The following notification has been received from the delegation of Canada on 4 October 2007 for circulation to the Council for TRIPS.
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In accordance with paragraph 2(c) of the WTO General Council Decision of 30 August 2003 on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, attached* is the authorization granted on 19 September 2007 by Canada's Commissioner of Patents to Apotex, Inc, pursuant to section 21.04 of the Patent Act. Rwanda had previously filed a related notification, dated 17 July 2007, pursuant to paragraph 2(a) of the same Decision of the WTO General Council (IP/N/9/RWA/1).
Pursuant to paragraph 2(c) and 2(b)(iii) of the Decision of 30 August 2003 on the Implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, the information on the shipment (quantities and distinguishing features) will be posted on the licensee’s website at: www.apotex.com/apotriavir/abouttriavir.asp.
ANNEX
AUTHORIZATION UNDER SECTION 21.04 OF THE PATENT ACT
In the matter of application for authorization number CAMR-1 by Apotex, Inc. for export to Rwanda of the following pharmaceutical product:
(a) if the pharmaceutical product is a drug as set out in section 2 of the Food and Drugs Act: A fixed dose combination tablet of lamivudine (150mg) + nevirapine (200mg) + zidovudine (300mg), as provided in Schedule 1 to the Patent Act
(b) if the pharmaceutical product is a medical device:
1. I hereby authorize Apotex, Inc. whose postal address is
150 Signet Drive
Toronto, Ontario
M9L 1T9
to make, construct and use, the patented inventions identified in patent numbers 2,311,988; 2,070,230; 2,068,790; 2,286,126; 2,216,634; 2,105,487; 2,059,263; 2,009,637 and 2,030,056 solely for purposes directly related to the manufacture of the above-mentioned pharmaceutical product, and to sell it for export to the above-mentioned country or WTO Member.
2. The quantity of the pharmaceutical product authorized to be manufactured by this authorization is 15,600,000 tablets.
3. In accordance with section 21.09 of the Act, this authorization is valid for a period of two years, beginning on the date shown below.
Granted at Gatineau, Quebec, the 19th day of September, 2007-10-05
Mary Carman
Commissioner of Patents
