C-349
First Session, Thirty-ninth Parliament,
55 Elizabeth II, 2006
HOUSE OF COMMONS OF CANADA
BILL C-349
An Act to amend the Patent Act
first reading, June 22, 2006
Mr. Masse
391374
SUMMARY
This enactment excludes medicines from the scope of the regulation-making power set out in subsection 55.2(4) of the Patent Act. It makes other amendments to that Act to reduce the extent of patent protection for medicines.
The enactment also repeals the Patented Medicines (Notice of Compliance) Regulations.
Also available on the Parliament of Canada Web Site at the following address:http://www.parl.gc.ca
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1st Session, 39th Parliament,
55 Elizabeth II, 2006
house of commons of canada
BILL C-349
An Act to amend the Patent Act
Her Majesty, by and with the advice and consent of the Senate and House of Commons of Canada, enacts as follows:
R.S., c. P-4
PATENT ACT
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:
Definitions
55.3 (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.
“Regulations”« Règlement »
“Regulations” means the Patented Medicines (Notice of Compliance) Regulations, as they read immediately before the coming into force of this Act.
“second person”« seconde personne »
“second person” has the same meaning as in section 2 of the Regulations.
“submission”« présentation »
“submission” means a submission referred to in section C.08.004 of the Food and Drug Regulations.
Reversal of orders
(2) Any order under subsection 6(1) of the Regulations is reversed.
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.
Rights preserved
(7) Nothing in this section abrogates or derogates from the right of action a second person might have to commence or continue any action against, or to obtain relief from, a first person under section 8 of the Regulations.
REPEAL
SOR/93-133
3. The Patented Medicines (Notice of Compliance) Regulations are repealed.
Published under authority of the Speaker of the House of CommonsAvailable from:Publishing and Depository ServicesPublic Works and Government Services CanadaOttawa, Ontario K1A 0S5Telephone: (613) 941-5995 or 1-800-635-7943Fax: (613) 954-5779 or 1-800-565-7757publications@pwgsc.gc.cahttp://publications.gc.ca