كندا

Her Excellency the Governor General in Council, on the recommendation of the Minister of Industry, pursuant to subsection 55.2(4)a of the Patent Actb, hereby makes the annexed Regulations Amending the Patented Medicines (Notice of Compliance) Regulations.

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a S.C. 2001, c. 10, s. 2(2) b R.S., c. P-4

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REGULATIONS AMENDING THE PATENTED MEDICINES (NOTICE OF

COMPLIANCE) REGULATIONS

AMENDMENTS

1. The definition “court” in section 2 of the Patented Medicines (Notice of Compliance) Regulations1 is replaced by the following: “court” means the Federal Court or any other superior court of competent jurisdiction; (tribunal)

2. The Regulations are amended by adding the following after section 3:

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 patent is found, under paragraph 6(5)(a), not to be eligible for inclusion on the register.

(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.

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1 SOR/93-133

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3. (1) The portion of subsection 6(5) of the Regulations before paragraph (a) is replaced by the following:

(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

(2) Section 6 of the Regulations is amended by adding the following after subsection (5):

(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.

TRANSITIONAL PROVISIONS

4. (1) Words and expressions used in this section have the same meaning as in the Patented Medicines (Notice of Compliance) Regulations. (2) If, after March 29, 2007, the Minister

deleted from the register a patent on a patent list that was submitted before June 17, 2006 solely on the basis that the patent was not relevant to the submission for a notice of compliance to which the patent list relates, the first person may, within 30 days after the day on which these Regulations come into force, deliver a written request to the Minister asking that the patent be added to the register.

(3) The Minister shall, within 30 days after the day on which the request referred to in subsection (2) is received, add the patent to the register.

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(4) If, after March 29, 2007, the Minister refused to add to the register a patent on a patent list submitted before June 17, 2006 solely on the basis that the patent was not relevant to the submission for a notice of compliance to which the patent list relates, the first person may, within 30 days after the day on which these Regulations come into force, deliver a written request to the Minister asking that the patent be added to the register. (5) The Minister shall, within 30 days

after the later of the day on which the request referred to in subsection (4) is received and the day on which the notice of compliance referred to in that subsection is issued, add the patent to the register.

(6) A second person is not required to comply with subsection 5(1) of the Patented Medicines (Notice of Compliance) Regulations in respect of a patent added to the register under subsection (3) or (5) on or after the date of filing of the submission referred to in that subsection 5(1). (7) A second person is not required to

comply with subsection 5(2) of the Patented Medicines (Notice of Compliance) Regulations in respect of a patent added to the register under subsection (3) or (5) on or after the date of filing of the supplement referred to in that subsection 5(2). (8) Subsection 6(5.1) of the Patented

Medicines (Notice of Compliance) Regulations does not apply to a motion of the second person brought under subsection 6(5) of those Regulations before the date of the publication of these Regulations in Part I of the Canada Gazette.

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COMING INTO FORCE

5. These Regulations come into force on the day on which they are registered.