IP/N/1/CAN/16  
IP/N/1/CAN/P/12  
 
8 June 2016  
(16-3057)  Page: 1/2  
Council for Trade-Related Aspects 
of Intellectual Property Rights  Original: English/French  
 
   
 
NOTIFICATION OF LAWS AND REGULATIONS 
UNDER ARTICLE 63.2 OF THE TRIPS AGREEMENT 
 
CANADA: ORDER AMENDING SCHEDULE 1 TO THE PATENT ACT (2014-1) 
Notifying Member C ANADA  
 
Details of the notified legal text 
 
Title  
 Order Amending Schedule 1 to the Patent Act (2014-1) 
Subject matter 
 Industrial property; Patents (including plant variety protection)  
Nature of 
notification  Main dedicated intellectual property law or regulation  
  Other law or regulation 
 
Link to legal text http://members.wto.org/crnattachments/2016/IP/CAN/16_2200_00_e.pdf  
 
Notification status  First notification 
 Amendment or revision to notified legal text 
 Replacement or consolidation of notified legal text(s) 
 
Previous 
notification(s) referred to IP/N/1/CAN/P/5 (Act to Amend the Patent Act and the Food and Drugs 
Act) 
"https://docs.wto.org/dol2fe/Pages/FE_Search/FE_S_S006.aspx?DataSour
ce=Cat&query=@SymbolMa tch=IP/N/1/CAN/P/5&Language=English&Cont
ext=ScriptedSearches&languageUIChanged=true# " 
 
IP/N/1/CAN/P/10 (Patent Act – consolidated – December 2014)  
"https://docs.wto.org/dol2fe/Pages/FE_Search/FE_S_S006.aspx?DataSour
ce=Cat&query=@SymbolMa tch=IP/N/1/CAN/P/10&Language=English&Con
text=ScriptedSearches&languageUIChanged=true# " 
 
Brief description of the notified legal text  
 
The Order Amending Schedule 1 to the Patent Act (2014-1)  adds the following names of 
three additional HIV/AIDS treatments to Schedule 1 to the Patent Act :  
 
 "efavirenz + emtricitabine + tenofovir disoproxil" in tablet form and in the specified 
strength of 600 mg, 200 mg, and 300 mg, respectively;  
 
 "emtricitabine + tenofovir disoproxil" in tablet form and in the specified strength of 200 mg, 
and 300 mg, respectively; and  
 
 "tenofovir disoproxil" in tablet form and in the specified strength of 300 mg.  
 
 IP/N/1/CAN/16 • IP/N/1/CAN/P/12 
 
- 2 - 
 
  The Decision of the General Council of 30 August 2003 allows WTO member countries with 
pharmaceutical manufacturing capacity to authorize the non-consensual use of a patented 
invention (i.e. compulsory licences) to manufacture  and export generic versions of patented drugs 
and medical devices to developing countries without the capacity to manufacture the products 
themselves.  
 
Canada's Access to Medicines Regime (CAMR) implements the 30 August 2003, decision by 
permitting the grant of "export-only" compulsory licences to Canadian pharmaceutical 
manufacturers who wish to supply drugs and medical devices to countries unable to manufacture 
their own. The products that are eligible for ex port under CAMR are listed on Schedule 1 of the 
Patent Act. When CAMR received Royal Assent in May 2004, Schedule 1 was primarily composed 
of the pharmaceutical products on the World Health Organization's Model List of Essential 
Medicines (EML) that were patented in Canada. The EML represents the minimum medicine needs 
for a basic health-care system and, at the time, pr ovided a baseline to ensure that CAMR was able 
to meet the basic healthcare needs of developing and least-developed countries in a clear and 
transparent manner.  
 
Language(s) of notified text English and French 
Date of adoption 17 June 2015 
Entry into force 17 June 2015 
 
Notification details 
 
Submission date 
of notification  30 May 2016 
Other information  
 The Order Amending Schedule 1 to the Patent Act (2014-1)  adds 
three additional HIV/AIDS treatments to Schedule 1 to the Patent Act   
 
http://www.gazette.gc.ca/rp-pr/p2/ 2015/2015-07-01/html/sor-dors154-
eng.php%20  
 
Agency or 
authority 
responsible Innovation, Science and Economic Development 
Patent Policy Directorate, Marketplace Framework Branch 
 
235 Queen Street 
Ottawa, Ontario 
K1A 0H5