Vol. 140, No. 26 — July 1, 2006

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

Statutory authority

Patent Act

Sponsoring departments

Department of Industry and Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Description

Pursuant to subparagraph 21.03(1)(a)(i) of the Patent Act (the "Act") the Government is proposing an amendment to Schedule 1 of the Act to add to the list of patented pharmaceutical products the name "oseltamivir phosphate" in capsule form in specified strength of 75 mg, as well as in powder for oral suspension form in specified strength of 12 mg/mL. The pharmaceutical product so-named is a neuraminidase inhibitor used in the treatment and prophylaxis of Type A and Type B influenza.

Schedule 1 is a list of patented pharmaceutical products that 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), now referred to as Canada's Access to Medicines Regime (CAMR).

Accordingly, if the proposed amendment is passed, a Canadian pharmaceutical manufacturer that wishes to manufacture a specified quantity of a low-cost version of the above-named pharmaceutical product for export to an eligible importing country could 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 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, to date, human cases have been reported in nine countries, first in Asia and more recently in the Middle East. All human cases have coincided with outbreaks of H5N1 in poultry. Altogether, more than half of the laboratory-confirmed cases have been fatal.

The WHO has recommended that countries implement two primary strategies for addressing the avian influenza situation and reducing the related threat of a pandemic. The first consists of efforts to contain outbreaks of H5N1 avian influenza in poultry and to prevent 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 tend to lack the technical capacity to manufacture antiviral drugs and the financial resources to purchase sufficient quantities of anti-viral drugs at developed country prices.

Two drugs in the neuraminidase inhibitors class, oseltamivir (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 drugs depends in part on their early administration (i.e. within 48 hours after symptom onset). For cases of human infection with H5N1, the drugs may improve prospects of survival if administered early, but, to date, clinical data are limited.

Tamiflu was developed and patented by Gilead Sciences and is currently marketed under licence by Hoffmann-La Roche Inc. (Roche). In early 2005, Roche announced a production shortage of oseltamivir owing to the limited availability of shikimic acid, an originating compound used in the synthesis of oseltamivir said to be derived from the star anise, a plant indigenous to China. More recently, in March 2006, Roche announced that it is expanding its global manufacturing network for Tamiflu in order to produce 400 million treatments (4 billion doses) annually by year's end. Roche has also donated 5.125 million treatments of Tamiflu to the WHO and is offering substantial discounts to developing country purchasers. According to the WHO, it may take a decade to produce enough of the drug to treat 20% of the world's population.

In February 2006, Biolyse Pharma, a Canadian pharmaceutical company, announced that it had developed a process to produce a generic version of oseltamivir 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 oseltamivir to Schedule 1 in order that the company can eventually apply for a compulsory licence to export it to developing countries under CAMR. The present proposed amendment is further to that request and does not reflect an official Government position on Roche's ability to meet global demand for Tamiflu, or on the viability of Biolyse's alternative manufacturing process.

Alternatives

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

Benefits and costs

The addition of oseltamivir to Schedule 1 could potentially benefit developing and least developed countries who are eligible to import pharmaceutical products under CAMR. There are no costs associated with this measure.

Consultation

Officials from Industry Canada have met with representatives of Roche and have advised them of the Government's intention to proceed with Biolyse's request to add oseltamivir to Schedule 1. Prepublication in Part I of the Canada Gazette will be followed by a 30-day period during which interested members of the public may submit written representations on the proposed amendment.

Compliance and enforcement

Not applicable.

Contacts

Susan Bincoletto, Director General, Marketplace Framework Policy Branch, Industry Canada, East Tower, 10th Floor, 235 Queen Street, Ottawa, Ontario K1A 0H5, (613) 952-0736 (telephone), (613) 948-6393 (fax), bincoletto.susan@ic.gc.ca (email); or Omer Boudreau, Director General, Therapeutic Products Directorate, Health Canada, Holland Cross, Tower B, 6th Floor, 1600 Scott Street, Ottawa, Ontario K1A 1B6, (613) 957-0368 (telephone), (613) 952-7756 (fax), C9@hc-sc.gc.ca (email).

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to subparagraph 21.03(1)(a)(i) (see footnote a) of the Patent Act, proposes to make the annexed Order Amending Schedule 1 to the Patent Act (Oseltamivir Phosphate).

Interested persons may make representations concerning the proposed Regulations within 30 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Susan Bincoletto, Director General, Marketplace Framework Policy Branch, Industry Canada, 10th Floor, East Tower, 235 Queen Street, Ottawa, Ontario K1A 0H5 (tel.: (613) 952-0736; fax: (613) 948-6393; e-mail: bincoletto.susan@ic.gc.ca).

Ottawa, June 22, 2006

DIANE LABELLE
Acting Assistant Clerk of the Privy Council

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.

[26-1-o]

Footnote a

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

Footnote 1

R.S., c. P-4

NOTICE:
The format of the electronic version of this issue of the Canada Gazette was modified in order to be compatible with hypertext language (HTML). Its content is very similar except for the footnotes, the symbols and the tables.

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