RESTRICTED  
  
IP/C/M/90/Add.1  
 
15 January 2019  
(19-0234) Page: 1/75 
Council for Trade -Related Aspects of  
Intellectual Property Rights    
 
MINUTES OF MEETING  
HELD IN THE CENTRE W ILLIAM RAPPARD ON 8-9 NOVEMBER  2018 
Chairperson: H.E. Ambassador Dr Walter Werner (Germany)  
Addendum  
The present document contains the statements made during the Council for TRIPS meeting held on 
8-9 November  2018.  
 
_______________  
 
Table of Contents  
 
1   NOTIFICATIONS UN DER PROVISIONS OF TH E AGREEME NT ................................ ........  5 
2   REVIEW OF NATION AL IMPLEMENTING LEGI SLATION  ................................ ................  8 
3   REVIEW OF THE PR OVISIONS OF ARTICLE 27.3(B)  ................................ .....................  8 
4   RELATIONSHIP BET WEEN THE TRIPS AGREE MENT AND THE CONVENT ION ON 
BIOLOGICAL DIVERSITY  ................................ ................................ ................................ .. 8 
5   PROTECTION OF TR ADITIONAL KNOWLEDGE AN D FOLKLORE  ................................ ..... 8 
6   ANNUAL REVIEW OF  THE SPECIAL COMPULS ORY LICENSING SYSTEM  
(PARAGRAPH 7 OF THE ANNEX TO THE AMENDED TRIPS AGREEM ENT AND 
PARAGRAPH 8 OF THE D ECISION ON THE IMPLE MENTATION OF PARAGRA PH 6 
OF THE DOHA DECLARAT ION ON THE TRIPS AGR EEMENT AND PUBLIC HE ALTH)  ...........  16 
7   NON-VIOLATION AN D SITUATION COMPLAIN TS ................................ .......................  19 
8   REVIEW OF THE IM PLEMENTATION OF THE TRIPS AGREEM ENT UNDER 
ARTICLE 71.1  ................................ ................................ ................................ .................  23 
9   REVIEW OF THE AP PLICATION OF THE PRO VISIONS OF THE SECTI ON ON 
GEOGRAPHICAL INDICAT IONS UNDER ARTICLE  24.2 ................................ ....................  23 
10   SIXTEENTH ANNUA L REVIEW UNDER PARAG RAPH 2 OF THE DECISI ON ON 
THE IMPLEMENTATION O F ARTICLE 66.2 OF TH E TRIPS AGREEM ENT ............................  23 
11   TECHNICAL COOPE RATION AND CAPACITY BUILDING  ................................ ............  32 
12   INTELLECTUAL PR OPERTY AND INNOVATIO N: THE SOCIETAL VALU E OF IP 
IN THE NEW ECONOMY – IP AND NEW BUSINESS  ................................ ..........................  39 
13   INTELLECTUAL PR OPERTY AND THE PUBLI C INTEREST: PROMOTIN G PUBLIC 
HEALTH THROUGH COMPE TITION LAW AND POLIC Y................................ ......................  60 
14   INFORMATION ON RELEVANT DEVELOPMENT S ELSEWHERE IN THE W TO ...............  71 
14.1   DISPUTE SETTL EMENT  ................................ ................................ ..........................  71 IP/C/M/90/Add.1  
 
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  14.2   IPR-RELATED ISSUES IN  TRADE POLICY REVIEW S ................................ ..............  73 
15   OBSERVER STATUS  FOR INTERNATIONAL INTE RGOVERNMENTAL 
ORGANIZATIONS  ................................ ................................ ................................ ...........  73 
16   ANNUAL REPORT  ................................ ................................ ................................ ..... 75 
17   OTHER  BUSINESS  ................................ ................................ ................................ .... 75 
17.1   DATES FOR THE  COUNCIL 'S MEETINGS IN 2019  ................................ ...................  75 
17.2   WORK PROGRAMM E ON ELECTRONIC COMMERCE  ................................ ................  75 
 
  IP/C/M/90/Add.1  
 
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  INDEX OF THE STATEMENTS MADE  
AT THE MEETING OF COUNCIL FOR TRIPS 8-9 November  2018* 
 
 
 
African Regional Intellectual Property 
Organization  
Technical Cooperation  ..........................  38 
Argentina  
Non-Violation  ................................ ...... 21 
Australia  
Article 66.2  ................................ ........  28 
Biotech, Biodiversity, TK  ......................  14 
Information on Developments in WTO  .... 72 
IP and Innovation - IP and New Economy – 
IP and New Business  .........................  44 
Technical Cooperation  ..........................  33 
Bahrain, Kingdom of  
Observer Status  ................................ .. 74 
Bangladesh  
Biotech, Biodiversity, TK  ......................  10 
Non-Violation  ................................ ...... 20 
Bolivia, Plurinational State of  
Biotech, Biodiversity, TK  ......................  11 
Brazil  
Biotech, Biodiversity, TK  ......................  10 
IP and Innovation - IP and New Economy – 
IP and New Business  .........................  52 
IP and Public Interest - Promoting Public 
Health Through Competition Law and 
Policy  ................................ .........  62, 70  
Non-Violation  ................................ ...... 20 
Observer Status  ................................ .. 75 
Special Compulsory Licensing  ...............  16 
Cambodia  
Article 66.2  ................................ ........  31 
Canada  
Article 66.2  ................................ ........  26 
Biotech, Biodiversity, TK  ......................  13 
IP and Innovation - IP and New Economy – 
IP and New Business  .........................  56 
Non-Violation  ................................ ...... 21 
Special Compulsory Licensing  ...............  17 
Technical Cooperation  ..........................  32 
Central African Republic, on behalf of the 
LDC Group  
Article 66.2  ................................ ........  30 
Chile  
Biotech, Biodiversity, TK  ......................  12 
IP and Innovation - IP and New Economy – 
IP and New Business  .........................  46 
China  
Biotech, Biodiversity, TK  ........................  9 
IP and Innovation - IP and New Economy – 
IP and New Business  .........................  57 
IP and Public Interest - Promoting Public 
Health Through Competition Law and 
Policy  ................................ ..............  64 
Non-Violation  ................................ ...... 21 
Observer Status  ................................ .. 75 Colombia  
IP and Public Interest  ..........................  59 
Notifications  ................................ .........  5 
Cooperation Council for the Arab States 
of the Gulf  
Observer Status  ................................ .. 73 
Technical Cooperation ..........................  36 
Dominican Republic  
Information on Developments in WTO  ... 71 
Ecuador  
Biotech, Biodiversity, TK  ......................  11 
Non-Violation  ................................ ..... 19 
Egypt  
Biotech, Biodiversity, TK  ........................  9 
Non-Violation  ................................ ..... 20 
Observer Status  ................................ .. 75 
European Union  
Article 66.2  ................................ ........  23 
IP and Innovation - IP and New Economy – 
IP and New Business  ........................  49 
IP and Public Interest - Promoting Public 
Health Through Competition Law and 
Policy  ................................ ..............  69 
Notificati ons ................................ .........  7 
Technical Cooperation ..........................  34 
Honduras  
Information on Developments in WTO  ... 71 
India  
Biotech, Biodiversity, TK  ........................  8 
IP and Innovation - IP and New Economy – 
IP and New Business  ........................  54 
IP and Public Interest - Promoting Public 
Health Through Competition Law and 
Policy  ................................ ..............  63 
Non-Violation  ................................ ..... 19 
Notifications  ................................ .........  7 
Special Compulsory Licensing  ...............  17 
Indonesia  
Biotech, Biodiversity, TK  ......................  13 
Information on Developments in WTO  ... 72 
IP and Public Interest - Promoting Public 
Health Through Competition Law and 
Policy  ................................ ..............  64 
Non-Violation  ................................ ..... 21 
Japan  
Article 66.2  ................................ ........  28 
Biotech, Biodiversity, TK  ......................  15 
IP and Innovation - IP and New Economy – 
IP and New Business  ........................  47 
IP and Public Interest - Promoting Public 
Health Through Competition Law and 
Policy  ................................ ..............  68 
Notifications  ................................ .........  5 
Special Compulsory Licensing  ...............  17 
Techni cal Cooperation ..........................  33 IP/C/M/90/Add.1  
 
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  Jordan  
Observer Status  ................................ .. 74 
Kuwait , the State of  
Observer Status  ................................ .. 74 
Moldova, Republic of  
Notifications  ................................ .........  6 
Morocco  
Observer Status  ................................ .. 74 
Norway  
Article 66.2  ................................ ........  29 
Information on Developments in WTO  .... 71 
IP and Innovation - IP and New Economy – 
IP and New Business  .........................  51 
Technical Cooperation  ..........................  34 
Oman  
Observer Status  ................................ .. 74 
Qatar  
Observer Status  ................................ .. 74 
Russian Federation  
Non-Violation  ................................ ...... 23 
Singapore  
IP and Innovation - IP and New Economy – 
IP and New Business  .........................  54 
South Africa  
Biotech, Biodiversity, TK  ......................  12 
IP and Innovation - IP and New Economy – 
IP and New Business  .........................  58 
IP and Public Interest - Promoting Public 
Health Through Competition Law and 
Policy  ................................ .........  60, 66  
Non-Violation  ................................ ...... 19 
Switzerland  
Article 24.2  ................................ ........  23 
Article 66.2  ................................ ........  30 
Biotech, Biodiversity, TK  ......................  15 
IP and Innovation - IP and New Economy – 
IP and New Business  .........................  42 
Non-Violation  ................................ ...... 22 Special Compulsory Licensing  ...............  18 
Chinese Taipei  
Biotech, Biodiversity, TK  ......................  12 
IP and Innovation - IP and New Economy – 
IP and New Business  ........................  55 
Non-Violation  ................................ ..... 21 
Thailand  
Biotech, Biodiversity, TK  ......................  14 
Ukraine  
Article 24.2  ................................ ........  23 
Notifications  ................................ .........  6 
United Nations Conference on Trade and 
Development  
Technical Cooperation ..........................  37 
United States of America  
Article 66.2  ................................ ........  29 
Biotech, Biodiversity, TK  ......................  15 
IP and Innovation – IP and New Economy – 
IP and New Business  ........................  39 
IP and Public Interest - Promoting Public 
Health Through Competition Law and 
Policy  ................................ ..............  68 
Non-Violation  ................................ ..... 22 
Notifications  ................................ .........  7 
Special Compulsory Licensing  ...............  18 
Technical Cooperation ..........................  33 
World Health Organization  
IP and Public Interest - Promoting Public 
Health Through  Competition Law and 
Policy  ................................ ..............  70 
Technical Cooperation ..........................  35 
World Intellectual Property Organization  
Technical Cooperation ..........................  38 
WTO Secretariat  
Information on Developments in WTO  ... 72 
Notifications  ................................ .........  7 
Technical Cooperation ..........................  34 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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*A record of statements as delivered in the formal session of the Council. Some statements have been lightly 
edited as appropriate to ensure the consistency of presentation.  
  IP/C/M/90/Add.1  
 
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  1  NOTIFICATIONS UNDER PROVISIONS OF THE AG REEMENT  
1.1  Colombia  
1.  Law No. 1915 of 2018 (IP/N/1/COL/9) amends Law No. 23 of 1982 and establishes other 
provisions on copyright and related rights, clarifies and updates the general copyright regime in 
areas such as presumption of authorship, prote ction of first publication or fixation abroad, the scope 
of certain authors ' rights in their works including digital media storage, the term of copyright 
protection for legal persons, the rights of performers to their performances, etc. The law entered 
into force on 12 July 2018, repealing articles 58 to 71, 243, and the other contrary provisions of Law  
No. 23 of 1982.  
2.  Law No. 1835 of 2017 amending Article 98 of Law No. 23 of 1982 on copyright and providing for 
the remuneration of authors of cinematographic  works  (IP/N/1/COL/C/10)  is also known as the 
"Pepe Sánchez " Law in honour of a well -known Colombian director, screenwriter and actor. This law 
amends the general copyright regime and recognizes the right to fair remuneration of authors of 
cinematographic works for acts of communication to the public of their works , without prejudice to 
the presumption of transfer of copyright and economic rights to the producers.  
3.  Decree No. 670 of 2017 partially amending the Single Regulatory Decree for the Trade, Industry 
and Tourism Sector No. 1074 of 2015 (IP/N/1/COL/C/11; IP/N/ 1/COL/I/5 ) explains the procedure 
for the declaration of the existence of reasons of public interest for compulsory licensing. Compulsory 
licensing is referred to in Article 65 of Andean Decision 486 of 2000. Decree No. 670 of 2017 provides 
for an Interins titutional Technical Committee made up of the competent authority (i.e. the authority 
that initiated the procedure), the Ministry of Commerce, Industry and Tourism, and the National 
Planning Department. This Committee has to examine the application submitt ed, request any further 
information that may be required, and seek opinions and technical support from other entities and 
natural persons. Following its assessment, the Committee makes a recommendation to the 
competent authority on whether or not to declar e the existence of reasons of public interest. It is 
important to note that the Decree establishes a clear procedure with a specific time frame to ensure 
the participation of all interested parties.  
4.  Law No. 1834 of 2017 promoting the creative economy (Ley Naranja, or Orange Economy Law , 
IP/N/1/COL/I/6 ) is an initiative that seeks to promote the development and growth of creative 
industries in Colombia. Creative industries include the sectors that combine creation, production and 
marketing of goods and servi ces based on intangible cultural content, and those that generate 
copyright protection. The Law seeks, inter alia , to create a strategy to improve interinstitutional 
coordination, support for the formalization and adaptation of the creative industry, and t he 
promotion of international instruments to ensure greater and better access to foreign markets.  
1.2  Japan  
5.  This delegation is pleased to inform the Council that Japan recently amended its Acts of Patent s, 
Design s and Trademark s. The amendments have been notified to this Council in accordance with 
Article 63.2  TRIPS in documents  IP/N/1/JPN/P/13, IP/N/1/JPN/D/8 and IP/N/1/JPN/T/8. We would 
like to briefly explain some points about the amendment s. 
6.  First, the amendments to the Patent Ac t and to the Design Act were made in order to expand the 
"grace period " from six months to one year, in regard to the exception to lack of novelty of 
inventions. This delegation firmly believes that this expansion will make the Japanese IP system 
more user -friendly, and will promote innovations through appropriately protecting inventions and 
designs.  
7.  Second the amendment to the Trademark Act added a requirement of divisional applications to 
improve the trademark filing procedures.  
8.  The Government of Japan wi ll continuously fulfil its obligation to ensure the accessibility and the 
transparency of the Japanese intellectual property system.  IP/C/M/90/Add.1  
 
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  1.3  Moldova , Republic of  
9.  The Republic of Moldova has submitted the notification of l aws and regulations under Article 63.2 
of the TRIPS Agreement , announcing the new Government Decision N umber  741 of 18  July 2018 
amending Decision 541 of 18  July 2011 which establishes the legal framework for the activity of the 
authorized intellectual property rights attorneys  (IP/N/1/MDA/O/3 and IP/N/1/MDA/O/4 ).  
10.  The notified document regulates the fundamental principles and rules of professional conduct 
for the authorized intellectual property attorneys both in relation s with customers, national and 
international authorities, non -governmental organizations and in relations with other authorized 
authorities. The operated amendments take over the best practices and the international standards 
of professional conduct for IP lawyers.  
11.  The principle  of tran sparency and the notification obligations remain at the core of the 
well-functioning of this Council, to which we attach great importance. We thank the delegations that 
have submitted notifications prior to t he meeting and encourage other Members  to do so.  
1.4  Ukraine  
12.  The first notification , circulated in document  IP/N/1/UKR/C/4 , concerns the new legislation of 
Ukraine regarding collective management system (CMO) and, in particular, the Law of Ukraine "On 
Efficient Management of Pr operty Rights of Rights holders in the Sphere of Copyright and/or Related 
Rights " Number  2415 of 15  May 2018, which entered into force on  22 July 2018.  
13.  The Law provides that collective management of copyright and related rights is exercised in a 
form of vo luntary, extended and mandatory collective management.  
14.  The main principles of CMO are:  
a. Strict compliance with the interests of the rightsholders;  
b. Equality;  
c. Transparency, accountability; and  
d. Efficient management.  
15.  The Law determines clear requirements for  the Statute of CMO, membership conditions , the 
powers of General Assembly, and Supervisory and Executive Bodies of CMO. I also include  a 
provision on transparency of operation of CMOs , requirements for annual reports on activity of CMOs, 
and rules of declaration and withdrawal of rights.  The n ew legislation provides for clear and 
transparent procedures of collection, distribution and payment of rights revenue.  
16.  According to this Law , the current system of CM O will be reloaded. All certificates of regist ration 
and of authorization of CMOs, issued before the entry into force of this Law, shall become invalid.  
17.  The Law strictly determin es the sphere of extended and mandatory collective management.  The 
accredited CMO shall be designated by an open competition  organized by the Ministry of Economic 
Development and Trade ( MEDT ) and conducted by the Accreditation Committee in the manner 
prescribed by this Law.  
18.  Ukraine 's second notification (IP/N/3/UKR/3) provides new information regarding its contact 
points. Speci fically, it informs Members that the MEDT  of Ukraine is established as a contact point 
for the exchange of information and cooperation on all intellectual property matters. Ukraine 
previously notified its updated contact points, which were established in t he State  Fiscal Service of 
Ukraine for the law enforcement purpose.  
19.  To conclude, we would like to note that work in the IP sphere is one of the key priorities of the 
Government of Ukraine . We do our best to create a modern transparent, effective and effici ent CMO 
regime in Ukraine that ensures that right holders will receive fair compensation for their creative 
works consumed in Ukraine.    IP/C/M/90/Add.1  
 
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  20.  Ukraine wants to reassure Mem bers in its intention to fulfil  its commitments under the 
TRIPS  Agreement . The MEDT of Uk raine as the central body of executive power will put its best 
efforts within its competence for ensuring efficient protection and enforcement of IP rights.  The 
delegation of Ukraine will actively participate in addressing all challenges jointly with all M embers of 
the World Trade Organization.  
1.5  United States of America  
21.  The United States  appreciates the notifications made for the meeting and will follow up with 
delegations.  
1.6  European Union  
22.  The European Union takes note of the questions from the Indian delegation  (on enforcement of 
IP rights regarding goods in transit, circulated in document IP/C/W/636/Add.1) . Since we received 
the document only a couple of days ahead of the TRIPS Council on a subject involving several 
services of the European Commission, the European Union  is not in a position to provide replies  at 
this meeting .  
23.  The European Union is compliant with its TRIPS obligations, including those related to 
enforcement. We are not aware of a single recent case in the European Union  were there was an 
issue of seizure of legally transiting pharmaceutical products not destined for the European Union  
internal market.  
24.  As India is aware, there is an ongoing bilateral consultation process on matters of transit 
between India and the European Union . The European Union  remains committed to that bilateral 
process.  
1.7  India  
25.  India t akes note of the European Union 's response and will wait for the ir response.  
1.8  WTO Secretariat  
26.  The work on the e -TRIPS project, particularly the notification submission tool, is at a very 
advanced stage, and we have reported extensively on this project in the past, so our report will be 
very brief.   
27.   The WTO Secretariat is fine -tuning the IT aspects of the project, with the aim of opening to 
Members for tri al usage in the new year. Current work includes cleaning, tagging and confirming the 
integrity of legacy data, and improving the IT to make it clearer and more user -friendly for Members. 
We are currently introducin g specific refinements in the light of the direct experience of Members in 
preparing and submitting notifi cation and reporting material. We are conscious that it is much easier 
and more cost -effective to refine the system now rather than returning to it su bsequently after it is 
released ; hence the emphasis on fine -tuning it now.  
28.   The WTO Secretariat  would welcome any further feedback, comments and suggestions, in 
particular through informal consultations and demonstrations with delegates. This would h elp us  to 
shape the final version which would then go on line for Members to use directly when providing 
notifications and other reports relating  to the work of this Council.  
29.   The Secretariat is also developing a comprehensive step -by-step guide on how to use e -TRIPS, 
which also provides information on the various categories of material – notifications and regular 
reports - that Members may wish to submit as part of their ongoing contribution to the transparency 
function of th is Council. The Secretariat will be i n touch with Members with further details in due 
course, and again will refine this mate rial in the light of feedback  received . Our technical assistance 
work will also include advice on notifications and , in particular , how Members can make use of e -
TRIPS to track their existing notifications and to keep them up to date and complete.  
30.   This work has concerned an improved notification and reporting sub mission tool – the input 
side. We are also working on the improved gateway for access to and easier searching  of this IP/C/M/90/Add.1  
 
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  material. This, too, will be the subject of consultations with Members to ensure that it corresponds 
with the practical needs of Geneva -based delegates and capital -based officials seeking better access 
to the TRIPS -related material contained in th e system. Again, we will be in touch with delegations 
to arrange for informal consultations to facilitate this stage of work.   
31.   I conclude by thanking delegates for their guidance and cooperation in the development and 
implementation of this new system. T his has been indispensable for the efforts made to ensure that 
this will be a tool that is practical to use and efficient and timely in the processing and dissemination 
of the key worki ng materials for this Council. We therefore place strong emphasis on th is continuing 
feedback from Members in taking this project forward.  
2  REVIEW OF NATIONAL I MPLEMENTING LEGISLAT ION 
32.  No statements were made under this agenda item.  
3  REVIEW OF THE PROVIS IONS OF ARTICLE 27.3 (B)  
4  RELATIONSHIP BETWEEN  THE TRIPS AGREEMENT  AND THE CONVENTION ON 
BIOLOGICAL DIVERSITY   
5  PROTECTION OF TRADIT IONAL KNOWLEDGE AND FOLKLORE  
5.1  India  
33.  The WHO report on Traditional Medicine Strategy 2014 -2023 notes that demand for traditional 
and complementing medic ines has been growing at a fast pace. The extent of economic value 
contained in herbal medicines is evident from the fact that the output of Chinese medical  material 
was estimated to amount to US D 83.1 billion in 2012, an increase of more than 20% from the  
previous year.  
34.  The Trilateral Study (WHO-WIPO -WTO) on Promoting Access to Medical Technologies  and 
Innovation  (2013) acknowledges the fact that traditional medicine s and medical knowledge provide 
leads for the development of new treatments. It goes on to  mention that many existing modern 
medicines are originally based on herbal products.  
35.  India is an ancient civilization with a rich body of traditional knowledge associated with biological 
resources. This traditional knowledge is both coded, as in the text s of Indian systems of medicine 
such as Ayurveda, Unani and Siddha; and non -coded, which exists in the oral undocumented 
traditions. India is also one of the seventeen identified mega bio -diverse countries of the world, 
home to a vast and a rich diversity of biological resources.  
36.  In more recent years, with the establishment of the Traditional Knowledge Digital Library  in 
India, more than 1000 patent applications could be identified in a short period of time where a patent 
was being sought for knowledge that  already existed in codified traditional knowledge system s such 
as Ayurveda, Unani, Siddha and Yoga.  
37.  Countries have adopted various methods to protect traditional knowledge and associated 
genetic resource s at the national level. However, it is important t o note that what can never be 
addressed by the domestic/national regimes is misappropriation of existing knowledge in foreign 
patent offices. Absence of an international regime therefore is a major gap in addressing the problem 
of biopiracy.   
38.  It has there fore been a long -standing demand that there should be an international regime that 
makes the patent office the check point to contain misappropriation. Patents should not be granted 
for existing traditional knowledge and associated genetic resources. Furth er where genetic resources 
and associated traditional knowledge form the basis of scientific development, it is important that 
patent applications must disclose source or origin of the resource and also disclose whether the 
access was on mutually agreed te rms. Disclosure is important not only to address information 
asymmetry at the Patent Office but also to enable a better assessment of th e inventive step. The 
TRIPS /CBD l inkage is therefore important for developing countries because it seeks to address 
biopiracy.   IP/C/M/90/Add.1  
 
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  39.  Pursuant to the Convention on Biological Diversity (CBD), India has been active in taking steps 
to implement its provisions leading to conservation of biodiversity, its sustainable use and equitable 
sharing of benefits. We enacted the Biological D iversity Act in 2002, notified the Biological Diversity 
Rules in 2004 and also established a three -tier institutional structure.  
40.  The Nagoya Protocol of the Convention on Biodiversity (CBD) entered into force on 
12 October  2014. 105 Countries, including India , have ratified the Protocol, till now.  
41.  The D oha Ministerial Declaration in P aragraph 19 mandated that the TRIPS Council examine the 
relationship between the TRIPS Agreement and the CBD, and the protection of traditional kno wledge 
and folklore.  
42.  We also need to take note of the recent developments of the 2030 Agenda for Sustainable 
Developmen t to which we are all committed. It  specifically calls for promoting access to and fair and 
equitable sharing of benefits arising from t he utilization of genetic resources and associated 
traditional knowledge, as internationally agreed, in targets 2.5 and 15.6 . 
43.  It would also be  useful to the  delegates of the TRIPS Council  if the CBD Secretariat were 
requested to brief the TRIPS Council on the latest developments in the implementation of the Nagoya 
Protocol. The briefing by the CBD Secretariat would be very important to understand the implications 
of the entry into force of the Nagoya Protocol, to which 105 Members  have acceded . We reiterate  
our demand for a formal briefing by the CBD  Secretariat in the interest of the large majority of 
Members. We also support updating the three factual briefs by the Secretariat.  
44.  I conclude by stating that we hope to continue our efforts in building momentum  on the issue 
of the TRIPS /CBD linkage , taking into account the new developments , such as the finalization of the 
Sustainable Development Goals and the ratification of the Nagoya Protocol by more than 100 
countries.  
5.2  Egypt 
45.  With regard to agenda items 3, 4, and 5 , the delegation  of Egypt  would like to reiterate its 
position that the protection of biological resources, traditional knowledge and folklore presents an 
important developmental issue. In view of the importance of these implementation -related issues, 
we believe it is important to  continue discussions of these issues by the TRIPS Council in order to 
find solutions in light of the existing mandates.  
46.  We also would like to support the proposal to invite the CBD Secretariat to brief the 
TRIPS  Council on the latest developments in the implementation of the Nagoya Protocol, and we 
support Ecuador 's proposal for updating the three factual notes by the Secretariat on these three 
agenda items in order to facilitate future discussions in the TRIPS Council.  
5.3  China 
47.  The relationship between the TRIPS Agreement  and the CBD is an important issue in this 
Council. Over years, Members have conducted use ful discussions on this issue. China attaches great 
importance to the TRIPS Agreement and the CBD and hopes tha t Members could be constructively 
involved in this discussion.  
48.  Regarding the substantial issues, in order to ensure the mutual support of the 
TRIPS  Agreement , the CBD and the Nagoya Protocol, the majority of Members are supportive to 
amend the TRIPS Agree ment, to include  a mandatory requirement on disclosure of genetic resources 
and traditional knowledge in patent applications.  
49.  As to the issue of disclosure, China ha s provided detailed suggestions on negotiation model, 
improving the transparency on geneti c resources utilization, preventing the misappropriation of 
genetic resources and traditional knowledge, and preventing the grant of erroneous patent s in 
documents TN/C/W/52  and TN/C/W/59  that were  co-sponsored by M embers.  
50.  We also believe the prior informed consent and benefit sharing could bring better protection for 
genetic resources without adding extra burden to patent applicants. The benefit arrangement s on a IP/C/M/90/Add.1  
 
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  contractual basis and the database solution could not serve t he purpose of sufficient protection for 
genetic resources.  
51.  With regard to procedure, we consider that the discussion and negotiation on this issue in WIPO 
does not form any obstacle s for WTO Members on finding solutions. The Minist erial Meeting has 
instruc ted the TRIPS Council to examine the relationship between TRIPS and CBD . Members should 
follow this mandate to work on solving this issue. China supports to invite the CBD Secretariat to 
brief on the Nagoya Protocol and hopes that the Secretariat could ren ew the three  factual notes  
(IP/C/W/368/Rev.1, IP/C/W/369/Rev.1 ，and IP/C/W/370/Rev.1 ). China believes that the discussion 
and negotiation in WIPO 's IGC should not hinder Members  to find solution s in the WTO, as Ministers 
have given the Council the mandate t o examine the relationship between the TRIPS Agreement and 
the CBD. 
5.4  Brazil  
52.  Brazil has a well -known position on the importance of promoting the neutral support between 
the TRIPS Agreement  and the Convention on Biological Diversity (CBD), which is contained in 
document TN/C/W/59.  
53.  The introduction in to the TRIPS Agreement of a mandatory requirement for the disclosure of 
origin of these resources in patent applications is an important objective  for Brazil . A multil ateral 
and mandatory disclosure would be the most effective way to address the misappropriation of 
genetic resources and traditional knowledge. This would require patent applicants to disclose the 
country of origin of a biological resource and provide evid ence of compliance with prior informed 
consent and benefit -sharing. It would also contribute to patent examinations by providing additional 
information to patent offices. These, however, would not be overloaded with extra work since they 
would be just chec king points in the new system.  
54.  A mandatory disclosure requirement in patent applications will also contribute to enhance 
transparency about the utilization of associated traditional knowledge. This will not only ensure 
compliance with the CBD, but also ac complish one of the primary purposes of any intellectual 
property regime, namely, providing appropriate incentives and rewards to knowledge holders in 
acknowledgment of a benefit to society as a whole.  
55.  In the past, we have heard some Members stating at thi s Council that WIPO is conducting 
negotiations on genetic resources. However, those same delegations have consistently blocked any 
textual advances in WIPO and negotiations there have been ongoing for the last eighteen years, 
without any concrete result. T his leads to a frustration on the part of countries hosting a rich 
biodiversity and there is a need of a concrete answer from the multilateral IP regime.  
56.  There were great, recent developments at the CBD level, with the entering into force of the 
Nagoya Pro tocol, which already has 109 Parties, more than half of all UN Members . The majority of 
WTO Members are likewise parties to both the CBD and Nagoya Protocol. More recently, the UN 
Sustainable Development G oals have given us a clear mandate to safeguard bio diversity and to 
promote compliance with the Nagoya  Protocol . 
57.  Therefore, Members would greatly benefit from an update of the factual notes, as proposed and 
supported by Ecuador and South Africa , India and other countries . This update does not prejudge 
positions of delegations, as those documents are restricted to facts. We also support inviting the 
CBD Secretariat to provide us a briefing on recent developments at the CBD level.  
5.5  Bangladesh  
58.  Under these triplet age nda items , the position of Bangladesh , as well a s that of the LDC Group, 
is well -known. Although there is no change in it, I would like to reiterate our position for the sake of 
record.  
59.  On the issue of the Review of the Provisions of Article 27.3( b), my de legation does not support 
the patenting of life forms comprising plants and animals. We call for the review of this Article in 
order to protect developing countries and LDCs from the negative effects of this provision on the 
key sectors that affect their l ivelihood , such as agriculture, health, food and climate change. This IP/C/M/90/Add.1  
 
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  would help ensure, inter alia , food security and preserve the integrity of rural and local communities. 
Patenting of life forms at a multilateral level should be prohibited.  
60.  On the relationship between the TRIPS Agreement  and the CBD, we hold that States  have the 
right and duty to protect their traditional knowledge and genetic resources. There is, therefore, a 
need to amend the TRIPS Agreement  with a view to requir ing applica nts of patent relating to 
biological materials to provide information on the source and country of origin of biological resources 
and traditional knowledge used in the invention.   
61.  In addition, applicants must show evidence of prior informed consent from, and benefit sharing 
arrangements with, the authorities and /or persons under  the relevant national regime. This 
disclosure requirement, which is consistent with the transparency principle established in the 
multilateral trading system, will help to reduce t he number of erroneous patents and biopiracy.  
62.  We believe that traditional knowledge should receive legal recognition as its protection could as 
well contribute significantly to the achievement of development goals.  
5.6  Bolivia , Plurinational State of  
63.  We would like to emphasize the importance of keeping this item under discussion and on this 
Council 's agenda. The Plurinational State of Bolivia wishes to reiterate the relevance of document 
IP/C/W/545 of 26 February 2010, in which it submitted a contribution to this Council . The review of 
Article 27.3 (b) is an issue within the mandate of the  Doha Development Agenda under P aragraph 
19 of the 2001 Doha Ministerial Declaration. Article 27.3 must be cla rified in order to prohibit the 
patenting of all life forms and to protect all the rights of farmers, genetic resources, traditional 
knowledge and traditional pra ctices in developing countries.  
64.  There is no reason why microorganisms, microbiological processes and non -biological processes 
for obtaining plants and animals should be singled out for patentability, while Members are given 
the discretion to prohibit patents on plants and animals, and on  essentially biological processes. The 
patenting of life forms promotes an imbalance in the current intellectual property system. The TRIPS 
Agreement , while granting private monopoly righ ts, does not explicitly recogniz e the collective rights 
of indigenous  peoples and local communities over their biological resources and traditional 
knowledge, farmers ' rights or the sovereign rights of States.  
5.7  Ecuador  
65.  Ecuador would like to reiterate its position regarding agenda ite ms 3, 4 and 5 and calls on the 
Council to consider encouraging discussion on the review of Article 27.3(b) of the TRIPS  Agreement  
and the adoption of new rules on the patentability of all life forms or parts thereof. Ecuador has 
stated that it is imperativ e to prohibit this type of patent s because life or parts thereof should not 
be considered a tradeable good.  
66.  It is important for Article 27.3(b) to be in line with the themes of the Convention on Biological 
Diversity: countries have sovereign rights over th eir biodiversity and the benefits resulting from its 
use should be distributed equitably.  
67.  This takes us to the second item, regarding the relationship between the TRIPS Agreement  and 
the Convention on Biological Diversity. As we have said, the two are rela ted and complement each 
other.  
68.  The CBD, the objectives of which are the conservation of biological diversity, the sustainable 
use of its components, and the fair and equitable sharing of the benefits arising out of the utilization 
of genetic resources, rec ognizes that systems of intellectual property protection may have an 
influence on its implementation. In that regard, its Contracting Parties undertake to cooperate in 
order to ensure that such rights are supportive of and do not run counter to its objecti ves. 
Additionally, in many cases these genetic resources represent traditional knowledge.  
69.  This leads to the third item on the protection of traditional knowledge and folklore. Ecuador has 
noted the importance of having multilateral legal instruments that c an improve the use of genetic 
resources, associated traditional knowledge and traditional cultural expressions and give them IP/C/M/90/Add.1  
 
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  effective and adequate protection. It has also noted the need to establish legal mechanisms to allow 
disclosure of the source of or igin, prior informed consent, access and equitable benefit sharing.  
70.  With respect to these points, we would lastly like to refer to the updating of the factual note on 
the relationship between the TRIPS Agreement  and the Convention on Biological Diversity, which 
was last updated in 2006.  
71.  Ecuador must insist that the aim of this update is to provide Members with greater input in 
order to enrich the discussions and help move them forward, and stresses that each Member 's 
position would remain intact.  
72.  As we have said, we acknowledge the small gains that have been made to date in achieving 
this objective, which will certainly be of benefit to the Council, and we call on the delegation of the 
United States  to show flexibility in its position.  
5.8  Chinese Taip ei 
73.  On the issue of the relationship between the TRIPS Agreement  and the CBD, the delegation of 
Chinese Taipei believe s that there are still some important technical issues that need to be clarified, 
such as the definition of associated traditional knowledge and the trigger for the disclosure 
requirements and so on.  
74.  My delegation would not oppose the request by Members for a briefing on the current work by 
the CBD Secretariat, provided that the briefing would  be helpful in clarifying technical issues and the 
mode is acceptable to Members.  
5.9  Chile  
75.  The delegation of Chile would like to reiterate its position regarding these agenda items, which 
it has expressed on previous oc casions before the TRIPS Council.  
76.  Chile believes it is important to maintain the flexibilities contained in the TRIPS Agreement . 
Each Member has the sovereign right to define and take into account the ethical, social and economic 
aspects that its considers  relevant when developing its intellectual property system, so as to promote 
areas such as access to health, access to cultural heritage, and innovation development.  
77.  In Chile 's view, intellectual property systems are not an end in themselves, but are tools  for 
promoting innovation, development and the transfer of knowledge, while also facilitating access to 
health. We therefore believe that a country 's decision regarding the creation of monopolies over life 
forms must be made in accordance with the situatio n existing in that country. In the case of Chile, 
plants and animals are excluded from patentability under Law No. 19.039 on industrial property.  
78.  Chile, like other delegations, agrees that the TRIPS Agreement  and the CBD are complementary 
instruments and t hat there is therefore no need to amend the TRIPS Agreement  to ensure 
consistency between the two texts. We feel it is appropriate to highlight the work being done at the 
World Intellectual Property Organization on genetic resources, traditional knowledge and traditional 
cultural expressions, and we reaffirm Chile 's commitment to continue working and facilitating 
discussion in that forum.  
79.  Lastly, we would like to express our support for the proposal that the CBD Secretariat provide 
a briefing to this Counci l. We believe that a factual description could shed light on this topic for 
Members and provide further elements for discussion.  
5.10  South Africa  
80.  South Africa would like to recall its previous interventions on the  substantive items that 
constitute the  triplets . Specifically, on the issues of the relationship between the TRIPS Agreement 
and the CBD, we recall Paragraph 19 of the Doha Declaration. Document TN /C/W/59 constitutes an 
approach that a large number of deve loping countries have supported. This document requires 
access and benefit sharing, prior informed consent and disclosure of the source of material when a 
patent is applied for. South Africa is a Contracting Party to the C BD and has ratified the Nagoya IP/C/M/90/Add.1  
 
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  Protocol on Access to Genetic  Resources and  the Fair and Equitable Sharing of Benefits Arising from 
their Utilization.  
81.  The issue of unauthorised use of biological resources and traditional knowledge remain s a 
serious problem internationally. The failure to a sk permission or acknowledge the origin or source 
of the invention or creativity, failure to share benefits, culturally offensive use, and grant of patents 
or other forms of IP rights in error remain unaddressed. Given the international dimension of 
biopro specting and patenting activities, national legislation is insufficient to address 
misappropriation and misuse of genetic resources  and traditional knowledge . Strong multilateral 
disciplines are required in this area . Given the continued impasses in the WIPO IGC, the most 
appropriate forum to address these issues would be the WTO.  
82.  In respect of procedural issues, this delegation once again calls on the Secretariat to update 
the three factual notes contained in documents IP/C/W/368/Rev.1, IP/C/W/369/Rev.1 an d 
IP/C/W/370/Rev.1. We believe that an update of these documents will stimulate a debate that is 
characterize d by persistent restatement of long held positions. We further support a briefing by the 
CBD Secretariat on the Nagoya Protocol and subsequent deve lopments.  
5.11  Indonesia  
83.  Indonesia would like to reiterate its view that the relationship between the TRIPS Agreement  
and the Convention on Biological Diversity should be reflected in this Council by ensuring and 
maintaining the cohesion, coherence, and consistency between the two. These two internationally 
agreed instruments must be implemented in manner that is mutually supportive with respect to their 
objectives. Since the Convention on Bi ological Diversity and the Nagoya Protocol have formed the 
basis for the protection of genetic resources and/or associated traditional knowledge with provisions 
on prior informed consent for access and fair and equitable benefit sharing, the TRIPS  Agreemen t 
needs to reflect the said provisions to avoid misappropriation and obliges Members  to take necessary 
measures to ensure fair and equitable benefit sharing.  
84.  The protection of genetic resources is of paramount importance to Indonesia and we consider 
that a  legal obligation to establish a mandatory disclosure of origin as a requirement for patent 
application s will not only prevent misappropriation and enhance transparency on the utilization of 
genetic resources and/or associated traditional knowledge , but wi ll also provide greater legal 
certainty as to the rights and obligations of the providers and users of genetic resources.  
85.  We would also like to add that we should not delay substantive discussions in this Council for 
reasons that it is being negotiated in other fora, such as WIPO. The discussions to take place in this 
Council should reinforce what has already been agreed at the multilateral level, such as CBD, and 
should complement negotiations/discussions in other fora. We believe that parallel discussions  will 
enhance effort and understanding of achieving a fair and balanced trading system with regard to 
intellectual property.  
86.  In this regard, Indonesia would like to support the briefing by the CBD Secretariat in this 
Council .  
5.12  Canada  
87.  Canada continues to firmly believe that the TRIPS Agreement  and the Convention on Biological 
Diversity are complementary, and that there is therefore no need to amend the TRIPS  Agreement  
in this regard.  
88.  Canada welcomes the ongoing work of the WIPO Intergovernmental Committee on Intellectual 
Property and Genetic Resources, Traditional Knowledge and Folklore (IGC). Canada continues to 
believe that the IGC is the best and most appropriate forum for discussion on these complex issues, 
provid ing an important venue to bring together expert views, to discuss their IP -related dimensions 
in order to identify evidence -based, balanced, appropriate and mutually -beneficial approaches . 
Canada has been, and continues  to be, an active and committed parti cipant to this important work, 
and welcomes the concrete discussions and exchanges of national experiences at the IGC, which are 
so important to accurately pinpointing the issues at hand. In this regard, Canada looks forward to 
the upcoming session of the IGC this December.  IP/C/M/90/Add.1  
 
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  89.  Similar to our positions at the IGC, Canada also continues to welcome presentations by any 
interested Members containing the latest information on the operation and functioning of their 
national IP regimes concerning genetic resources an d traditional knowledge, to inform other 
Members in this Council. Canada notes the valuable and factual exchanges that have taken place on 
other issues at recent meetings of the TRIPS Council, such as on "IP and Innovation " and "IP and 
the Public Interest ", and would welcome presentations and communications on national regimes 
regarding genetic resources and traditional knowledge at future meetings of the Council, with a view 
to informing the TRIPS Council Membership in this regard. This suggestion remains without prejudice 
to our position that the IGC remains the most appropriate forum for negotiations in this area.  
90.  With respect to procedural matters at the TRIPS Council, as Canada  has previously noted, and 
without prejudice to our position on substantive matters, Canada can support from a procedural 
standpoint a briefing from the CBD Secretariat to the TRIPS Council, should there be sufficient 
interest from other Members on the matter. Canada could also support the compilation of the three 
factual notes on the TRIPS Agreement  and the CBD (documents IP/C/W/368 /Rev.1 , 
IP/C/W/369 /Rev.1 , and IP/C/W/370 /Rev.1 ) by the WTO Secretariat. Canada remains of the 
understanding that this would remain an information collating e xercise, and in both cases, this is 
without prejudice to national positions on these issues.  
5.13  Thailand  
91.  The Doha Ministerial Declaration in 2001 instructed the Council for TRIPS to examine the 
relationship between the TRIPS Agreement  and the CBD, and the protection of traditional knowledge 
and folklore. Since then, this is one of the long-standing  issues that  has been discussed in the TRIPS 
Council.   
92.  Despite the fact that some proposals were tabled to the TRIPS Council with the intention to 
move forward the discussion on the relationship between the TRIPS Agreement  and the CBD, no 
significant  progress has been m ade.  
93.  Biopiracy , including misappropriation of genetic resources , could happen in any corner of the 
world. The CBD is put in place to ascertain that utilization of genetic resources shall be based on key 
principles such as prior informed consent and fair a nd equitable benefit sharing.  It is noted that 
misappropriation of genetic resources and associated traditional knowledge can be prevented in the 
intellectual property regime on the basis of  a "disclosure requirement ". 
94.  In addition to the discussion in the TRIPS Council at the WTO, aspects of genetic resource s in 
relation to inte llectual property have also  been discussed in the Intergovernmental Committee on 
Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC)  at WIPO. Due 
to the significance of genetic resources, it is believed that both international for a should pursue their 
works on this matter in parallel and in mutually supportive ways.  
95.  Last but not least , I wish to repeat Thailand 's suppo rt for the briefing by the CBD S ecretariat.  
5.14  Australia  
96.  Australia believes that  the WIPO IGC is best placed, with appropriate technical expertise, to 
consider the complex issues relating to intellectual property , genetic resources and associated 
traditional knowledge and cultural expressions. We hope WIPO Members  will build on the momentum 
in the IGC process when the issue of genetic resources is next considered in 2019.   
97.  Australia believes the TRIPS Agreement  and the Convention on Biological Div ersity are fully 
consistent, and that the TRIPS Agreement  therefore does not need to be amended.  
98.  Australia fully implements our obligations under both agreements, which we view as mutually 
supportive.  
99.  In relation to procedural matters, Australia is open to a briefing by the CBD Secretariat on the 
Nagoya Protocol, and can be flexible in relation to the Secretariat updating the three factual notes.  IP/C/M/90/Add.1  
 
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  5.15  Japan  
100.  We have discussed this agenda at length during a series of me etings of the TRIPS Council. The  
delegation  of Japan , therefore, believes that our position is well -recognized among Members, so we 
would like to make our intervention brief, highlighting some major points.  
101.  The delegation of Japan would like to reiterate our position that the Convention on Biological 
Diversity is by nature not relevant to the intellectual property system. Therefore, we need to seek 
appropriate ways to deal with the misappropriation of genetic resources. This means that we should 
bear in mind t hat any measures taken must not adversely affect the existing intellectual property 
system or hinder the creation of innovations utilizing genetic resources and associated traditional 
knowledge.  
102.  This delegation is firmly convinced that the disclosure requi rement would discourage industries 
from conducting research and development activities on biological materials. This is the very 
consequence of the disclosure requirement that Japan has been concerned about. The same holds 
true for not only developed count ry Members  but also emerging and developing countries. Therefore, 
Japan believes that the disclosure requirement is not an adequate means for dealing with such 
misappropriation . Therefore, we have to avoid including it in the intellectual property system.  
103.  In addition, this delegation believes that the WIPO IGC is the most appropriate forum for 
holding technical discussions on genetic resources, traditional knowledge and folklore from IP 
aspects. This delegation has been actively contributing to the discussi ons at the IGC meetings, 
making various proposals, and remains willing to contribute to evidence -based discussions on these 
issues in a constructive and effective manner.  
5.16  United States of America  
104.  Regarding genetic resources, traditional knowledge and folklore, we continue to believe that 
WIPO serves as the best forum to address these issues. The WIPO IGC is looking at addressing 
unresolved issues and working on a common understanding of core issues,  using an evidence -based 
approach and examples of national experiences.  
105.  The United States  will continue to engage in technical discussions at WIPO 's IGC and looks 
forward to hearing more from the demandeurs  regarding data supporting their position on this issue.  
106.  With respect to the various request s made, the United States  is not in a position to support 
these requests, but remains open to discussions, including bilaterally with delegations in between 
and at the margins of the TRIPS Council meetings.  
5.17  Switzer land 
107.  The TRIPS/CBD issues, including the question of a disclosure requirement for genetic 
resources , have been on the agenda of the TRIPS  Council as outstanding implementation issues for 
many years. Switzerland  recognizes that these are important concerns for many biodiversity rich 
countries. Switzerland being a Party to both the CBD and the TRIPS Agreement , we remain open to 
continue exploring ways to further enhance the mutual supportiveness of both internatio nal 
agreements .    
108.  In relation to patent applications for inventions that are directly based on genetic resources, 
as for example in certain inventions in the field of biotechnology, or if an invention is directly based 
on associated traditional knowledge , disclosure of the source of such genetic resources  and 
traditional knowledge provides additional transparency. Such additional transparency may be 
particularly relevant for patent examiners to facilitate "prior art searches " and to avoid the granting 
of erroneous patents, as well as for providers of genetic resources and traditional knowledge  to 
facilitate the implementation of access and benefit -sharing obligations . Transparency is a core value 
of the patent system. For these reasons, Switzerland remains open to the TRIPS Council looking into 
how a disclosure requirement for genetic resources and traditional knowledge  in patent applications 
can further enhance transparency under the TRIPS Agreement .  IP/C/M/90/Add.1  
 
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  109.  We are aware that here , as everywhere , the devil is in the detail s. This should not discourage 
the TRIPS Council or prevent the WTO from undertaking the necessary efforts to work out solutions, 
which are adequate, practical, non -burdensome and non -prejudicial to an expeditious and effective 
patent application, examination and grant procedure. My delegation is confident that this can be 
achieved . This  is why Switzerland is a co -sponsor of TN/C/W/52 which proposes draft modalities for 
such a disclosure requirement in the TRIPS Agreement , as well as for the other  two outstanding 
implementation issues in the field of geographical indications.  
110.  In our view, the fact that work is under way in the IGC of WIPO on an international legal 
instrument for the protection of genetic resources and traditional knowledge and traditional culture 
expression s does not discharge the TRIPS Council from its duty to work out a solution for the specific 
context of the TRIPS regulatory framework. We thus support technical discussions unde r this agenda 
item in the TRIPS Council and we remain open to work on a solution in the TRIPS Agreement . In our 
view, the basis for such work should be document TN/C/W/52, while taking into account that, in the 
meantime, the international legal environment  has advanced, with some of the concerns now being 
addressed by the Nagoya Protocol on Access and Benefit -Sharing.  
6  ANNUAL REVIEW OF THE  SPECIAL COMPULSORY LICENSING SYSTEM (PA RAGRAPH 7 
OF THE ANNEX TO THE AMENDED TRIPS AGREEMENT  AND PARAGRAPH 8 OF THE 
DECI SION ON THE IMPLEMEN TATION OF PARAGRAPH 6 OF THE DOHA DECLAR ATION ON 
THE TRIPS AGREEMENT  AND PUBLIC HEALTH)  
6.1  Brazil  
111.  The entry into force of the Protocol Amending TRIPS was an important signal for the 
multilateral trading system that the protection of IP can go hand in hand with measures to ensure 
access to medicines. The Protocol provides a legally secure and predictable option for those countries 
wishing to use the TRIPS flexibilities to get affordable medicines. We would like to highlight the 
importance of this periodic review of the implementation of the System, which became even more 
necessary after the Protocol entered into force.  
112.  While we reiterate our concern that the Special Compulsory Licensing System was used only 
once so far, it would be important to reflect on ways to improve it. According to reports provided by 
participants in the single case of use of the System, it is considered too complex and administratively 
unwieldy. In 2017, Brazil, India and Sou th Africa organized a side event to the TRIPS Council in 
order to receive the assessment of the System from representatives of industry, Government, non -
governmental organizations and academia. Future discussions in the Council could benefit from 
additiona l information that can be provided by stakeholders other than Members . 
113.  We believe it is important that this Organization continues to provide technical support to 
Members , including through the provision of legal assistance, awareness -raising activities an d 
capacity building. This will ensure that the System becomes a practical option for the procurement 
of medicines in countries without industrial capacity, allowing that the fruits of the IP system are 
enjoyed in an inclusive way. The regional event held l ast year in Brasília for Latin American countries 
was considered a great success by participants and we will continue to support those actions by the 
Organization, including through the provision of experts from Brazil. We also support that the 
Secretariat  continues its efforts to reach out to those Members not yet parties to the Protocol. 
Members  could also act through the periodic Trade Policy Review mechanism.  
114.  We have always been of the view that the Doha Declaration on the TRIPS Agreement and 
Public Hea lth constitutes a major landmark in the history of the WTO, because it recognized the 
primacy of public health needs and the preparedness of the Organization to take up the problems 
faced by the poor and developing countries. The recent agreement on the Un ited Nations ' 
Sustainable Development Goals clearly reinforces that agenda, as its Goal number 3 mandates the 
global community to ensure healthy lives and promote well -being for all at all ages. To attain the 
goals of reducing child mortality and end the e pidemics of AIDS, tuberculosis, malaria and neglected 
tropical diseases, access to medicines is a fundamental part of that. The global community needs to 
act together through a multitude of ways, including through the Special Compulsory Licensing 
System be fore us . IP/C/M/90/Add.1  
 
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  6.2  India  
115.  India attaches high importance to the Doha Declaration on the TRIPS Agreement and Public 
Health, the Paragraph 6 System as established under the 2003 Waiver Decision and the Protocol 
Amending the TR IPS Agreement. India is one of the first countries that notified its acceptance of the 
Protocol in March 2007.  
116.  India has always been of the view that the Doha Declaration on TRIPS and Public Health 
constituted a major landmark in the history of the WTO be cause it recognized the primacy of public 
health needs and the preparedness of the Organization to address the problems in access to 
medicines faced by the poor in developing countries. The 2003 Waiver Decision was expected to 
address the public health con cerns faced by Members with insufficient or no manufacturing capacities 
in the pharmaceutical sector. It may have sounded prophetic at that time when India voiced certain 
apprehensions in the General Council meeting of August 2003 by stating: "the results accruing from 
this mechanism should not be negated by the creation of cumbersome systems that would lead to 
huge delays in getting medicines across at reasonable cost to those that needed them or discourage 
Members from using the System for the benefit of the people. In order to make this System 
successful, a sincere collective effort is required on the part of all Members and the entire 
pharmaceutical industry ". Regrettably, we have been proven right. The export of HIV/AIDS 
medicines by the Canadian pharma ceutical company Apotex to Rwanda in September 2008 has been 
the first and only use of the System so far.  
117.  The UNSG High Level Panel on Access to Medicines, in its report released in September 2016, 
also recognized that the Paragraph 6 System is complex and  cumbersome.  
118.  My delegation urges Members to constructively engage on improving the Paragraph 6 System 
for making it more workable and effective, so that it can benefit Members with insufficient or no 
manufacturing capacities in the pharmaceutical sector.   
6.3  Japan  
119.  The delegation  of Japan  would like to express our gratitude to the Secretariat for preparing a 
draft report so we can review the Special Compulsory Licensing System. We welcome this work, 
hoping that it will encourage all remaining Members to notify their acceptance of the Proto col.  
120.  This delegation would like to reiterate the importance of access to medicines, which needs to 
be discussed in a broader context, taking into account not only the Special Compulsory Licensing 
System, but also various other relevant measures and factor s, such as procurement and tariffs. 
Japan supports the Paragraph 6 System as established under the 2003 Waiver Decision and the 
2005 Protocol Amending the TRIPS Agreement. The very objective of the System is to support WTO 
Members in obtaining greater acce ss to medicines, specifically Members that have either insufficient 
or no pharmaceutical manufacturing capacity. Compulsory licenses are, whether granted under the 
System or not, just one of the potential means that can be utilized for this objective under  an 
exceptional circumstance and, therefore, the System should not be considered as the only solution, 
but rather as just an option we could consider.  
121.  In addition, this delegation would like to mention that voluntary efforts to streamline access 
to medicin es have been increasing. For example, in September WIPO and IFPMA collaboratively 
launched a new medicinal patent information database, Pat -INFORMED, to help procurement 
agencies better understand the global patent status of medicines. We believe such a vo luntary and 
collaborative effort will be one of the possible ways forward to respond to better access to medicines . 
6.4  Canada  
122.  The Government of Canada considers access to medicines to be a key priority in our ongoin g 
efforts to promote global health and prosperity. Canada recognizes that improving access to 
medicines needs to be achieved through the promotion of health equity, stronger health systems, 
and universal health coverage. Indeed, Canada 's international deve lopment priorities and significant 
investments in strengthening health systems and the health and rights of women and children are 
contributing to improved access in this regard.  IP/C/M/90/Add.1  
 
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  123.  Canada is a global leader in supporting partnerships such as the Global Fund to Fight AIDS, 
Tuberculosis and Malaria; the Global Drug Facility; and Gavi, the Vaccine Alliance, which strengthens 
health systems and provides targeted programming to increase access to medicines and vaccines.  
124.  In September 2016, Canada hosted the Fifth Replenishment Conference of the Global Fund 
and pledged CAD 804 million, which is roughly USD 613 million for 2017 -2019. Canada is also the 
sixth largest donor to Gavi , having pledged CAD 520 million for 2016 -2020.  
125.  Canada 's Access to Medicines R egime (CAM R), which implements P aragraph 6 of the Doha 
Declaration on the TRIPS Agreement and Public Health, is another measure Canada uses to promote 
access to medicines. Canada continues to believe that CAMR is a useful and effective tool to enhance 
access to medi cines in the specific circumstances the System was designed to address.  In 2015, 
Canada amended the list of medications covered by CAMR to add three new antiretroviral drugs. 
Canada notified this Amendment to the TRIPS Council in June 2016.  
126.  Canada also re cognizes the 2017 entry into force of the Protocol Amending the TRIPS 
Agreement. The Amendment provides countries with another important tool to improve access to 
affordable medicines. As the only country to have exported medicine pursuant to the temporary  
waiver, Canada has always been a strong proponent of the Amendment, and would be pleased to 
share our experiences and lessons learned in implementing our own system with any Members who 
wish to learn more.  
127.  It is also important to recall that no single fa ctor is responsible for preventing access to 
medicines. As the Doha Declaration emphasizes, the WTO is part of wider action required to improve 
access to medicines. This is why Canada relies on a variety of measures to promote access to 
medicines. Our view  is that only by addressing all of the factors affecting access to medicines can 
we end the tragedy of people suffering from treatable illnesses. To this end, Canada is open to 
discussing how best to promote access to medicines that considers all relevant factors and effective 
tools to promote access. Canada looks forward to learning more about the views of other Members 
on this issue, including with respect to Members ' experiences, challenges, and other considerations . 
6.5  United States of America  
128.  The United States  thanks the Secretariat for the update regarding the status of notifications 
of acceptance of the 2005 Protocol Amending the TRIPS Agreement contained in JOB/IP/32.  
129.  We congratulate the Members that have accepted the Protocol since last year 's review.  
130.  We welcomed the entry into force of the Protocol Amending the TRIPS Agreement in 
January  2017 and are pleased that the amended TRIPS Agreement applies to 126 Members, as of 
September 2018 . 
6.6  Switzerland  
131.  The delegation of Switzerland would like to first thank the Secretariat for circulating the draft 
annual report; for the helpful, detailed information and the Guide to Notifications facilitating the use 
of the System offered on the dedicated WTO web page ; as well as for the technical assistance it has 
provided, throughout last year, relating to the functioning of the Special Compulsory Licensing 
System and its effective use.  
132.  Incorporating the Sys tem into the TRIPS Agreement by way of adding Article 31bis and the 
Annex provides welcomed transparency, clarity and legal certainty. The System is there and ready 
for use by eligible beneficiary Members.  
133.  The Secretariat 's draft annual report indicates t hat no notifications for the use of the System 
have been received in the year under review. No quick conclusions should be drawn from this fact 
with regard to the workability of the System. It has not been conceived for frequent use.  
134.  Its purpose is to ext end the TRIPS flexibility of Article 31 of the TRIPS Agreement to eligible 
beneficiary Members without relevant manufacturing capacity in the pharmaceutical sector. The 
System applies to a certain number of WTO Members, in a specific case and under particu lar IP/C/M/90/Add.1  
 
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  circumstances. There are many instances where the lack of access to needed medicines in potential 
beneficiary countries is not related to patent protection. In such cases, recourse to the System will 
not and cannot provide a remedy.  
135.  Should eligible ben eficiary Members meet concrete problems when actually making use of the 
System, then it would be the Council 's duty to examine these specific difficulties in its reviews and 
look into how they can be addressed best in a practical manner. Until we have hear d in this Council 
of such concrete problems from eligible beneficiary Members, it is not helpful for the Council 's review 
of the System if some delegations claim in the abstract that the System is not workable or should 
be amended . 
7  NON-VIOLATION AND SITUAT ION COMPLAINTS  
7.1  India  
136.   India's position on the issue of non -violation complaints under the TRIPS Agreement  remains 
unchanged.  
137.  Serious concerns remain on the debilitating impact non -violation complaints in TRIPS can have 
on the r egulatory policy space of Members , on TRIPS flexibilities as well as increasing the complexity 
in interpreting the TRIPS provisions. It can not only have a chilling effect on Members ' exercise of 
their IP regimes , but also severely restrain the ability of Members to achieve other public policy 
objectives.  
138.  The absence of non -violation complaints in the TRIPS context does not in any manner threaten 
or dilute the enforceability of TRIPS -related rights and obligations. On the contrary, the application 
of non -violation complaints in the TRIPS context could potentially present issues relating to 
intellectual property right holders versus the legitimate exercise of regulatory policy choice by 
governments. Introducing non -violation and situation complaints into the TRIPS  Agreement  is 
unnecessary and inconsistent with the interests of WTO Members . Any benefits arising from the 
Agreement can be adequately protected by applying the text of the Agreement in accordance with 
accepted principles of international law, and wi thout introducing the legally uncertain notion of non -
violation and situation complaints.  
139.  We look forward to continuing  working with like -minded Members in making non -violation 
complaints inapplicable to TRIPS.  
7.2  Ecuador  
140.  With respect to this item, our delegation would like to reiterate its position that complaints of 
the types provided for under Article XXIII:1(b) and (c) of the GATT 1994 should not be applicable 
to dispute settlement under the TRIPS Agreement . 
141.  As the Coun cil is aware, our position is reflected in document IP/C/W/385/Rev.1, which 
Ecuador co -sponsored together with other countries.  
142.  Our delegation will, accordingly, continue to participate actively in the Council 's deliberations 
so as to reach a definitive so lution on this matter.  
7.3  South Africa  
143.  The issue of modalities for non -violation and situation complaints ha s been discussed in the 
TRIPS Council for the longest time. Article 64.2 of the TRIPS Agreement  imposed a moratorium  on 
the application of such complaints to the TRIPS Agreement  for a period of five years. Furthermore, 
Article 64.3 of the TRIPS Agreement  instructed the TRIPS Council to examine the so -called scope 
and modalities under which such complaints could be made.  It required the TRIPS Council to make 
recommendations to the Ministerial Conference in 1999. Since then the moratorium has been 
extended various times, most recently  at the Ministerial Conference in Buenos Aires, Argentina  
(MC11) in 2017. The Ministerial Decision instructs the TRIPS Council to continue its examination of 
scope and modalities and to make recommendations to the next Ministerial Conference.  IP/C/M/90/Add.1  
 
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  144.  We recall our last intervention in this house. I will briefly recall the elements of the 
intervention:  
145.  There is already broad agreement amongst Members that non -violation complaints are of an 
exceptional nature to which a cautious approach should be taken. This could already constitute a 
modality that all Members seem to agree on.  
146.  Further scope to address Article 26 of the DSU that sets out special procedures that apply in 
the case of successful non -violation complaints. In WTO disputes, the usual remedy, under 
Article  19.1 of the DSU, is the withdrawal of the WTO -inconsistent measure. Article 26.1(b) of th e 
DSU states clearly that there is no obligation on the respondent to withdraw the measure. Rather, 
the respondent is required to address the nullification and impairment caused by its measure, by, 
for instance, offering compensation. Members may agree tha t compensation would be explicitly 
excluded as an option should non-violation  claims apply to the TRIPS Agreement .  
147.  There remain several other possible modalities that may be applied to non-violation  and 
situation complaints, including some suggestions tha t TRIPS flexibilities should not be subject to 
such complaints.  
148.  This delegation once again invites Member s that ha ve an interest in discuss ing this matter to 
contact us. South Africa is not a proponent of the application of draft modalities but would 
nonet heless have an interest to ensure that the matter is discussed.  
7.4  Bangladesh  
149.  My delegation 's position on the proposed lifting of the moratorium on non-violation and 
situation complaints is well -known. We registered this on m any earlier occasions, and would like to 
reiterate our position in favour of establishing a permanent moratorium.  
150.  Bangladesh , however, invited the views and ideas of our friends who are proponents of the 
application of the non -violation and situation compl aints on the scope and modalities of the 
proceedings as required by Article 64.3 of the TRIPS Agreement . The Council needs to be better 
informed, and only then it will be in a better position to examine and consider the proposal.  
151.  The concept appears to be  still an unknown territory, and unless the scope and modalities are 
outlined first we cannot go any further in this discussion. As we perceive it now, if non -violation and 
situation complaint s are made applicable to TRIPS, any issue under the sun can be b rought as 'cases ' 
under this umbrella. Clear delimitations, therefore, need to be conceived and thoroughly  examined 
first. 
152.  We reiterate our readiness to engage on this issue further.  
7.5  Egypt   
153.   Egypt continues to firmly believe tha t non-violation and situation complaints (NVSCs)  are not 
applicable to the TRIPS Agreement . The application of NVSC s to IP disputes would generate systemic 
imbalances and reduce the legal certainty of multilateral IP law. In light of the above, Egypt 
reiterates its understanding that non -violation and situation complaints should not be applied to the 
TRIPS Agreement .  
154.  We urge Members to engage in discussions towards reaching an acceptable and permanent 
solution to this issue before MC12. Egypt stands ready to participate in a constructive manner in 
such discussions.  
7.6  Brazil  
155.  The debate on the applicability of non -violation complaints to the TRIPS Agreement  has been 
part of the Council agenda for many years and our delegation would also like to recall the importance 
of addressing the concerns raised by Members more than fifteen years ago in document IP/C/W/385. 
Since the last Ministerial Conference, in light of the mandate given to this Council, our delegation 
has continued its work on the study of non -violation and situation complaints, despite the fact that IP/C/M/90/Add.1  
 
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  demande ur countries have not provided us with information about scope and mod alities. Having 
carefully analys ed statements made in past sessions of the Council by proponents of applying NVSCs 
to TRIPS, we continue to hold the view that the dispute settlement mechanism as currently applied 
to the TRIPS Agreement  is sufficient to guarantee effective and adequate pr otection of intellectual 
property rights. Claims that the availability of NVSC s would prevent Members from evading their 
TRIPS obligations are not supported by evidence , and proponents have not once provided a concrete 
example of the envisaged use of NVSC.  
156.  In fact, the extension of NVSC to the TRIPS Agreement  could pose  an additional and 
unnecessary burden on the dispute settlement body. The DSB is already in a worrisome state caused 
by one country blocking the launch of the process to fill the vacancies of  the A ppellate Body. 
157.  To automatically apply GATT cases without addressing TRIPS specificities – and there  are many 
– does not seem the best way ahead. Any discussion about scope and modalities should ensure that 
the policy space of Members  to define their level of protection be preserved, in accordance with 
TRIPS Article 1.1. Brazil remains attentive to any proposal that may be brought by proponents.  
7.7  Argentina  
158.  Argentina 's position on this matter is well -known and remains unch anged. We believe that 
complaints of this type are not applicable to the TRIPS Agreement  for the reasons explained in 
document IP/C/ W/385/Rev.1, which Argentina co -sponsored together with a large number of other 
Members. Argentina is ready to continue cons tructive discussions on this issue with a view to finding 
an acceptable and permanent solution.  
7.8  China  
159.  Regarding non-violation and situation complaints, China appreciates the efforts made by 
delegations in Buenos Aires and welcom es the outcome on this issue.  
160.  China reaffirms its position that non -violation and situation complaints are not applicable under 
the TRIPS Agreement , as has been elaborated in document IP/C/W/385/R ev.1 submitted by us and 
15 other Members . Also , we welcome the discussion on this issue in accordance with the decision 
and the mandate given by the Buenos Aires Ministerial Meeting.  
7.9  Canada  
161.  Our position on this issue is well -known, and remains unchanged. Canada continues to  have 
concerns regarding the applicability of the non-violation nullification and impairment (NVNI)  remedy 
to the TRIPS Agreement . 
162.  Recognizing that the current moratorium exists based on consensus, Canada wishes to express 
its continued interest in partici pating in any consultations that take place on this issue amongst other 
interested Members.  
7.10  Chinese Taipei  
163.  My delegation understands  that there are concerns among Members over the applicability of 
non-violation and situ ation complaints to the TRIPS Agreement . We are looking forward to more in -
depth substantive discussions among Members on the scope and type of the said non -violation and 
situation complaints applicable under the Agreement.  
7.11  Indonesia  
164.  Indonesia 's position on the issue of non-violation and situation complaint s under the 
TRIPS  Agreement  remain s unchanged.  
165.  As state d in the last meeting, it is our view that the application of non -violation and situation 
complaint s to the minimum regulatory standards for protecting private property rights remain s 
unclear. The application of non -violation and situation complaint will disrupt the delicate balance of IP/C/M/90/Add.1  
 
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  rights and obligation in the TRIPS Agreement . In this regar d, we believe that introducing NVSCs into 
the TRIPS Agreement  is unnecessary and inconsistent with the interests of WTO Members.  
166.  We are also concern ed about the impact of NVSC s on the regulatory policy space of Members  
including on using TRIPS flexibilit ies. We view that NVSC s will have an effect not only on Member s' 
exercise of their IP regime, but also severely restrain the ability of Members to achieve public policy 
objective s. Based on the statement made by the proponents under this agenda  item, we are still 
unconvinced of the necessity to provide NVSC s under the TRIPS Agreement .  
7.12  United States of America  
167.  The United States 's position on this issue remains unchanged and while we recognize that the 
decision by  Ministers in December places a moratorium on Members bringing non-violation 
nullification and impairment (NVNI)  complaints under TRIPS for a period of two years, we reiterate 
our support for allowing the current moratorium to expire so that Members may bring such 
complaints in the future, as appropriate.  
168.  The language of Articles 64.1 and 64.2 explicitly states that, after five years, complaints under 
Article XXIII:1(b) and (c) of GATT would be available under the Agreement. Therefore, the United 
States  is of the view that the drafters intended for non -violation complaints to constitute an 
additional obligation for Members that is not expressed elsewhere in the provisions of the Agreement. 
Disallowing Members from having recourse to this remedy is the action that upsets this balance.  
169.  We also disagree with some Members ' assertion that NVNI claims could undermine regul atory 
authority and limit the ability of a Member from undertaking policies to promote certain public policy 
objectives.   
170.  The United States  is of the view that the availability of non -violation complaints will protect 
Members from evasions of obligations under the TRIPS Agreement  while preserving the ability of 
any Member to implement legitimate social, economic development, health, environmental, and 
cultural policies.  
171.  Further, non -violation complaints will only be successful if they could not have been f oreseen 
when the Uruguay Round negotiations were under  way.  Because of this, there are a number of ways 
to implement social and cultural policy goals . A Member may take this element of non -violation 
complaints into consideration when crafting measures to protect these goals.  
172.  Finally, WTO adjudicatory bodies will continue to be bound by Article 3.2 of the DSU , which 
clearly States  that "recommendations and rulings of the Dispute Settlement Body cannot add or 
diminish the rights and obligations provided in t he covered agreements. "  Furthermore, past GATT 
and the WTO rulings provide sufficient guidance on the scope of such complaints, which ensure that 
the scope of any non -violation complaint would have to be precisely drawn and clearly supported 
with detailed  justification.  
173.  We continue to believe that WTO Members are being deprived of an important tool to enforce 
their rights under the TRIPS Agreement , which is why we support the expiration of the current 
moratorium so that complaints of this type may be appl icable to the TRIPS Agreement . 
174.  While we remain of the view that the text of the WTO Agreements and dispute settlement 
rulings provide Members with sufficient guidance on the application of NVNI disputes to the 
TRIPS  Agreement , the United States  remains ope n to considering specific proposal from Members 
wishing to further examine the scope and modalities for complaints of these types.  
7.13  Switzerland  
175.   Switzerland 's position under this agenda item is, I assume, well -known and I w ill thus not 
take your and delegates ' time to repeat it in full.  
176.  The distinguished colleague from Brazil in his intervention inquired what the scope and 
modalities are that proponents envisage to apply to NVSC s under the TRIPS Agreement . My 
delegation has  explained this repeatedly in earlier discussions of this Council under this agenda but IP/C/M/90/Add.1  
 
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  I will confirm that the modalities we consider sufficient and applicable to such complaints in the 
TRIPS context  are those contained in the WTO's  DSU and those containe d in past rulings of the 
dispute settlement  body.  
177.  I also wish to confirm that my delegation stands ready to examine and constructively discuss 
any proposal that a Member may have on scope and modalities of NV SCs in the TRIPS context, 
whether in formal or informal mode. We listened with interest to the intervention and thoughts of 
the distinguished delegate of South Africa in that respect and look forward to continuing  this dialog.  
7.14  Russian Federation  
178.   The Russia n Federation 's position on the issue remains the same. We consider that 
non-violation and situation complains shall not be applicable to TRIPS Agreement  for the reasons 
outlined in document number IP/C/W/385/Rev.1 cir culated in 2015.  
8  REVIEW OF THE IMPLEM ENTATION OF THE TRIPS AGREEMENT  UNDER ARTICLE 71. 1 
179.  No statements were made under this agenda item.  
9  REVIEW OF THE APPLIC ATION OF THE PROVISI ONS OF THE SECTION O N 
GEOGRAPHICAL INDICAT IONS UNDER ARTICLE 2 4.2 
9.1  Ukraine  
180.  Ukraine has submitted its answers to the Checklist of questions IP/C/13 and IP/C/13/Add.1. 
We believe that such exercise could enhance the transparency of our domestic system for the 
protection of geographical indications and we invite WTO Members to have a look at the document 
IP/C/W/117/ADD.35 that contains Ukraine 's answers. We also encourage other WTO Members to 
provide their answers to the mentioned checklist.  
9.2  Switzerland  
181.  Switzerland t hanks Ukraine and Mexico for submitting their responses to the checklist of 
questions under this agenda item , respectively up -dating their set of responses submitted earlier.  
182.  Geographical indications are a field of IP in which there have been considerable deve lopments 
over the last 20 years, both at the international and national level. Many WTO Members have put in 
place new protection systems or considerably adapted and improved their  existing regulatory 
framework for the protection of GIs.  
183.  Therefore, to make  the Council 's discussion under this agenda item reflect t he reality, it should 
be based on up -to date information from Members on their national application of the TRIPS 
provision on geographical indications.  
184.  We thus join you  in your call to Members not having done so yet, to submit their responses to 
the checklist or, if applicable, to up -date the information they provided in the past, if changes in 
their national system have been introduced since. On this basis, we should resume the Council 's 
substantiv e discussion under this agenda item in the Council 's meetings next year in a meaningful 
and inclusive manner.  
10  SIXTEENTH ANNUAL REV IEW UNDER PARAGRAPH 2 OF THE DECISION ON  THE 
IMPLEMENTATION OF AR TICLE 66.2 OF THE TRIPS AGREEMENT  
10.1  European Union  
185.  The European Union  and its Members  take their commitments and obligations under 
Article  66.2 TRIPS seriously and try to deliver technology transfer programmes to least developed 
countries (LDCs) in a way that reacts to natural, social, health, climate and economic changes. The 
programmes are specifically ta ilored  to the current needs of least LDCs  and their regional 
organizations and concern mainly public health, environment, sustainable agricultu re, 
water -management and water -sanitary systems. The programmes listed in the report are provided IP/C/M/90/Add.1  
 
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  by the European Commission or other European institutions or the European Union  Members . The 
main incentive for the European Union  companies to voluntarily tr ansfer technologies to LDCs is that 
they get funding from the European Commission or the European Union  Members  for these activities. 
The high number of programmes shows that this incentive proved to be very effective.  
186.  Technology transfer refers to the wa ys and means through which companies, individuals and 
organizations acquire technology or know -how from third parties, whether such technology is 
IPR-protected or not. The majority of the technology transfer programmes in the report put in place 
new techno logies, which in most cases will be managed by the local communities after the 
completion of the programme. Many of the technologies are not protected by patents, trade secrets 
or any IP right; therefore, local Governments are encouraged to replicate them in their countries, 
using the know -how and management and production skills acquired through these programmes.   
187.  Technology transfer is often only one component of a more complex project and not a 
stand -alone activity. The acquisition by LDCs of a sound an d viable technological base does not 
depend solely on the provision of technology or equipment, but also on acquisition of know -how, 
management and production skills, improved access to knowledge sources as well as on adaptation 
to local economic condition s. 
188.   Therefore, training and education of university graduates, exchanges of qualified staff, and 
joint research projects must accompany the buying or licensing of IP rights related to the transferred 
technology. Relevant literature has proven that the mere  transfer of technology without the training 
of local employees does not enable the recipients to achieve the internalization of the provided 
technology and to reduce the technology gap with developed country Members . Several projects put 
in place by the E uropean Union and its Members  are accordingly aimed at providing such training 
and education.  
189.  One of the most important pre -conditions of technology transfer is the improvement of the 
absorption capacity of LDCs. Absorptive capacity relates to the availabi lity of human capital and 
presence of technological capability and other factors, such as access to finance and infrastructure, 
which helps assimilate and replicate knowledge gained from external sources. Absorptive capacity 
is key for diffusion of any kno wledge, originating domestically or abroad, and thus for determining 
how technology can contribute to economic transformation and "catching -up" of a country. The 
improvement of the absorption capacity of LDCs generates voluntary technology transfer and 
attracts foreign direct investment in certain sectors of the economy that are vital for sustainable 
development in LDCs.  
190.  Policies aimed at improving absorptive capacity can help to remove some of the key 
bottlenecks to technology transfer, particularly in le ast developed countries. Inward technology 
diffusion to LDCs could be the primary source of technical change and productivity growth. This 
technology diffusion directly affects production capacities and increases consumer access to new 
innovative goods. Th is technology diffusion raises local productivity through various spillovers as 
domestic firms learn improved technologies and standards. The most effective strategy for LDCs to 
attract technology transfer is to reach out to multinational companies, initia te dialogues with them 
about the conditions, under which these companies would be willing to move some of their capacities 
to these countries and embark in further technology transfer.  
191.  Absorptive capacity policies encompass a wide range of measures addres sing workforce, 
organisational and adjustment deficiencies. Increasing the pool of trained workforce able to 
understand and assimilate technology, improving the quality of higher educational institutions and 
scientific infrastructure as well as of networks  between these educational and research institutions 
and enterprises, and better access to finance and efficient institutions, can all have significant impact 
on technology absorption, thus stimulate technology transfer.  
Second European and Developing Cou ntries Clinical Trials Partnership Programme (EDCTP2) 2014 -
2024 
192.  The successful Second European and Developing Countries Clinical Trials Partnership 
Programme continued also this year and keeps contributing to the reduction of the social and 
economic burden  of poverty -related diseases in developing countries, in particular in sub -Saharan 
Africa, by accelerating the clinical development of effective, safe, accessible, suitable and affordable 
medical interventions for poverty -related diseases (vaccines, drugs,  microbicides, diagnostics), IP/C/M/90/Add.1  
 
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  including neglected ones, in partnership with sub -Saharan Africa. This partnership targets 32 LDC 
Members . The allocated budget is around 1.9 million euros. The goals are to maximize the public 
health impact of interventions to  control malaria in pregnancy through the translation of EDCTP -
funded evidence -based global policies to country level policies, improving the impact of existing 
Malaria Products as well as improving HIV prevention and sexual and reproductive health care in  
high risk women, etc.  
Environment  
Dhaka Environmentally Sustainable Water Supply Project  
193.  Dhaka in Bangladesh has been relying heavily on groundwater as a source of water supply, 
but the current abstraction is beyond sustainable yields and an urgent int ervention was needed. The 
Dhaka Environmentally Sustainable Water Supply Project is helping to provide reliable and improved 
water supply in Dhaka by developing a new surface water supply scheme for supply augmentation. 
This will include the development of  a water intake at Meghna River, a raw water transmission 
pipeline, a water treatment plant at Gandharbpur with capacity of 500 million litres per day, a treated 
water transmission pipeline to the existing water supply network and distribution reinforcemen ts. 
The project will also improve distribution networks to reduce nonrevenue water (NRW) and will 
improve the quality of water supply services, including support to low -income communities. The 
project will help provide sustainable water supply to a growing  population in service areas - including 
improved access, convenience, and reliability of water supply, as well as increased quantities of 
water and improved water quality. Other indirect benefits arise from the employment of skilled and 
semiskilled worker s in the construction works. The project will last until 2020 and the Commission 's 
contribution is EUR 5.2 million, but also the European Investment Bank contributed around EUR 130 
million.  
194.  The project will support organizing community based organizations  in order to make sure that 
the transferred technology is used by the local communities of Dhaka. Households in low -income 
communities, including those headed by women, will have access to water supply through new water 
connections.    
FRESAN – Strengtheni ng Resilience and Food and Nutrition Security in Angola  
195.  South Angola 's population have been suffering from the impact of climate change, which 
increases their vulnerability and affects their livelihoods. This programme aims to contribute to the 
reduction o f hunger, poverty and vulnerability to food and nutrition insecurity, in the provinces of 
Angola most affected by climate change, namely Cunene, Huila and Namibe.  
196.  The programme has four distinct but complementary components:  
197.  Component 1 is to strengthen r esilience and production of smallholder farming in the context 
of climate change through adoption and use of technologies, practices and innovative solutions to 
reduce vulnerability.  
198.  Component 2 is to improve households ' food and nutrition security, incre asing consumption 
and availability of more diversified and nutritious food.  
199.  Component 3 is to enhance institutional capacity and mechanisms for multi -sector food and 
nutrition security information management and data analysis, planning, coordination, monitoring, 
and reaction in areas of food insecurity, malnutrition and climate change. Prediction and 
early-warning systems and monitoring tools for risk management will be developed to cope with 
climate -induced crisis and the occurrence of natural disaste rs.  
200.  Component 4 is to find evidences and knowledge on the utility of different nutrition -sensitive 
actions that are effective, in the context of Angola, to curb undernutrition in children and reduce 
under -five mortality. It will also encourage scientific and technical knowledge transfer and exchange 
of experiences in the three target regions of Angola.  
201.  The European Union 's contribution is EUR 68 million and the project started in 2018 and will 
last until 2022.   IP/C/M/90/Add.1  
 
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  SafeWaterAfrica project  
202.  SafeWaterAfrica Project already started in 2016 but continued also this year and will continue 
until 2022. The key objective of the project is to improve access to clean water in Africa through 
research and development of an autonomous and decentralized water treatment sy stem for rural 
and peri -urban areas. The project will develop new types of autonomous low -cost and solar powered 
water sanitation systems tailored for the specific needs in the rural areas of Mozambique and 
operated independently by local communities. Acce ss to safe water through this project will reduce 
health risks. The total requested EC cont ribution is slightly less than EUR  3 million.  
 VicInAqua project  
203.  VicInAqua Project aims at integrated aquaculture based on sustainable water recirculating 
system for  the Victoria Lake Basin, which would mainly benefit Uganda. The project is developing a 
sustainable combined sanitation and recirculating aquaculture system for wastewater treatment and 
reuse in agriculture in the Victoria Lake Basin area. VicInAqua proje ct follows an integrated approach 
in order to develop a sustainable aquaculture fish pond system and simplified recirculation 
aquaculture systems combined with a domestic sanitation system and agriculture activities for the 
Victoria Lake Basin.  
204.  The projec t is developing a novel and robust membrane bioreactor (MBR) system for a 
recirculating aquaculture system (RAS), fish ponds and sanitation. Moreover, this will contribute to 
the development of a sustainable energy supply system based on photovoltaics and biogas 
(generated from the sludge of the recirculating aquaculture system) which will be integrated to the 
system for autonomous operation.  
Rift Volcanism: Past, Present, Future – United Kingdom  
205.  Rift Volcanism Programme, is a research and technology prog ramme which is funded by the 
Natural Environment Research Council (NERC) of the United Kingdom. The programme 's results will 
be used to integrate volcanic hazard and risk into policies for long -term planning and short -term 
emergency management, mostly in E thiopia. A contribution to this is the real -time connection of 
seismic stations to the responsible local institution to facilitate early warning of volcanic unrest and 
eruptions.  
206.  The programme will focus on the volcanoes of the Main Ethiopian Rift in centr al Ethiopia. The 
aim is to understand their past behaviour, look for subtle signs of present -day activity and assess 
the threat posed to the infrastructure and people on and around them. RiftVolc will involve scientists 
from many disciplines working togeth er to produce an integrated view of the past, present and future 
of the volcanoes in this region and compare it to other parts of East Africa and volcanoes elsewhere. 
Experts in hazard assessment will model possible scenarios and create a long -range erupti on forecast 
for Ethiopia.  
Conclusion  
207.  This overview could only give a couple of examples of the many technology transfer projects 
and incentives that the European Union  and its Members  have put into place. The European 
Commission remains committed to work with LDCs and to finance technology transfer programmes 
and if LDCs have questions and suggestions, we are ready to provide replies.  
10.2  Canada  
208.  As part of its ongoing commitments under Article 66.2 of the TRIPS Agreement , Canada is 
pleased to report on its work in providing incentives to enterprises and institutions for the purpose 
of promoting and encouragi ng technology transfer to least developed country Members in order to 
enable them to create a sound and viable technological bas e. 
209.  Canada 's 2018 report on the implementation of Article 66.2 of the TRIPS Agreement  
(document IP/C/W/646/Add.4) provides a comprehensive update on the range of projects and 
initiatives undertaken by Canada in recent years. Before discussing some of the mo re noteworthy 
projects included in this year 's report, it is noted that Canada 's report on Article 66.2 TRIPS focuses 
primarily on non -market projects, as financed by Canadian departments, agencies, and institutions, 
through official development assistance  (ODA), grants, and other concessional financing. For IP/C/M/90/Add.1  
 
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  instance, the development branch of Global Affairs Canada provides financial incentives in 
partnership with Canadian educational and research institutions in key development areas like 
agriculture and f ood security, public health, sustainable development, as well as business 
development and capacity -building for small and medium -sized enterprises (SMEs).  
210.  For instance, as part of the Canadian International Food Security Research Fund – Phase II, 
Global A ffairs Canada has allocated CAD 50.5 million (or approximately USD 38.37 million) over five 
years, to multiple countries, including Benin, Ethiopia, Nepal, Tanzania, and Uganda, towards the 
development of more productive, sustainable, and gender -sensitive agricultural techniques for 
women subsistence farmers. Project activities under this initiative include developing farming 
methods that can better withstand the effects of climate change, as well as reducing post -harvest 
losses through adaptable and afford able technologies.  
211.  As well, under the Canadian International Food Security Research Fund (CIFSRF), Global 
Affairs Canada and the International Development Research Centre (IDRC) research in agricultural 
innovation and fosters collaboration between Canadian  experts and partner countries. Notable 
projects under the CIFSRF include Scaling Up Improved Legume Technologies in Tanzania, which 
aims to make legume technologies accessible to 100,000 small -scale farmers across Tanzania, 
including through farm -level tr ials and farmer -to-farmer demonstrations. Another notable project, 
Enhanced Preservation of Fruits Using Nanotechnology, will extend and optimize the use of 
post-harvest applications, including through improved packaging systems for transporting fruit in 
multiple countries, including Tanzania.  
212.  In 2017, Global Affairs Canada also launched Canada 's Feminist International Assistance 
Policy, which supports targeted investments, partnerships, innovation and advocacy efforts to close 
gender gaps and improve ever yone's chance for success. Canada 's feminist international assistance 
will help protect and promote the human rights of all vulnerable and marginalized groups and 
increase their participation in equal decision making, and will help women and girls achieve more 
equitable access to and control over the resources they need to secure ongoing economic and social 
equality. Notable examples of technology transfer -focused project in this area include Improving 
Market Opportunities for Women Producers, which support s access to credit, inputs, market linkages, 
and new technologies for women in Myanmar, for instance, by providing matching grants to small 
and medium -sized enterprises (SMEs) for technology upgrades, as well as designing new and 
improved financial product s for women producers in partnership with financial institutions.  
213.  Global Affairs Canada also supports programme s that encourage technology transfer and 
related technical assistance in the area of information and communications technology (ICT) Global 
Affairs Canada provides support for a number of ICT -related projects, such as Entrepreneurship and 
Business Growth for Youth, which uses ICTs to provide business development services and capacity -
building to deliver entrepreneurship programme s for youth in Ethiopia. As of March 2018, 40,398 
youths (60% of which were young women) have completed training through this initiative.  
214.  Multilaterally, Canada continues to actively contribute to several international institutions 
which, in turn, provide incentives for technology transfer to LDCs. On environment and climate 
change, for instance, Global Affairs Canada works with the World Bank on a number of technology 
transfer -related investment funds and initiatives, including the Clean Technology Fund. Global Affairs 
Canada has allocated CAD  200 million (or approximately USD  152 million) in financing to support 
the use of clean, low -carbon technologies, as well as investment in energy efficiency in the power 
and transport sectors, in multiple countries in Asia, Africa, and the Americas. As well, though 
financial support to the Global Environmental Facility, Canada supports the accelerated adoption of 
innovative technologies and management practices in areas such climate change, biodiversity, land 
degradation, and sustain able forest management.  
215.  Canada would be pleased to provide further information on these and other technology transfer 
projects and programme s, upon request. Canada also invites interested delegations to consult Global 
Affairs Canada 's searchable "Internat ional Development Project Browser " for further information on 
these and other initiatives.  
216.  Canada also looks forward to the upcoming workshop on the implementation of 
Article  66.2 TRIPS , to be held on the margins of the next TRIPS Council meeting in Februa ry 2019, 
and to exchanging further information and views on Canada 's annual 66.2 report in that regard. IP/C/M/90/Add.1  
 
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  Canada would also be interested in hearing more about some of the priorities and best practices that 
LDCs might identify in the incentives fo r technolog y transfer under Article 66.2 TRIPS obligation, 
including notable examples that Members might identify from developed country Members ' annual 
reports.  
217.  We also take note of the recent TRIPS Council discussions on Article 66.2  TRIPS , including the 
LDC propo sal document IP/C/W/640. Canada remains of the view that the workshop provides a 
useful venue to draw commonalities and best practices from developed country Members ' annual 
reports, with a view to better informing Members of how future incentives and proj ects in the area 
of technology transfer might best respond to LDCs ' evolving priorities and needs. The workshop also 
provides a useful opportunity for further practical and evidence -based discussion on these issues. 
Canada is open to discussion with any in terested Members on how the workshop can be enhanced 
in this regard, and to discussing with any interested Members intersessionally in advance of the 
February  2019 session.  
10.3  Japan  
218.  Even though it is not necessary to mention again, this delegation recognizes the importance 
of Article 66.2 of TRIPS for LDCs, taking into account their economic, financial and administrative 
constraints and so on. From such a perspective, Japan is earnestly engaged in improving the 
business environment f or technology transfer to LDCs  
219.  This time, this delegation would like to briefly describe this year 's report on our implementation 
of Article 66.2  TRIPS , IP/C/W/646/Add.3. The report consists of four sections, namely, I) Activities 
Undertaken by Technical C ooperation Organizations, II) Activities in the field of Climate Change, III) 
Activities in the Pharmaceutical Sector, and IV) Activities in the Field of Intellectual Property Rights.  
220.  Furthermore, this report has an annex in a spreadsheet format, which provides detailed 
information on each activity involving technology transfer. In this annex, participating LDCs are 
shown in bold where they are included as parts of beneficiaries.  
221.  Japan understands that incentives to enable technology to be transferred in clude a variety of 
measures such as financial support and business environment support, because one of the main 
obstacles for enterprises and institutions in developed country Members  to transfer technologies to 
LDCs is the lack or insufficiency of busines s environment in LDCs. Furthermore, improving the 
business environment helps create incentives that are stable and self -sustainable, which is especially 
important considering that technology transfer often takes time.  
222.  Japan believes that activities in the  report contribute to creating a sound and viable 
technological base in LDCs, which will bring about further technology transfer by enterprises and 
institutions in developed country Members . 
223.  Japan will continue to make its utmost efforts to improve the bus iness environment and make 
it even more conducive to transfer technology. In the coming Workshop to be held next February, 
this delegation is willing to introduce our report in detail, and strongly believes that the workshop 
will be a good opportunity to e nhance mutual understanding, which will lead to greater cooperation 
in the future.  
10.4  Australia  
224.  Australia was pleased to submit its Article 66.2 TRIPS report to the Secretariat on 12  October.  
225.  We take our Article 66.2 TRIPS reporting seriously, and are careful to submit our reports using 
the template preferred by LDC Members . 
226.  Australia is committed to implementing Article 66.2 of the TRIPS Agreement . Australia is also 
committed to sharing information with other WTO Members ab out incentives and support it offers 
enterprises and institutions to promote and encour age technology transfer to LDCs.  IP/C/M/90/Add.1  
 
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  227.  We are always happy to discuss our technology transfer activities with interested Members, 
and we look forward to detailed discussions a t the Article 66.2 TRIPS workshop scheduled for 
February next year.  
10.5  United States of America  
228.  The United States  attributes great importance to this review with respect to the obligations 
under Article 66.2  TRIPS . 
229.  Our submission this year, IP/C/W/646, is a new report, detailing the intellectual property, 
trade capacity, training, development assistance, educational, financing, entrepreneurship, and 
infrastructure -related programme s, aimed to support LDCs in foster ing the necessary environment 
to encourage the effective, voluntary transfer of technology to LDC Members. This year 's submission 
also includes comments from host countries regarding the value of several of the programme s listed 
in the report.  
230.  The United S tates continues to believe that the effective functioning of Article  66.2 of the 
TRIPS Agreement 's requires a robust dialogue between developed country Members  and LDC 
Members in order to target incentives in a way that is most responsive to the self -identified 
technology transfer interests and needs of LDC Members.  
231.  We welcomed the 7 November  logistical discussions with LDC Members and the Secretariat 
and we look forward to Article 66.2 Workshop on 11-12 February 2019 which will provide an 
opportunity to co ntinue to exchange views and to further address important questions.  
232.  Please allow me to mention some elements contained in our 2018 report, highlighting a few 
programme  updates.   
233.  The United States  Agency for International Development (USAID) works with th e Ministry of 
Health in Liberia to improve its ability to communicate priority information with frontline health 
workers.  Communication during the Ebola outbreak was a critical challenge.  To address this, USAID 
worked with the Ministry to integrate a tex t message platform, mHero, into their existing health 
information systems.  This allows the Ministry to send information to health workers in specific 
counties in a matter of minutes.  Today, mHero is used on a regular basis by a variety of departments 
within the Ministry of Health to inform health governance and service delivery.  
234.  Also, in Togo, MoLab is the United States  Embassy 's mobile S.T.E.M. (science, technology, 
engineering and math) learning lab.  Built by young Togolese inventors, it is a vehicle filled with 
science, engineering, chemistry, and math activities.  The United States  Embassy and Contour 
Global, an American ene rgy company with a plant in Togo, financed MoLab.  Its mission is to bring 
STEM education to under -resourced rural schools, and it has a full calendar of activities.  By next 
year, it expects to be fully financially independent through private sector and c rowd-sourced 
donations.  
235.  We look forward to further discussing our report in greater detail with LDC Members  at the 
February workshop.  
10.6  Norway  
236.  Norway submitted its annual report on the implementation of Article 66.2 TRIPS after th e 
deadline, due to unforeseen delays in capital. We apologise for the inconvenience this has caused in 
terms of shorter time for translation and studying of the document.  
237.  We will come back with a more detailed presentation of our report at the workshop tha t will 
take place in the margins of the next TRIPS Council meeting.  
238.  The report contains information on the same two agencies that we have reported on in previous 
years, with funding for private sector development and technology transfer: 1) Norad 's indust rial 
and commercial support schemes; and 2) Norfund 's risk capital for investment in private business 
in Developing Countries. The report, of course, focuses on the in centives that were provided to l east 
developed countries in 2017.  IP/C/M/90/Add.1  
 
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  239.  This year we have made use of the agreed format for reporting preferred by the LDC Group. 
We have shortened the main text somewhat, and separated the disbursements into a set of separate 
tables - specified by programme incentive, policy objective, funding agency, type of support , and 
recipient LDC.  
240.  This being the first time, we will also be pleased to receive feedback on our use of the format 
when we present the report in the forthcoming workshop.  
10.7  Switzerland  
241.  Switzerland 's new detailed report (IP/C/W/646/Add.1) reflects all latest relevant developments 
in Switzerland.  
242.  We reviewed the content and format of our reports from previous years, also taking into 
account the room document submitted by the LDC Group for the last TRIP S Council (meeting of 5 -6 
June 2018), RD/IP/24.  
243.  The major concern of the LDC group that solely projects which include LDCs as beneficiaries 
be listed in the report has been taken into account. Switzerland updated its list of projects 
accordingly, also furt her specifying which LDCs can benefit from which projects.  
244.  To take just one example, the new phase of the successful project "Medicines for Malaria 
Venture (MMV) " is open to 26 LDCs, mainly in Sub -Saharan Africa. The report now specifically lists 
each of t he beneficiary LDCs. For more detail and substance, we would like to refer to our report.  
245.  We anticipate the workshop and the exchange with the LDCs scheduled on the margins of the 
next Council meeting.  
246.  This delegation remains committed to actively engaging  in the discussion and further 
promoting the transfer of technology.  
10.8  Central Africa n Republic , on behalf of the LDC Group  
247.  Central African Republic, on behalf of the LDC Group , do have a few questions we would like 
to pose on some of them.  However, before doing so we would like to reiterate our intention to 
pursue further discussion of our proposal in IPC/C/W/640 and the room document found in  RD/IP/24, 
which we request to be place d on the agenda for the next TRIPS Council. In addition, the LDC Group 
intends to hold further bilateral discussions with the Members obligated under Article 66.2  TRIPS , in 
order to explore possible convergence on a way forward.   
248.  On the reports , we can sa y that some Members have provided new and interesting incentives 
that we might wish to explore further with the relevant named LDCs.  However, the reports still 
contain information that appear to fall more appropriately under TRIPS Agreement  Article 67, 
technical assistance and capacity building , than as incentives toward technology transfer.  
249.  Questions we would like to pose for the time being, without prejudice to the LDC Group coming 
back seeking more clarifications or individual LDCs doing so are the foll owing.  
250.  The LDC Group appreciates the comment made in the United States  submission that "the 
United States  continues to believe that the effective functioning of Article 66.2 of the TRIPS 
Agreement  requires a robust dialogue between developed country Member s and LDC Members, in 
order to target incentives in a way that is most responsive to the self -identified technology transfer 
interests and needs of LDC Members. The United States  encourages the efforts of the TRIPS  Council 
Secretariat and Members  to organi ze discussions among the Members  regarding Article 66.2 TRIPS 
implementation. " In this light we also hope that our proposal found in IPC/C/W/640 will be 
considered.  
251.  We note that Papua New Guinea is specifically reported yet Papua New Guinea is not an LDC.    
Article 66.2 TRIPS is only available with respect to LDCs.  IP/C/M/90/Add.1  
 
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  252.  Regarding item 13.1, which is read as for Nepal, there is a reference to a workshop in 
PhnonPhem.  Can the United States  clarify the relationship to Nepal?  
253.  The LDC Group appreciates where the United States  has referred to specific transfer or 
dissemination of technology for example, in items 3.5.4 for Togo, 10.4 in Cambodia, 11.8.25 for 
Zambia, and others.  
254.  Regarding the other country specific programmes for LDC countries, can the United States  
further summarize for us where an incentive was provided for technology transfer ? 
255.  The LDC Group also wonders if in future the United States  can use the template which would 
help the LDC Group better identify the application of United States  programmes to t he specific 
elements of Article  66.2 TRIPS . 
256.  The LDC Group thanks Switzerland for their submission and we continue to examine further 
the programmes with the relevant LDC Members.  
257.  The LDC Group appreciates Switzerland 's use of the template and also where it  has provided 
clear information on specific benefitting LDCs and on technology transferred or incentives for 
technology transfer.  
258.  Regarding those programmes identified in the submission as "open to all LDCs " can 
Switzerland inform us of which LDCs have be nefitted from the programmes or there have been none 
as yet?  
259.  Regarding Japan, Aus tralia, Canada and Norway, and we also thank them for using the 
template and request if they could highlight for us specific technology transfer or incentives that 
resulted in  more than know -how and training, but included for example dissemination or transfer of 
software, equipment or methodologies retained by the LDC?  In the case of Canada, where 
references are made to LDC transferees being to only "multiple countries " in sub -Saharan Africa or 
just multiple countries, can Canada elaborate any specific countries?  Where Norway refers to 
technology transfer as "risk capital " can Norway elaborate further?   
260.  The LDC Group would like to thank all the delegations having submitted re ports and we have 
made these comments without prejudice any comments by any individual LDC.  
10.9  Cambodia  
261.  Cambodia associates itself with the statement made by the Central African Republic on behalf 
of the LDC Group.  
262.  On behalf my d elegation, I would like to express our appreciation and thanks for the reports 
submitted by the United States , Switzerland, Australia, Japan, Canada, Norway, European Union  and 
its Members  and New Zealand with respect to the implementation of Article 66.2 of the TRIPS 
Agreement . In particular, we would like to thank Members  for providing incentives, technical 
assistance and capacity building as listed in its reports.  
263.  Taking this opportunity, I would like to reiterate that the transfer of technology is very  
important for LDCs including Cambodia. In this context, we call upon Members  to further assist LDCs 
in transferring technology know -how along with assistance and making available projects for our 
countries.  
264.  Together with the LDC Group, we will make examin ations and assessments of the reports to 
verify with our proposal contained in documents IP/C/W/640 and RD/IP/24. We will get back to 
Members  in forms of comments, questions or consultations for the matters under Article 66.2 of the 
TRIPS Agreement .  
265.  Finally, we are look forward to the workshop in February 2019 for this issue.  IP/C/M/90/Add.1  
 
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  11  TECHNICAL COOPERATIO N AND CAPACITY BUILD ING 
11.1  Canada  
266.  Pursuant to Article 67 of the TRIPS Agreement , Canada is pleased to submit its annual report 
on the implementation of Article 67  TRIPS , which provides an update on Canada 's activities 
concerning IP -related technical and financial cooperation for developing and LDC Members, covering 
the 2017 -2018 period (IP/C/W/647/Add.4).  
267.  Canada has underta ken a number of technical cooperation activities at the multilateral, 
plurilateral and bilateral levels. For instance, at the multilateral and plurilateral levels, Canada works 
in close collaboration with WIPO, as well as with the Asia -Pacific Economic Coo peration Intellectual 
Property Rights Expert 's Group (APEC -IPEG), where Canada participates in regular discussions aimed 
at sharing information and best practices on IP rights. Canada also provides a number of technical 
cooperation activities administered by the Canadian Intellectual Property Office (CIPO), Global 
Affairs Canada, the International Development Research Centre (IDRC), and the Royal Canadian 
Mounted Police (RCMP). Other Canadian institutions that receive funding from the Government of 
Canada, such as the Centre for Trade Policy and Law and the University of Ottawa, are also involved 
in international technical cooperation efforts.  
268.  For instance, as noted in this year 's report, CIPO hosted and delivered its annual CIPO -WIPO 
Executive Workshop for senior officials from developing countries on management techniques in the 
delivery of IP services in June 2018. This workshop, which was delivered in French for the second 
year, benefitted from fruitful participation from Tunisia, Algeria, Cameroon, Benin , Guinea, Guinea -
Bissau, Mali, Madagascar, Togo, Haiti, Belarus, and the Organisation Africaine de la Propriété 
Intellectuelle  (OAPI) . CIPO also made available online a number of pre -recorded webinars on IP and 
patents in collaboration with the Trade Facil itation Office of Canada. These webinars, which were 
available for embassies, consulates, and businesses from developing countries, covered topics such 
as the basics of Canadian IP, registration of patents and trademarks, and IP foundations for women 
entre preneurs. Moreover, CIPO provided research and examination reports for patent examinations 
upon the requests of Madagascar and Djibouti, through WIPO 's programme of International 
Cooperation in the Search and Examination of Inventions (or ICSEI).  
269.  Canada 's 2018 report on Article 67 TRIPS also includes a number of IP -related technical 
assistance projects funded by the IDRC. These include the Copyright and Innovation in the 
Developing World Project in India, Colombia, Brazil, and Chile, which provides evidenc e to support 
Governments on copyright and innovation issues in the digital economy. This project has worked to 
develop a transnational index of changes in copyright law s in fifteen countries, studying the impact 
of copyright laws on the behaviour  of firms,  and is developing sector -specific case studies. The 
project has also examined new forms of payment and reward for developing country -creators 
seeking to distribute their content.  
270.  Canada also contributes to the work of the Open African Innovation Research  Network (Open 
AIR), which aims to investigate how IP regimes in Africa can be harnessed to facilitate innovation 
through collaboration, and to make processes more participatory, knowledge more accessible, and 
benefits more widely -shared. Open AIR is engag ed in several research areas. For instance, Open 
AIR's work on high -technology hubs examines the role of formal IP rights in African tech initiatives. 
As well, Open AIR 's work on informal sector innovation is examining, among other things, whether 
there ar e IP-related solutions or challenges in scaling up informal businesses.  
271.  With respect to discussions on technical cooperation in the  TRIPS Council, Canada remains 
interested in hearing Members ' views on some of the successes and challenges in seeking techn ical 
assistance and cooperation to address their priority needs. Canada would also be interested in 
hearing how priority needs have changed since LDCs ' initial work on TRIPS implementation, and 
where gaps in technical assistance might remain. As well, Cana da would be interested in Members ' 
experiences and best practices on the types of technical assistance that have proven most effective 
in supporting the implementation of TRIPS obligations and in using IP to support economic and social 
development.  
272.  Canada  looks forward to discussing these issues further, with a view to ensuring that technical 
assistance continues to meet the priority needs and development objectives of its recipients.  IP/C/M/90/Add.1  
 
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  11.2  Australia  
273.  Australia takes an active role in promoting technical cooperation and capacity building in the 
intellectual property field as we have highlighted in our 2018 Article 67 Report.  
274.  Australia fulfils its Article 67 technical cooperation commitment through multilateral, regional 
and bila teral programs and activities. Many activities are focused on developing and least  developed 
countries in the Indo -Pacific region. Australia works closely with the World Intellectual Property 
Organization (WIPO), the Association of Southeast Asian N ations (ASEAN) Secretariat and other 
partners to assist developing and least developed countries to build their intellectual property 
capacity and systems.  
275.  Many of the technical co -operation activities implemented under Article 67 of the TRIPS 
Agreement al ign with Australia 's strategic focus on using aid as a catalyst to promote economic 
growth and poverty reduction, including through a strong emphasis on aid for trade. This is 
embedded in the UN Sustainable Development Goals and our future investments, inc luding activities 
under the WIPO -Australia Funds in Trust program, will in turn be influenced by these goals.  
276.  Since our last meeting, the ongoing work of the WIPO -Australia Funds in Trust (FIT) 
programme has continued to support least developed and develop ing countries with the 
development and implementation of IP systems and enhance IP capabilities.  
277.  We reiterate our commitment to technical cooperation and intellectual property capacity 
building activities.  
11.3  Japan  
278.  The delegation  of Japan  would like to briefly describe this year 's report on Japan 's technical 
cooperation (IP/C/W/647/Add.3 ). The report consists of the main body and its annex. The main body 
highlights recent technical activities, while the annex lists the det ails of each activity.  
279.  This report categorizes cooperative activities into four areas, namely, industrial property, 
copyright, plant varieties, and border measures.  
280.  When it comes to industrial property, the Japan Patent Office (JPO) organize d 21 training  
courses for both G overnment officials and the private sector in FY2017. More than 300 people 
attended in total. Moreover, based on the JPO 's long history of conducting training courses, alumni 
associations have been established in the trainees ' home count ries. The Japan Patent Office 
continues to support the alumni associations by holding follow -up seminars in Asian countries.  
281.  Turning now to copyrights, in FY2017, the Japan Copyright Office, with the support of the 
WIPO, held seminars where around 100 peo ple attended.  
282.  Moreover, Japan provided technical coop eration to developing and least -
developed  country  Members  on the protection of plant varieties and border measures.  
283.  Japan will continue to ma ke its utmost efforts to fulfil  its obligation under Article 67  TRIPS . 
11.4  United States of America  
284.  The United States  is pleased to highlight its report under Article 67  TRIPS , contained in 
IP/C/W/647 on the technical assistance programme s provided by the United States  Government 
concerning the protection, utilization and enforcement of intellectual property rights, including 
patents, trademarks and enforcement for developing and least developed countries.  
285.  In the past year, our re port accounts for more than 85 training, technical assistance, and 
capacity building programme s for 83 different countries, including developing countries and LDCs.  IP/C/M/90/Add.1  
 
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  Of these 83 countries, 11 programmes were provided for ten  least developed countries, inclu ding 
Bhutan, Cambodia, Lao PDR, Myanmar , Nepal, Rwanda, Sudan, Tanzania, Uganda and Zambia.1 
286.  Technical cooperation to improve IP legal, administrative and enforcement infrastructure is 
crucial to countries ' economic development that is directly linked to c ontributing to foreign 
investment and voluntary, private sector -led technology transfer in developing countries and for 
developing country innovators to capitalize on their creativity.  
287.  The United States  Government technical assistance is driven by demand a nd individual priority 
needs of beneficiary countries. The diversity of needs and interests identified by beneficiary countries 
results in tailored technical assistance activities on specific areas of interest.  
288.  We look forward to continued discussions on r eports in the Council concerning technical 
cooperation of governments and IGOs for the strengthening of IP systems . 
11.5  Norway  
289.  Norway has for a number of years provided technical assistance and capacity building through 
two sets of activities : 
• Annual one -week training courses for up to 15 participants from national industrial property 
offices in developing countries - a collaboration between the Norwegian Industrial Property 
Office and WIPO;  and 
• A training programme, normally every two years, on exercise and management of copyright 
and related rights directed towards staff of collective management organizations and 
government officials in the cultural sector in developing countries - a collaboratio n between 
the Norwegian Copyright Development Organisation (NORCODE) and WIPO.  
290.  In previous reports we have covered these activities through 2016. Unfortunately, due to 
budgetary constraints, the Ministry of Foreign Affairs had to suspend the cooperation wi th our 
Industrial Property Office in 2017. For this reason, we have not submitted a written report for this 
year. We will, however, submit a report in 2019 that covers both sets of activities through 2018.  
11.6  European Union  
291.  The d etails of the European Union  and its Members ' technical assistance activities in LDCs and 
developing countries can be seen in the submission made under Article 67 TRIPS on 6 November 
2018.  
292.  This report confirms the European Union 's commitme nt to technical co operation and capacity 
building and shows  that the European Union  fulfils its TRIPS obligations on the matter.  
11.7  WTO Secretariat  
293.  Document IP/C/W/645 reports on technical cooperation activities concerning TRIPS that were 
undertaken by the WTO Secretariat between 1 Oct ober 2017 and 30 September 2018 . The document 
provides a general overview of trends; details of each activity are provided in Annex I  of the 
document . 
294.   Technical cooperation activiti es, implemented by the WTO Secretariat under the aegis of 
TRIPS, have the objective of assisting Members and Observers to meet their developmental and 
other domestic policy objectives within the framework of the  IP system established by the 
TRIPS  Agreement , and to respond to the needs and priorities articulated by the Members concerned. 
Activities are driven by demand from developing country and least  developed  countr ies, as well as 
from governments preparing to accede to the WTO. Hence, focussing on the TR IPS framework itself, 
this work touches on areas such as innovation and industrial policy, health, regulatory aspects, 
competition policy and environmental protection, through the trade and intellectual property regime, 
                                                
1 For more information about GIPA, see www.uspto.gov/gipa .  IP/C/M/90/Add.1  
 
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  in line with domestic circumstances and priority needs. These activities also have the objective of 
strengthening the capacity of Members to fully participate in the WTO 's work on TRIPS matters.  
295.   A central focus also remains on assisting Members and Observers to understand their rights 
and o bligations under the Agreement. As we have reported under Item 1, Members and Observers 
continue to receive tailored assistance regarding their participation in the transparency for the work 
of this Council, and this will be stepped up in line with the opp ortunities provided by the e -TRIPS 
system.  
296.   Among the more recent developments, since the entry into force of the Protocol Amending 
the TRIPS Agreement  in January 2017, activities have increasingly focused on implementing the 
Protocol at the domestic level  and supporting the utilization of the Special Compulsory Licensing 
System as an effective procurement tool to ensure access to affordable medicines. Given the 
increasing interest in sharing practical experience with the implementation of certain aspects o f Part 
III of the TRIPS Agreement , the Secretariat also organized the first WTO activity dedicated to 
intellectual property judges from developing countries and economies in transition.  This workshop 
shared experience with the application of relevant TRIPS Agreement  provisions in a wide range of 
jurisdictions and fostered a network for continuing practical dialogue.  
11.8  World Health Organization  
297.  The overall objective of the World Health Organization (W HO) technical cooperation is to 
strengthen the capacity of developing countries to respond to needs in the areas of public health, 
health innovation, access to medicines and vaccines, and intellectual property.  
298.  WHO's technical cooperation is based on its ma ndate derived from the Global Strategy and 
Plan of Action on Public Health, Innovation and Intellectual Property (GSPoA) as well as other 
relevant resolutions of the World Health Assembly and WHO Regional Committees.  
299.  The WHO Secretariat will be  presenting at its Executive Board in January  2019 a Roadmap on 
Access to Medicines, Vaccines and Health Products, developed in consultation with Members , which 
outlines WHO 's work in this area, including activities, actions and deliverables for the period 
2019−2023. The access roadmap will include some activities on IP, which are in line with the GSPoA, 
including the application and management of intellectual property to contribute to innovation and 
promote public health.  
300.  This year WHO published the second edition of a global report on access to hepatitis C 
treatment that reviews the progress countries have made in expanding access to life -saving DAAs. 
The report includes the main challenges countries face . It describes recent developments in relation 
to five key facto rs that determine access to DAA medicines: affordability, quality assurance, 
regulatory approval, government commitment and financing. It highlights key areas for action by 
Ministries of Health and other government decision -makers, pharmaceutical manufactu rers and 
technical partners . It is available in different languages  on the WHO website . 
301.  Another issue of importance is the emergence and spread of antimicrobial resistance in all 
geographical areas, which is jeopardizing the effectiveness of these potentia lly life -saving 
treatments. It not only impedes the ability to treat bacterial infections in humans and animals but 
has broader societal and economic effects that ultimately threaten achievement of the Sustainable 
Development Goals. There are scientific an d economic challenges for ensuring investment in R&D. 
The traditional profit -driven biomedical R&D model has not led to the development of new antibiotic 
candidates; limited potential commercial markets and consequent low profit margins compared to 
other i nvestments are being cited as contributory factors.  In that sense, WHO published an in-depth  
analysis of all antibacterial agents currently in clinical development. The report showed a serious 
lack of new antibiotics under development to combat the growin g threat of antimicrobial resistance 
and found very few potential treatment options for those antibiotic -resistant infections identified by 
WHO as posing the greatest threat to health.       
302.  The seventh WHO -WIPO -WTO Joint Technical Symposium on "Sustainabl e Development Goals 
(SDGs): Innovative technologies to promote healthy lives and well -being " discussed challenges and 
opportunities for the international community to ensure that innovative technologies are developed 
and reach patients in order to realize the right to health and the health -related SDGs. Access to, and IP/C/M/90/Add.1  
 
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  innovation in, health technologies is essential for ensuring progress toward universal health coverage 
and achievement of SDG 3: Ensure healthy lives and promote well -being for all at all ages . The 
discussion highlighted innovative, inclusive, and multi -stakeholder initiatives and partnerships that 
research, develop and facilitate access to novel, needs -based health technologies.  
303.  Finally, WHO is organizing an inter -agency meeting at the end of November , with technical 
staff from UN and other international agencies working on IP and health , including the High 
Commissioner for Human Rights, UNAIDS, UNCTAD, UNDP, UNITAID, WIPO, WTO to exchange 
information on ongoing and planned activities to help a void duplications and where possible align 
activities.  
304.  Further details about WHO technical support in framing national policies, laws and regulations 
to favour application and management of intellectual property in a manner that maximizes health -
related in novation and promotes access to health products are available in our report 
(IP/C/W/644/ Rev.1/A dd.2). 
11.9  Cooperation Council for the Arab States of the Gulf  
305.  I would like first  to thank you for allowing me to present the main technical cooperation 
activities undertaken by the Secretariat General of the Cooperation Council for the Arab States of 
the Gulf (GCC) which are relevant to the intellectual property issues and to highligh t more specifically 
those activities aimed at enhancing awareness on IP issues, performing patent -related activities, 
understanding some aspects of dispute resolution when it comes to intellectual property rights, as 
well as contributing to strengthening i nnovation. These activities are organized in mutual cooperation 
among the GCC Patent Office, GCC national patent offices, WIPO as well as with partners from other 
national IP offices. They are conducted either in the form of specialized workshops, on -job training 
or secondment at national IP offices.  
306.  As part of its leading role in developing an effective regional patent system and in 
implementing GCC Patent Law, the GCC Patent Office continues to intensify its activities on technical 
assistance aimed among  others at enhancing the capacity of GCC national patent offices to 
contribute to patent enforcement and the improvement of the IP environment in general in GCC 
Members .   
307.  In order to contribute to enhancing awareness on IP issues, the GCC Patent Office ha s actively 
participated in IP day celebration organized on 26 April 2018 respectively at Rabigh -Saudi  Arabia 
King AbdulA ziz University and Oman Scientific Research Council in Muscat, and on 29  April 2018 at 
the GCC -SG Headquarters in Riyadh, Kingdom of Saudi Arabia. The GCC  Secretariat General has 
also organized a workshop at the GCC IP  Training Centre in  the State of Kuwait on 9  and 10 October 
2018 with the objective of Strengthening Innovation through Better IP Management in the GCC 
Region.   
308.  As for pa tent examination, the GCC Patent Office has conducted during  the last quarter of 
2017 six on -job trainings at the State of  Kuwait IP Office for the benefit of the examiners of that 
office during a period of ten to twenty days for each training. These activ ities have focused on a 
substantive examination of all patent application s filed at the State of  Kuwait IP Office. Another 
on-job training on the same issue was conducted for the benefit of Bahraini examiners in two phases 
at Bahrain nation al IP Office res pectively on 12 –19 and 19 –26 November 2017. The third on -job 
training on patent examination was organized with cooperation of SIPO (Chinese IP Office) at the 
GCC headquarters in Riyadh, Kingdom of Saudi Arabia, from 19 November  to 18 December 2017 
with the  participation of examiners from the GCC Patent Office and GCC national IP offices.  
309.  On the same topic, a four days specialized workshop on strategic examination procedures was 
organized during the first week of November 2017 at the GCC IP Training Centre 
(the State of Kuwait) in cooperation with USPTO ( the United States  Patent Office) for the benefit of 
examiners from GCC PO and GCC national IP offices. Another workshop was conducted during the 
last week of January 2018 on PCT National Phase Examination and  Utilization of External Examination 
work products at the GCC headquarters for the benefit of the same participants in cooperation with 
WIPO and EPO (European Patent Office).  IP/C/M/90/Add.1  
 
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  310.  On other aspects of patent, a Workshop on classification, analysis, and search of  patent 
applications by KIPO (Korean IP Office) was organized at the GCC headquarters in Riyadh from 20  to 
23 November 2017 for the benefit of Specialists from the GCC Patent Office and GCC national IP 
offices in cooperation with WIPO, the State of  Kuwait National IP Office and KIPO.  
311.  On the IT aspects of patent, an on -job training was organized at Oman national IP office with 
the participation of IT experts from that office during the period 1 –3 July 2018 focusing on utilizing 
GCC Patent Office E -Systems an d re-designing such systems in conformity with Oman Patent Law. 
Another technical cooperation activity on IT aspects was conducted in the Kingdom of  Bahrain for 
the benefit of Bahraini specialists aimed at working on developing electronic systems at the Bahrain 
IP Office and launching E -filing system by IT experts of the GCC Patent Office.  
312.  On the IP dispute resolution aspects, a Conference on arbitration in the field of IP was 
organized on 23 December 2017 at the State of  Kuwait Chamber of Commerce & Indu stry with the 
participati on of specialists from GCC Members  and in cooperation with WIPO, the State of  Kuwait 
Commercial Arbitration Centre and GCC IP  Training Centre. I n cooperation among the GCC IP 
Training Centre and the USPTO, a Training programme  was conducted on the litigation on intellectual 
property rights at the USPTO ( United States ) from 30 July  to 2 August 2018 with  the participation 
of judges and consultants from GCC  Members . 
313.  With the objective of encouraging inventors in GCC Members , the GCC Pa tent Office grants a 
yearly award of SAR 50,000 for the top three GCC inventions on the occasion of International 
exhibition held annually in the State of  Kuwait (28  to 31 Jan uary 2018) or any other GCC  Member,  
as well as hosting and supporting the partici pation therein of inventors from GCC Members . For the 
same objective, the GCC Patent Office has also supported the hosting and participation of one 
inventor from each GCC Member  in the International exhibition which takes place annually in 
different countr ies (Nuremberg, 2  to 5 Nov ember  2017). On the occasion of this event, the GCC 
Patent Office participates along with inventors from GCC  Members  to open up doors for 
communications with those concerned around the world.  
11.10   United Nations Conf erence on Trade and  Development  
314.  I refer to the submission by the United Nations Conference on Trade and Development 
(UNCTAD)  to this Council on our technical cooperation and capacity building activities  
(IP/C/W/644/Rev .1/Add .1). I would like to highlight a few elements of our technical cooperation 
programme  during the reporting period.  
315.  Policy coherence for local pharmaceutical production and access to medicines: Considering the 
cross-cutting n ature of domestic pharmaceutical production and access to medicines, UNCTAD with 
the support of German International Cooperation (GIZ) in 2018 published the "Tool Box for Policy 
Coherence in Access to Medicines and Local Pharmaceutical Production ". The Too l Box provides 
interested governments with an overview of policy tools to create a framework conducive to 
promoting local pharmaceutical production and access to medicines. It has been used in our technical 
cooperation activities, for instance in national consultations for Thailand on policy coherence in the 
pricing and procurement of essential medicines that was organized jointly with UNDP.  
316.  African regional integration: UNCTAD has been actively supporting African countries in their 
efforts to promote regi onal trade integration. In 2018, w e provided technical inputs to ongoing 
negotiations of a Tripartite free trade area made up of COMESA, the EAC and SADC. Our inputs were 
directed at Tripartite efforts to develop a regional IP regime.  
317.  We work closely with  the African Union and the United Nations Economic Commission for Africa 
to prepare Phase 2 negotiations of the African Continental Free Trade Area (AfCFTA), which concerns, 
inter alia , intellectual property. We are currently planning a project to assist i n the implementation 
of Phase 1 of the AfCFTA by analy sing non -tariff measures (NTMs) in AfCFTA Members ' legislation. 
Under the same project, we also intend to build capacities of the African private sector and public 
research organizations to increase res earch and development collaborations, including with foreign 
investors.  
318.  Investment and Antimicrobial resistance/AMR: Picking up on the ad hoc Expert Group Meeting 
on New Investment Models in Health -related R&D - The Case of Antibiotic Resistance, which we  IP/C/M/90/Add.1  
 
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  organized in 2017 and which was reported to this Council, we have continued our work on AMR from 
the investment perspective. In cooperation with WHO, we organized, as part of the UNCTAD World 
Investment Forum this year, a multi -stakeholder discussion on "Fostering Investment in the 
Development of New Antibacterial Treatments ". The objective of this meeting was to discuss ways 
of increasing private sector involvement in AMR -related R&D. UNCTAD and WHO are currently 
discussing follow -up.  
11.11   World Intellectual Property Organization  
319.  The document IP/C/W/644/Rev.1/Add.5 provides a detailed list of activities undertaken by the 
World Intellectual Property Organization  (WIPO)  that were relevant t o the implementation of the 
TRIPS  Agreement . The document covers activities organized during the period 
September  2017 to September 2018.   
320.  It may be seen from this document that WIPO has provided extensive legal and technical 
assistance to Members  to supp ort their efforts in implementing obligations arising from the TRIPS 
Agreement .  The activities that have been undertaken have contributed to enhancing the ability of 
Members  to use the intellectual property system for economic, social and cultural develop ment and 
to promote innovation.  Further, WIPO has assisted countries in integrating intellectual property in 
their national development and public policies.  
321.  WIPO remains committed to continue providing assistance to Members States  to implement 
their oblig ations under the TRIPS Agreement  and to leverage the IP system to promote creativity 
and innovation.   
11.12   African Regional Int ellectual Property Organization  
322.  The African Regional Intellectual Property Organization (ARIPO)  as an Intergovernmental 
Organization, currently with 19 Members  across Africa, was established with the purpose of pooling 
together resources of its Members  for the promotion, development and harmonizatio n of Intellectual 
Property laws and policies for the social, economic and technological development of its Members .  
323.  In pursuance of its mandate, ARIPO , in some cases in collaboration with its cooperating 
partners, undertook activities which mainly focused  on IP awareness raising and capacity building.  
324.  On IP awareness, ARIPO continued its initiative which commenced in 2017 of engaging 
Universities and Research Institutions as the main generators of Intellectual Property. Six seminars 
were conducted with sel ected Universities and Research Institutions in Rwanda, Zimbabwe, Liberia, 
Namibia, Botswana and Mozambique, where a total of 534 participants attended. The seminars were 
organized on the theme "Fostering Creativity and Innovation for Economic Growth and D evelopment 
in Africa ". The seminars were intended to enhance intellectual property awareness in Academic and 
Research Institutions with a view to promoting the creation, protection and utilization of research 
results using intellectual property tools for t he economic and technological development of our 
Members .   
325.  On capacity building, ARIPO provided ten scholarships to students to pursue the Masters 
Programme in Intellectual Property that is jointly offered by the World Intellectual Property 
Organization ( WIPO), ARIPO and Africa University in Mutare, Zimbabwe in collaboration with the 
Japan Patent Office. The programme has so far produced 296 graduates from 26 countries across 
Africa since its inception in 2008.  
326.  It is also worthy highlighting that ARIPO in  collaboration with the Ghana IP Office partnered 
with Kwame Nkrumah University of Science & Technology in Kumasi, Ghana and launched another 
Masters Programme in IP on 28 August 2018 where ARIPO has sponsored 12 students.  
327.  In conclusion, allow me to presen t highlights of other capacity building and IP awareness 
activities  undertaken by ARIPO. In June 2018, ARIPO and WIPO jointly organized a Symposium on 
Copyright and Related Rights at ARIPO H eadquarter s in Harare on the theme: "Shaping the 
Copyright and Rel ated Rights System in Africa ". The S ymposium brought together participants from 
Copyright Offices and Collective Management Organizations from 18 ARIPO Members  to discuss 
critical copyright issues affecting Africa and explore ways to address copyright in t he digital IP/C/M/90/Add.1  
 
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  environment for the benefit of right holders, use rs and other stakeholders. The S ymposium also 
sought to promote efficiencies in the administration and management of the copyright offices and 
collective management organizations.  
328.  In July 2018, AR IPO, WIPO and the Japan Patent Office jointly organised a Regional Training 
of Trainers Workshop on Teaching of IP in Police Colleges of the ARIPO Members  at the ARIPO HQs 
in Harare to build capacity of law enforcement officers to prosecute IP infringement .  
329.  In August 2018, ARIPO in collaboration with WIPO , organized a Regional Seminar on the 
Implementation and Use of Patent -Related Flexibilities, at the ARIPO Headquarters in Harare, to 
enhance the knowledge of available patent -related flexibilities and to develop skills in the optimal 
use and implementation of the flexibilities for the benefit of ARIPO Members . 
330.  In August again, ARIPO, WIPO and the Japan Patent Office jointly organized a sub-regional 
meeting on the development of a sub-regional Technology an d Innovation Support Centre (TISC) 
Network, ARIPO Headquarters, Harare. The meeting agreed to establish a Regional TISC at ARIPO 
in order to share best practices in effectively using technology found in patent databases and science 
and technology journal d atabases.  
331.  In September, WIPO, ARIPO and Japan Patent Office organized a Patent Drafting Course at 
the ARIPO Headquarters in Harare, to enhance the capacity and skills of targeted participants in 
ARIPO Members  and Observer States  in drafting patent applicat ions. 
332.  In promoting IP awareness and dissemination of research results, ARIPO and the Africa 
University in Mutare, Zimbabwe jointly launched the African Journal of Intellectual Property (AJIP) 
which is published twice a year.  
333.  ARIPO in partnership with Afri ca University and with financial support from JPO has published 
an IP Textbook titled "Intellectual Property Law, Practice and Management: Perspectives from 
Africa ". The book is mainly intended for students pursuing the Masters in IP.  
334.  On 10 September 2018,  ARIPO launched its Regional Intellectual Property Database, that was 
developed with the support of WIPO, to efficiently serve multiple purposes, including on line provision 
of published IP data, encouragement of regional trade and IP scientific research. T he database has 
currently more than 400,000 IP titles from ARIPO Office and 12 Members . 
12  INTELLECTUAL PROPERT Y AND INNOVATION: TH E SOCIETAL VALUE OF IP IN THE 
NEW ECONOMY – IP AND NEW BUSINESS  
12.1  United States of America   
335.  The United States  is pleased to co -sponsor this agenda item and contribute to the discussion 
of "The Societal Value of IP in the New Economy – IP and New Business. " I would also like to thank 
Switze rland, Australia, the European Union, Japan, Republic of  Korea, Chinese  Taipei, and Brazil for 
co-sponsoring this item.  
336.  The day before this meeting , the Friends of IP and Innovation sponsored a side event where 
speakers highlighted the incentivizing role o f IP in the areas of economic growth, development, 
societal benefits as well as a catalyst for new businesses.  This featured economic perspectives and 
innovators who have relied on IP to produce game -changing technology. We thank everyone who 
came and sup ported the event.  
337.  As we have discussed during the course of the year, there is a critical nexus between business 
development, intellectual property, and economic growth.  IP -intensive industries support at least 
45 million US jobs and contribute more than USD 6 trillion to, or 38.2 % of, US gross domestic 
product (GDP).  
338.  The importance of intellectual property is no less for small and medium sized companies, 
including start-ups, which are the backbone of the American economy.  The United States ' 30 million 
SMEs have accounted for nearly two -thirds of net new private sector jobs in recent decades.  And IP/C/M/90/Add.1  
 
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  our youngest companies – those less than one year old – have created on average 1.5 million jobs 
annually over the past three decades.   
339.  These figures indicate t hat creating the conditions for new businesses and start-ups to succeed 
is key to America 's future economic success. Entrepreneurship is critical to both the United States 
and the global economy.  
340.  The United States Government agencies support entrepreneurs  throughout every phase of the 
business -life-cycle: in addition to promoting transparency and rule of law, they provide for patent, 
trade secret, trademark, copyright and other IP protections to allow entrepreneurs to protect their 
work and bring it to the  marketplace.  
341.  For new businesses, IPR protection can often help determine whether a firm survives and 
thrives.  In particular, the United States  manufacturing firms that use intellectual property are a 
boon for the economy.  
342.  In the case of SMEs, trade secrets may play a critical role in the development of innovation 
and are among the primary forms of intellectual property that companies use to protect their 
innovations, as smaller firms tend to have fewer resources and limited expertise and capacity for  
managing intellectual assets using formal IPRs.  
343.  Patent protection also plays a critical role for the development of new companies.  Start -ups, 
as compared to larger firms, may factor into their growth strategies, considerations such as the 
marketing advan tages that ensue from being able to claim patent protection.   
344.  Studies have shown that SMEs tend to use their patents more actively than large firms and 
smaller companies generally license a higher proportion of their portfolios than do larger ones. 
A recent study out of the UK on the survival of new technology -based firms also concludes that 
patent development during firms ' initial years is critical to survival.  
345.  Registering and maintaining relevant trademarks can also help ensure that a firm rightfully 
enjoys the benefits of its investment in creating a distinctive brand, including brands that feature 
innovative products and services. Without this legal protection, an unscrupulous competitor may 
attempt to usurp the goodwill that another company has worked hard to create.   
346.  Traditionally, research on the role of IPRs for small firms and start -ups has been 
patent -focused. Recently, however, research on trademarks has gained momentum and has 
established that trademarks are a similarly important form of IPR, pa rticularly for start -ups. 
347.  Recent studies have shown that start -ups are more likely to file for trademarks instead of 
patents when entering markets with a higher market concentration. The same study also shows that 
start-ups that are primarily active in bus iness-to-consumer markets are more likely to file 
trademarks than start -ups primarily in business -to-business markets.  
348.  Exporters are significantly more likely to rely on IPR than other firms. Firms holding patents 
in the United States  account for over 90 % of the United States  exports. Similarly, innovative firms 
are better exporters. An examination of the performance of 1700 firms before and after acquisition 
of a first patent found that, whereas the number and value of firms ' export transactions remained 
constant up to the date of the patent acquisition, the number and value of export transactions rose 
afterward.  
349.  Industries in the United States  that rely on IP are ones that flourish the most.  One example 
is the copyright industry, which as a whole, generat es jobs, and produces economic growth, both in 
the United States , and globally.  Copyright protection plays a key role in a large number of 
companies.  Even those not engaged in content creation and distribution often have a strong need 
to protect importan t materials via copyright.   
350.  In the United States , copyright -intensive industries supplied 5.6 million jobs and copyright 
industry workers earn on average 38% higher wages than other US employees. The  United States  
music industry specifically, supports 1.9  million American jobs and added USD 143 billion in value IP/C/M/90/Add.1  
 
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  to the US economy in 2016, increasing over 37% since 2012. Many creative artists are small 
businesses, who rely on copyright protection to improve their livelihood.  
351.  The United States  Government want s to make sure new businesses have knowledge of, access 
to, and benefit from, existing government resources aimed at helping start-ups and new businesses 
realize international opportunities.  
352.  Many start-ups, in particular technology start-ups, face unique c hallenges, so counselling  from 
government or private sector organizations can make a big difference.  
353.  The International Trade Administration (ITA) at the United States  Department of Commerce 
launched an initiative entitled "Start-up Global " in partnership w ith the Global Innovation Forum to 
provide focused advice to small and early -stage American companies looking to grow their 
businesses by engaging in the global marketplace.   
354.  Separately, the Global Entrepreneurship Summit, sponsored by the United States  State 
Department, aims to showcase inspiring entrepreneurs and investors from around the world creating 
new opportunities for investment, partnership, and collaboration; it connects American 
entrepreneurs and investors with international counterparts to for m lasting relationships; and 
highlights entrepreneurship as a means to address some of the most intractable global challenges.  
355.  The Global Entrepreneurship Summit was held for the first time in South Asia in Hyderabad, 
India, last year and this year will b e in The Hague .  
356.  These programme s aim to increase survival and success rates of technology -based start -ups. 
The programme s also enable technology -based start -ups to scale their growth faster. Both of these 
goals are achieved by encouraging start-ups to exp and into international markets where there is 
demand for their products & services and potentially less competition.  
357.  Other USG agencies, such as the United States  Patent and Trademark office, offer programme s 
for new businesses and start-ups to protect th eir IPR.  
358.  Through the Patent Pro Bono Programme , the USPTO partners with non -profit organizations 
and law schools to establish regional programme s throughout the country. By working with their 
regional patent pro bono programme , under -resourced independent inventors and small businesses 
are eligible for free legal advice and representation to help them file and prosecute patent 
applications.  
359.  International cooperation also plays an important role for start-up development and growth. 
The Americas Competitivene ss Exchange, is done in coordination with  United States  Department of 
Commerce 's International Trade Administration (ITA) and Economic Development Administration 
(EDA), in coordination with the United States  Department of State and the Organization of Ame rican 
States  (OAS), and brings 50 representatives from 24 countries throughout the Western Hemisphere 
to explore global and regional partnerships and economic development opportunities to establish 
new global commercial relationships.  
360.  Furthermore, the United States  and the European Union  work together to make sure their 
start-ups and small businesses share best practices about how to protect their IPR in each other 's 
markets. The EU -US SME Best Practices Workshops are held annually and are an ongoing oppor tunity 
for small businesses to engage directly and discuss trade topics of interest with United States and 
European Union  officials and small and medium businesses and associations from both sides of the 
Atlantic.  
361.  IP protection also plays a big role in ne w emerging technologies and start-ups that are quickly 
integrating into the global economy.  
362.  Marvin Caruthers, Inventor of Chemical Synthesis of DNA, and co -founder of Amgen and 
Applied Biosystems testifies to the importance of IPR to biotechnology developm ent.  He emphasizes 
that the biotechnology industry would not exist without patents, as he must have patents to protect 
his technology in order to attract investors, as they want to know what the company is bringing to 
the table.  IP/C/M/90/Add.1  
 
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  363.  Artificial intelligence i s another emerging area focusing in IPR protection, used mostly in the 
tech industry, producing new products and services every year. Artificial intelligence ( AI) will 
redefine how individuals think about daily life, and start-ups will need to start levera ging AI to get 
ahead.  
364.  The USPTO offers programme s and tools for businesses to learn to protect AI -related 
inventions, navigate the quickly evolving sector, and learn about the United States  approach as well 
as how other major economies are addressing AI in  terms of intellectual property rights protection.  
365.  New enterprises, start-ups, and small businesses, are the core of the United States  and global 
economies. As we have discussed over the past year, the nexus between trade, IPR, and economic 
growth is profo und, as intellectual property not only fosters new business, but it creates new jobs 
and leads to higher wages.  
366.  IPR is an integral part of our local American innovative economy, and through trade and 
investment, IPR contributes to the economic growth of th e global economy, improving lives and 
society as whole.  We look forward to hearing from other Members on this topic.  
12.2  Switzerland  
367.  Switzerland is pleased to co -sponsor this topic in partnership with Australia, Brazil, the 
European Union, Japan, Republic of  Korea, Chinese Taipei, and the United States . We welcome the 
opportunity to exchange experiences on how intellectual property contributes to creating new 
business. This is an important topic for the WTO, whose goals are, among others, to promote trade 
between and economic development of its Members .  
368.  For large companies, the protection of intellectual property is often a cornerstone of their 
business strategy. They consider IPRs key to protecting their intellectual property, investment and 
reputation against unfair competition, misuse and freeriding.  At least in innovation -driven industries, 
intellectual property rights are often the most valuable assets in their balance sheet. For small 
companies and start -ups, the use of IP as an essential asset -building instrument is not always that 
obvious. There may be a lack of awareness. Or the start -up may know about the potential value of 
IP rights but shies away from the administrative work and financial costs associated with seeking IP 
protection – or falsely assume that they can deal with securing IP rights  at a later stage in their 
business development.  
369.  My delegation would now like to share some experience we have made in S witzerland with 
regard to the three aspects addressed in IP/C/W/648 on how IPR can help new business drive their 
success .  
370.  In 2015, mor e than 580,000 companies were located in Switzerland. 40,000 new businesses 
started operations in the same year, with the majority in the services sector. The economic 
significance of these newly founded companies does not only lie in the number of newly c reated 
jobs. It lies also in the business momentum, the value -added for the economy and society they 
generate, including intangible assets such as IP. Founding a start -up may be the initiative of an 
independent entrepreneur. Frequently, however, they are t he result of a spin -off from research 
institutes or universities.  
371.  Government activity and policies as well as the legislator can best serve research initiatives 
and entrepreneurs by providing favourable business conditions, i.e. lean procedures for the cr eation 
of new businesses, an attractive tax system, and not least: clear, reliable legislation for adequate 
and effective protection of intellectual property and for licensing IP rights. This provides a safe and 
effective regulatory framework for new busin esses or university spin -offs entering the market and 
doing trade with their innovations.  
372.  We would like to illustrate this with two examples of new businesses that were the result of 
the partnership between academia and Innosuisse, Switzerland 's innovation  promotion agency.  
373.  Innosuisse, the Swiss Government 's Innovation Agency supports science -based innovation in 
the interest of industry and society, with the aim of laying the groundwork for successful Swiss start -
ups and their innovative products and servi ces. Its long -term mission and goal is to contribute with IP/C/M/90/Add.1  
 
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  its activity to a prosperous and sustainable economy in Switzerland. The activities of Innosuisse 
involve promoting entrepreneurial thinking by providing targeted and personalised training to start -
ups, by funding science -based innovation projects, by helping the internationalisation of Swiss SMEs, 
and by promoting networking and events in key innovation fields.  
374.  Part of Innosuisse 's mandate is raising awareness of SMEs of the importance of protecting  
their intellectual property. Innosuisse promotes business ideas in accordance with the subsidiarity 
principle, i.e. it only supports projects if the market potential is not otherwise tapped into. Innosuisse 
follows predominantly a non -monetary policy, i.e . a coaching and knowledge -pooling approach 
rather than substituting private market funds from, for example, venture capitalists. This approach 
helps avoid wrong incentives and ensures sustainable use of limited public means.  
375.  Of course, new businesses need  substantial kick -off financing from private sources. Often, 
however, their sheer lack of expertise and experience of how to establish and run a business are by 
themselves handicaps. Here, governmental institutions can lend assistance as temporary partners , 
trainers, coaches and intermediaries. Innosuisse especially promotes partnerships between 
academia and the private sector.  It is also a networking platform, bringing the right partners from 
the academic and private sector together. Moreover, by helping to promote the market potential of 
innovations at an early stage of development, the agency can facilitate a start -up's entry into 
international markets.  
376.  Such cooperative assistance and support can benefit companies in all economies, whether 
high-, middle,  or low income, of course adapted to the particular circumstances, needs and capacity 
of the companies in an individual country. The World Bank 's research paper by Cravo and Piza on 
the impact of business support services for SMEs in low and middle -income countries shows how 
business support in these countries helps improve performance of companies and create jobs. The 
research paper informs policy debates with its meta -analysis on how such engagement of the public 
with the private sector benefits companies  in a country, even if such support and engagement is 
limited to training courses.  
377.  In Switzerland, around 200 start -ups benefited from such  individually tailored coaching  in 
2017. The projects which were mentored by Innosuisse, have contributed to the dev elopment of 
innovative solutions, some responding to everyday problems, others producing breakthrough 
innovations.  
378.  At the side event on IP & Innovation, Jonas Pollard, a Swiss post -doctoral researcher at the 
University of Freiburg in Switzerland, presente d his highly innovative project Hemolytics Malaria 
Diagnostic  for which he  entered a partnership with Innosuisse. The business case of his project was 
to develop a highly sensitive, inexpensive, portable, robust diagnostic device for malaria parasite 
detec tion in human blood. It relies on the patented chemical amplification of a malarial biomarker, 
a molecule found only in infected people. When this biomarker is present, a transparent liquid 
containing the chemical reagents ( "re-agent ") turns cloudy. By rec ording the formation of 
cloudiness, one can assess the infection of a patient. Mr. Pollard explained that the BRIDGE 
programme of Innosuisse had been essential for developing his innovative work beyond the stage 
of basic scientific research. The BRIDGE pro gramme is a joint project run by Innosuisse and the 
Swiss National Science Foundation. It enabled the grant of a kick -off funding (of CHF  130,000), 
during which Pollard had to change his scientific mindset to an entrepreneurial one. This was also 
possible thanks to the BRIDGE programme, which aims to help young researchers apply their 
research results and gain the confidence needed to enter the market. To achieve this, Jonas Pollard 
participated in training courses such as the Innosuisse Business Concept an d soon thereafter the 
Business Creation Training. He considered the support from different Innosuisse mentors to be 
crucial in helping him carry out the business development of his venture.  
379.  But how do academia, doctoral students and start -ups manage to ha ndle their intellectual 
assets, their IP rights? Let 's look at the example of Jonas Pollard, whose new business holds a first 
patent filed in European countries and the USA. The patent is still owned by his employer, the 
Adolphe Merkle Institute, which cov ered the cost for the patent application under WIPO 's Patent 
Cooperation Treaty PCT. The institute 's policy is that the research group where the patent originated 
from covers half of the patenting costs incurred for the national filing phase. This policy a pplies if 
the invention is not licensed -out to a corporation as an external partner. Pollard is now negotiating 
either to obtain an exclusive license or to buy the patent from the Adolphe Merkle Institute. A second 
patent is already in the pipeline for an important follow -on invention.  IP/C/M/90/Add.1  
 
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  380.  Summing up his experience, Jonas Pollard States  that the patent was helpful in giving 
credibility to his project and attracting funding from other institutions and the private sector. It also 
enabled the disclosure of the tec hnology to potential partners and customers without the need for a 
non-disclosure Agreement.   
381.  Let us also briefly present a second project supported by the BRIDGE programme. It concerns 
a new, innovative and sustainable business model that relies, inter a lia, on trademark protection.  
382.  Colombian national Catalina Jossen -Cardozo arrived in Switzerland four years ago. She 
prepared  for a Master 's degree at the Lucerne School of Art and Design. In her studies, she 
thoroughly analysed the footwear market and obs erved that this sector was not only characterised 
by very complex logistics, but also dominated by monopolies. Against this backdrop, Jossen -Cardozo 
created a smart production chain for commercialising shoes in a new and sustainable way. To do 
this, she us es a sophisticated online tool and is building up her brand "By Maria ", a registered 
trademark.  
383.  Ms. Jossen -Cardozo has collaborated with Columbian footwear designers who create their 
collections using her online tool and her trademark ( "By Maria ") thanks to a licencing agreement. 
This allows them to have their designs produced in a small, high quality, handcrafted limited edition. 
The shoe designers earn 10% of the product 's selling price – compared to the normal average of 
only 1%. Furthermore, the Columb ian shoemakers involved also receive a larger share of the selling 
price than is average. The project further aims at training and equipping footwear makers, enabling 
them to build up an independent livelihood for themselves and a better living for their f amilies.  
384.  At the end of the supply chain, consumers acquire bespoke designer footwear that addresses 
their specific needs, while being reassured that the brand they are buying is a sustainably produced 
product at a fair and transparent price.  
385.  Ms. Jossen -Cardozo hopes that, in the future, she will be able to apply her concept and brand 
to other products and in other countries. Trademark law will allow her to do so through licensing 
contracts. Further relevant IP rights that she may rely on are industrial de signs and copyright.  
386.  To sum up, IP can play a key role throughout the whole process of creating a new business. 
IP can positively shape an entrepreneur 's incentive to innovate and protect investments. It can help 
science -based start -ups to step into market s and it can help new businesses connect with partners 
and gain a foothold in the international market. We encourage Members  to take part in a 
comprehensive discussion on this. My delegation is looking forward to hearing from other delegations 
about their own experience and examples of the role of IP for new business, and about their policy 
approaches to support and promote new businesses.  
12.3  Australia  
387.  Australia extends its sincere  thanks to Switzerland for introducing this paper, which we are 
pleased to co -sponsor, on an issue that is assuming a growing importance for the entire membership 
of the WTO.   
388.  As suggested by our Swiss colleagues, we have based our intervention around the  three 
guiding questions listed at the end of the paper, which sought information on i) the local IP and 
knowledge based business landscape; ii) the IP regulatory environment facing new businesses; and 
iii) real world examples of successful start -ups and I P policy settings.   
389.  Turning to the first of these questions, Australia enjoys one of the highest levels of 
entrepreneurial activity in the world. In 2016, an estimated 48.7 % of all employing firms were 
'innovation active ', and nearly 15 % of the Australian  adult population was actively engaged in 
starting new businesses, equating to 2.2 million early stage entrepreneurs.  IP/C/M/90/Add.1  
 
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  390.  It is difficult to determine the exact number of start -ups operating in Australia.  By one 
measure2 the total number of start -ups rose from 954 to 1 ,465 - an increase of 54 % - between 2015 
and 2018.  An other report found there were 2, 770 start -ups in the State of Victoria alone.  
391.  Despite these discrepancies, all sources agree that Australia 's start -up ecosystem has grown 
dramaticall y in recent years.  Access to finance is improving, and the start -up industry is becoming 
more mature. On average, start -ups are now surviving for longer, testament to their growing ability 
to develop marketable products and workable business models.   
392.  In keeping with global trends, Australia 's venture capital market declined sharply in the wake 
of the Global Financial Crisis (GFC). Since the GFC, Australian venture capital investment has 
averaged around AUD 300 million a year,  down from the pre -GFC peak of  AUD 900 million. However, 
it increased dramatically in 2016 -2017, more than doubling to AUD 463 million, while venture c apital 
fundraising jumped from AUD 211 million to AUD 959 million.   
393.  While the venture capital market is well established, venture debt  remains for the time being 
a relatively unfamiliar concept in Australia, with just three lenders operating in the local venture 
credit market.  
394.  The Australian Government offers a number of programme s aimed at supporting venture 
capital and investment in early stage companies, including tax incentives, and flow -through taxation 
vehicles.   
395.  We now turn to the second question, concerning the IP regulatory environment for new 
businesses, and the importan ce of international cooperation.  
396.  Australia 's IP system seeks to strike a balance between the needs of our inventors, 
entrepreneurs and creative artists, who require sufficient protections to encourage them to embark 
on their innovative work, and the needs of consumers and producers, who wish to benefit from the 
products and ideas which this innovative work creates.    
397.  The Australia Government offers a range of programme s and support mechanisms aimed at 
helping local businesses bring their innovations to the  marketplace.  The IP Toolkit for Collaboration, 
for example, is designed to promote the commercialisation of IP by facilitating collaborative ventures 
between research organisations and industry.  It offers a range of tools, including model contracts 
and advice on navigating difficult issues, such as confidentiality provisions and the use of existing 
IP.  
398.  Another initiative, Source IP, connects businesses with Australian public -sector  research 
organisations that are looking to license their patented techno logy.   
399.  Australia 's annual IP Summit builds understanding of our IP system by bringing together 
entrepreneurs, industry and government for a day long discussion on strategies for businesses 
looking to expand their commercial footprint, particularly oversea s. In 2018, the theme was "Launch 
to Export – Take your Ideas Global ", and work has already begun on the 2019 summit, which will 
focus in part on businesses expanding into China.  
400.  Finally, the 'Accelerating Commercialisation ' initiative provides support to innovators who are 
looking to commercialise their intellectual property. To be eligible for an 'Accelerating 
Commercialisation ' grant, a project must aim to commercialise intellectual property in the form of a 
novel product, process or service. As well as financial support, participants also receive assistance 
from Commercialisation Advisers who closely monitor each project and provide more detailed 
guidance if required.  
401.  Cooperation with our international partners makes a vital contribution to our broader e fforts 
to create an IP regime that fosters innovation and creates a supportive environment for fledgling 
businesses. For example, we look to include commitments on IP in our free trade agreements to 
                                                
2 Start-up Muster 2018 report . IP/C/M/90/Add.1  
 
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  address developments in, and achieve a consistent interna tional approach to, IP protection and 
enforcement.  
402.  Australia is also committed to helping developing countries, particularly those in our own 
region, to build strong domestic IP regimes that support local entrepreneurs and encourage 
innovation. Our Funds i n Trust (FiT) programme , which we implement in close cooperation with 
WIPO, has supported the development of national IP strategies and the creation of an IP toolbox 
that has been translated into local languages.  It has also funded training activities in the fields of 
trademarks, copyrights and patents, and workshops on IP marketing, commercialisation, and women 
and IP.   
403.  In a similar vein, IP Australia 's Regional Patent Examination Training Programme  (RPET) offers 
intensive competency -based patent examina tion training to examiners from ASEAN Intellectual 
Property Offices, to enable them to meet international Patent Cooperation Treaty (PCT) standards. 
This will in turn help create local regulatory environments that are conducive to innovation and 
entreprene urship.  
404.  At the multilateral level, the global protection treaties administered by WIPO, such as the PCT, 
provide a clear demonstration of the benefits of international cooperation. While entrepreneurs and 
innovators have always had the option of pursuing protection for their inventions, trademarks and 
designs directly with individual IP offices, the WIPO -administered treaties substantially simplify the 
process for those wishing to market their innovations on a global scale.   
405.  Turning to the third and final  question, there is a range of Australian businesses that have 
expanded into global markets thanks to the protection afforded to their intellectual property.   
406.  We offer the example of Win Win Parenting. Win Win Parenting, founded in 2013, provides 
educatio n programme s that help working parents across Australia balance their work -life priorities. 
After establishing a strong business at home in Australia, working with a client list that included 
leading banks and universities, the company 's founder set her si ghts on expanding overseas.  
Recogni zing the importance of securing IP protection in foreign jurisdictions, the owner began the 
process of filing for trademark protection in the United States , the United Kingdom and New Zealand.  
Having initially secured the  services of a local IP attorney, the company subsequently elected to 
seek protection via the Madrid Protocol, which allowed it to file simultaneously in all three countries, 
rather than having to deal individually with their respective IP offices.  
12.4  Chile  
407.  Our delegation thanks the delegations of Australia, the European Union, Japan, 
Republic  of Korea, Switzerland, Chinese Taipei  and the United States  for the document on intellectual 
property and innovation.  
408.  Chile views intellectual property as a tool for the promotion of technological innovation and 
the transfer and dissemination of knowledge, to the mutual advantage of producers and users of 
technological knowledge and in a manner con ducive to social and economic welfare and to a balance 
of rights and obligations.  
409.  In this context, we believe that intellectual property plays a role in the creation of new 
undertakings that base their focus on intangible assets. The dynamic shift in trade  towards a model 
focused on the knowledge based economy continues to heighten the importance of measures that 
promote the creation and sustainability of this type of undertaking.  
410.  In this light, and on the basis of the three questions posed in document IP/C /W/648, we would 
like to share with the TRIPS Council some information and statistics regarding public initiatives and 
policies aimed at facilitating the creation of undertakings and businesses in Chile.  
411.  In statistical terms, and according to information p rovided by the Start-up Chile programme, 
there are currently around 1,300 start-ups that were created under this programme, more than 50% 
of which are active and which are valued at  USD 1.4 billion. The Start-up portfolio is a colourful one, 
covering areas such as big data, biotechnology and the Internet. According to the 2016 Global IP/C/M/90/Add.1  
 
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  Entrepreneurship Monitor report on Chile, there has been a sharp rise in innovation and development 
transfer from universities sinc e 2015.  
412.  Regarding specific regulatory measures conducive to the creation of new undertakings, we 
would like to tell you about some initiatives that have been introduced:  
413.  First of all, we have the "Your Business in One Day " initiative (Tu Empresa en un Día) , which, 
through a single web portal, seeks to facilitate the creation of businesses by eliminating costs and 
reducing the amount of time it takes to set up an enterprise. The initiative, introduced by the Ministry 
of Economy of Chile, has achieved excelle nt results. Today, entrepreneurs and innovators can set 
up their businesses without seeking legal advice or paying notary fees, and do not need to waste 
time dealing with the Internal Revenue Service.  
414.  The second initiative was introduced by the General Directorate of International Economic 
Relations of the Chilean Ministry of Foreign Affairs and is aimed at Chilean exporters. Under this 
initiative, exporters of goods with a high technology content and those in creative industries receive 
training on aspe cts of intellectual property that should be taken into account when exporting goods 
to third countries. To this end, fact sheets have been produced on the main aspects of intellectual 
property systems in export markets. This initiative has enabled Chilean exporters to better 
understand the importance of considering intellectual property related aspects when exporting.  
415.  The third initiative is the Start-up Chile initiative, a business accelerator created by the Chilean 
Government to encourage a high level of innovation based entrepreneurship using Chile as a 
platform. Start-up Chile is the leading accelerator in Latin America and among the top ten 
accelerators worldwide. It has the largest and most diverse community of start-ups in the world. 
Start-up Chile ha s changed the vision of entrepreneurship at global level. Since its creation, around 
50 other countries have introduced similar programmes.  
416.  Lastly, a draft law has been presented to incorporate the acquisition of start-ups as a tax 
incentive. This measure reflects the importance of technology transfer hubs, the mission of which is 
to protect technologies at global level and transfer the technological developments generated in 
universities and centres of technology off campus, either to businesses or to gene rate new spin offs. 
The measure also seeks to boost private investment in innovation.3 
417.  We would like to finish by showing you a specific example of a new business that is based on 
intellectual property. The video you are about to see tells the story of Lui s Cheul whose passion for 
music led him to invent the smallest electric bass guitar in the world. Thanks to his invention, he 
established links with the Wing Instruments company, which now sells his product throughout the 
world.4 
12.5  Japan  
418.  This delegation would like to thank the delegation of Switzerland for its clear introduction of 
our concept paper. As is written in the concept paper, in the current economy "knowledge is the 
main dri ver of economic growth " and "intangible assets play an important role ". In this situation, 
this delegation fully supports the idea that protecting IP is highly important in the process of creating 
a new and innovative business.  
419.  This delegation is of the vi ew that strategic IP protection facilitates rapid growth of new 
business. In order to support the growth of new business, the Japanese Govern ment has established 
various IP -related policies for start-ups in Japan. Taking this opportunity here, this delegat ion would 
like to mention what we are currently doing a nd show how start-ups made good use of their IP.5 
420.  First, we will show you the general situation of new business. According to statistics by our 
Government, the number of new business start-ups in Japan is about 200 ,000 a year. Since a new 
and innovative business is essential to drive economic growth and create jobs, the Japanese 
                                                
3 Video Start Up Chile - http://www.startupchile.org/es/sobre -nosotros . 
4 Video Inventando Chile - https://www.youtube.com/watch?v=Cx5l1TPVQCE . 
5 The PowerPoint presentation is available i n Room Document RD/IP/29 . IP/C/M/90/Add.1  
 
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  Government supports the so -called "start-up ecosystem " in various ways, supporting start-ups from 
their beginnings, u p to their mature stage.  
421.  Then, what kind of support programme  is needed for start-ups, in particular in the IP field? 
According to the questionnaire conducted by the Japan Patent Office, the following three points will 
be addressed.  
a. Lack of awareness o f the importance of developing an IP strategy;  
b. Lack of opportunities to meet IP experts familiar with the start-up ecosystem; and  
c. Need for speedy support . 
422.  In response to this situation, just this past summer the JPO, in collaboration with other 
agencies, launc hed a brand -new IP policy to support start-ups. Currently there are five policy 
keywords, which are: (1) strategy (2) expansion (3) speed -up (4) low cost and (5) information. We 
will talk about two out of five areas of support, which are the "Hands -on programme " and the 
"Accelerated Examination ". In addition, this delegation will show you a model case that made use of 
IP as a development tool.  
423.  This is the "IP Acceleration programme  for Start-ups", which we call IPAS ". The JPO just started 
this programme  from this July.  Under this programme , the JPO sends Special Professional Teams to 
start-ups during their early stage of growth, for a certain period of time. The team consists of several 
business experts such as Venture Capitalists, Business Consultants and A ttorneys. The team 
provides hands -on support to form and work with the start-ups' IP strategies. Based on this 
programme , we hope that start-ups in their early stages can expand their business quite smoothly , 
based on developing appropriate IP strategies a nd making use of professional support.  
424.  The next is "Accelerated Examination " which also started from this July. Speed is of the 
essence for start-up' businesses, so it is important to adapt patent examination to enable start-ups 
to strategically acquire an d utilize their patent rights at the right timing. In addition, it is also 
important to provide fine -tuned support to start -ups that have little experience in acquiring patents.  
425.  Based on this, the JPO launched two programme s: "Accelerated Examination Using  Interviews " 
and "Super -Accelerated Examination " in order to fulfil start-ups' needs.  
426.  Conducting "Accelerated Examination using Interviews ", start-ups can meet patent examiners 
face-to-face and directly explain the details of their patents. And examiners give general advice on 
patentability and various initiatives provided by the JPO for supporting start-ups. 
427.  In the "Super -Accelerated Examination ", start-ups can request the fast -track programme  if 
the inventions are already being worked. This system enables start-ups to acquire patent rights 
much sooner compared with the standard application process. Obviously,  these programme s enable 
them to acquire pat ent rights in a speedy manner, and enable them to achieve strategic business 
activities.  
428.  Finally, this is a successful case in which IP was used as a means for a start-up to collaborate 
with a big company and expand its business . A joint -venture in Osaka, called "Microwave chemical ", 
developed a factory process utilizing micro -radio waves. Its IP activities are worthwhile to note, in 
particular the following three points.  
429.  First, t he company regularly holds an "invention committee " to maintain a solid IP str ategy. 
The committee Members  are comprised of the CEO, staff Members  in the IP division, and external 
IP and legal experts based on a partnership agreement. In addition,  it has a good training system 
in IP literacy for the staff, which enables the company as a whole to raise the awareness of IP 
protection.  
430.  Second, t he company utilizes its IP rights for building a collaborative relationship with a big 
company. It enables the company to conduct collaborative research on bigger projects.  IP/C/M/90/Add.1  
 
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  431.  Third, leveraging its IP rights, the company can easily obtain financial subsidies from the public 
sector. The subsidies make it possible for the company to expand its business with foreign partners.  
432.  This company was awarded a special prize by the JPO because it adopted a succe ssful IP 
strategy. This kind of exceptional role model is included in brochures issued by JPO, in order to 
enhance IP awareness and show that IP strategies are highly important.  
433.  In summary, this delegation would like to emphasize again that in the current 
knowledge -based economy IP is extremely important for driving new and innovative businesses. To 
facilitate t he growth of new business,  the Japanese Government provides many  programme s for 
start-ups. This delegation hopes that its information helps other de legations create their own 
domestic policies  and looks forward to hearing other delegations ' input under  this agenda item.  
12.6  European Union  
434.  Intellectual property rights (IPRs) play a crucial role in catalysing innovation and creativity, 
promoting economic growth and development, creating jobs, improving the quality and enjoyment 
of our lives, and combatting the manifold challenges we face as i ndividuals, as nations and as a 
global community.   
435.  In today 's knowledge society, the European Union thinks that innovation is a key asset. For 
many countries, it is a more valuable source of growth and wealth than natural resources - which 
are increasingl y scarce.  
436.  The impressive development and growth of many countries, relies to a large extent on 
innovation and technology. An effective IPR system is crucial to promote innovation, as it makes it 
possible to protect intellectual assets such as inventions an d brands, but also music, literature and 
agricultural products, which are as relevant for developing as they are for developed country 
Members .   
437.  Therefore, insofar as IPR regimes are concerned, legal certainty is important in encouraging 
innovation and in vestment, which underlines the need for stable and predictable IPR regimes, 
domestically and internationally.  
438.  It is clear that IPR regimes need to be properly balanced, and this has been a central concern 
throughout the history of IPR, with frequent contro versy regarding how exactly to achieve such 
balance.  But ultimately, there is very broad agreement about the central role of intellectual property 
in a knowledge based society to ensure, competitiveness, scientific progress and access to culture.  
439.  It is th erefore not surprising that the fostering and development of intellectual property rights 
has become one of the crucial areas of policy initiatives in the development of a growth conducive 
business climate, in particular with regards to start -ups and o ther forms of new businesses.  
440.  The key role of intellectual property in the success of start -ups and innovative new b usinesses 
has long been recogniz ed. It allows innovative businesses to profit from the results of their creativity, 
inventiveness and R&D inves tments, and creates an incentive for further investment in innovation.  
441.  Given that knowledge -based parts of the economy in developing and developed country 
Members  is made up of businesses whose most valuable assets are intangible, innovative and 
creative start-ups need to be aware of the advantages of using IP and the dangers of neglecting it. 
Among other reasons, to better assist those companies in this regard, the European Commission set 
up the Executive Agency for Small and Medium -sized Enterprises, whi ch manages the vast majority 
of the European Union  programmes designed for SMEs and new business to help them innovate and 
do research.  
442.  In the Single Market Strategy, the Commission announced in 2015 that it would come forward 
with European Union -level me asures to support the use of IP by SMEs and start -ups. Honouring that 
commitment, the Commission is putting in place a package of IP -support measures for start -ups, 
aiming at improving coordination and consistency in addressing sub -optimal use of IP across  the 
European Union . This package was presented together with another Communication titled "Europe 's 
next leaders: the Start -up and Scale -up Initiative ". The Communication  aims at enhancing a IP/C/M/90/Add.1  
 
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  coordinated approach across the European Union  policies through a set of pragmatic measures in 
order to boost innovation and research with the involvement of new businesses.  
443.  The measures include:  
• Streamlining European IP awareness schemes for new businesses and providing a 
cooperation platform for European Union  Membe rs;  
• Developing a European Union  IP mediation and arbitration network;  
• Encouraging the creation of European -level insurance schemes for litigation and IP theft, 
building on a common IP valuation method; and 
• Improving coordination of IP support funding sch emes, including by means of a possible 
guidance to Members  and by developing monitoring methods their impact.  
444.  Working in partnership with all levels of G overnment in European Union  Members , regions and 
cities and all stakeholders - including start -ups and scale- ups themselves - is necessary for the 
efficient and successful implementation of initiatives intended to help new business and allow them 
to approach the complex matter of IP more effectively.  
445.   In recent years, the European Commission and European U nion Members  have supported the 
creation of 'communities ' to help start -ups connect with potential partners (e.g. investors, business 
partners, universities, research centres ) through events, platforms, business clusters, networking 
and supportive local/regional 'ecosystems '.  
446.  At European Union  level, the Start-up Europe initiative has emerged as a recognized brand for 
creating links between those ecosystems, focusing on conne cting people, international outreach and 
providing information through a One Stop Shop for start -ups. Start-up Europe also helps new 
businesses , in particular,  through matchmaking between investors, corporates and entrepreneurs 
as well as networking of reg ional decision -makers.  
447.  Start-up Europe 's objectives are:  
• To reinforce the links between people, business and associations who build and scale up 
the start-up ecosystem (e.g. the Web Investors Forum, the Accelerator Assem bly, the 
Crowdfunding Network);  
• To inspire entrepr eneurs and provide role models; and  
• To celebrate new and innovative start-ups, help them to expand their business, and give 
them access to funding under Horizon 2020, which is the main research and innovation 
framework programme of the Europ ean Union .  
448.  To mention one of these European Union -level initiatives particularly relevant in the context 
of IP, the Web Investor Forum brings together top-level Investors and Accelerators from all over 
Europe with the goal to foster a more scale -up-friend ly ecosystem. The Investors Forum acts as an 
internal channel conversation for the European Investment Fund and European Commission with 
European and international investors. Specifically, the Investors Forum bridges investors to 
Corporate Development Head s, like the Start-up Europe Partnership, European Matching Funds and 
the European Commission.  
449.  Intellectual property rights play an increasingly important role in corporate strategy and 
financial investment. The intangible assets created through the proces ses of innovation represent a 
major share of the value of today 's businesses. The IP rights associated with those assets are the 
legal underpinning for potential returns on investment in that innovation.  
450.  The European Expert Group on Intellectual Property V aluation assessed the commercialisation 
of innovative ideas, with the value of the IP asset acting as collateral. They looked especially at 
start-ups. Equity investors typically invest into companies as a unit, but not into IP assets as such. IP/C/M/90/Add.1  
 
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  In return for  their investment investors receive an equity stake of a company which owns IP and 
intends to exploit the IP. Therefore, investors using this model are indirectly financing based on IP.  
451.  The Expert Group notes that an issue which influences a company 's decision to protect its IP, 
especially in the case of new business, is to what extent such rights are enforceable, the time and 
costs involved in litigation, and the foreseeable economic results. The quality of the enforcement 
system has an important impac t in IP protection. Companies need to be assured an accessible justice 
system for infringement, validity and other cases.  
452.  Large investment banks and private equity firms alike have raised and invested funds targeted 
at IP and other intangible assets. Rathe r than looking for entrepreneurs and start -up companies, 
these firms are often looking to invest in IP for development and commercialization purposes. These 
enterprises work with companies to either buy the IP or invest in the company for commercialization  
of the IP.  
453.  The PATLICE Survey enquired about European firms ' patent licensing activities and found 
financial use is very important for small companies. There is a significant difference in the use of 
patents to obtain funding and finance by start -ups comp ared with larger firms. All types of finance 
uses are much more important for start -ups than for large firms. They particularly use patents more 
for raising capital through private investors and Venture Capital and private equity.  
454.  To conclude, we would li ke to underline that transparent and predictable intellectual property 
rules assist start -ups to engage confidently in domestic and international markets. Intellectual 
property rights can provide the framework for ownership, protection and the use of ideas  and 
knowledge created in Europe and beyond.   
12.7  Norway  
455.  Norway would first of all like to thank the proponents of the paper for their efforts in keeping 
this discussion on the agend a of the TRIPS Council. I will provide some answer s to the questions put 
forward in the  paper and will address them chronologically.  
456.  The first question asked "what country -specific information could Members share on IP and 
knowledge -based businesses, e.g.  the number of new enterprises they have each year, an overview 
of the start -up landscape in their country or figures relating to their venture capital and venture debt 
markets, and the particular role IP plays in it ". 
457.  The Norwegian Industrial Property Off ice (NIPO) conducted in 2018 an analysis of the 
Intellectual property rights -intensive industries and their economic performance in Norway. The 
analysis was performed by applying the methodology and industry ranking developed for the 
European Union by the European Patent Office and the European Union Intellectual Property Office 
(EUIPO). As outlined in the EU studies, IPR -intensive industries are those with an above -average 
use of IPR per employee, as compared with other IPR -using industries. These industri es are 
concentrated in manufacturing, technology and business services sectors.  
458.  The results show that, as in the European Union , IPR-intensive industries pay significantly 
higher wages than other industries, create more export revenue per capita, etcetera.  Some of the 
main findings:  
• IPR-intensive industries generated 25.9% of all jobs in Norway in the period 2011 -2013 
(EU: 27.8%) . This corresponds to 655 ,000 jobs. 
• IPR-intensive industries generated on average more than 51% of total economic activity 
(GDP) i n Norway in the same period, corresponding to EUR 196 billion.  
• IPR-intensive industries paid much higher wages than other industries, with a wage 
premium of 53% over other industries (2013 figures).  
459.  We have also started to bring IP data into our standard  statistical framework. A few years ago, 
Statistics Norway established a regular database on patenting, design protection and trademarks by 
enterprises. The enterprises in the database are organised by regular organisational numbers rather IP/C/M/90/Add.1  
 
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  than by name. By  using these numbers, information from other administrative registers with 
patenting information can be linked to each enterprise.  
460.  For example,  we can now easily study enterprises by specific indicators, such as patents, size, 
age and the patenting enterp rise's statistical industry rather than the patent 's technology area. 
Given our extensive and digital administrative registers, we can look at such issues as ownership or 
financial structure and patenting activity. However, these are still time -consuming a nd resource 
intensive studies. At the moment, descriptive statistics are therefore more easily available.  
461.  Some of results we do see, are that patenting takes place in small enterprises and in large 
enterprises , with the frequencies being lower in medium s ized firms. Design protection is mostly 
taking place in smaller enterprises.  
462.  The second question asked "what IPR -specific regulatory measures, policies and practices do 
Members consider to be conducive to, or even necessary for, creating new businesses, e .g. how 
easy is it to create a new business for young entrepreneurs and, in light of that, what is the role of 
IP in that process? Furthermore, what impact does international cooperation have in promoting a 
positive new business IP environment ". 
463.  Awareness of intellectual property values, when to use formal protection and some insight into 
patent law; it translates into stronger IPR inclusion in higher education, business studies, 
engineering and such areas.  
464.  Awareness translates into the two sides of IPR : my rights and how I exercise them,  and other s’ 
rights and whether I infringe on them. In our case, raising awareness was an aim of a recent White 
Paper on IPR (2014).  
465.  The third question invited Members to share  "any specific examples of new businesses, the ir 
IP-protected innovations and other IP -related assets, or successful governmental IP -related policies 
that help new businesses in tegrate into the global economy ". 
466.  In 2012, a group of PH.D.-students and their professor at a polytechnical University in Nor way 
(NTNU) co -founded the start -up company CrayoNano AS. With production in Asia and customers all 
over the world, this start -up was born global.  
467.  The company has developed nanowire/graphene based deep -UV LEDs for sterilization and 
disinfection. CrayoNano h as patented the use of graphene as a semiconductor substrate. The 
technology platform is protected through nine priority patents. Some of the underlying results have 
been published in journals like Nano Letters and Nature Communications.  
12.8  Brazil  
468.  I woul d like to thank the co -sponsors for presenting this agenda item on IP and Innovation. 
Our delegation welcomes the debate for its contribution to deepening the understanding of the 
intellectual property system related to the achievement of the objective of Article 7 of the  TRIPS 
Agreement . In fact, we identify complementarity between this agenda item and the one on IP and 
Public Interest.  They both highlight the complex relation of the IP system with the concrete reality 
routinely faced by policymakers and stakeholders. Th is is one of the reasons why Brazil is a 
cosponsor of both documents IP/C/W/648 and IP/C/W/649.  
469.  There is a range of regulatory measures that can be used by Members to support new business. 
For instance, our patent office provides fee reductions for micro a nd small enterprises as well as to 
individual inventors. Since 2016, the patent office offers accelerated examination of patent 
applications from SMEs. One of the reasons for these initiatives is that start-ups begin relatively 
small and rely on the patent s to attract investments. A fast and affordable patent application process 
will undoubtedly improve their competitive conditions.  
470.  Furthermore, we are active in promoting awareness -raising activities on the importance of IP 
protection for innovation, dissem inating a better understanding for the strategic use of IP by 
companies and allowing the culture of IP to flourish. In order to bridge the gaps between start-ups IP/C/M/90/Add.1  
 
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  and funding, Brazil has a start-up programme  implemented by FINEP, a governmental agency. FINE P 
grants investments of up to  USD 1 million to start-up companies.  
471.  Brazil is also interested in developing studies that allow us to evaluate existing mechanisms 
for supporting innovation.  Last month, in partnership with the OECD we initiated a review of SMEs 
and entrepreneurship in Brazil. The goal is to assess the struc ture and performance of Brazilian 
SMEs, map policies and programmes that support their entrepreneurship and strengthen policy 
design and implementation. We hope to  present the results of that work  in future sessions of the 
Council . 
472.  I would like to present two cases of success of Brazilian start-ups. The first one is a company 
called Integra, a University spinoff originated from the University of Brasília. Integra develop ed a 
genetically -modified yeast that can be used to convert residues of the biodiesel in dustry into 
bioplastic. Protected by four patents, the company received investments of more than BRL 1 million 
that allowed it to do further research on technologies to convert agroindustrial residues into products 
of high added value. Integra 's goal now  is to achieve a turnover of BRL 40 million by 2020, 
underlying its success.  
473.  TNS Nanotechnology is a company that won a start-up prize promoted by the Brazil -Germany 
Chamber of Commerce for an antibacterial  that can be used to clean air conditioners and wash ing 
machines. The company also developed a biological sensor for diagnosing salmonella in food 
products. The sensor allows the detection of salmonella in up to five hours, in comparison with the 
seven days required by the previous technology. Those inventi ons are protected by patents and 
allowed the company to receive investments from Germany and Italy. The company currently 
exports its products to ten countries in South America, Europe, Africa and Asia.  
474.  Our discussion should also take into account other ba rriers to the dissemination of the use of 
the IP system by innovative companies. For instance, those companies may have limited resources 
for spending with lawyers. Patent search is another costly area for smaller companies. Lastly, 
enforcement measures an d the need for surveillance of possible infringements of their IP assets 
often require much resources. A broad discussion on the subject cannot overlook thos e obstacles.  
Members  would greatly benefit from exchanging experiences on the solutions found.  
475.  As also stated by other delegations, it is important to highlight that patents are not the single 
element driving innovation, but rather one element among different tools. Having the right 
infrastructure for innovation, collaboration and research are fundamen tal ingredients of innovation. 
Earlier this week the WTO organized a seminar on IP and knowledge flows, in which a recurrent idea 
mentioned by speakers was the need for providing an ecosystem that fosters innovation. This 
includes not only appropriate and effective IP protection, but also other mechanisms such as 
adequate funding for start -ups, tax measures and free trade agreements that enhance integration 
to global value chains. The absorptive capacity of countries is another important aspect mentioned 
by speakers.  
476.  I would like to conclude by stressing the efforts that Brazil has been undertaking to improve 
our internal innovation environment. The process of accession of Brazil to the Madrid Protocol is 
ongoing in Congress and we hope that it will provide an additional opportunity for companies 
interested in internationalizing their businesses. In the meantime, INPI initiated preparatory 
procedures, such as hiring additional trademark examiners and adapting IT infrastructure. Those 
initiatives allowed us to  substantially reduce the trademark backlog and pendency time: we expect 
that by the middle of next year the examination of trademark applications can be concluded in eight 
months counted from the date of filing.  
477.  There are also ongoing efforts by INPI in p atents. We have hired 210 new patent examiners 
in the last two years, almost duplicating the office 's capacity to process patent applications and 
allowing us to slash the patent backlog by 10% in the last eighteen months. We hope we can continue 
the trend of reducing the patent backlog and pendency time, benefiting applicants and competitors 
alike through faster examination and enhanced  legal certainty.  
478.  Brazil is deeply committed to continue encouraging and rewarding innovation and its 
widespread disseminat ion in the economy and society.  IP/C/M/90/Add.1  
 
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  12.9  Singapore  
479.  Thanks to Switzerland and the proponents for preparing this very useful discussion paper.  
480.  In today 's knowledge -driven economy, Singapo re sees innovation as a key driver for our 
development and IP as the new currency for economic growth.  
481.  With 67,000 companies registering in Singapore annually, the Singapore Government has put 
in place several efforts to help these businesses innovate and grow. For example:  
• To help create synergies amongst technology start -ups, a shared physical space (Block  71) 
has been set up to pull together a community of entrepreneurs, innovators and investors. 
To date, this physical space/hub is home to more than 250 start-ups, 30  incubators, 
accelerators and venture capitalists ;   
• Efforts have also been made to provide a conducive environment for the financial 
technolo gy (fintech) sector to flourish;   
• Singapore 's National Intellectual Property Office has as one of its  objectives, enabling 
companies with IP resource potential to move to the next development stage, such as to 
develop new produ cts or to expand to new markets;  and 
• We have undertaken efforts to encourage voluntary mediation, so as to make it easier to 
enforce contracts, including on IP matters.  This is part of our ongoing effort to improve 
the ease of doing business in Singapore.   
482.  Singapore 's IP regime also aims at striking a balance so as to encourage the development of 
innovative enterprises in ways that  do not stifle competition. In this way, we hope to promote a 
positive new business IP environment that enables businesses to integrate better into the global 
economy . For example:  
• We are strengthening our linkages with other IP regimes for better market a ccess. Since 
2010, patent applications by Singapore firms via the Patent Cooperation Treaty (PCT) 
system have grown almost 60%, while applications via the Madrid sys tem have grown 
more than four-fold; and  
• Singapore also participates in patent acceleration programmes, such as Global Patent 
Prosecution Highways and the ASEAN Patent Examination Co operation. There are also 
many other ASEAN initiatives that facilitate the protection of IP of international investors 
in the region, as well as encourage greater dom estic innovation in the region.  
483.  Through our work, we have also observed challenges that new businesses face in relation to 
IP. For example, we note that start -ups tend to have a preference for debt funding in order to 
preserve their ownership stake in the business. However, innovation -driven start -ups are usually 
light on tangible assets. As such, this poses a challenge for raising debt as the current banking model 
is not designed to collateralise intangible assets such as IP rights. Singapore believes ther e is a need 
to overcome this debt financing constraint faced by IP heavy enterprises, and is working on policies 
to address this.  
484.  We also look forward to hearing from other Members on their best practices and experiences 
in fostering new businesses in rel ation to IP.  
12.10   India  
485.  India thank those Members  for the new submission.  
486.  The history of evolution of IP rules in developed countries suggests that the design of IP rules 
and policies should be adaptable to the changing needs of societies. This is reflected by the fact that 
the levels of IP protection in developed countries increased as their industrial and technological 
capacities improved over time. While IPRs may provide an incentive  to innovate, they are neither a 
necessary nor a sufficient condition and could only be effective in certain contexts . IP/C/M/90/Add.1  
 
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  487.  Innovation is a sine qu a non for growth. It is in this context that India has taken many steps 
to improve the innovation ecosystem  - whether it is through the quality of the human resource or 
the research and development activities or strengthening of academia industry linkages and 
availability of capital.  
488.  The result of such actions is visible. India has moved up on the Global Innovation I ndex from 
a rank of 76 in 2014 to 57 in 2018. At the indicator level, India ranks well in a number of important 
indicators including, graduates in science and engineering, productivity growth, ICT service exports. 
This year India was second in both the qua lity of its universities and the quality of its scientific 
publication among the middle -income economies.  This has been possible due to a number of 
initiatives taken by the Government to support and promote innovation.  Start -up India is one such 
programm e of the Government.  
489.  Another development is India 's rank ing in the World Bank 's Ease of Doing Business 2019 
Survey . It climbed up 23 places to 77 th among 190 countries surveyed, making it the only country 
to rank among the top ten  improvers for the second consecutive year. Since 2014, India 's ranking 
improved 65 places from 142nd in 2014 to 77th in 2018.  
490.  While we strongly believe in promoting and nurturing innovation, we are also of the view that 
IPRs are neither a necessary nor a sufficient condition for innovation. If it had been so software 
development would not have thrived on open source development.  
491.  On the contrary, unbridled power to IPR holders can adversely affect innovation. We are all 
well aware of how patent thickets, exclusive gra grantbacks an d coercive licenses can deter 
innovation. Non -Practicing Entities (NPEs) also have been identified by many policymakers as a 
costly impediment to innovation and economic growth.  
12.11   Chinese Taipei  
492.  As the co -sponsor of this proposal, we are very happy to share our thoughts on this subject.  
493.  In the era of knowledge economy, innovation and use of knowledge are the main driving forces 
of a member 's competitive edge and economic grow th. There  is no doubt that patent s are crucial to 
the success of a start -up or new business.  
494.  However, it can be a huge burden for a new company with limited capital to pour in manpower 
and expenditure on developing a new product that may or may not be suc cessful.  
495.  Considering this, we are proactively creating an environment that is friendly to entrepreneurs 
with creativity or innovation wishing to expand their busi nesses. I would like to share two points 
regarding our policies and measures on establishing new businesses and bridging financial resources.  
496.  First, there is no minimum capital requirements for setting up new companies according to our 
Company Act. A new company may be registered so long as there  is enough capital to this end. The 
Act also allows for capital contribution by shareholders in the form of technologies. In other words, 
technology owner s (or intangible assets) may use their technologies as contribution for stock and 
invest it in the company through transferring or licensing of their tech nologies. This will not only 
ease the pressure of capital flows for technologies owner s in the process of commodification but also 
help companies obtain the results of technologies developed by domestic and foreign businesses. 
Over the years, this approach  has successfully facilitate d many Start -ups or new businesses 
overcome financing constrains by demonstrat ing the value of their patents.   
497.  Second, many small and medium -sized enterprises and academic institutions have invested in 
research and development, possessing patents and technologies, but have not been able to obtain 
bank financing. Many good ideas and inventions cannot be commercializ ed because of lack of 
financial assistance. In this context, we launched the "Start-up angel project " to pour in more than 
USD 3 million , targeting 300 start -ups in five years period. Its policy goal is to assist companies with 
ideas or patents to successf ully convert intellectual property rights into business opportunities. Also, 
this influx of business operation capital will effectively help innovators cross the start -up threshold.  IP/C/M/90/Add.1  
 
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  498.  A very good case benefited from this "Start-up angel project " is a company  named "Deepblu ". 
Deepblu is a start -up concentrating on developing a diving watch, which is able to record and 
instantly share diving data using the connection between built -in apps and cloud services. Following 
its receipt of the angel fund in 2015, the company has successfully conducted sales of its product in 
countries/regions with a thriving diving industry, such as Indonesia, Malaysia, Thailand in Southeast 
Asia, as well as the European Union  and the United States . The amount of the company 's capital has 
grown from USD 130,000 since its founding in 2013 to  USD 1.65 million in 2018, registering an 
increase of 12 times.  
499.  To sum up, intellectual property and innovation are indispensable driving forces of economic 
development, especially for start -ups or an y new business. In other word, start -ups need patents. 
Patents help facilitate venture capital investment, defend attack by rivals, ensure a freedom to 
operate, increase the chance for partnership, and most importantly, secure a long -term 
competitiveness. Therefore, how the government helps innovators start new businesses through 
well-planned patent strategies remains an important lesson. We welcome and look forward to 
hearing other Members  share their experiences and views on relevant measures.  
12.12   Canada  
500.  Canada is  pleased to participate in the  discussion on "IP and New Business ", as part of the 
three -part theme "The Societal Value of IP in the New Economy ". We would like to thank Switz erland 
for the discussion paper that se rves as the basis of this agenda item (IP/C/W/648), as well as those 
Members that have shared their experiences and insights so far on the role of IP in the development 
of new businesses.  
501.  In order to get at the issue of how IP -specific measures can assist new businesses, it is perhaps 
useful to first provide an overview of the start -up landscape in Canada. According to a recent study 
by Canada 's Department of Innovation, Science and Economic Development (or ISED) entit led 
"Canadian Start -Ups – A perspective based upon the 2014 Survey on Financing and Growth of Small 
and Medium Enterprises ", almost 8 % of small and medium -sized enterprises (SMEs) in Canada in 
2014 were start -ups. In Canada, these are defined as firms that are two years or younger. Notably, 
the study also found that firms appeared to be more innovative when they were young and in the 
growth stage. For instance, in 2014, 43 % of start -ups and 44 % of firms three to ten  years old 
introduced at least one type of innovation (defined as a product, process, organizational or market 
innovation), compared with 40 % of firms 11 to 20 years old and 41 % of firms more than 20 years 
old. The study also found that sales growth expectations were higher among start -ups than non -
start-ups, with younger firms more growth -oriented than older firms.   
502.  However, despite being relatively more innovative, the study also found that start -ups were 
less likely to own IP than non -start-ups. In  2014, for instance, roughly 19 % of Canadian start -ups 
owned s ome type of IP compared with 22 % of non -start-ups. Notably, this dynamic is also evident 
when firms grow, as well as ag e. For instance, according to ISED 's 2014 "Survey on financing and 
growth of SMEs ", among SMEs with between one and four employees, just over 21% held IP, 
whereas among businesses between 100 and 499 employees, 51% of these firms held at least one 
type of IP. ISED 's study on start -ups also found that Canadian start -ups were less likely to export 
than older forms, and also were more likely to seek external financing, than non -start-ups. 
503.  In addition, Canadian start -ups have been found to have relatively highe r demands for external 
financing than non -start-ups, with 58 % of start -ups requesting some form of external financing 
compared with 51 % of non -start-ups. As well, requests for debt financing were also higher among 
start-ups. In 2014, 37 % of start -ups reque sted debt financing compared with 31 % of firms in 
operation for three to ten  years. The inverse was also apparent in respect of debt financing approval 
rates, which were marginally lower than for non -start-ups (75 % and 78 %, respectively).  
504.  In view of these dynamics, and returning to the topic of IP and new business, it is important 
then, to consider the role that IP -specific measures, and other related policies, can play in assisting 
start-ups to both grow and seek export opportunities in other markets. For instance, with respect to 
financing, in January 2016, the Government of Canada announced the launch of CanExport, a five -
year programme  which will provide CAD  50 million (or approximately USD  40 million) in direct 
financial assistance to SMEs that are regi stered in Canada and seeking to develop new export 
opportunities. Delivered by Global Affairs Canada 's Trade Commissioner Service in partnership with IP/C/M/90/Add.1  
 
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  the National Research Council Industrial Research Assistance Programme , CanExport provides 
financial suppo rt for a wide range of export marketing activities, including in respect of IP protection 
and certification expenses in foreign markets. As well, the Business Development Bank of Canada 
(or BDC), which is a federal Crown corporation owned by the Government  of Canada, provides 
financing and advisory services with a focus on SMEs, such as start -up financing and small business 
loans. For instance, BDC 's Xpansion Loan is designed to help business develop products that are key 
to growth and expanding their marke t, as well as to seek IP protection and purchase IP licenses.  
505.  Turning to IP policy more specifically, the Canadian Intellectual Property Office (CIPO) also 
provides a number of measures to encourage small businesses to use the IP system. For instance, 
with a view to encouraging small businesses to seek patent protection, certain CIPO fees for 
obtaining and maintaining a patent are reduced by 50 % for "small entities ". Canada 's Patent Rules 
define a small entity as one that employs 50 or fewer employees or is  a university. In order to take 
advantage of the reduced fees for small entities, applicants must submit a small entity declaration 
before or at the time of their fee payment, if there is not already one on file.  
506.  CIPO has also launched an IP Awareness and Education Programme  to deliver products, 
services, and training to SMEs. For instance, CIPO 's IP Awareness and Education Programme  
offerings include guides, one -pagers, and process maps, in addition seminars and training sessions 
that provide businesses wi th tools and information to better acquire, manage, and leverage their IP 
assets (IP for Business); seminars and training services for businesses, partners and intermediaries 
(IP Academy); and a suite of networked services, including referral, consultation , and support to 
advisory services (IP Hub).  
507.  Finally, IP for new and growing businesses serves as a key focus of Canada 's recently -launched 
national IP Strategy. With research showing that start -ups are relatively more innovative than older 
firms, but less  likely to own IP, initiatives to assist new and growing businesses in obtaining and 
utilizing IP can serve as an avenue to leverage their innovations into commercial success. Canada 's 
IP Strategy focuses on addressing a number of IP issues facing growing businesses, as well as to 
provide clarity for IP stakeholders. These include forthcoming legislative amendments, such as 
minimum requirements for patent demand letters, as well as measures to reinforce the importance 
to use in the trademark regime (e.g. to  prevent the misuse of the trademark registration system, or 
what is sometimes referred to as "trademark squatting "). The IP Strategy also includes measures 
on IP awareness, education and advice, which will build on CIPO 's current learning tools and 
resour ces, and will also include IP legal clinics, as well as IP advisors through existing federal 
programme s. Finally, in recognition of the importance of business growth and success in the global 
marketplace, the IP Strategy will include measures on strategic IP tools for growth, such as 
expedited IP dispute resolution; a centralized IP marketplace for businesses,  entrepreneurs and 
innovators; and the establishment of a patent collective to support SMEs in coming together to 
facilitate better IP outcomes for co llective Members . 
508.  Canada will be pleased to present on these and other elements of our national IP Strategy as 
they further develop over in the coming months. In the meantime, we would like to again thank 
those Members that have shared their insights and experiences so far, and look forward to  hearing  
further views on th is important topic.  
12.13   China  
509.  We recognize that innovation plays a positive role in cultivating new industries. Many emerging 
industries, including e -commerce, are driven by innovations and an effective intellectual property 
protection system. To these emerging industries, innovation a bility of SMEs is particularly important.  
510.  In order to promote the development of SMEs and to enhance the generation, usage an d 
management of IPR in SMEs,  China ha s adopted a series of measures. Particularly, at the end of 
2016, China National Intellectual Property Administration and Ministry of Industries and Information 
Technologies jointly released a document "Guiding Opinions on the Comprehensive Implementation 
of the SME Intellectual Property Strategy Promotion Project ", providing seven possible methods  to 
enhance the abilities related to IPR in SMEs . 
511.  The first is "patent information navigation " system, that is regularly sending high -quality, low -
cost intellectual property information to SMEs. The second is to establish incentive mechanisms to IP/C/M/90/Add.1  
 
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  stimulate the vitality of SMEs, including promotion on industry -university cooperation mechanism. 
The third is to enhance the ability of IPR management in SMEs. This includes providing new financial 
services, such as patent insurance. The fourth is to strengthen the  protection of IPRs for SMEs, 
including providing specific IPR protection enforcement actions. The fifth is to provide scientific 
guidance for SMEs, including guiding SMEs to build suitable and scientific IPR management systems. 
The sixth is to deepen inte rnational IPR cooperation in SMEs, including actively conducting 
international IPR activities for SMEs. The seventh is to provide more public services for SMEs, 
including encouraging industry associations to recruit more SMEs. We believe those measures wil l 
have a positive effect on promoting the protection and utilization of IPRs of SMEs.  
512.  However, we also hope to draw Members ' attention to the following facts. First, it is agreed 
that for the generation and development of emerging business, besides innovat ion and IPR 
protection, we also need capital, human resources and other essential elements. To developing 
Members , capital and human resources play an e ven more important role. Second , innovation cannot 
be achieved in one day. It needs huge amount of inves tment and primitive accumu lation. Compared 
to developed  Member s, developing  Members  suffer deficiency in many areas. Currently, there still 
exists a wide gap between developed country Members  and developing Members  on the level and 
ability of innovation. W e hope that Members  can pay attention to these facts and explore effective 
solutions.  
12.14   South Africa  
513.  South Africa would like to thank the co -sponsors for putting this important item on the agenda.  
514.  Like many developing countries, South Africa faces a great development problem relating to 
the high failure rate that is present among Small and Medium Enterpr ises (SMEs) . This is due to the 
fact that entrepreneurs are not able to turn their businesses into sustainable ventures. SMEs play a 
significant role i n a number of economic development issues that South Africa  is facing  as a nation. 
The SME sector has con tributed immensely to job creation, poverty alleviation and assisting in the 
prosperity of the nation.  
515.  South Africa has progressively shifted away from dependence on primary resource production 
and commodity -based industries to open up to international tr ade and to building capacity in some 
knowledge -intensive industries. However, the country 's economic growth has remained weak by 
emerging -market standards, with GDP rising at 3.1% per year from 2000  to 2014.  
516.  The National Development Plan (NDP) - A Vision for 2030 (2011 -30) provides a general 
roadmap for South Africa 's transition towards a diversified economy, with innovation underpinning 
almost every aspect and a strong focus given to strengthening human capital. The National R&D 
Strategy (2002 onwards) ha s planned for increasing public and private investment in the science 
base and improving the system of S&T governance. In parallel, the Ten -Year Innovation Plan (2008 -
2018) identified five areas of competitiveness to be developed, i.e. bio -economy (formerl y 
pharmaceuticals), space, energy security, global change including climate change, and social and 
human dynamics. In that respect, the National Industrial Policy Framework (NIPF) articulates South 
Africa 's overarching approach to industrial development an d innovation.  
517.  Innovation is widely viewed as a driver of company competitiveness and, indeed, the economic 
growth of countries. The South African Government has approved Phase I of the National Intellectual 
Property Policy. It earmarks the IP Policy as one  of the core elements needed to thrust South Africa 
toward a knowledge economy. This objective is the cornerstone of the Government 's broader 
National Development Plan which includes a greater emphasis on innovation, improved productivity 
and better exploi tation of comparative and competitive advantages. South Africa is also focusing on 
creating an enabling environment for businesses to operate . The 2018 World Bank Ease of Doing 
Business Report (EDB) notes two areas of improvement in 2018. These include Sou th Africa making 
starting a business easier by reducing the time for online business registration and the country 
improving the monitoring of electricity outages through recording data.  
518.  There are various Government schemes that assist small businesses and start-ups. The 
IDC (Industrial Development Corporation), founded in 1940, is a state -owned finance institution. It 
functions as a means to generate balanced and sustainable growth in Africa. The IDC funds start-ups 
and existing businesses up to a maximum o f ZAR 1 billion. The Small Enterprise Finance Agency was IP/C/M/90/Add.1  
 
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  established in 2012 and has the mandate to foster establishment, survival and growth of SMMEs. 
They also aim to contribute to poverty alleviation and job creation.  SEFA provides loans from ZAR 
50 00 0 to ZAR 5 million to SMMEs and co -operatives. The Isivande Women 's Fund specialises in 
start-up funding, business expansion, rehabilitation as well as financing.  
519.  The IP Policy is aimed at promoting local manufacture, utilising and preserving the country 's 
resources, encouraging innovation and empowering the domestic stakeholders to take advantage of 
the IP system. The IP Policy acknowledges  that there is no automatic correlation between an increase 
in protection of IP and an increase in innovat ion. However , the South Africa G overnment believes a 
stronger framework is required to ensure that other objectives are met, including access to public 
health. South Africa regards the IP system as an important policy instrument to promote innovation, 
technology trans fer, research and development and economic growth. However, the public 
understanding of benefits remains incomplete. In this regard, South Africa recently co-hosted  the 
High-Level Conference on Respect for Intellectual Property with the World Intellectual Property 
Organization (WIPO), the International Criminal Police Organization (INTERPOL), the World Customs 
Organization (WCO) and the World Trade Organization (WTO). More than 400 participants from a 
broad range of countries and sect ors came together to discuss various IP issues ranging from the 
economic value of IP and its public value, to the practical challenges that face authorities when 
enforcing IP frameworks.  
520.  As to some examples of start-ups, there are a good number of compani es and start-ups in 
South Africa that would not just be classified as big but also innovative. South Africa has made a 
huge impact in science and technology . Several important scientific and technological developments 
originated from South Africa. An early  internet security company started by Mark Shuttleworth was 
bought by VeriSign, while another South African born and educated entrepreneur, Elon Musk went 
on to found companies like Tesla Motors, PayPal and SpaceX.  
12.15   Colombia  
521.  Colombia is extremely interested in the promotion and development of the creative industry, 
which is why it issued Law No. 1834 of 2017 promoting the creative economy (Ley Naranja – Orange 
Law), presented under agenda item 1. Our interest is justi fied, because "the creative and cultural 
industries report edly generate revenues of USD 2. 250 billion and 29.5 million jobs worldwide, 
employing approximately 1% of the active population ". In Latin America and the Caribbean, 
estimates suggest that the crea tive industries generate USD 124 billion worth of revenue, or 2.2% 
of the regional GDP (Ernst & Young, 2015).  
522.  The "orange " sectors of Colombia include activities that are different from those of the great 
creative economies of the world capitals. Opting to  "squeeze the orange " may help to solve the 
country 's production and employment challenges. Colombia has an enormous potential for 
developing the orange economy, linked with the need to take advantage of the demographic dividend 
(Buitrago & Duque, 2013). T he development and consolidation of the creative sectors is essential to 
generate employment and value added, transform production, increase competitiveness and boost 
exports, and attract foreign direct investment (FDI) (Duque, 2018 ; Benavente & Grazzi, 20 17). 
523.  The development of the creative economies will bring benefits to the rest of the economy, 
including tourism. Creativity and design, being closely linked to innovation, contribute to the 
proliferation of new ideas and increase the probability of their reaching the business and marketing 
stages (Hollanders & Cruysen, 2009).  
524.  Colombia 's policy to harness the potential of the orange economy will be conducted on three 
fronts:  
• Establishment of an institutional environment conducive to the development and 
consolidation of the orange economy and the consolidation of information on the different 
sectors of the orange economy;  
• Development of the necessary conditions and public goods for the different sectors of the 
orange economy and the so-called  Orange Developm ent Areas (ADN). This includes human 
capital development for the orange economy, protection and promotion of intellectual IP/C/M/90/Add.1  
 
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  property, financing mechanisms, and stimulation of domestic consumption and exports of 
orange economy goods and services; and  
• The dev elopment of tools to help generate "orange value added " transversally throughout 
the Colombian production system.  
13  INTELLECTUAL PROPERT Y AND THE PUBLIC INT EREST: PROMOTING PUB LIC HEALTH 
THROUGH COMPETITION LAW AND POLICY  
13.1  South Africa  
525.   The communication  circulated in document IP/C/W/649  continues the ad hoc  item on 
"Intellectual Property and the Public Interest: Promoting Public Health Through Competition Law and 
Policy " that was introduced by the co -sponsors in documents IP/C/643 and Add.1 of 24 May and 29 
May 2018 respectively.  
526.  IP protection per se  cannot be presumed to confer market power or to indicate anti -competitive 
behaviour. IPR holders are , for this reason, as a general rule, not prevented from exercising their 
exclusive rights. Different approaches are taken by various jurisdictions regarding the interface of 
competition law and policy and IP. A recent WTO staff working paper found that despite d ifferent 
levels of development, constitutional systems and/or economic structures and industrial profiles in 
jurisdictions surveyed displayed a pervasive interest in the interface between competition law and 
policy and IP. All the jurisdictions surveyed in  this study have rudimentary rules that have a bearing 
on potential anti -competitive abuses of IPRs. It is also apparent that clearer competition policy 
treatment of IPRs has evolved over time through either iterative processes or evolving practice of 
comp etition authorities. This evolution is informed by jurisdictional cross -fertilization and peer 
learning as evidenced by greater interest in and concerns with ensuring an appropriate balance 
between IP and competition law and policy in these jurisdictions. This development underscores the 
need for further debate and analysis since competition law and policy is no longer the preoccupation 
of only a few jurisdictions.  
527.  During the June 2018 TRIPS Council session, the cosponsors demonstrated that there are 
variou s pro -competitive provisions in the TRIPS Agreement , including Article 6, Article 8.1, 
Article  31(k) and Article 40. There is no doubt that these provisions leave WTO Members broad policy 
space to apply competition law in respect of acts related to the acq uisition or exercise of IP rights. 
As a consequence of accommodating the variety of potential competition approaches, remedies 
available to address anti -competitive behaviour may permit a broader range of remedial action than 
some other public health -related flexibilities associated solely with patents. Competition policy has 
an important role to play in ensuring access to medical technology and fostering innovation in the 
pharmaceutical sector. WTO Members have absolute policy space under international law  to design 
their national competition laws in accordance with their domestic interests and needs and the level 
of their development.   
528.  The use of competition law is not without difficulties, since many developing countries may 
not have the capacity to admin ister or enforce such a system. Since a substantial body of precedent 
exists, the sponsor of this document wishes to demonstrate that many WTO Members already use 
competition law to address various anti -competitive practices that affect access to medicines  and 
medical technologies. Practices that have been identified as detrimental include, but are not limited 
to the following instances: (i) abuses of IPRs due to a refusal to deal with or imposition of overly 
restrictive conditions in medical technology lic ensing; (ii) preventing generic competition through 
anti-competitive patent settlement agreements; (iii) mergers between pharmaceutical companies 
that lead to undesirable concentration of research and development and IPRs; (iv) cartel agreements 
between ph armaceutical companies, including between manufacturers of generics; (v) anti -
competitive behaviour in the medical retail and other related sectors; and (vi)  bid rigging in public 
procurement. In this respect, not all jurisdictions follow the same approach , for instance, refusal to 
license may amount to an abuse of dominance in some jurisdictions while others consider this within 
the rights of IPR holders.  
529.  The "objectives " and "principles " enshrined in Articles 7 and 8 of the TRIPS Agreement  form 
central e lements of the interpretation of the TRIPS Agreement , especially with regard to the relevant 
provisions that recognize flexibilities to legislate at the national level. In the WTO case of Canada – IP/C/M/90/Add.1  
 
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  Patent Protection for Pharmaceutical Products , the panel no ted that "the exact scope of Article 30 's 
authority will depend on the specific meaning given to its limiting conditions. " To this end, the goals 
enumerated in Articles 7 and 8.1 are relevant when doing so.  
530.  The Panel in Australia – Tobacco Plain Packaging  referred to the report in Canada -Patent 
Protection for Pharmaceutical Products regarding the interpretation of the terms of Article 30 of the 
TRIPS Agreement  in light of its object and purposes. It noted that paragraph 5 of the Doha 
Declaration is formulat ed in general terms, thereby inviting the interpreter of the TRIPS  Agreement  
to read "each provision of the TRIPS Agreement " in light of the object and purpose of the Agreement, 
as expressed in particular in its objectives and principles. Fundamentally, th e panel concludes that 
paragraph 5 of the Doha Declaration constitutes a subsequent agreement of WTO Members within 
the meaning of Article 31(3)(a) of the Vienna Convention on the Law of Treaties. This finding may 
have important consequences for how flexib ilities in the TRIPS Agreement  are interpreted.  
531.   Competition law and policy remains an important topic and is subject to much multilateral 
focus and discussion. The United Nations Conference on Trade and Development (UNCTAD) produces 
seminal work on this s ubject -matter and provides technical assistance in order to improve worldwide 
cooperation on competition policy matters. Each year, an  Intergovernmental Group of Experts 
(IGE)  on Competition Law and Policy meets to discuss ways of and enhancing convergence  through 
dialogue. UNCTAD produces a list of competition laws and annotated commentary contained in the 
Handbook on Competition Laws (Volume II)  (UNCTAD/DITC/CLP/2009/2). It also has a Model Law 
on Competition which is available in all the UN languages.  
532.  The World Intellectual Property Organisation (WIPO) has actively discussed the issue of IP and 
competition.  At its thirteenth session (3 –5 September 2018), the WIPO Advisory Committee on 
Enforcement discussed, inter alia , the interface between IP enforcement  and competition law. Brazil 
and Peru presented case studies of competition on administrative approaches to address the 
interplay of IP enforcement and competition law.  Through concrete examples, the contributors 
discussed the limitations of unfair compet ition laws in relation to the exercise of IP rights as well as 
interventions of competition rules in cases where the IP system was abused to prevent competitors 
from entering or remaining in a market.  
533.  The sponsor urges Members to once again share their na tional experiences and examples of 
how competition law is used to achieve public health and related national objectives. Debate and 
information exchange could serve to enhance the understanding of Members of various approaches 
to the use of competition law  and policy to prevent or deter practices such as: collusive pricing or 
the use of abusive clauses in licensing agreement that unreasonably restrict access to new 
technology, and the use of measures that prevent the entry of generic companies and result in  
higher prices for medicines. Capacity building and technical assistance remain the most important 
means to enable WTO Members to increase their capacity to administer and implement competition 
law regimes.  
Guiding Questions  
534.  The questions are designed to build on previous questions circulated in document IP/C/W/643. 
Some delegations indicated that they may revert to some of the questions that were posed during 
the last TRIPS Council session. Bearing this in mind, delegations are invited to share their 
experiences of using competition law regimes to address anti -competitive practices that affect access 
to medicines and medical technologies or to share challenges that they face in the enforcement of 
competition law issues that affect access to medicines or me dical technologies.  
(1) What types of behaviours do WTO Members consider abuses of intellectual property rights in the 
pharmaceutical and medical sectors? Has there been any evolution in the approaches that WTO 
Members take to assess such types of behavio urs? 
(2) What examples of best practice can Members identify on the subject of the control and remedies 
for excessive pricing? Are there context -specific methodologies employed by Members for 
determining if prices are excessive, and the mechanisms to remed y and control pricing abuse?  
(3) What examples of best practice can be identified through national competition laws and 
practices? Are there certain common trends that can be identified across various jurisdictions?  IP/C/M/90/Add.1  
 
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  (4) To what extent can technical assista nce and capacity building contribute to the delivery of more 
effective policies by WTO Members in the field of competition law to address the abuse of intellectual 
property rights?  
13.2  Brazil  
535.  I would like to thank South Africa for circulating document IP/C/W/649. The communication 
builds on documents IP/C/W/630 and IP/C/W/643, with the goal of expanding the discussions on 
the complex interplay between intellectu al property and public interest. The debate on the relation 
between intellectual property and competition lies at the heart of the IP system and is certainly of 
interest to this Council. This is an issue that has been attracting increased attention in inte rnational 
forums, as evidenced by the discussions held in September at the WIPO Advisory Committee on 
Enforcement.  
536.  Intellectual property and antitrust law have common objectives: to stimulate economic 
development, promote innovation and foster competition . However, these two disciplines deploy 
different methods to achieve these same objectives, which, at first, may seem contradictory. 
Antitrust law stimulates economic development by promoting competition and preventing abuse of 
dominance and exclusionary p ractices, whereas intellectual property stimulates innovation by 
creating exclusive rights, which prevent competition and use of immaterial goods by unauthorized 
third parties.  
537.  For a long time, the two fields were considered incompatible. However, the deb ate has evolved 
to consider that antitrust and intellectual property are complementary, even though there may be a 
tension between them. A dynamic analysis of the competition process shows that intellectual 
property is not by itself harmful to competition.  Rather, exclusive rights granted under IP laws 
promotes competition between companies, which are compelled to invest in research and 
development in order to innovate and keep up with the market.  
538.  Therefore, antitrust and intellectual property should work together towards their common 
goals. This is particularly true in the context of the new economy, in which innovation, knowledge 
and intellectual property rights are a central part of the competition dynamics. It does not mean, 
however, that the two fields  will remain without conflicts. In the concrete economic reality, there is 
growing attention from competition authorities to the relationship between the two areas, because 
there is also an increasing possibility of abuse of IP rights in innovative and dig ital markets.  
539.  At the Council 's last meetings,  we presented a case of sham litigation involving a drug used 
against breast cancer. Our competition authority, whose acronym in Portuguese is CADE, imposed 
a fine of BRL 36.6 million or USD 10 million on the de fendants . 
540.  I would like now to mention two other cases decided by CADE, the first one regarding the use 
of auto parts industrial design rights in the aftermarket and the second involving a merger filing.  
541.  The "ANFAPE Case", as it came to be known, was filed by the National Association of 
Independent Manufacturers of Automobile Parts against original equipment manufacturers. The 
plaintiff alleged that the defendants had abused their dominant position and their IP rights over  
automobile spare parts by exercising their industrial design rights in the aftermarket, thus effectively 
monopolizing the aftermarket. Certain original manufacturers filed legal claims in the judiciary to 
safeguard their intellectual property and preclude  the independent manufacturers from 
commercializing auto parts without properly licensing the industrial design. ANFAPE argued that 
those injunctions intended to prevent independent manufacturers from effectively competing in the 
aftermarket and argued tha t the industrial design was restricted to the primary market. The decision 
by CADE held that the Brazilian Industrial Property Law did not restrict the enforcement of the 
industrial design protection in the aftermarket. The registrations were obtained lawf ully and the 
means used to enforce the IP rights were reasonable, so there was no trace of sham litigation. For 
this reason, no abuse in the exercise of the IP rights was identified and the case was closed. This 
understanding reveals CADE 's balanced positi on when confronting intellectual property matters, 
achieved after careful consideration of the issues.  
542.  In the merger filing between Bayer and Monsanto, CADE had the opportunity to address 
intellectual property rights issues as they pertain to the sale of g oods and tangible assets. The IP/C/M/90/Add.1  
 
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  merger involved the seeds and agricultural defensives markets. The analysis undertaken by CADE 
highlighted the importance of IP rights for the companies involved, who heavily rely on patents and 
plant varieties protection. Bay er and Monsanto are active in all those areas, which gave rise to 
competitive concerns related to increased entry barriers and market concentration deriving from IP 
rights. CADE conditioned approval of the merger on remedies that addressed the competitive 
concerns caused by the concentration of IP rights. For the merger to go through, the companies 
were required to license certain patented seed traits and protected plant varieties. This merger 
analysis shows that competition authorities can effectively and timely intervene to prevent the 
concentration of economic power generated by IP rights, as well as potential abuses of dominant 
position by IP rights holders.  
543.  Policy coherence between the IP system and competition must be strengthened in order to 
promote t o the full extent innovation and ac cess to technologies. Article 8. 2 of the TRIPS  Agreement  
provides flexibilities for governments to adopt competition law measures to prevent abuse of 
intellectual property rights, including IP rights related to the life s ciences.  
544.  Abuses of intellectual property rights, such as reverse payment agreements and 
anticompetitive licensing practices, may favour  undue extension of the market power granted by a 
patent. These practices impact both traditional and innovative companie s, stifling competition and 
harming consumers. One way to deal with these practices is through the improvement of the patent 
system, for example by carefully designing patentability requirements. While some changes may 
indeed decrease or eliminate abuses, they should be implemented cautiously to avoid unforeseen 
outcomes.  
545.  Competition law, on the other hand, may be useful in situations where changes to IP policies 
are ineffective in dealing with these types of practices. In the pharmaceutical industry, comp etition 
policy benefits consumers in the form of increased access to affordable medicines by detecting, 
halting and correcting anti -competitive practices, without harming the dynamic competition effect 
granted by IP rights. Furthermore, countries should be  able to retain freedom to utilize to the full 
flexibilities available in the TRIPS Agreement  to ensure access to medicines. It is also important that 
technical assistance and capacity building contribute to the delivery of more effective policies on 
poten tially abusive practices in the pharmaceutical sector in support of access to medicines.  
546.  The relationship between antitrust and intellectual property is complex  and there are still many 
issues  to be addressed by authorities. As new competitive strategies r elated to new businesses arise, 
there will be a growing number of antitrust cases involving IP rights. The core issue is to determine 
the optimal level of competition law intervention in the field of intellectual property rights. We must 
fine tune enforcem ent work to ensure competition and intellectual property laws each play their 
complementary role in encouraging innovation and enhancing consumer welfare.  
13.3  India  
547.  My delegation would like to support the statements made by South Africa and Brazil.  
548.  In India, both specific IP legislations and the Competition Act deal with anticompetitive 
activities, abuse of dominance and other market unfriendly activities when it comes to abuse of 
intellectual property rights. Therefore, complaining parties often move to either t he Competition 
Commission of India (CCI) the adjudicating authority under the Competition Act , or High Courts 
(under different IP legislations) for redress al. In 2015, questions were raised regarding the 
self-sufficiency of IP legislation where complaining parties alleged that the IP legislation is sufficient 
to deal with anticompetitive concerns and does  not need any interventions from the Competition 
Act.  This dispute is settled for now as the Hon'ble High Court of Delhi has meticulously analy sed 
both IP provisions and the Competition Act and has come to the conclusion that the objectives, 
procedure and nature of remedies of both the legislations differ to  good extent.  Therefore, both the 
laws can determine the manner in which the anticompetitive issues are to be resolved.  
549.  In recent years there have been several instances, where courts have engaged on the issue 
of anticompetitive practices in the context o f Standard Essential Patents and in some other 
industries. We have, however, not had any authoritative decisions on an issue that interacts directly 
with competition law and public health. We expect that the jurisprudence on competition law issues 
in the p ublic health will also evolve overtime to address the concern more comprehensively.  IP/C/M/90/Add.1  
 
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  13.4  China  
550.  We would like to thank South Africa, Brazil and India for submitting  this proposal. We share 
the same concern and would like to co -sponsor this proposal.  
551.  During the second meeting of the TRIPS Council in June this year, Members  have been actively 
involved in this issue. Although divergences still exist, we believe a full d iscussion will help Members  
to get a better understanding and promote deepening of this issue.  
552.  First, we believe that intellectual property protection should not exclude the application of 
competition law. In the TRIPS Agreement , Articles 6, 8.1, 31(k) and  40 are closely related to 
competition. As part of the TRIPS Agreement , most of these provisions have been transformed into 
Members ' domestic laws or regulations that must be abided by. In addition, judicial cases related to 
intellectual property and compe tition have been found worldwide. These all clearly indicate that 
intellectual property protection is not boundless, it should be constrained by the application of 
competition laws.  
553.  Second,  we believe that intellectual property protection and competition a re not in conflict. 
They share the goal of improving economic efficiency, safeguarding consumer interests and 
protecting public interests while promoting competition and innovation. According to Article 7 of the 
TRIPS  Agreement  "[t]he protection and enforc ement of intellectual property rights should contribute 
to the promotion of technological innovation and to the transfer and dissemination of technology, to 
the mutual advantage of producers and users of technological knowledge and in a manner conducive 
to social and economic welfare and to a balance of rights and obligations ." It clearly indicates that 
the purpose of intellectual property protection is to achieve a balance between the creators and 
users of IPR, rather than to form a monopoly. The legislati ve purposes of each member 's competition 
law are basically the same, that is, to protect fair competition, to stimulate innovation, and to 
safeguard the legitimate rights of operators and consumers. It is clear that there is a common goal 
between intellect ual property protection and competition. In fact, China 's Anti -Monopoly Law and 
the regulation on the Prohibition of Conducting , Eliminating or Restricting Competition by Abusing 
Intellectual Property Rights have also followed the above principles.  
554.  Third,  we bel ieve that the TRIPS Council is the appropriate forum to discuss intellectual 
property and competition issue. Currently intellectual property and competition issue ha ve become 
an important subject in WIPO and FTAs. With clear competition provisions i n the TRIPS  Agreement , 
as an important forum for intellectual property, the TRIPS Council could not avoid this issue.  
555.  China believes the discussion on intellectual property and public interest should be open and 
inclusive . Members  are encouraged to exchang e views and experiences on how to make better use 
of flexibility provisions of TRIPS Agreement , including the competition law and policy.  
13.5  Indonesia  
556.  Indon esia would like to thank South Africa for the proposal outline in document IP/C/W/649.  
557.  As the world 's fourth most populous country, Indonesia places public health as an important 
part of its national development strategy and policies, that include access to medicines and medical 
technologies as well as the development of its pharmaceutical industry.  
558.  We understand that in the fields of medicines and medical technologies development, IP plays 
an important role to stimulate Research and Development. However, we need to always remind 
ourselves, that competition, fair working market -competition process, also stimulates R&D and the 
development of pharmaceutical industry. Competition policy and competition authorities are 
therefore important in making sure that market s are working well, and that  no industry has to leave 
a market do to abuses of market rights, su ch as monopoly rights.  
559.  In Indonesia, in addition to IP rules and regulations, we believe that regulating antimonopoly 
and unfair practices in the pharmaceutical sector is paramount in achieving our national development 
objectives, especially in the field of public health.  IP/C/M/90/Add.1  
 
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  560.  Indonesia enacted  the Law No. 5 of 1999 concerning the Prohibition of Monopolistic  Practices 
and Unfair Business Competition which contains specific and comprehensive rules governing 
competition between business actors. Article 3 of the Law states that its basic objective is to 
safeguard the public interest and improve the efficiency of the national economy to improve the 
welfare of the public.  
561.  To that effect, Indonesia has  established an independent agency to enforce the Law called 
Commi ssion for the Supervision of Business as Komisi Pengawas Persaingan Usaha (KPPU).  
562.  In this regard , we would like to share a case handled by KPPU regarding high price of medicine 
caused by monopoly practices.  
563.  In Indonesia, the structure of pharmaceutical ma rket is competitive. It can be seen from the 
healthy amount of national players or companies in the market, such as Kalbe Farma, Sanbe, Soho, 
Dexa Medica, Tempo Scan Pacific and Pharos Indonesia. However, market practices are distorted by 
pharmaceutical ag ents and doctors that undermine competition mechanism. A doctor has a dominant 
role in determining the choice of drugs, both to be obtained by patients and those  available at 
hospitals . It is suspected that there is a transactional deal  between doctors and  pharmaceutical 
companies that gives incentives to doctors in prescribing particular medicines.  
564.  Acting upon that, KPPU issued recommendations to the Ministry of Health for:  
• Improvement of pharmacist 's role, "Pharmacists must inform  about  patent and generic 
drugs that have the same active substance to every patient "; 
• The obligation to write prescription of the generic name and drug availability at 
Pharmaceutical Installations of Private Hospitals; and  
• Enforcement of Doctor 's Code of Ethics . 
565.  Improving pharmacist 's role help s strengthen ing their role to minimise doctor 's role in 
prescribing certain brand names and in eliminating transactional deals between doctors and 
pharmaceutical companies.   
566.  KPPU's Policy recommendations related to the st rengthening of pharmacist 's role were well 
accepted and actualised by the Ministry of Health of the Republic of Indonesia with the stipulation 
and issuance of Regulation of the Ministry of Health of the Republic of Indonesia No. 98 of 2015 on 
Providing Inf ormation of the Highest Retail Price for Drugs, set out in Articles 8 and 9.  
567.  Article 8 reads as follows:  
• Pharmacists at the pharmacy or hospital/clinic 's pharmaceutical installation must inform 
the Highest Retail Price for Drugs to patients or patients ' family when giving services 
related to doctor 's prescriptions ; and  
• In addition to providing information on the Highest Retail Price for Drugs as stipulated in 
paragraph (1) Pharmacists must inform pati ents or p atients ' family of other drugs, 
particularly gen eric drugs that contain the same active substance as those prescribed that 
are available at the pharmacy or hospital/clinic pharmaceutical installation.  
568.  Article 9 reads as follows:  
• Patients or patients ' family have the right to make choices of drugs based on the 
information conveyed by the Pharmacists as referred to in Article 8.  
569.  The policy recommendation provided by KPPU is effective because it is recognized  by the 
Ministry of Health of the Republic of Indonesia through its regulation.  It has shown what competition 
law and policies could do to protect competitive process, by honouring consumers ' preferences with 
respect to the quality, price, and other attributes of goods and services, in this case, of medicines.   IP/C/M/90/Add.1  
 
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  570.  In concluding, we would like to once aga in highlight that stimulating the development of the 
pharmaceutical industry should take into account the relationship between IP protection and 
competition law.  
571.  Finally, we look forward to hearing other Members ' comment s and experience s on this subject 
matter. Indonesia would also like to take the opportunity to once again thank South Africa as the 
proponent of this agenda. Therefore , we support that this agenda item be maintained for the next 
meeting of the TRIPS Council, especially wit h regard to discussions on IP issues and Public Interest 
including the sharing of experience s regarding the utilization of TRIPS flexibilit ies by Members.  
13.6  South Africa  
572.  South Africa has a proud history of robustly engaging with issues that concern the intersection 
between intellectual property rights and public health. Indeed, the South African Government 's 
stance in the case between the Pharmaceutical Manufacturers Association versus the President of 
South Africa (the late President Nelson Mandela) in 1998, was a key factor leading to global dialogue 
around the potential negative impacts of intellectual property rights on public health, culminating in 
the Doha D eclaration on TRIPS and Public Health.  
573.  The South African Competition Act, for example, is intended to "advance the social and 
economic welfare of South Africans ", "correct structural imbalances and past economic injustices " 
and "reduce the uneven development, inequality and absolute poverty " which is so prevalent in 
South Africa. The South African Competition Commission has not issued specific guidelines on 
application of the Competition Act to IP. However, it has explained its general approach by indicating 
that firms are not automatically exempt from the rules of the Competition Act as a result of the 
rights granted in terms of laws like the intellectual property laws. It further reiterated that firms 
cannot be automatically allowed to continue wi th a particular prohibited practice as outlined in the 
Competition Act because that practice is allowed by another Act.   
574.  The Competition Act covers both horizontal and vertical modes of competition. Horizontal anti -
competitive activity refers to conduct a mong independent enterprises that are suppliers of 
competitive (or potentially competitive) goods or services. Vertical anti -competitive activity refers 
to the supply chain controlled by a producer, beginning with inputs to production, into production, 
intermediate distribution and, ultimately, the retail sale of goods or services. Instances of horizontal 
anti-competitive behaviour that are per se  illegal in most jurisdictions include price -fixing among 
competitors, output restraints and allocation of geogr aphic territories. Examples of vertical restraints 
that are  per se  illegal in many, but not all, jurisdictions are resale price maintenance (or fixing the 
minimum price at which retailers may sell) and 'exclusive grant -back' requirements in patent 
licences .  
575.  There are some significant risks of anti -competitive conduct in pharmaceuticals markets that 
are fairly widespread and deserve close attention from competition authorities. These include bid 
manipulation in procurement of health technologies, whereby a group of potential competitors may 
agree not to submit bids below a set price and to allocate the 'lowest set price ' bid to a particular 
firm. Such activity may also involve inappropriate payments to government officials who might 
otherwise report the anti -competitive practice. Anti -competitive conduct by patent -owning 
enterprises may include requiring a distributor or retailer of health technologies to purchase a 
complete line of products as a condition of purchasing a particular product or products (i.e. a tying 
arrangement). Perhaps the most widely discussed form of anti -competitive conduct involving patent 
owners inv olves 'buying out ' generic challenges to patents that might otherwise result in generic 
products entering the market at an early date.  
576.  Since 2001 many generic manufactures secured voluntary licenses to produce medicines in 
South Africa, including over 20 licenses for medicines in the antiretroviral category. The inc rease in 
voluntary licensing agreements for ARV drugs was often a result of civil society pressure, and the 
use of competition law. For example, in 2002 activist initiatives of the Anti -Retrovir al Therapy (ART) 
treatment campaign, resulted in some multinational companies found guilty of excessive pricing by 
the South African Competition Commission.  
577.  South Africa 's Competition Commission investigated several cases involving the interface of IP 
and competition concerns, particularly in cases where complaints of excessive pricing and refusals IP/C/M/90/Add.1  
 
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  to license competitors were alleged. The landmark case in South Africa arose out of a September 
2002 complaint by Hazel Tau and the South Africa Treatment Actio n Campaign (TAC) and others 
against GlaxoSmithKline (GSK) and Boehringer Ingelheim (BI), suppliers of the first -line 
antiretroviral medicines zidovudine and lamivudine. In the Hazel Tau case, the prices for 
antiretroviral medicines from the patent holders were, at the time, from three to ten times higher 
than the least expensive generic version of the same medicines.  
578.  There had been requests for licenses by generic pharmaceutical producer Cipla and from the 
medical services humanitarian organisation, Médecins Sans Frontières  (MSF, or Doctors without 
Borders). Respondents admitted in documents filed with the South African Competition Commission 
a general policy to refuse licences for the generic supply of their products. It also admitted that they 
prices were  unaffordable by at least 80% of all South Africans. The case resulted in an order of the 
Commission finding that high prices and a refusal to license Indian generic manufacturers constituted 
three abuses of dominance under Section 8 of the Competition Act : (a) excessive pricing; (b) 
refusing to give a competitor access to an essential facility, when it is economically feasible to do 
so; and (c) engaging in exclusionary conduct if the anti -competitive effect of that act outweighs its 
technological, efficien cy or other pro -competitive gains. In reference to remedy, the C ommission  
stated that it would "request the Tribunal to make an order authorising any person to exploit the 
patents to market generic versions of the respondents ' patented medicines or fixed d ose 
combinations that require these patents, in return for the payment of a reasonable royalty ".  
579.  Before the referral and prosecution of the case, GSK and BI negotiated a settlement agreement 
in terms of which they admitted no liability. GSK and BI agreed to:  
• Grant licences to generic manufacturers;  
• Permit the licensees to export the relevant ARV medicines to sub -Saharan African 
countries;  
• Where the licensee did not have manufacturing capability in South Africa, permit the 
importation of the ARV medicines for distribution in South Africa only, provided all the 
regulatory approvals were obtained;  
• Permit licensees to combine the relevant ARV 's with other ARV medicines; and  
• Not require royalties in excess of 5% of the net sales of the relevant ARV 's.  
580.  In 2007, the Commission received another complaint relating to an HIV/AIDS medicine from 
the TAC alleging that Merck (and its South African subs idiary, MSD) ha d abused their dominant 
positions in the markets for the ARV medicine efavirenz (EFV) by refusing to license other firms to 
import and/or manufacture generic versions of this medicine on reasonable and non -discriminatory 
terms. MSD h eld a tw enty-year patent on efavirenz that expired in 2013. The TAC case resulted 
directly in MSD and Merck reaching agreement with multiple licensees on reasonable terms to bring 
a wide range of generic products containing EFV (an essential drug used as part of f irst-line ARV 
treatment in South Africa) to market. While the Hazel Tau case was settled only after the Commission 
had taken a decision to refer the matter to the Tribunal for adjudication, the TAC case was resolved 
before the Commission completed its inve stigation on the matter.  
581.  In February 2009, Aspen notified the Commission of its intention to acquire the Lanoxin brand 
from GSK South Africa. In its investigation, the Commission noted that GSK had voluntarily licensed 
three patented antiretroviral medici nes, including Zidovudine , where the parties (GSK and Aspen) 
held a combined market share of 95.7% The Commission focused predominantly on the horizontal 
aspects of the merger since GSK, to some degree also competed with its generic licensees. To avoid 
the reversal of gains obtained by licensing of patented products in the Hazel Tau case (above), the 
Commission sought conditions for extension of the license of antiretroviral medicines to include the 
Abacavir product. Abacavir was a GSK patented product whic h was used primarily for the treatment 
of children suffering from HIV. At the time of the merger, GSK was the only supplier of this product 
in South Africa. The Commission sought and obtained as a condition for the approval of the merger 
an undertaking by GSK to not only license the production and/or importation of this product by 
Aspen but to also extend the license to other generic companies.  IP/C/M/90/Add.1  
 
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  582.  The Commission announced in April 2018 its intention to investigate local pharmaceutical 
company Aspen Pharmacare  for alleged "abuse of dominance ". Reports in April this year indicated 
that the Spanish Markets and Competition Commission initiated anti -trust proceedings against 
Aspen. In October  2016, Aspen was fined over EUR 5 million by the Italian Competition Autho rity 
for having abused its dominant position by increasing prices of four of its anti -cancer medicines by 
up to 1,500%. The Commission also announced in June 2018 that it would initiate an investigation 
against pharmaceutical company Pfizer Inc. for "suspe cted excessive pricing of lung cancer 
medication ". Furthermore, the Competition Commission announced in July 2018 that it would 
investigate the price of cancer medicines of three pharmaceutical companies. One of these 
companies is Roche Holdings AG, which will be investigated for the excessive pricing of Trastuzumab. 
The investigation specifically relates to "excessive pricing ", "exclusionary conduct ", and "price 
discrimination ".  
583.  The Competition Commission has also finalized its Health Market Inquiry which  looked at how 
pharmaceuticals and related activities may be a cost driver in the private sector.  
13.7  United States of America   
584.  The United States  notes the desire of some Members  to introduce discussion of competition 
law and policy before the TRIPS Council, and recalls the June 2018 intervention of the United  States  
on this subject matter.  
585.  The United States believes that the intellectual pro perty laws and the antitrust laws share the 
common purpose of promoting innovation and enhancing consumer welfare, but also that intellectual 
property and competition are distinct disciplines implemented and overseen by different 
administrative authorities .  Given that relatively few TRIPS Council delegates can be expected to 
have deep expertise both in intellectual property and competition law and policy, the TRIPS Council 
is not the ideal venue to hold the discussions proposed under this agenda item.   
586.  Work by non -experts could easily lead to a misapplication of competition law in the context of 
intellectual property rights.  
587.  In the words of a leading United States  competition law enforcement official, "antitrust 
enforcers should…strive to eliminate as much  as possible the unnecessary uncertainties for 
innovators and creators in their ability to exploit their intellectual property rights, as those 
uncertainties can also reduce incentives for innovation. " 
588.  I would also like to remind the Council that the UN Se cretary General 's High-Level Panel on 
Access to Medicines Report includes the following statement from one panellist : "without innovation, 
there will be no new tools for public health needs, new pandemics, and AMR.  There are already 
precious few diagnosti cs, vaccines, and medicines that can address these menaces and limited 
sources to support research into basic biology that underpins them.  It would be unwise to set into 
motion activities or policies that further choke innovation, placing large population s at risk and 
contradicting the core principles under which the HLP was convened. " 
589.  The United States  references but will not otherwise repeat its June 2018 intervention on this 
agenda item.  We continue to express our reservations regarding discussion of t his subject matter 
in this forum.   
13.8  Japan   
590.  For the purpose of having meaningful discussions under  this agenda item, the delegation of  
Japan would like to ask other Members  to note that it might be better to take a more thorough and 
cautious approach, taking into account not only the interests of third p arties but also those of patent 
rights holders.  
591.  In this context, this delegation would also like to point out that provisions such as those in 
Article 31(k) and Article 40 of the TRIPS Agreement , rest on an intricate balance. Therefore, Japan 
believes that we should be cautious in discussing this agenda item. And, these provisions should not 
be interpreted too bro adly. From this perspective, this delegation has concerns about document 
IP/C/W/649. In addition, it is important to note that any measures taken under these provisions IP/C/M/90/Add.1  
 
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  should be fully consistent with the TRIPS Agreement , as is stipulated in Article 8 of t he TRIPS 
Agreement . 
13.9  European Union  
592.  As already stated at the last TRIPS Council, in general, we do not consider the TRIPS Council 
the appropriate forum to discuss competition policy. There are other international fora, such as the 
International Competition Network, where such international exchanges and cooperation are taking 
place.  
593.  While the submission from South Africa seems to consider the use of  competition policy a 
TRIPS flexibility, the European Union  would be cautious and would emphasise the following: while 
the TRIPS  Agreement  is obviously compatible with the application of competition policy measures, 
it clearly does not allow for "absolute policy space ". As provided for in Article 8. 1 and 8.2, as well as 
in Article 40 .2, these measures have to be consistent with the provisions of the TRIPS  Agreement  
and cannot be used as tools in avoiding the obligations under the Agreement.   
594.  Generally, com petition policy plays an important role in controlling and sanctioning 
anti-competitive market behaviour in any sector, including the pharmaceutical sector.  
595.  Concerning excessive pricing as a competition law infringement in the pharmaceutical sector, 
there have been only very few decisions in the European Union , specifically, by Denmark, Italy, and 
the United Kingdom.  
596.  At the European Union  level, the European Commission is currently conducting one 
investigation into unfair pricing of medicines. That case concerns pricing practices by Aspen, a global 
pharmaceutical company headquartered in South Africa, with several subsidiaries in the EEA. The 
investigation con cerns Aspen 's pricing practices for niche medicines used for treating cancer. Aspen 
acquired these medicines many years after their patent protection had expired and hence the 
investigation concerns generic pharmaceutical products. The European Commission 's investigation 
of Aspen 's pricing in the European Union  markets with the exception of Italy is ongoing and therefore 
we cannot comment it any further.  
597.  In a related case concerning the Italian market, the Italian competition authority found that 
Aspen 's pricing amounted to an abuse of dominance, and ordered the company to set new fair prices 
for the medicines concerned. The Italian authority applied a two-step test (referred to as the United 
Brands test). First, it examined whether the difference between co st and price indicated excessive 
profit margins and, second, whether that the price was unfair in relation to a number of factors.  
598.  Apart from the investigation into unfair, or excessive pricing, the European Commission has 
sanctioned also other measures. In 2005, the Commission found that AstraZeneca misled patent 
offices to enjoy a patent extension (in the form of a Supplementary Pro tection Certificate) to which 
it was legally not entitled. This finding was confirmed in a final judgment by the Court of Justice in 
2012. In 2013 and 2014, the Commission issued three pay -for-delay decisions (Lundbeck, 
Johnson&Johnson, Servier) against ag reements which sought to extend exclusivity of originator 
products by paying out would -be generic entrants, including for discontinuing litigation to remove 
patent barriers.  
599.  The European Union  Commission has not pursued any case involving unreasonably hig h 
royalties for a technology transfer. Nor has it ordered an originator company as the IP holder to 
grant a licence for its proprietary technology to remedy a competition law infringement.  
600.  At the European Union  level, the application of competition policy has so far not been needed 
as a remedy against excessive pricing as a result of IPR protection (i.e. a licence to generics to bring 
down the price) or to otherwise remedy patent barriers to generic entry.  
601.  The above examples show that competition law enfor cement in the European Union  is done 
on a case -by-case basis. Where the Commission intervenes in cases involving IPRs, it gives particular 
attention to preserving the balance between static competition (short term price effects) and 
dynamic competition (lo ng term innovation effects).  IP/C/M/90/Add.1  
 
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  602.  On the international level, the European Union  cooperates with other national authorities, 
including from WTO Members, on competition policy and enforcement issues of mutual interest. Our 
main objective has been to promote conv ergence of competition policy instruments and practices 
across jurisdictions and to facilitate cooperation with competition authorities in other jurisdictions in 
enforcement activities.  
603.  Cooperation with other competition authorities takes place at two leve ls.  First, the Commission 
discusses competition -related matters in various international fora, such as the International 
Competition Network (ICN), where excessive pricing was discussed during its annual conference in 
Portugal in 2017. ICN brings together  competition authorities from more than 100 jurisdictions which 
exchange experiences and best practices in several meetings every year. Second, the Commission 
is also regularly engaged in bilateral cooperation, including related to the pharmaceutical secto r. The 
nature of the cooperation activity varies between countries and can cover cooperation on specific 
investigations, dialogue on competition policy issues as well as capacity building support.  
604.  Therefore, we remain to be convinced about the need to disc uss competition policy at the 
TRIPS Council.  
13.10   World Health Organization   
605.  The World Health Organization (WHO) works under the premise that "Health is a human right. 
No one should get sick or die just because they are poor, or because they cannot access the services 
they need " (Director -General, Dr Tedros Adhanom Ghebreyesus ). The Nations of the world agreed 
on SDGs , in particular  SDG 3  to "Ensure healthy lives and promote wellbeing for all at all ages ". 
WHO needs to work with all Members  and other international organizations to achieve this specific 
health goal, but health is also relevant for all the other SDGs and it lays the foundation fo r long -
term economic development.  
606.  Competition Law is one important tool to promote innovation and access to health 
technologies. Anti -competitive behaviour in relation to intellectual property could appear , for 
example , with life -cycle management practice s and defensive patenting. For example,  the European 
Commission welcomed the Court of Justice judgment in a case on abuse of dominant position to 
prevent or delay market entry of generic competitors through misuse of the patent system and 
regulatory proced ures. There are also other cases in relation to overly restrictive conditions in 
medical technology licensing or mergers between pharmaceutical companies that can lead to 
undesirable market concentration and pay -for-delay agreements between originator and generic 
companies. More examples of abuse of dominant position for driving out competitors are in China 
where NDRC fined two pharmaceutical companies for abusive conducts, found the  UK Compet ition 
Authority imposed a fine on two pharmaceutical companies (o riginator and distributor) for abuse of 
a dominant position and charging excessive and unfair prices for a medicine.  Other cases in 
Indonesia, Thailand or cases involving more than one country a re reported by UNCTAD Commission 
on Investment, Technology an d Financial Issues and also a further case analysis  was made by UNDP 
in several publications on that topic.  
607.  Anti-competitive practices may lead to barriers to innovation and access in the medical sector. 
It is essential therefore to utilize all policy tool s available to increase access to medicines, vaccines 
and other health technologies . IP protection is not exempted from the application of competition 
law. Effective use of competition policy could be in the best interests of patients and health systems.  
608.  WHO with its transparency policy in terms of pricing of medicines is seeking to contribute to 
the assessment of such anti -competitive practices. We are open to work in this field with Members  
and other international organizations , including the WTO.  
13.11   Brazil  
609.  I would like to comment on two interventions that were made before by Members.  
610.  The first one, was a comment made that IP and competition are distinctive dis ciplines and are 
implemented by different agencies, thus they should not be discussed at the TRIPS Council. We 
disagree with that point. We observe for instance that enforcement measures are implemented by 
very different agencies than those responsible for  trademarks and patent applications. Enforcement IP/C/M/90/Add.1  
 
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  measures for instance are implemented by customs which have very different disciplines and very 
different stakeholders involved in comparison with patent office s. The same could be said for 
copyright and pat ent, which are dealt by different agencies. The TRIPS Council is mandated to 
discuss issues which are disciplined by the TRIPS Agreement. This involves copyrights, transfer of 
technology, patent, enforcement and competition policy.  
611.  The second point was a c omment made that the International Competition Network already 
discusses competition. We certainly recognize the very high -level work that is done by the 
International Competition Network but it is an informal venue, as mention ed on  their website, and 
we do not think that this should preclude discussion at the TRIPS Council. There is an established 
relation between IP and competition in academic literature and by national age ncies. So, we think 
this is an appropriate forum. We look forward  to continuing this discussion perhaps in another session 
of the Council.   
14  INFORMATION ON RELEV ANT DEVELOPMENTS ELS EWHERE IN THE WTO  
14.1  Dispute Settle ment  
14.1.1   Honduras  
612.  Honduras wishes to support the statement  to be made  by the Dominican Republic.  
613.  Honduras believes that the Panel made a number of serious errors in its report, both of legal 
interpretation and in its appreciation of the facts.  
614.  The implications of these errors are not limited to tobacco products, a nd set a dangerous 
precedent for all Members, undermining the protection of trademarks.  
615.  Given that the appeals of Honduras and the Dominican Republic are pending before the 
Appellate Body, Honduras prefers not to make any statement regarding detailed aspec ts of the panel 
report. We hope to be able to discuss these details once the Appellate Body issues its report.  
14.1.2   Dominican Republic  
616.  The Dominican Republic wishes to note that the Panel Report unde r discussion under  the first 
point of agenda item 14 refers to the panels established by Cuba and Indonesia in relation to 
Australia 's tobacco plain packaging measures.  There were separate panels established in the four 
complainants ' complaints against Au stralia 's measures for plain packaging of tobacco products under 
Article 9.3 of the DSU. The other two complainants, the Dominican Republic and Honduras, appealed 
the Panel Report, on 23 August 2018, and 19 July 2018, respectively. The fact that Cuba (DS45 8) 
and Indonesia (DS467) have not appealed their panel reports has no impact on the rights of the 
Dominican Republic (DS441) or the rights of Honduras (DS435) to appeal their panel reports.  
617.  As the appeals of the Dominican Republic and Honduras are ongoing , the Dominican Republic 
considers that it would not be appropriate to make any statement on the Panel 's findings in the 
cases brought by Cuba and Indonesia.  The Dominican Republic notes only that it is of the view that 
the Panel committed several legal e rrors as set forth in its Noti fication  of an Appeal (WT/DS441/23).  
We look forward to the Appellate Body 's review of the merits of the Dominican Republic 's appeal in 
due course.  
14.1.3   Norway  
618.  Norway has followed the development in these panel cases with particular interest while 
participating as a third party. Public health and tobacco control are topics of particular interest to 
Norway, something that we have repeatedly stressed in various fora.  
619.  Norway was theref ore very pleased to note the Panel 's acknowledgement of Australia 's right 
to introduce the plain packaging measures, in consistency with its WTO obligations, to fulfil its 
obligations under the Framework Convention on Tobacco Control to protect public heal th. IP/C/M/90/Add.1  
 
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  620.  In our view, it is within the rights of each WTO Member to adopt measures which are necessary 
to protect public health, as long as the measures chosen are consistent with the WTO agreements.  
14.1.4   Australia  
621.  Australia reiterates its strong support for the decision by other WTO Members to legislate for 
the mandatory plain packaging of tobacco products . 
622.  The important steps made by these Members in tobacco control demonstrate that efforts to 
delay the adoption of tobacco plain packaging measures in these countries have not been successful.  
They reinforce that tobacco plain packaging is a legitimate public health measure to combat the 
tobacco epidemic.  
623.  Contrary to claims previously made in this forum, tobacco plain packaging is not about the 
destruction of intellectual property rights . The measure prevents the use of tobacco product 
packaging to advertise and promote a unique product that causes significant damage to public 
health.  
624.  As other Members are aware, i n its report circulated in June of this year, the Panel found that 
Australia 's tobacco plain packaging measure is a legitimate public health measure that is capable of 
making a meaningful contribution to reducing the use of, and exposure to, tobacco produc ts; and 
rejected all claims that the measure is inconsistent with Australia 's WTO obligations.  
14.1.5   Indonesia  
625.  We thank Australia for bringing this issue to this Council .  
626.  Indonesia associates itself with the position taken by the  Dominican Republic and Honduras . 
It reiterate s its position as stated during the DSB Meeting on 27  August  2018.  
627.  Indonesia did not appeal the panel report  in DS467. However, w e believe  that the de cision of 
the Panel  is not just about the regulation of tobacco products and packaging. Indonesia believes that 
the Panel report in DS467 will harm trade in other perfectly legal and legitimate products such as 
certain foods and drinks. As everyone presumably knows, there have been calls to in troduce 
measures similar to tobacco plain packaging to high -fat and high -sugar products in order to combat 
obesity and diabetes. As a result of the Panel 's decision, plain packaging requirements may now be 
applied to alcoholic beverages for religious or mo ral reasons. In short, Indonesia fears that the report 
in DS467 and its companion disputes signal the beginning of a slippery slope to fundamental 
disruption of global consumer markets.  
14.2  IPR-Related Issues in Trade Policy Reviews  
14.2.1   WTO Secretariat  
628.  Since the last TRIPS Council Meeting in June, the Trade Policy Reviews of Colombia, Norway, 
Uruguay, China, Israel, Chinese Taipei and Vanuatu have taken place. We will not attempt to 
summarize the full rang e of IP issues covered in each of these reviews . Update s are limited  to those 
matters on which Members, including both developed and developing countries, actively registered 
an interest by posing questions during the review process. The issues that were o f particular interest 
in this concrete sense included:  
• copyright and neighbouring rights management;  
• geographical indications;   
• protection of well -known and unregistered trademarks in use;   
• legislative amendments and updates regarding copyrights, trademarks and patents;  
• patent linkage;  IP/C/M/90/Add.1  
 
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  • intellectual property protection of medical and pharmaceutical inventions;  
• protection of undisclosed information and trade secrets;  
• protection of domain names;  
• identification of owners of traditional knowledge or  cultural expressions;  
• relationship of IP with e-commerce  and competition policy;  
• national strategies to foster innovation and economic growth;  
• enforcement of IPRs, civil remedies, criminal penalties online and at the border;  
• customs intelligence and coo peration with neighbouring countries;   
• commercialization and trade of IPRs; and  
• Accession to WIPO Conventions.  
629.  Additi onally, we have contributed  to the TRIPS -related section for the forthcoming G20 and 
WTO-wide Director -General 's Monitoring Reports.  The contributi on highlights certain trade -related 
IP policy initiatives undertaken by Canada, the Kingdom of Saudi Arabia, Republic of Moldova, and 
South Africa.  
15  OBSERVER STATUS FOR INTERNATIONAL INTERG OVERNMENTAL ORGANIZA TIONS  
15.1  Cooperation Council for the Arab States of the Gulf  
630.  I am taking the floor to reiterate the request of my Organisation, the GCC, for the granting of 
a permanent observer status to  the Council for TRIPS.  
631.  Our six years ' experience as an ad hoc observer have been  very rich in substance and have 
helped us to actively follow, since 2012, the valuable work of the TRIPS Council. The GCC Secretariat 
General, which gathers among its operati onal bodies the GCC Patent Office and the IP Training 
Centre, was able, thanks to this status, to present to the TRIPS Council its yearly report on technical 
cooperation activities with the aim of sharing its experience and those of the GCC Members States  
in the field of IP.  
632.  The G CC achieved different level of cooperation among its Members  in intellectual property 
such as patents, trademarks, copyright, trade secrets, in addition to effective collaboration with 
many international organization and patent of fices around the world; such as WIPO . 
633.  In the field of patents and trademark the GCC achieved the following;  
a. Adopting the statute of the GCC Patent Office in 1992;  
b. Adopting the patent office ( GCC Patent Law ) in 1992;  
c. Establishing the GCC Patent Office in 1992;  
d. Establishing Intellectual Property T raining Centre in 2011 ; and  
e. Adopting the Trademark Law of the GCC in 2012.  
634.  The GCC Secretariat General is an executive and coordinating institution in charge of managing 
the day -to-day business of  economic and trad e-related issues, including in the area of enforcement 
of intellectual property rights.  IP/C/M/90/Add.1  
 
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  635.  The GCC intends to develop its activities on all IP aspects mainly on technical cooperation and 
capacity building in cooperation with the WTO and WIPO , as well as with  the relevant institutions in 
the WTO Members.  
636.  That is why we are convinced that granting the GCC permanent observer status to the TRIPS 
Council will help us to better follow the work of the TRIPS Council on a predi ctable basis and develop 
our IP -related activities to support the GCC Members  in enforcing national IP laws and GCC IP laws.  
15.2  Jordan  
637.  Jordan supports the request  to grant the GCC a permanent observer status a s its works cover 
the economic and trade -related issues, i ncluding in the area of enforcement of intellectual property 
rights.  
15.3  Kuwait , the State of  
638.  We would like to fully associate ourselves with the statement made by the GCC representative.  
639.  The State of Kuwait suppo rts granting of permanent observer status to the GCC SG, to allow 
it to follow the work of the Council for TRIPS on a regular basis.  
640.  The GCC Secretariat General has always attached a great importance  to all aspects of the work 
of the TRIPS Council, including its work related to the implementation of the TRIPS  Agreement  and 
IP systems.  
15.4  Morocco  
641.  We believe that the request made by the Cooperation Council for the Arab States of the Gulf 
(GCC) reflects a keen willin gness to follow more closely, and in a constant and institutionalized 
manner, TRIPS -related developments within the WTO.  
642.  The delegation of Morocco supports this request and believes that granting permanent 
observer status to the GCC will ensure the involve ment of this organization and encourage its 
Members to make further progress in this area.  
15.5  Oman   
643.  The Sultanate of Oman echoes the statement delivered by the GCC Secretariat General. The 
GCC Secretariat General has always attach ed a great importance to all aspects of the work of the 
TRIPS  Council, even prior to having been granted an ad hoc observer statu s since November 2012. 
The GCC S ecretariat is actively following under its current observer stat us the discussion in the 
TRIPS Council on all its agenda items especially those related to capacity  building  and technical 
cooperation. Taking into  account the role that the GCC S ecretariat would play in different aspects of 
the work of the TRIPS Council, t he Sultanate of Oman supports granting the GCC Secretariat 
permanent observer status.  
15.6  Qatar  
644.  We would like to associate ourselves with the statement made by the GCC Secretariat and the 
statement of the State of  Kuwait as coordinator of the GCC. We believe t hat there will be a lot of 
benefits o f granting the GCC Secretariat permanent observer status at the TRIPS Council. As they 
are in charge of the day -to-day operation and host the GCC regional Patent Office they have been 
granted an ad hoc  observer status s ince November 2012. We would like to seek the support of the 
WTO membership in granting them permanent observer status.  
15.7  Bahrain , Kingdom of  
645.  Like others before us, we would also like to support the proposal to g rant the Gulf Cooperation 
Council permanent observer status at the TRIPS Council.  IP/C/M/90/Add.1  
 
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  646.  While holding ad hoc observer status, the GCC via the GCC Patent Offic e has been actively 
following the TRIPS C ouncil , assisting GCC Members  to comply with their IP -related obligations and 
has provided several technical assistance and capacity building activities.  
647.  This is why we support its permanent observer status and hope for a favourable consideration 
by the Council.  
15.8  Egypt  
648.  Six years ago, the GCC Secretariat General and its Patent Office ha ve been granted a status 
of an ad hoc observer in the TRIPS Council, since then they attended all the sessions of the Council, 
presented reports on technical cooperation activities annually , and made statements on this issue 
under  the rel evant  agenda item.  
649.   The GCC is an intergovernmental regional organization which places the economic issues at 
the heart of its activities . Its Secretariat General is the executive body in charge of coordina ting the 
daily business of the GCC including the area of intellectual property enforcement. It is responsible 
for developing common regulations and instit utions to ensure protection of intellectual p roperty 
rights, as well as assisting GCC Members  in imple menting the TRIPS Agreement . 
650.  We believe that granting the GCC Secretariat General permanent observer status will be of 
merit, and will help in enhancing their engagement in the Council 's work on a closer and more regular 
basis.  
15.9  Brazil  
651.  Brazil would like to express its support in granting permanent observer status to the GCC. We 
recognize the merits of the request and also their very active participation in the TRIPS  Council . We 
think that giving them permane nt observer status will be beneficial for the whole community.  
652.  We also think that permanent observer status should be granted to the South Center and CBD 
Secretariat as soon as possible.  
15.10   China  
653.  Over years, as an ad hoc  observer of the TRIPS Council, the GCC has actively participated in 
the TRIPS Council and fulfilled observer 's obligations. China supports GCC to be granted permanent 
observer status.  We believe that granting a permanent observer status to GCC would help deepening 
Members ' knowledge on the GCC and its Members ' IP system.  
16  ANNUAL REPORT  
654.  No statements were made  under this agenda item . 
17  OTHER BUSINESS  
655.  No statements were made  under this agenda item . 
17.1  Dates for the Council 's Meetings in 2019  
656.  No statements were made  under this agenda item . 
17.2  Work Programme on Electronic Commerce  
657.  No statements were made  under this agenda item . 
__________