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Bill C-460

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1st Session, 37th Parliament,
49-50-51 Elizabeth II, 2001-2002

House of Commons of Canada

BILL C-460

An Act to amend the Patent Act

R.S., c. P-4

      Her Majesty, by and with the advice and consent of the Senate and House of Commons of Canada, enacts as follows:

1. Section 55.2 of the Patent Act is amended by adding the following after subsection (4):

Exception

(4.1) Subsection (4) does not apply in respect of medicines.

2. The Act is amended by adding the following after section 55.2:

Exception

55.3 It is not an infringement of a patent for any person to make, construct, use or sell a patented invention that is intended or capable of being used for medicine or the preparation or production of medicine solely for uses reasonably related to the export of an article, machine, manufacture or composition of matter, the making, constructing, using or selling of which would otherwise infringe that patent.

Definitions

55.4 (1) The definitions in this subsection apply in this section.

``court''
« tribunal »

``court'' means any court of competent jurisdiction.

``first person''
« première personne »

``first person'' has the same meaning as in section 2 of the Regulations, as they read immediately before the coming into force of this section.

``Regulations' '
« Règlement »

``Regulations'' means the Patented Medicines (Notice of Compliance) Regulations.

``second person''
« seconde personne »

``second person'' has the same meaning as in section 2 of the Regulations, as they read immediately before the coming into force of this section.

``submission''
« présentation »

``submission'' means a submission referred to in section C.08.004 of the Food and Drug Regulations.

Revocation of orders

(2) Any order under subsection 6(1) of the Regulations is revoked.

Dismissal of applications

(3) Any application under subsection 6(1) of the Regulations is dismissed without costs.

Notice of compliance

(4) Where, as a result of the operation of section 7 of the Regulations or an order under subsection 6(1) of the Regulations, the Minister of Health was prevented from or delayed in issuing a notice of compliance in respect of a drug that is the subject of a second person's submission, that Minister shall immediately issue

    (a) a certificate specifying the date on which a notice of compliance would have been issued had it not been for the operation of that section or that order; and

    (b) the notice of compliance, if it has not been issued already.

Payment

(5) The first person shall pay to the second person

    (a) costs on a solicitor and client basis in respect of the period beginning on the date specified by the Minister of Health under paragraph (4)(a) and ending on the date on which a notice of compliance was issued to the second person; and

    (b) damages in an amount to be determined by a court under subsection (6).

Assessment of damages

(6) In assessing the amount of damages, the court shall assume that

    (a) the number of prescriptions that would have been filled using the second person's drug would have been equal to fifty per cent of the number of prescriptions that were filled using the first person's drug; and

    (b) the price at which the second person's drug would have been sold would have been equal to seventy-five per cent of the price at which the first person's drug was sold.

Repeal SOR/93-133

3. The Patented Medicines (Notice of Compliance) Regulations are repealed.

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