Vol. 140, No. 20 — October 4, 2006

Registration
SOR/2006-204 September 21, 2006

PATENT ACT

Order Amending Schedule 1 to the Patent Act (Oseltamivir Phosphate)

P.C. 2006-996 September 21, 2006

Whereas the patented product known as "oseltamivir phosphate" 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 (Oseltamivir Phosphate).

ORDER AMENDING SCHEDULE 1 TO THE PATENT ACT (OSELTAMIVIR PHOSPHATE)

AMENDMENT

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

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 "oseltamivir phosphate" in capsule form in the specified strength of 75 mg, as well as the powder for an oral suspension form in the specified strength of 12 mg/mL. The pharmaceutical product so-named is an anti-viral drug in the neuraminidase inhibitor class, and is used in the treatment and prophylaxis of Type A and Type B influenza. The amendment was pre-published in the Canada Gazette, Part I, on July 1, 2006.

Schedule 1 is the list of patented pharmaceutical products eligible for export to countries in need 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), now referred to as Canada's Access to Medicines Regime (CAMR).

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

Background

The World Health Organization (WHO) reports that of all the influenza viruses that circulate in birds, the avian influenza A (H5N1) virus is of greatest present threat to human health, owing to the severity with which it can infect human victims who come into contact with afflicted birds, as well as its potential to mutate and become communicable among humans.

According to the WHO, as of August 8, 2006, ten countries have had laboratory-confirmed cases of H5N1 virus in humans, first in Asia and more recently in the Middle East. All of these cases coincided with national outbreaks of the same virus in poultry, and altogether, more than half have been fatal.

The WHO has recommended that countries implement two main strategies for addressing the avian influenza A situation and reducing the related threat of a pandemic. The first consists of efforts to contain outbreaks of the virus in poultry and preventing its spread to new countries. The second is to intensify the world's preparedness to cope with a pandemic, including improved access to affordable anti-viral drugs.

In many cases, developing and least developed countries lack the resources to rapidly detect and contain an emerging pandemic virus. They also often lack the technical capacity to manufacture anti-viral drugs on their own and the financial resources to purchase sufficient quantities of these products at developed country prices.

Two anti-viral drugs in the neuraminidase inhibitors class, oseltamivir phosphate (commercially known as Tamiflu) and zanamivir (commercially known as Relenza) can reduce the severity and duration of illness caused by seasonal influenza. The efficacy of these pharmaceutical products depends, in part, on their early administration (i.e., within 48 hours after symptom onset). For cases of human infection with the H5N1 virus, they may improve prospects of survival if administered early, but, to date, clinical data is limited.

Tamiflu was developed and patented by Gilead Sciences, and is currently manufactured and marketed worldwide under licence by Hoffmann-La Roche Inc. (Roche). In early 2005, Roche announced a production shortage of Tamiflu owing to the limited availability of shikimic acid, an originating compound used to synthesize the pharmaceutical product and said to be derived from the star anise, a plant indigenous to China. Later, in March 2006, Roche announced that it was expanding its global manufacturing network for Tamiflu to produce 400 million treatments (4 billion doses) annually by year's end. However, according to the WHO, the complexity and time-consuming nature of Tamiflu's manufacturing process means that it will take a decade to produce enough of this pharmaceutical product to treat 20 per cent of the world's population. It is unclear from the information available whether this estimate takes into account Roche's recent efforts to increase production capacity. To date, Roche has donated 5.125 million treatments of Tamiflu to the WHO, and is offering substantial discounts to developing country purchasers.

In February 2006, Biolyse Pharma Corporation (Biolyse), a Canadian pharmaceutical company, announced that it had developed a process to produce a generic version of Tamiflu using the needles of discarded coniferous trees. In a letter dated February 13, 2006, addressed to the Minister of Industry and the Minister of Health, Biolyse requested that the Government add Tamiflu to Schedule 1 so that the company could eventually apply for a compulsory licence under CAMR to export its generic version of the product to eligible developing and least developed countries. This amendment is further to that request. It does not reflect an official Government position on Roche's ability to meet global demand for Tamiflu, nor on the viability of Biolyse's purported alternative manufacturing process for the pharmaceutical product.

Alternatives

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

Benefits and Costs

Adding Tamiflu to Schedule 1 will potentially benefit eligible developing and least developed countries who wish to import a low-cost version of this pharmaceutical product under CAMR. There are no costs associated with this measure.

Consultation

Pre-publication of the amendment was followed by a 30-day period during which interested persons could submit written representations to Industry Canada and Health Canada. Eleven submissions were received, including from Roche, Biolyse, innovative pharmaceutical and biotech trade associations, a number of Parliamentarians, non-governmental organizations (NGOs) and consumer groups. The majority were supportive and urged timely adoption of the amendment. Opponents, however, argued that the amendment was unnecessary, claiming that there is no present unmet need for Tamiflu in eligible importing countries under CAMR. They also criticized the Government for amending Schedule 1 without first establishing the expert advisory committee contemplated by CAMR to advise the Ministers of Industry and Health in this regard.

While public notification of the need for a particular pharmaceutical product from an eligible importing country is a necessary pre-condition for the issuance of a compulsory license under CAMR, it is not a legal prerequisite to the product's addition to Schedule 1. Similarly, there is no legal requirement that the expert advisory committee contemplated by CAMR be struck prior to amending this Schedule.

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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