IP/C/W/639  
 
16 February 2018  
(18-1013) Page: 1/2 
Council for Trade -Related Aspects of  
Intellectual Property Rights  Original: English  
 
 
 INTELLECTUAL PROPERT Y AND THE PUBLIC INT EREST: REGULATORY RE VIEW 
EXCEPTION  
COMMUNICATION FROM THE PLURINATIONAL ST ATE OF BOLIVIA , BRAZIL , CHILE  
AND SOUTH AFRICA  
 
The following communication, dated 15 February 2017, is circulated at the request of 
the delegations of the Plurinational State of Bolivia , Brazil , Chile and South Africa.  
 
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1.  In May 2017, the delegations of Brazil, China, Fiji, India and South Africa circulated document 
IP/C/W/630 to encourage discussions in the Council for TRI PS regarding the relation between 
intellectual property and public interest. In this respect, reference was made to the importance of 
WTO Members making full use of the flexibilities contained in the Agreement on Trade -Related 
Aspects of Intellectual Prope rty Rights (TRIPS) to promote access to health technologies when 
necessary, as confirmed by the Doha Declaration. With a view to continuing discussions of a topic 
of general interest to WTO Members and to broaden understanding about the complex interplay 
between intellectual property and public interest, the sponsors of the present communication invite 
delegations to share their experience regarding the existence and use of the regulatory review 
exception ( "Bolar exception ") under their national or regional  frameworks.  
2.  Countries put in place regulatory requirements in certain industries in order to grant 
authorization for the commercialization of products. The underlying rationale is to ensure the 
safety and efficacy of such products, thereby protecting cons umers. Those requirements are 
particularly stringent in the pharmaceutical sector, in light of their possible effects on human 
health. Compliance with regulatory requirements often entails experimental trials and other related 
preparatory steps by companie s so they may acquire data necessary for regulatory approval.  
3.  In some countries, legislation allows a third party to undertake, without authorization from the 
patent right holder, measures in respect of a patented product necessary for obtaining regulatory  
authorization for commercializing that product. The regulatory review exception is also known as 
"Bolar exception ", a term derived from case law in the United States1. In Canada  – Pharmaceutical 
Patents  (DS114), the panel held2 that Canada 's regulatory re view exception is fully in compliance 
with the TRIPS Agreement, in particular with Article 30, which pertains to exceptions to rights 
conferred. Following the panel decision, numerous Members have introduced a regulatory review 
or similar exception in thei r national legislation.  
4.  The reasoning for such exception is to enable generic medicine producers to make all necessary 
preparations to enter the market without delay as soon as the patent expires. Absent such an 
exception, generic manufacturers would be blocked from undertaking t he trials required for 
regulatory approval, taking months, perhaps years, to obtain such approval. In such 
circumstances, the patent owner would be able to artificially extend the protection beyond the 
patent term as determined by national law. Not only do es this hurt competition, but it also runs 
                                                
1 Roche Products Inc. v Bolar Pharmaceuticals Co 733 F. 2d 858 (Fed Cir 1984)  
2 Document WT/DS114/R.  IP/C/W/639  
 
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  counter to the delicate balance of interests reflected in Article 7 of the TRIPS Agreement between 
the interests of inventors and those of the public.  
5.  As the global burden of disease expands and countries increasi ngly face the need of providing 
life-saving medicines at a reasonable cost, an integrated approach that ensures the continuous 
production of new, innovative medicines without endangering access to off -patent medicines is 
needed. Under this framework, the B olar exception is of particular importance and provides a 
valuable tool for stimulating competition in the market and ensuring the protection of public 
health.  
6.  Members are invited to share their experiences and provide information about the general 
feature s of the exception in their national or regional legislation, based on the following guiding 
questions:  
 What is the general characteristic of the "Bolar exception " or equivalent regulatory review 
exception in WTO Members ' legislation?  
 Which measures undert aken by legitimate third parties are exempted from the 
enforcement of patent protection under the exception?  
 Is the exception applicable to a specific industry or is it neutral in that regard?  
 What were the challenges faced by WTO Members in implementing s uch exception?  
 
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