacture particularly described and claimed in the patent, or by their obvious chemical equivalents, it shall be considered that the drug proposed to be produced by the second person is, in the absence of proof to the contrary, prepared or produced by those methods or processes.

  • (7) On the motion of a first person, the court may, at any time during a proceeding,

    • (a) order a second person to produce any portion of the submission or supplement filed by the second person for a notice of compliance that is relevant to the disposition of the issues in the proceeding and may order that any change made to the portion during the proceeding be produced by the second person as it is made; and

    • (b) order the Minister to verify that any portion produced corresponds fully to the information in the submission or supplement.

  • (8) A document produced under subsection (7) shall be treated confidentially.

  • (9) In a proceeding in respect of an application under subsection (1), a court may make any order in respect of costs, including on a solicitor-and-client basis, in accordance with the rules of the court.

  • (10) In addition to any other matter that the court may take into account in making an order as to costs, it may consider the following factors:

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

    • (b) the inclusion on the certified patent list of a patent that should not have been included under section 4; and

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

  • 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.

Notice of Compliance

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

    • (a) [Repealed, SOR/98-166, s. 6]

    • (b) the day on which the second person complies with section 5,

    • (c) subject to subsection (3), the expiration of any patent on the register that is not the subject of an allegation,

    • (d) subject to subsection (3), the expiration of 45 days after the receipt of proof of service of a notice of allegation under paragraph 5(3)(a) in respect of any patent on the register,

    • (e) subject to subsections (2), (3) and (4), the expiration of 24 months after the receipt of proof of the making of any application under subsection 6(1), and

    • (f) the expiration of any patent that is the subject of an order pursuant to subsection 6(1).

  • (2) Paragraph (1)(e) does not apply if at any time, in respect of each patent that is the subject of an application pursuant to subsection 6(1),

    • (a) the patent has expired; or

    • (b) the court has declared that the patent is not valid or that no claim for the medicinal ingredient, no claim for the formulation, no claim for the dosage form and no claim for the use of the medicinal ingredient would be infringed.

  • (3) Paragraphs (1)(c), (d) and (e) do not apply in respect of a patent if the owner of the patent has consented to the making, constructing, using or selling of the drug in Canada by the second person.

  • (4) Paragraph (1)(e) ceases to apply in respect of an application under subsection 6(1) if the application is withdrawn or discontinued by the first person or is dismissed by the court hearing the application.

  • (5) If the court has not yet made an order under subsection 6(1) in respect of an application, the court may

    • (a) shorten the time limit referred to in paragraph (1)(e) if the first and second persons consent to it or if the court finds that the first person has failed, at any time during the proceeding, to reasonably cooperate in expediting the application; or

    • (b) extend the time limit referred to in paragraph (1)(e) if the first and second persons consent to it or if the court finds that the second person has failed, at any time during the proceeding, to reasonably cooperate in expediting the application.

  • SOR/98-166, ss. 6, 9;
  • SOR/2006-242, s. 4;
  • SOR/2010-212, s. 1.
  •  (1) If an application made under subsection 6(1) is withdrawn or discontinued by the first person or is dismissed by the court hearing the application or if an order preventing the Minister from issuing a notice of compliance, made pursuant to that subsection, is reversed on appeal, the first person is liable to the second person for any loss suffered during the period

    • (a) beginning on the date, as certified by the Minister, on which a notice of compliance would have been issued in the absence of these Regulations, unless the court concludes that

      • (i) the certified date 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 and therefore a date later than the certified date is more appropriate, or

      • (ii) a date other than the certified date is more appropriate; and

    • (b) ending on the date of the withdrawal, the discontinuance, the dismissal or the reversal.

  • (2) A second person may, by action against a first person, apply to the court for an order requiring the first person to compensate the second person for the loss referred to in subsection (1).

  • (3) The court may make an order under this section without regard to whether the first person has commenced an action for the infringement of a patent that is the subject matter of the application.

  • (4) If a court orders a first person to compensate a second person under subsection (1), the court may, in respect of any loss referred to in that subsection, make any order for relief by way of damages that the circumstances require.

  • (5) In assessing the amount of compensation the court shall take into account all matters that it considers relevant to the assessment of the amount, including any conduct of the first or second person which contributed to delay the disposition of the application under subsection 6(1).

  • (6) The Minister is not liable for damages under this section.

  • SOR/98-166, ss. 8, 9;
  • SOR/2006-242, s. 5;
  • SOR/2010-212, s. 2(F).

Service

  •  (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.

 
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