Vol. 139, No. 19 — September 21, 2005

Registration
SOR/2005-276 August 31, 2005

PATENT ACT

Order Amending Schedule 1 to the Patent Act

P.C. 2005-1524 August 31, 2005

Whereas the patented product known as "lamivudine + nevirapine + zidovudine" may be used to address a public health problem afflicting many developing and least-developed countries and therefore, in accordance with subparagraph 21.03(1)(a)(i) (see footnote a) of the Patent Act, may be added to Schedule 1 to that Act;

And whereas the Governor in Council considers it appropriate to add to Schedule 1 a dosage form and strength in respect of that patented product;

Therefore, Her Excellency the Governor General in Council, on the recommendation of the Minister of Industry and the Minister of Health, pursuant to subparagraph 21.03(1)(a)(i) (see footnote b) of the Patent Act, hereby makes the annexed Order Amending Schedule 1 to the Patent Act.

ORDER AMENDING SCHEDULE 1 TO THE PATENT ACT

AMENDMENT

1. Schedule 1 to the Patent Act (see footnote 1) is amended by adding the following in alphabetical order:

amendment	amendment
lamivudine + nevirapine + zidovudine	tablet, 150 mg + 200 mg + 300 mg

COMING INTO FORCE

2. This Order comes into force on the day on which it is registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Order.)

Description

Pursuant to subparagraph 21.03(1)(a)(i) of the Patent Act (the "Act") the Government is amending Schedule 1 of the Act to add to the list of patented pharmaceutical products the name "lamivudine + nevirapine + zidovudine" in tablet form and in specified strengths of 150 mg, 200 mg and 300 mg respectively. The pharmaceutical product so-named is a fixed-dose combination (FDC) consisting of three antiretroviral agents used in the treatment of HIV-AIDS.

Schedule 1 is a list of patented pharmaceutical products which are eligible to be exported under compulsory licence in accordance with the amendments to the Act brought into effect by Bill C-9, being chapter 23 of the Statutes of Canada, 2004, An Act to amend the Patent Act and the Food and Drugs Act (The Jean Chrétien Pledge to Africa), hereafter "JCPA".

As a result of the amendment, a Canadian pharmaceutical manufacturer that wishes to manufacture a specified quantity of a low cost version of the above named FDC for export to an eligible importing country could apply to the Commissioner of Patents for an export-only compulsory licence under section 21.04 of the Act.

Background

Antiretroviral (ARV) FDCs are a major breakthrough for HIV-AIDS treatment in developing and least developed countries as they promote greater patient adherence and require less medical supervision. Patient adherence is critical in HIV therapy because suppression of the virus depends upon daily and continuous ARV treatment. Inadequate or irregular ARV treatment can lead to 'rebound' in viral replication and rapid development of drug resistance.

In the case of the FDC subject to the amendment, it was not originally listed on Schedule 1 at the time the JCPA was adopted because of questions relating to how such a product would be reviewed for safety and efficacy by Health Canada. This is due to the fact that FDCs tend to be manufactured solely as generic medicines for use in resource poor settings and are thus not marketed in developed countries like Canada. As such, there is no single Canadian Reference Product against which this particular FDC could be compared for the purposes of establishing bioequivalency, a condition precedent to obtaining Health Canada approval of a generic drug.

Since that time, however, Health Canada has made a preliminary assessment of the process for reviewing an FDC and is satisfied that approval would be possible in circumstances where sufficient clinical data respecting the composite antiretroviral agents is supplemented by bioequivalency comparisons between the product and the agents in question, the latter having already been individually approved and marketed in Canada.

It should be noted that while section 21.18 of the Act provides for the establishment of an expert committee to advise the Ministers of Industry and Health on their recommendations to the Governor in Council respecting the amendment of Schedule 1, that committee is not yet in place. The Government has nonetheless elected to add the above mentioned FDC to Schedule 1 immediately on the understanding that discussions are already underway between Health Canada and parties intent on securing approval to export the FDC in question. Furthermore, the antiretroviral agents which make up the FDC already appear individually on Schedule 1 and the Canadian manufacturers of those agents have consented to the present amendment.

Alternatives

As only those patented pharmaceutical products appearing on Schedule 1 can be exported under the JCPA regime, no alternative to the present amendment was considered.

Benefits and Costs

Adding this FDC to Schedule 1 will benefit eligible developing and least developed countries who wish to import the product under the terms of the JCPA regime. There are no costs associated with this measure.

Consultation

Following pre-publication, interested persons were given 30 days to formally comment on the proposed addition of the FDC to Schedule 1. Two submissions were received, one from the generic pharmaceutical industry and another from an interested non-governmental organization (NGO). While both commentators expressed support for the proposed amendment, both reiterated their view that Schedule 1 constitutes an unnecessary limitation on the universe of pharmaceutical products which should be eligible for export under the JCPA regime.

Compliance and Enforcement

Not applicable.

Contacts

Susan Bincoletto
Director General
Marketplace Framework Policy Branch
Industry Canada
10th Floor, East Tower
235 Queen Street
Ottawa, Ontario
K1A 0H5
Telephone: (613) 952-0736
FAX: (613) 948-6393
E-mail: bincoletto.susan@ic.gc.ca

Omer Boudreau
Director General
Therapeutic Products Directorate
Health Canada
Holland Cross, Tower B, 6th Floor
1600 Scott Street
Ottawa, Ontario
K1A 1B6
Telephone: (613) 957-0368
FAX: (613) 952-7756
E-mail: C9@hc-sc.gc.ca

Footnote a

S.C. 2004, c. 23, s. 1

Footnote b

S.C. 2004, c. 23, s. 1

Footnote 1

R.S., c. P-4

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