IP/C/W/630  
 
6 June 2017  
(17-2975) Page: 1/3 
Council for Trade -Related Aspects of  
Intellectual Property Rights  Original: English  
 
INTELLECTUAL  PROPERTY  AND THE PUBLIC  INTEREST  
COMMUNICATION  FROM  BRAZIL,  CHINA,  FIJI, INDIA  AND SOUTH  AFRICA  
 
The following  communication,  dated  31 May 2017 is circulated  at the request  of the delegations  of 
Brazil,  China,  Fiji, India and South  Africa.  
 
_______________  
 
 
1.  The Trade -Related Aspects of Intellectual Property Rights (TRIPS) Agreement of the World 
Trade Organization (WTO) established minimum standards of protection that each government has 
to give to the intellectual property of fellow WTO Member s. Each of the main elements of 
protection is defined, namely the subject  matter to be protected, the rights to be conferred and 
permissible exceptions to those rights, and the minimum duration of protection. WTO M embers 
have the flexibility to design thei r national intellectual property (IP) systems within the minimum 
standards set by the  TRIPS  Agreement,  in cognizance  of a country 's economic,  developmental  and 
other  objectives,  including  public  health.   
2.  The TRIPS  Agreement  attempts  to strike  an appropriat e balance  between  the interests  of rights  
holders  and users.  Article  7 of the TRIPS  Agreement  entitled  "Objectives " recognizes  that the 
protection  of intellectual  property  should  contribute  to the promotion  of technological  innovation  
and to the transfer  and dissemination  of technology,  to the mutual  advantage  of users  and 
producers  of technological  knowledge  and in a manner  conducive  to social  and economic  welfare  
and to a balance  of rights  and obligations.  The search  for a balance  between  the need to protect 
IPRs to provide  incentives  for R&D on the one hand and, on the other  hand,  to address  concerns  
about  the potential  impact  of such protection  on the health  sector  – in particular  its effect  on 
prices  – has been an important  consideration  in the WTO's work.1 
3.  The TRIPS  Agreement  also recognizes  that the principles  of IP protection  are based  on 
underlying  public  policy  objectives.  Article  8 of TRIPS  Agreement  entitled  "Principles " states  that 
WTO Members  may, in formulating  or amending  their laws and regula tions,  adopt  measures  
necessary  to protect  public  health  and nutrition,  and to promote  the public  interest  in sectors  of 
vital importance  to their socio-economic  and technological  development,  provided  that such 
measures  are consistent  with the provisions  of this Agreement.  Article  8 (2) further  states  that 
appropriate  measures  may be needed  to prevent  the abuse  of IPRs by right holders,  or to resort  to 
practices  which  unreasonably  restrain  trade  or adversely  affect  the international  transfer  of 
technology.  
4.  In furtherance  of the objectives  and principles  of TRIPS  enshrined  in Articles  7 and 8, a number  
of safeguards  or flexibilities  have become  an integral  part of the TRIPS  framework.  These  
flexibilities  can be used to pursue  public  health  objectives.  Howeve r, to implement  these  
flexibilities,  action  is needed  at the domestic  level by incorporating  them into national  IP regime s 
                                                
1 Promoting Access to Medical Te chnologies and Innovation: Intersections between Public Health, 
Intellectual Property and T rade by WHO, WIPO and WTO , 2013, available at 
https://www.wto.org/english /tratop_e/trips_e/trilatweb_e/trilat_web_13_e.htm . This document is more 
commonly known as the "Trilateral Study ".  
 
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  keeping  in mind each country 's individual  needs  and policy  objectives.  Key TRIPS  flexibilities  
include  transition  periods  for LDCs (extended  by the WTO until 01 January  2033),  differing  IP 
exhaustion  regimes,  refining  the criteria  for grant  of a patent  (patentability  criteria),  pre-grant  and 
post-grant  opposition  procedures,  as well as exceptions  and limitations  to patent  rights  once 
granted,  including  the regulatory  review  exception  ("Bolar" exception)  to facilitate  market  entry of 
generics,  compulsory  licences  and government  use.  
5. For pharmaceutical  patents,  these  flexibilities  have been clarified  and enhanced  by the 2001 
Doha Decla ration  on TRIPS  and Public  Health.2 WTO Members  have the flexibility  to interpret  and 
implement  TRIPS  provisions  in a manner  supportive  of their right to protect  public  health.  Another  
new flexibility  was added  by the Doha Declaration,  which  was put into practice  in 2003 by the WTO 
with a Decision3 enabling  countries  that cannot  manufacture  medicines  themselves,  to import  
pharmaceuticals  made  under  compulsory  licences.  In 2005,  Members  agreed  to make  this decision  
permanent  through  a Protocol  Amend ing the TRIPS Agreement,  which  entered  into force on 
23 January  2017 after two thirds  of Members  accepted  it. The amendment  provides  legal certainty4 
that generic  versions  of patent -protected  medicines  can be produced  under  compulsory  licences  
specifically  for export to countries  with limited  or no pharmaceutical  production  capacity.   
 
6. Many  governments  have not used the flexibilities  available  under  the TRIPS  Agreement for 
various  reasons , such as capacity  constraints  or political pressure  from states  and corpora tions 
mentioned in the  UN Secretary -General 's High Level Panel  Report on Access  to Medicines. 
Moreover,  even where  some  developing  countries  used the flexibilities  available  to them under  the 
TRIPS  Agreement  to address  public  interest  objectives  through  measures  which  are fully consistent  
with the TRIPS  Agreement,  these  attempts  have been challenged  legally  as well as politically.  
Political  and economic  pressure  placed  on governments  to forgo the use of TRIPS  flexibilities  
violates  the integrity  and legitim acy of the system  of legal duties  and rights  created  by the TRIPS  
Agreement,  as reaffirmed  by the Doha Declaration.5 
 
7. A slew of regional  trade  agreements  containing  "TRIPS  plus" standards  of IP protection  and 
enforcement  have the potential  to significan tly affect  the policy  space  available  for effective  and 
full use of the TRIPS  flexibilities.  The most common  "TRIPS  plus" provisions  in free trade 
agreements  (FTA)  that affect  the pharmaceutical  sector  are: the definition  of patentability  criteria;  
patent  term extensions;  test data protection;  the linkage  of regulatory  approval  with patents  and 
enforcement  of IPRs, including  border  measures.  Such provisions  can delay  market  entry  of 
generics  and increase  prices  of medicines .6 Investor -State  disputes  under  regional  or bilateral  
investment  protection  agreements  are also emerging  as significant  threats  to the use of TRIPS  
flexibilities  in the public  interest.   
 
8. Ironically,  the abovementioned  challenges  to the use of TRIPS  flexibilities  to further  the public  
interest  objectives  underlying  IP protection,  have been occurring  in spite of the emergence  of laws 
and jurisprudence  in developed  countries  that seek to limit the scope  of IP protection  and 
enforcement.  For example,  in the Myriad  Genetics  (2013)  case7, the US Supreme  Court  had ruled 
unanimously  that naturally  occurring  genes  cannot  be patented,  even if they are isolated.  In 2003,  
the US Federal  Trade  Commission  had proposed  tightening  the non-obviousness  standard,  in order  
to limit the grant  of unwarranted  patents .8 
 
9. There  is a growing  concern  about  an imbalance  between  intellectual  property  and the public  
interest.  With regard  to health  technologies,  for example,  patents  and related  monopoly  rights  in 
                                                
2 https://www.wto.org/english/thewto_e/minist_e/m in01_e/mindecl_trips_e.htm  
3 See document WT/L/540, General Council Decision of 30 August 2003.   
4 https://www.wto.org/english/news_e/news17_e/heal_30jan17_e.htm  
5 The Report o f the UN Secretary -General's High Level Panel on Access to Medicines is available at 
http://www.unsgaccessmeds.org/final -report/  
6 Promoting Access to Medical Technologies and Innovation: Intersec tions between Public Health, 
Intellectual Property and Trade, 2013, see footnote 1.  
7 Association for Molecular Pathology v. Myriad Genetics, USCC No. 12 -398 (569 U.S. _ June 13, 2013 ) 
8 https://www.ftc.gov/sites/default/files/documents/reports/promote -innovation -proper -balance -
competition -and-patent -law-and-policy/innovationrpt.pdf  
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  test data, without  sufficient  use of balancing  excep tions and limitations  to protect  the public  
interest,  permit  companies  to maintain  high prices  and exacerbate  crises  of access  around  the 
world,  where  many  patients  cannot  afford  medicines,  and force governments  with finite health  
budgets  to ration  care. Increased  copyright  protections  create  similar  problems  of access  to 
knowledge  goods,  limiting  the ability  of many  people  around  the world  to access  print,  audio,  or 
visual  works  of education  or entertainment  that we take for granted.  These  are only a few 
examples  of the problem.  There  is a need to pursue  a development -oriented  approach  towards  
formulating  IP laws and policies  rather  than pursue  an iconoclastic  approach  of IP for development.  
 
10. More than 20 years  after the adoption  of the TRIPS  Agreement,  there  is a need for discussion  
in the TRIPS  Council  on the relationship  between  IP and the public  interest  and to broaden  the 
understanding  of how the IP system  can be more responsive  to public  interest  considerations.  
While  this issue is very pertinent  for developing  countries,  it has also been a topic of significant  
policy  debate  even in developed  countries.  During  the course  of the meetings  of the Council  for 
TRIPS  in this year and later,  WTO Members  could  exchange  views  and experiences  on measures  
within the IP system  that they have adopted  to promote  the public  interest,  including  but not 
limited  to compulsory  licensing,  patentability  criteria,  IP and competition,  and Bolar exception.  For 
the 13-14 June 2017 meeting  of the Council  for TRIPS,  the sponso rs of this communication  invite  
delegations  to share  their experiences  on the use of compulsory  licenses  for accessing  health  and 
other  technologies.   
 
Compulsory  Licensing  
11. Compulsory  licensing  occurs  when  a government  allows  someone  else to produce  the patented  
product  or process  without  the consent  of the patent  owner .9 Article  31 TRIPS  lays down  a set of 
conditions  for issuing  compulsory  licenses  of patents.  The Doha Declaration  on the TRIPS  
Agreement  and Public  Health  states  that, "Each Member  has the right to grant  compulsory  licenses  
and the freedom  to determine  the grounds  upon which  such licenses  are granted ".10 In spite of the 
clarity  of this language,  WTO Members around  the world  seeking  to make  use of compulsory  
licences as a tool to increase  access  to affordable  medicines  have faced various 
challenges/barriers.  
 
12. Some  possible  grounds  for compulsory  licensing  are suggested  in Article  5A of the Paris 
Convention  (e.g. abuse  of patent  rights,  including  failure  of the patent  holder  to work the 
invention)  and in Article  31 of the TRIPS  Agreement  (e.g. national  emergency  and public  
non-commercial  use). However,  this list is not exhaustive.  The Doha Declaration  on the TRIPS  
Agreement  and Public  Health  confirmed  what was already  implicit  in the TRIPS  Agreement  – that 
WTO Members  have the freedom  to determine  the grounds  upon which  compulsory  licenses  are 
granted.  They are thus not limited  to emergencies  or other  urgent  situations,  as is sometimes  
mistakenly  believed.  A range  of grounds  have been set out in national  laws like (i) non-working  or 
insufficient  working,  (ii) anti-competitive  practices,  (iii) public  interest,  (iv) dependant  and blocking  
patents,  (v) Government  use11.  
 
13. The sponsors  of this communication  invite  Members  to share  their national experiences  and 
examples  of using  compulsory  licenses.  The information  exchange  could  serve  to enhance  
understanding  of Members  on various  grounds  available  for issue of compulsory  licenses  and 
problems  faced  by Members  while using  them.  
 
Guiding  quest ions: 
 
 What grounds are available in their national laws to issue compulsory licenses?  
 What are the difficulties faced by WTO Members in using compulsory licenses, including 
constraints, such as insufficient or no manufacturing capacities?   
 How the measure  of compulsory  licence was used by governments  to obtain  price reduction  
from patent  holders?  
 What was the result of using compulsory licenses in terms of price and access to affordable 
products and technologies?  
__________  
                                                
9 https://www.wto.org/english/tratop_e/trips_e/public_health_faq_e.htm  
10 https://www.wto.org/en glish/thewto_e/minist_e/min01_e/mindecl_trips_e.htm  
11 Promoting Access to Medical Technologies and Innovation: Intersections between Public Health, 
Intellectual Property and Trade, 2013, see footnote 1.