RESTRICTED  
  
IP/C/M/88/Add.1  
 
12 April 2018  
(18-2234) Page: 1/58 
Council for Trade -Related Aspects of  
Intellectual Property Rights   
 
 MINUTES OF MEETING  
HELD IN THE CENTRE W ILLIAM RAPPARD ON 27 FEBRUARY 2018  
Chairperson: Ms Irene Young (Hong Kong, China)  
Addendum  
The present document contains the statements made during the Council for TRIPS meeting held on 
27 February 2018 . 
 
_______________  
 
AGENDA ITEM 1: NOTIF ICATIONS UNDER PROVI SIONS OF THE AGREEME NT ..................  4 
AGENDA ITEM 2: REVIE W OF NATIONAL IMPLEM ENTING LEGISLATION  ..........................  7 
AGENDA ITEM 3: REVIE W OF THE PROVISIONS OF ARTICLE 27.3(B)  ...............................  7 
AGENDA ITEM 4: RELAT IONSHIP BETWEEN THE TRIPS AGREEMENT AND THE 
CONVENTION ON BIOLOG ICAL DIVERSITY  ................................ ................................ ...... 7 
AGENDA ITEM 5: PROTE CTION OF TRADITIONAL  KNOWLEDGE AND FOLKLO RE ...............  7 
AGENDA ITEM 6: NON -VIOLATION AND SITUAT ION COMPLAINTS  ................................ . 16 
AGENDA ITEM 7: REVIE W OF THE IMPLEME NTATION OF THE TRIPS  AGREEMENT 
UNDER ARTICLE 71.1  ................................ ................................ ................................ ..... 20 
AGENDA ITEM 8: REVIE W OF THE APPLICATION  OF THE PROVISIONS OF  THE 
SECTION ON  GEOGRAPHICAL INDICAT IONS UNDER ARTICLE 2 4.2 ................................  20 
AGENDA ITEM 9: FOLLO W-UP TO THE FIFTEENTH ANNUAL REVIEW UNDER 
PARAGRAPH  2 OF THE  DECISION ON THE IMPLE MENTATION OF ARTICLE  66.2 
OF THE  TRIPS AGREEMENT  ................................ ................................ ............................  20 
AGENDA ITEM 10: TECH NICAL COOPERATION AN D CAPACITY BUILDIN G ......................  27 
AGENDA ITEM 11: INTE LLECTUAL PROPERTY AN D INNOVATION: SUMMAR Y OF 
THE 2017 THEME ON IN CLUSIVE INNOVATION A ND MICRO, SMALL AND  
MEDIUM -SIZED ENTERPRISES (M SMES): COLLABORATION , GROWTH AND 
TRADE; AND 2018 IP A ND INNOVATION THEME:  THE SOCIETAL VALUE O F IP IN 
THE NEW ECONOMY  ................................ ................................ ................................ ....... 28 
AGENDA ITEM 12: INTE LLECTUAL PROPERTY AN D THE PUBLIC INTERES T: 
REGULATORY REVIEW EX CEPTION  ................................ ................................ .................  46 
AGEN DA ITEM 13: INFORMAT ION ON RELEVANT DEVE LOPMENTS ELSEWHERE I N 
THE WTO  ................................ ................................ ................................ ........................  57 
AGENDA ITEM 14: OBSE RVER STATUS FOR INTE RNATIONAL 
INTERG OVERNMENTAL ORGANIZA TIONS  ................................ ................................ ....... 58 
  IP/C/M/88/Add.1  
 
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 INDEX OF THE STATEMENTS MADE  
AT THE MEETING OF COUNCIL FOR TRIPS 27 FEBRUARY 2018 * 
 
Argentina  
IP and Public Interest - Regulatory Review 
Exception  ................................ ........  52 
Non-Violation  ................................ ...... 19 
ARIPO  
Observer Status  ................................ .. 58 
Australia  
Article 66.2  ................................ ........  24 
Biotech, Biodiversity, TK  ......................  16 
IP and Innovation - Societal Value of IP  . 41 
IP and Public Interest - Regulatory Review 
Exception  ................................ ........  52 
Notifications  ................................ .........  4 
Bangladesh  
Article 66.2  ................................ ... 21, 24  
Biotech, Biodiversity, TK  ......................  12 
Benin  
Article 66.2  ................................ ... 25, 27  
Bolivia, Plurinational State of  
Biotech, Biodiversity, TK  ......................  10 
Non-Violation  ................................ ...... 17 
Brazil  
Article 66.2  ................................ ........  26 
Biotech, Biodiversity, TK  ........................  9 
IP and Innovation - Societal Value of IP  . 42 
IP and Public Interest - Regulatory Review 
Exception  ................................ ........  46 
Non-Violation  ................................ ...... 17 
Canada  
Biotech, Biodiversity, TK  ......................  11 
IP and Innovation - Societal Value of IP  . 43 
IP and Public Interest - Regulatory Review 
Exception  ................................ ........  51 
Non-Violation  ................................ ...... 20 
Chile  
Biotech, Biodiversity, TK  ......................  12 
IP and Public Interest - Regulatory Review 
Exception  ................................ ........  50 
China  
Biotech, Biodiversity, TK  ......................  10 
IP and Public Interest - Regulatory Review 
Exception  ................................ ........  52 
Non-Violation  ................................ ...... 17 
Observer Status  ................................ .. 58 
Colombia  
IP and Innovation - Societal Value of IP  . 38 
Costa Rica  
IP and Public Interest - Regulatory Review 
Exception  ................................ ........  50 
Cuba  
Biotech, Biodiversity, TK  ......................  12 
Ecuador  
Biotech, Biodiversity, TK  ........................  7 
Non-Violation  ................................ ...... 20 
El Salvador  
IP and Innovation - Societal Value of IP  . 40 
IP and Public Interest Regulatory Review 
Exception  ................................ ........  49 European Union  
Article 66.2  ................................ ... 23, 27  
IP and Innovation - Societal Valu e of IP  . 28 
IP and Public Interest - Regulatory Review 
Exception  ................................ ........  56 
Notifications  ................................ .........  4 
Haiti – on behalf of the LDC Group  
Article 66.2  ................................ ........  20 
Non-Violation  ................................ ..... 19 
Haiti on behalf of the LDC Group  
Article 66.2  ................................ ........  25 
Biotech, Biodiversity, TK  ......................  13 
India  
Article 66.2  ................................ ........  26 
Biotech, Biodiversity, TK  ........................  8 
IP and Innovation - Societal Value of IP  . 44 
IP and Public Interest - Regulatory Review 
Exception  ................................ ........  53 
Non-Violation  ................................ ..... 16 
Observer Status  ................................ .. 58 
Indonesia  
Biotech, Biodiversity, TK  ......................  13 
IP and Public Interest - Regulatory Review 
Exception  ................................ ........  54 
Israel  
IP and Innovation - Societal Value of IP  . 45 
Japan  
Article 66.2  ................................ ........  23 
Biotech, Biodiversity, TK  ......................  15 
IP and Innovation - MSME Collaboration, 
Growth and Trade  ............................  28 
IP and Innovation - Societal Value of IP  . 32 
IP and Public Interest - Regulatory Review 
Exception ................................ ........  55 
Non-Violation  ................................ ..... 20 
Mauritius  
Notifications  ................................ .........  5 
Norway  
IP and Innovation - Societal Value of IP  . 37 
Notifications  ................................ .........  4 
Singapore  
IP and Public Interest - Regulatory Review 
Exception  ................................ ........  51 
South Africa  
Biotech, Biodiversity, TK  ......................  11 
IP and Innovation - Societal Value of IP  . 45 
IP and Public Interest - Regulatory Review 
Exception  ................................ ........  47 
Non-Violation  ................................ ..... 16 
Switzerland  
Article 66.2  ................................ ........  23 
Biotech, Biodiversity, TK  ......................  15 
IP and Innovation - Societal Value of IP  . 35 
IP and Public Interest - Regulatory Review 
Exception  ................................ ........  54 
Non-Violati on ................................ ..... 19 
 
 IP/C/M/88/Add.1  
 
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  Chinese Taipei  
IP and Innovation - Societal Value of IP  . 38 
IP and Public Interest - Regulatory Review 
Exception  ................................ ........  55 
Ukraine  
Notifications  ................................ .........  6 
United States of America  
Article 66.2  ................................ ........  22 
Biotech, Biodiversity, TK  ......................  14 IP and Innovation - Societal Value of IP . 33 
IP and Public Interest - Regulatory Review 
Exception  ................................ ........  55 
Non-Violation  ................................ ..... 17 
Observer Status  ................................ .. 58 
WTO Secretariat  
Information on Developments in WTO  ... 57 
Notifications  ................................ .........  6 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
_____________________  
* 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/88/Add.1  
 
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  AGENDA ITEM 1: NOTIF ICATIONS UNDER PROVI SIONS OF THE AGREEM ENT 
1.1 European Union  
Finland notified its IP laws and regulations to the Council for TRIPS on 20  December  2017 in 1.  
accordance with Article 63.2 of the TRIPS Agreement. The notification submitted was a concise 
package that consists of both the amendments to existing acts and regulations as well as the 
newly adopted IP legislation in Finland between 2011 and 2017. It included inter alia  amending 
acts to the Copyright Act, Patents Act, Registered Designs Act, P lant Breeders Rights Act, 
Trademarks Act and also a cts related to the enforcement such as Code of Judicial Procedure and 
Criminal C ode. In addition to these  amending acts, Finland no tified also new acts that had been 
recently adopted , for example, the Act on the use of the Orphan Works, Act on Collective 
management of c opyrights, Courts Act, Act on the P roceeding s before the M arket Court and 
Customs A ct. 
Finland's notification include d a detailed list of notified laws, each of them with brief 2.  
descriptions of laws and the text s in Finnish, Swedish and English. Finland also notified the contact 
points according to Article 69 of the TRIPS Agreement and an updated Checklist of Issues on 
Enforcement.  
The Checklist of Issues on Enforcement included inter a lia information on the Finnish M arket 3.  
Court  that was established September 201 3. The Market Court is a specialized IP C ourt, having 
exclusive jurisdiction over all civil IP matters. Provisio nal measures related to IPR s are also 
handled by the Market Court as well as appealed over the main name registrations and d ecisions 
of the Finnish Patent and Registration O ffice. In addition to IP matters , the Market Court decides 
cases related to e.g. competition law, public procurement and unfair business practices.  
Since the notification was a concise package of all legislative changes made over a few years of 4.  
time, compiling the notifications was an arduous task. Therefore Finland would like to thank and 
give credit to the valuable  help and support given by the N otification 's Officer of the TRIPS Council 
Secretariat, in preparing the notification. Cooperation with the Secretariat was seamless and made 
the task a lot more effortless. We would also extend that thanks in the name of the EU. 
1.2 Norway  
The notification mentione d in today's agenda refers to the Norwegian Patents Act (LOV-1967- 5.  
12-15-9) which contains the main provisions on patent protection in Nor way. The latest 
amendments cover the implem entation of the EU Regulation on  the extension of 
the supplementary protection period for medicinal products for paediatric  use. These latest 
amendments entere d into force on 1 January 2018.  
The updated  translatio n also includes provisions of the Patents Act allowing for patents and 6.  
patent applications to be used as security interests.  
1.3 Australia  
Australia is pleased to notify the Council of the following amendments to our IP legislation and  7.  
regulations.  
The first amendment has been implemented under the Intellectual Property Legislation 8.  
Amendment (Fee review) Regulation 2016, which amended fees for obtaining intellectual property 
rights. Our intellectual property agency, IP Austra lia, reviews its fees every four years.  
The second set of amendments has been implemented under the Intellectual Property 9.  
Legislation Amendment (Single Economic Market and other Measures) Regulation 2016. This 
regulation made minor amendments to our regula tions to ensure they aligned with  rules under 
certain treaties administered by WIPO, and also provide regulations for the trans -Tasman  attorney 
regime.  
We have also notified an instrument that implemented  the machinery for Australia's  trans- 10.  
Tasman  patent a ttorney regime with New Zealand. The changes are contained in Schedule  4 of IP/C/M/88/Add.1  
 
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  the Intellectual Property Laws Amendment Act 2015. These changes marked the commencement  
of the trans -Tasman  attorney regime.  
The Copyright Amendment (Disability Access and other M easures) Act 2017 made 11.  
amendments to  the Copyright  Act 1968 to improve  access  to copyright  material  for libraries,  
archives and educational  institutions and the wider Australian community.  
The Copyright Regulations 2017 combined two existing copyright instruments into a single 12.  
consolidated  instrument and modernised certain provisions  from those  instruments.  
1.4 Mauritius  
In accordance with Article 63 .2 of the TRIPS Agreement and to ensure transparency, Mauritius 13.  
has provi ded information on national enforcement law and practices in response to the  Checklist of 
Issues o n Enforcement, during the last quarter of  2017. 
Mauritius has a long -standing tradition of legal protection of Intellectual Property Rights 14.  
(IPRs). The Patent , Industrial Designs and Trademarks Act represents the centrepiece of legislation 
relating to IPR s in Mauritius, serving primarily to curb the proliferation of counterfeit products.  
In Mauritius , IP cases are treated as normal civil cases. Courts follow th e established 15.  
precedent that "[i]t is no part of the duty or function of the court to enter upon any enquiry into 
the case before it other to adjudicate upon the  specific matters in dispute which the  parties 
themselves have raised by their pleadings." It is for a  party to prove its case before the  court by 
ushering the appropriate evidence.  
IPR infringement cases are typically dealt with by the Supreme Court of Mauritius. A large 16.  
number of cases of IPR infringement that has been entered before the Supreme Court, so far, 
have been settled within months, with the party against whom infringement had been claimed 
admitting liability and agreeing to pay damages to the complainant and to have the infringing 
articles destroyed.  
District Courts as well as Intermedi ate Courts have jurisdiction over criminal acts of 17.  
infringement of IPRs. The Anti -Piracy Unit of the Mauritius Police Force is responsible for initiating 
criminal investigations following complaints lodged with them or at the Industrial Property Office.· 
After receiving a report from the police, the Director of Public Prosecutions in an appropriate case, 
initiates criminal proceedings before the appropriate court.  
The Industrial Property Tribunal, set up under the Patents, Industrial Designs and Trademarks 18.  
Act, may also invalidate a patent, industrial design or trademark upon an application made by 
an interested person complaining of IPR infringement. The interested person may be the right 
holder but also an agent or an assignee of the right holder as well a s be represented by a counsel 
or an attorney. It is open to a party before the Tribunal to apply for an injunction from the 
Supreme Court to prevent the disclosure of confidential information before the Tribunal. A person 
who is aggrieved by a decision of the tribunal has a right of appeal to the Supreme Court.  
In cases of infringement, penalties include: imprisonment, monetary fines, seizure and 19.  
forfeiture and destruction of infringing goods and materials. Judicial authorities may order 
injunctions or awar d damages. The party against whom judgement is given is usually ordered to 
pay costs incurred by the other party in entering the case before the appropriate court.  
The Customs Department of the Mauritius Revenue Authority plays a significant role in 20.  
enforc ement of IPRs in Mauritius. The Customs Act provides that where the Director -General of the 
Mauritius Revenue Authority has reason to believe that the right of the owner or authorized user of 
a patent, industrial design, collective mark or mark or copyrigh t has been infringed or is likely to 
be infringed, he may, on his own initiative suspend the clearance of the goods for 21 working days 
and at the same time, give notice, to the owner or authorized user, of the suspension and invite 
the owner or the author ized user, as the case may be, to lodge, within 3 working days, an 
application for the suspension of the clearance of the goods.  IP/C/M/88/Add.1  
 
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  Intellectual property is central to the economic development of Mauritius, especially given 21.  
the emphasis on becoming an innovat ion-oriented economy. In this context, the Government of 
Mauritius has decided to review and reinforce the national IP policy. A new IP - Bill will shortly be 
introduced in National Assembly. The objective is to mainstream I ntellectual Property  in our 
econo mic, cultural and social development in order to promote and facilitate innovation and 
creativity. The new legislation will create better conditions to attract high quality investment.  
The existing  Industrial  Property  Office  will be empowered  and the Indus trial Property  Bill also 22.  
makes  provision  for the creation of an I ntellectual Property  Council,  the main function of which 
would be to coordinate  all matters  relating: to IP development,  and to ensure a coherent and 
cohesive  approach  to the whole issue of I P Rights  in Mauritius.  
1.5 Ukraine  
The Resolution of the C abinet of Ministers of Ukraine No.  877 of 4  December  2013 "On 23.  
Approval of the Procedure for Granting Permission by the Cabinet of Minister of Ukraine to Use the 
Patented Invention (Utility Model) concerning Medicines" approved the appropriate Procedure on 
usage of patented invention (utility model) concerning medicines without t he consent of the patent 
owner.  
The procedure establishes requirements in relation to a pplications for the grant of appropriate 24.  
permission with the purpose to protect public health, including the cases of HIV/AIDS and other 
socially dangerous diseases. It also provides for provisions on notification and payment of 
compensation to the patent owner in view of the grant of the permission by the Cabinet of 
Ministers of Ukraine and possibility to appeal such decision in court procedure.  
As of the date of the submission of this notification (28 December 2017), the aforementioned 25.  
procedure hasn't be en used by Ukraine to address public health problems.  
We want to assure that Ukraine will address in prompt manner any concerns if raised by 26.  
interested WTO M embers regarding this notification . 
1.6 WTO Secretariat  
We ha ve reported at the Council's successive meetings on the development and 27.  
implementation of the e -TRIPS  project , which includes a Notification Submission System (NSS) 
and an Information Management System (IMS) . In the nature of such a complex IT-project, it has 
taken longer than initially planned , but this has given us more opportunities to consult with 
interested delegations to help us fine -tune the project.  The project not only entails a major 
overhaul of delegations'  means of access to TRIPS notifications materials, but also reach es deep 
into our internal processes to updat e and streamlin e the rather complex manual procedures that 
are required for getting a notification through the full system and back to you as an official 
document.  
As regards the NSS, I r ecall that it  remains an entirely optional tool for Members to use. The 28.  
existing pathways for submitting notifications in other ways remain entirely open, but the intention 
is to provide a user -friendly tool for Members to be able more easily to identify t he gaps in their 
current notifications and to fill those gaps in a more manageable way . The EU's statement 
describing the challenges involved in a significant update of notifications for one Member in 
particular, in this case Finland, is a reminder that th is has been a complex task. We are conscious 
that this is an area which has seen a great deal of recent legislative development and reform in 
many Members, but that some Members have not updated the ir notifications for some time.  
Given the objective to create a notification submission system that is streamlined  and easy to 29.  
use, we are very grateful to those delegates who have taken the time to sit down with us to road -
test th e system while it has remained in beta-testing mode . Their feedback has been extre mely 
helpful in fine-tuning  the system and preparing for its operational roll-out. We would like to 
encourage any interested delegate to contact us to test the system and to work with us for their 
suggestions and feedback , in particular a ny Member in a sit uation , such as Finland was, looking to 
update comprehensively the range of laws it had earlier notified. This would be a very good 
opportunity to sit with us and to go through th e process  in a practical way. It will help us ensure IP/C/M/88/Add.1  
 
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  that the final product is most useful for you  in years to come . In time, we are making training 
sessions and materials on the use of the new system available and this will form a  regular part of 
our technical assistance programme.  
We are now turning to the next stage of the proj ect, which aims to make it easier to use the 30.  
notified  material  in practice , bearing in mind that already over 5 ,000 individual legal instruments 
have been put on the system , and we can expect many more as Members bring their notifications 
up to date . That is an enormous amount of extremely useful information, but it is frankly very 
difficult to navigate. Therefore , the current emphasis is on providing a gateway that makes it 
easier to access and use material that has been uploaded  through the Information Ma nagement 
System  (IMS), integral to continuing efforts to facilitate the time liness  and completeness of 
notifications and other information flows relating to TRIPS . The idea is to provide a user -friendly 
on-line resource for searching, consulting and tracki ng all the  range of TRIPS documentation and 
information , including notified laws and legal instruments and all of the other review and 
notification material s submitted to the Council , as well as the minutes of the Council itself. At the 
end of this meeting  of the Council , we would like to offer to all delegations a brief informal 
demonstration of the NSS, and to highlight some of the new features that will  make it easier for 
you to track the status of notifications during the submission pro cess. We will als o demonstrate at 
that session the progress we have made so far on the IMS. We will be working very closely with 
delegations so that this once -in-a-generation overhaul of the way that we present information to 
you corresponds most closely to your practical needs and requirements.  
Overall, our guiding objective has been to enable easier and more practical access to TRIPS 31.  
documentation and information. I should stress, as ever, that all of this system falls entirely within 
the requirements of the Agreement itself and the existing decisions of this Council concerning 
notification requirements. It is simply, we hope, a more efficient , accessible and user-friendly b asis 
for making those processes work. We therefore look forward to continu ing to engage with 
delegates on this project and we would like to again express our warm thanks to those who have 
helped us with this development so far.  
AGENDA ITEM 2: REVIEW OF NATIONAL I MPLEMENTING LEGISLAT ION 
No statements were made u nder this agenda item.  32.  
AGENDA ITEM 3: REVIEW OF THE PROVIS IONS OF ARTICLE 27.3 (B) 
AGENDA ITEM 4: RELATIONSHIP BETWE EN THE TRIPS AGREEME NT AND THE 
CONVENTION ON BIOLOG ICAL DIVERSITY  
AGENDA ITEM 5: PROTECTION OF TRADIT IONAL KNOWLEDGE AND FOLKLORE  
5.1 Ecuador  
We would like to thank you for all the work that you have put  in, and to refer to our earlier 33.  
statements on these three issues. We remain interested in the proposal from November 2012 
concerning the factual notes contained in document s IP/C/W/368/Rev.1 , IP/C/W/369/Rev.1 and 
IP/C/W/370/Rev.1. Updated documents would  enrich our debate and enable us to move forward 
with our debates . Most M embers are very favourable to this idea and we are just waiting for other 
Member s to show flexibilit y. My delegation is open to continue  consultations already under way 
with the United States with the view to reaching consensus . We would like to thank their 
delegation for being so open and willing to have these consultations. Also, Ma dam Chair, we would 
like to acknowledge your good offices and we trust that those good offices and those of the 
Secretariat will enable us to see this idea materialize, because the only objective is for Members to 
have the elements as presented by the Secr etariat without prejudging or calling into question any 
position of any Member. All Members' positions would remain intact, it is just that we would have 
more information that has come up during our debates and would be compiled in these factual 
notes.  IP/C/M/88/Add.1  
 
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  5.2 India  
India is an ancient civilization with a rich body of traditional knowledge associated with 34.  
biological resources and traditional knowledge which is both coded as in the text of the Indian 
system of medicine such as Ayurveda, Unani and Siddha, as well as non -coded, which exists in 
oral undocumented traditions. India is one of the seventeen identified mega bio -diversity countries 
of the world.  
TRIPS -CBD linkage  is important for India and other developing countr ies, because it seeks to 35.  
address  bio-piracy. It has been a long standing demand that patents should not be granted for 
existing traditional knowledge and associated genetic resources. This is all the more important for 
India,  being one of the seventeen meg a-biodiversity countries in the world and an ancient 
civilization .  
Pursuant  to the ratification of the C onvention of on Biological Diversity (CBD) , India developed 36.  
a comprehensive  legislation on biodiversity , including a Traditional Knowledge D igital Library  
(TKDL)  database to prevent misappropriation of India's traditional knowledge at international 
patent offices to tackle bio -piracy.  India has signed TKDL Access Agreement with international 
patent offices across the world.  
TKDL attempts to overcome language and format barriers by scientifically converting and 37.  
structuring  available contents of around 0.3 million medical formulations of the ancient texts on 
Indian Systems of Medicines into five international languages such as English, Japanese, French,  
German and Spanish. The results obtained by the India's Traditional K nowledge  Digital Library 
(TKDL) in 206 cases where the patent applications were either withdrawn/cancelled/declared 
dead/terminated, or where the applicant had to amend the claims or whe n the examiner(s) 
rejected the application on the basis of TKDL submissions brings out the interaction that traditional 
knowledge can have with the patent system.  
But, improving prior art searches through the TKDL was only one part of the solution. Further , 38.  
TKDL represented only a subset of the universe of available traditional knowledge and the realm of 
traditional knowledge in areas other than herbal cures and genetic resources was not covered 
by it. 
While India is undertaking a number of measures at the national level in order to prevent 39.  
misappropriation of genetic resources and/or associated traditional knowledge, the problem has an 
obvious international ramification and international dimension and this requires an international 
solution, to be effective . 
The TRIPS Agreement continues to ignore numerous IPR -related obligations in the CBD which 40.  
are of interest to the developing countries. The disclosure proposal (IP/C/W/474) which was 
submitted in 2006 was followed up by the submission TN/C/W/52 in June 20 08 with the support of 
109 members. The latest submission on this issue , TN/C/W/59 in April 2011, is a draft decision to 
enhance mutual supportiveness between TRIPS Agreement and CBD has been proposed by a vast 
majority of WTO Membership, including India. This proposal seeks amendment of the TRIPS 
Agreement b y inclusion of a new Article 29 bis for disclosure of origin of genetic resources and/or 
associated traditional knowledge. A mandatory disclosure requirement in patent applications to 
include disclosure of origin and evidence of prior informed consent and access and benefit sharing, 
would, in addition to combating bio -piracy, further strengthen the credibility of the  patent system 
by facilitating assessment of the novelty and inventiveness criteria.  
The Nagoya Protocol of the CBD entered into force on 12 October 2014 and 104 countries, 41.  
including India,  have ratified the Protocol, until now. Access and Benefit -sharing Clearing -House 
(ABS-CH), which is a platform for exchanging information on access and bene fit-sharing 
established by Article 14 of the Protocol, is now fully operational. The  ABS Clearing -House is a key 
tool for facilitating the implementation of the Nagoya Protocol, by enhancing legal certainty and 
transparency on procedures for access, and fo r monitoring the utilization of genetic resources 
along the value chain, including through the internationally recognized certificate of compliance. 
So far, twelve countries (Belarus, Bulgaria, Dominican Republic, Guatemala, India, Kenya, Malta, 
Mexico, Pa nama, Peru, South Africa and Spain) have published 146 internationally recognized IP/C/M/88/Add.1  
 
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  certificate of compliance (IRCC) with details of prior informed consent for access to genetic 
resources and benefit sharing on mutually agreed terms.  
The 2030 Agenda for Sust ainable Development agreed by the global community and notably 42.  
the UN Sustainable Development Goal 2.5 sets out the objective to maintain genetic diversity and 
promote access to and fair and equitable sharing of benefits arising from the utilization of gen etic 
resources and associated traditional knowledge. SDG 15.6 seeks to protect, restore and promote 
sustainable use of ecosystems and in this context mandates that the global community promote 
fair and equitable sharing of benefits arising from the utiliza tion of genetic resources and promote 
appropriate access to such resources. SDG 17.10 seeks to promote universal, rules based, open, 
non-discriminatory and equitable multilateral trading system under the WTO, including through 
the conclusion of negotiation s under the Doha Development Agenda. This demonstrates that ABS 
and the Nagoya Protocol are making an important contribution to the conservation of biodiversity 
and sustainabl e economic development for all.  
The Doha Ministerial Declaration in paragraph 19 mandated that the TRIPS Council examine 43.  
the relationship between TRIPS and CBD, and the protection of traditional knowledge and folklore. 
It also mandated that while doing so, the Council should be guided by the objectives and principles 
set out in Article s 7 (objectives) and 8 (principles) of the TRIPS Agreement and should fully take 
into account the development dimension. In the Hong Kong Ministerial in 2005, it was agreed that 
this work shall continue on the basis of paragraph 19 of the Doha Ministerial Declaration and the  
progress made in the Council for TRIPS to date. It was also decided that the General Council shall 
report on its work in this regard to the next Ministerial meeting.  
Given the mandate given by our Ministers in Doha and the mandate under  the Sustainable 44.  
Development Goals 2.5  & 15.6, to avert misappropriation of existing knowledge, promote 
conservation of the genetic resource with the view to maintain diversity and protect livelihoods of 
those who are directly dependent on them, it is impe rative we expedite our work towards a  
positive outcome.  
Given the fact that legal intent exists in most offices to not grant patents on existing 45.  
knowledge, the question really is of enabling this intent in practical sense. Mandatory disclosure is 
the practical way forward to operationalize the intent.  
In this regard, it would be quite useful to the delegates of the TRIPS Council, if the CBD 46.  
Secretariat is requested to brief the TRIPS Council on the latest developments in 
the implementation of the Nagoy a Protocol. The briefing by the CBD Secretariat would be very 
important to understand the implications of the entry into force of the Nagoya Protocol, which has 
been acceded by 104 Members, on the TRIPS Agreement. We reiterate our demand for a formal 
briefing by the CBD Secretariat in the interest of the large majority of Members. We also support 
Ecuador's proposal for updating the three factual briefs by the Secretariat.  
I conclude by stating that the TRIPS -CBD issue is one of the outstanding implementatio n 47.  
issues and positive outcomes on this is an important deliverable of the Doha Round for 
the developing countries.  
5.3 Brazil  
Brazil has a well-known  position on the importance of promoting the neutral support betwe en 48.  
the TRIPS Agreement and the Convention on Biological Diversity (CBD), which is contained in 
document TN/C/W/59.  
Today, I would like to address recent developments elsewhere to show that the topic is ever 49.  
more important. At the Food and Agriculture Organ ization, a Workshop on Access on Benefit -
sharing for Genetic Resources for Food and Agriculture was held last January, in Rome. The event, 
organized by the Commission on Genetic Resources for Food and Agriculture, was useful to identify 
gaps in knowledge r egarding the use of genetic resources for food and agriculture. Members also 
shared their experiences on the regulation of access and benefit -sharing requirements under their 
national legislation.  IP/C/M/88/Add.1  
 
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  At the United Nations level, there are ongoing discussions regarding the development of 50.  
an international legally binding instrument under the United Nations Convention on the Law of 
the Sea on the conservation and sustainable use of marine biological diversity of areas beyond 
national jurisdiction. The debates at the UNCLOS include benefit -sharing of marine genetic 
resources. This shows a continuous interest of the international community in developing solutions 
that enable the fair and equitable sharing of benefits arising from the utilization of genetic 
resources . 
Members would greatly benefit from an update of the 2003 factual note, as proposed by 51.  
Ecuador. This update does not prejudge positions of delegations, as those documents are 
restricted to facts. We urge delegations to show a constructive spirit in order to have a sustainable 
discussion on a topic that is ever more important.  
We hope to see the necessary measures to prevent biopiracy reflected in the TRIPS 52.  
Agreement. Enhancing the transparency and utilization of genetic resources and associated 
traditional  knowledge through the introduction of a mandatory requirement of the disclosure of 
the origin in patent applications will reinforce the view that IP rules can work for the benefit of all 
countries and stakeholders.  
In spite of national efforts, biopiracy and misappropriation of traditional knowledge and 53.  
traditional cultural expressions continue to occur. An amendment of the TRIPS Agreement would 
ensure cooperation between countries, reduce uncertainty for stakeholders and curb illegal 
activities related to  the matter.  
5.4 China  
The relationship between the TRIPS Agreement and CBD is an important issue in  this Council. 54.  
Over the years, M embers have conducted a lot of useful discussions on this issue.  China's position 
is well-known. China attaches great importance to the issue of the  relationship between the TRIPS 
Agreement and CBD, and hopes that M embers could constructively engage in this discussion.  
Regarding the substanti ve issues, Ch ina notes that the majority of M embers support 55.  
amending the TRIPS Agreement to ensure the coherence among TRIPS Agreement, the CBD and 
Nagoya Protocol.  China believes that the introduction of the requirement of mandatory disclosure, 
prior informed consent and benefit sharing could prevent  the misappropriation and erroneous 
patents.  As to the issue of disclosure, China has provided detailed suggestion on improving 
transparency on genetic resources utilization, on preventing the misappropriation of genetic 
resources and traditional knowledge, and on preventing the grant of erroneous patent in two 
documents TN/C/W/52 and TN/C/W/59 co -sponsored by many M embers.  China does not believe 
that the provision of information concerning the prior informed consent and benefit sharing will be 
burdensome. And the benefits sharing arrangement provided by contracts and the database 
solution cannot provide sufficient protection for genetic reso urces. 
With regard to the procedural issues, China supports inviting the CBD Secretariat to introduce 56.  
the Nagoya Protocol and hopes that the Secretariat could update the  three factual notes  
(IP/C/W/368/ Rev.1, IP/C/W/369/Rev.1 ，IP/C/W/370/Rev.1 ). China believes that the discussion 
and negotiation in WIPO/IGC will not prevent Members from seeking a solution in the WTO 
because the TRIPS Council was mandated to examine the relationship between TRIPS and CBD.  
5.5 Bolivia, Plurinational State of  
After the possibility of patenting life forms arose in the 1980s, biopiracy  increased 57.  
exponentially with the adoption of the TRIPS Agreement and, in particular, its Article 27.3(b)  in 
1995, which allowed for the patentability of life forms or parts thereof, such as genetic resources, 
based on their mere isolation.  
As a result, ma ny countries put forward initiatives capable of bringing about a fairer approach 58.  
under the right of access to genetic resources, but failed to stop this undue appropriation of 
genetic resources. These efforts led to the adoption of the Convention on Biolog ical Diversity in 
1992 and the Nagoya P rotocol  in 2014 , among other endeavours . IP/C/M/88/Add.1  
 
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  Recent research has shown that biopiracy continues to grow exponentially and the advance of 59.  
new technologies has now made it easier to patent genes by merely isolating them. It  is therefore 
becoming increasingly important for action to be taken globally so that this situation may continue.  
Patenting life forms is objectionable in many of the world's cultures and should be prevented.  60.  
Priority actions should include the initiation  of negotiations at the WTO to make the disclosure of 
the source of origin of genetic resources a mandatory requirement under international trade rules; 
and Article 27.3(b) should be amended to exclude the possibility of patenting genetic resources by 
merely isolating or characterizing them.  
We encourage Members affected by this issue to initiate actions in this Organization with 61.  
the aim of putting an end to this practice, which is detrimental to the interests of many developing 
countries.  
Bolivia supports updating the factual notes prepared by the Secretariat as proposed by 62.  
Ecuador, an initiative that has been raised many times here in the Council.  
5.6 South Africa  
My delegation takes the floor merely to reiterate statements that it has made in the past. 63.  
From a personal note, this year makes ten years for my involvement in TRIPS -related work . For 
this purpose , I went through many of the statements that South Africa has made during this time. 
What struck me  as quite instructive was that these statements repeated in many respects issues 
where there is potential for discussion, but necessar ily no discussion happens. It would seem that , 
in the TRIPS Council, the more things change, the more things stay the same . My delegation has 
always stressed the relationship between TRIPS and the CBD. Most of the interventions this 
morning from a small number of countries have stressed the importance of this relationship and 
have provided information regarding recent develop ments.  
We have also been a longstanding adherent to the call for the CBD Secretariat to be invited to 64.  
brief the TRIPS Council on developments within the implementation of the Convention on Biological 
Diversity, more specifically on the implementation of th e Nagoya Protocol . 
Further, there remains the issue of outstanding technical notes as referred to by colleagues 65.  
this morning. From this perspective, I would like to enc ourage Members to more actively engage in 
issues that are important to all of us. It wou ld seem that the paralysis that has taken hold of this 
house is to be seen generally in the paralysis that we see in the Organization in general. We have 
an opportunity to debate and we have an opportunity to become relevant, there are many issues 
that are  not reflected on the TRIPS Council agenda that are relevant to Members but which we do 
not discuss. At any rate, Madam Chair, thank you for your valuable work and the  consensus -
building initiatives that you have pursued during your term, and we wish you a ll the very best in 
the coming years here at the WTO.  
5.7 Canada  
Canada continues to firmly believe that the TRIPS Agreement and the Convention on 66.  
Biological Diversity are complementary, and that there is therefore no need to amend the TRIPS 
Agreement in this regard.  
Canada would also like to note its continued support for the important work of the WIPO 67.  
Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional 
Knowledge and Folklore (IGC ). As has been noted previously, the IGC remains the most 
appropriate forum for multilateral engagement in this area, providing an important venue to bring 
together expert views, to discuss the IP -related dimensions of these issues in order to identify 
evidence -based, balanced, appropriate and mutually -beneficial approaches to these complex and 
important issues. Canada welcomes both the concrete discussions and exchanges of national 
experiences in this area at the IGC, which are so important to accurately p inpointing the issues at 
hand, and looks forward to the upcoming thirty -fifth session of the IGC, to be held March 19 to 23, 
2018, in this regard.  IP/C/M/88/Add.1  
 
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  With respect to discussions at the TRIPS Council, as Canada has previously noted, and without 68.  
prejudice to ou r position on substantive matters, Canada is not opposed from a procedural 
standpoint to 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 compilati on of 
the three factual notes on the TRIPS Agreement by the WTO Secretariat. Canada remains of 
the understanding that this would remain a purely factual collating exercise, and in both cases, 
this is without prejudice to national positions on these issues.  
Similar to our positions at the IGC, Canada also continues to welcome presentations by any 69.  
interested Members containing the latest information on the operation and functioning of their 
national IP regimes concerning genetic resources and traditional know ledge, 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 ", "IP and 
the Public Interest, " e-commerce, and elsewhere. We would welcome presentations on national 
regimes concerning genetic resources and traditional knowledge at future meetings of the TRIPS 
Council in this regard, without prejudice to our position that the IGC remains the most ap propriate 
forum for negotiations in this area.  
5.8 Bangladesh  
On the Review of the Provisions of Article 27.3 (b), my delegation does not support 70.  
the patenting of life forms comprising plants and animals. We cal l 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 livelihood such as agriculture, health, food and climate change. 
This would help ensure inter alia : food security and preserve the integrity of rural and local 
communities. Patenting of life forms at a multilate ral level should be prohibited.  
On the relationship between the TRIPS Agreement and the CBD, we hold that states have 71.  
the right and duty to protect their traditional knowledge and genetic resources. There is therefore 
need to amend the TRIPS Agreement with the view to require patent applicants relating to 
biological materials to provide information on the source and country of origin of bio logical 
resources and traditional knowledge used in the invention.  
In addition, the applicants must show evidence of prior informed consent from, and benefit 72.  
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 the number of erroneous patents and 
bio-piracy . We believe that whilst traditional knowledge should receive leg al recognition, its 
protection could as well contribute significantly to the achievement of development goals.  
5.9 Cuba  
Cuba wishes to reiterate the position it has already taken in prior meetings of this Council with  73.  
respect to these three agenda items. Cuba is in favour of reactivating the work to review 
the relationship between the TRIPS Agreement and the Convention on Biological Diversity (CBD), 
and the protection of traditional knowledge and folklore. These are ne gotiating issues that are still 
awaiting outcomes and are of particular importance to the developing and least developed 
countries.  
Like previous speakers, we support Ecuador's request that the Secretariat update the factual 74.  
notes, which will be of great h elp in the discussions on these agenda items.  
5.10 Chile  
The delegation of Chile would like to reiterate as other delegations have, its position on these 75.  
matters. In particular, we would like to reiterate the importance of flexibility contained in  
the TRIPS Agreement. In this context, we consider that each Member has the sovereign righ t to 
take into account its own ethical and public health standards, among other criteria, when 
developing its intellectual property system.  IP/C/M/88/Add.1  
 
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  In Chile's view, intellectual property systems are not an end in themselves, but are intended 76.  
to be tools for promot ing innovation and development while also facilitating access to information 
and health. We therefore consider that a country's decision with respect to the creation of 
monopolies over life forms must be made in accordance with the situation existing in th at country. 
In the case of Chile, Law No. 19.039 on industrial property excludes the patentability of plants and 
animals. However, plants are covered by the system for protecting plant varieties under the UPOV 
Convention.   
Chile, like other delegations, co nsiders that the TRIPS Agreement and the CBD are 77.  
complementary instruments and that there is therefore no need for any amendments to ensure 
that they are consistent with each other. We wish to highlight the important work being done at 
the World Intellectu al Property Organization on genetic resources, traditional knowledge and 
traditional cultural expressions, and we reaffirm Chile's commitment to continue working and 
facilitating the discussions in that forum.   
Finally, we would like to indicate Chile's su pport for the proposal that the CBD Secretariat 78.  
provide a briefing to this Council. We believe that a factual description could shed light on this 
topic for Members . 
5.11 Indonesia  
We understand that these issues had been an outstanding agenda for some time and our 79.  
position remains the same.  However, since other M embers have re -stated their positions, we also 
would like to do the  same .  
The Delegation  of the Republic of Indonesia attaches great importance to  these issues. 80.  
We underlined the need for coherence and consistency between IP and CBD including the Nagoya 
Protocol. We believe the TRIPS Agreement can be amended to meet the challenges and dema nds 
of the current development.  The TRIPS Agreement shall be made complimentary and supportive to 
the CBD and Nagoya Protocol, in particular to the provisions of prior informed consent and access 
and benefit sharing.  
In our view,  Article 27.3(b) of the TRIPS Agreement does not provide an impetus to create 81.  
legal obli gation for M embers to take adequate measures for fair and equitable sharing of benefits 
as required by the CBD and the Nagoya Protocol. With such condition, there is a grey area which 
provides a room for misappropriation and misuse of genetic resources and  traditional knowledge. 
The lack of such legal norms in TRIPS will defeat the purpose and objective of the  CBD, Nagoya 
Protocol including the  sustainable development goals.  
We should not delay substantive discussions of these issues within this Council for  the reason 82.  
that they are  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 ot her fora.  
We believe that parallel discussions will enhance effort and understanding in achieving a fair 83.  
and balanced trading system with regard to intellectual property. In line with this, Indonesia 
believes that it is timely for the Council to give simul taneous and adequate attention to address 
the issue towards a common goal to ensure that genetic resources, traditional knowledge and 
traditional cultural expression be given adequate protection under internal law.  
5.12 Haiti – on behalf of the LDC Group  
The three items have been on the agenda for some time now and the group of LDCs attaches 84.  
great importance to these three issues. The group of LDCs would like to recall the position 
express ed during the previous meetings of the Council in this regard. The group of LDCs believes 
that the TRIPS Agreement and the Convention on B iodiversity should be implemented in 
a mutually enforcing manner. The Group therefore considers that the TRIPS  Agreeme nt should be 
amended to include a provision making it mandatory to disclose the origin of genetic resources and 
traditional knowledge when filing a patent application.  IP/C/M/88/Add.1  
 
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  The vast majority of LDCs are rich in terms of biodiversity and traditional knowledge, 85.  
nevertheless they are often victims of bio -piracy. T herefor e the disclosure of the origin of genetic 
resources and traditional knowledge would allow us not only to combat forms of bio -piracy but also 
to facilitate the sharing of benefits gained from the exp loitation of such resources and knowledge.  
The LDC Group believes that traditional knowledge and folklore must have adequate 86.  
international legal protection. This would contribute to socio -economic development within 
the Member States that possess these res ources.  
 In conclusion, the group of LDCs hope s that these three issues, whatever the discussions are 87.  
on these matters within this Council that  these three matters continue to be discussed here at 
the WTO in order to find an appropriate  solution. Lastly, t he LDC Group supports Ecuador's request 
that the three technical notes on these issues be updated.  
5.13 United States  of America  
The U nited States acknowledges Ecuador's request to have the Secreta riat update the three 88.  
2006 documents with information from recent TRIPS Council meetings. We have raised concerns 
about the utility of the Secretariat pulling Members' interventions  from the minutes of the TRIPS 
Council meetings which are already available  to Members and place citations to these interventions 
in a revised report. We appreciate meeting with Ecuador and the Secretariat on this issue  in early 
October. However, we are still not convinced that the utility in having a secretary compiling such 
a report. Our position on this matter has not changed, we do not support updating the three 
information documents at this time.  
Regarding genetic resources, traditional knowledge and folklore we continue to believe that 89.  
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. We took note that the WIPO General 
Assembly recently agreed on the renewal of the mandate of the WIPO  IGC, for the 2018 -2019 
biennium as well as the work plan for the IGC for the bienni um. The United States will continue to 
engage in technical discussion at WIPO'S IGC and looks forward to hearing more from the 
demandeurs regarding data supporting our position on this issue.  
As regards  item 3, as we have noted, the review of the provision s of Article 27.3(b ) has not 90.  
yielded  new information lately. We have also noted that the WTO membership is divided between 
Members that support the ability to grant a patent on plants and animals and essentially biological 
processes for the production of p lants and animals , and those Members who do not support the 
granting of such patents. For some time, we have noted the inherent tension between those 
Members intervening under item 3 on Article 27.3(b) of the TRIPS Agreement regarding 
prohibiting patents o n certain areas and those intervening under items 4 and 5 on the relationship 
between the TRIPS Agreement and the CBD, seeking to use the patent system to this very  thing.  
United States also noted that the statement that lifeforms, such as plants and anima ls, should 91.  
belong to the whole of mankind  is inconsistent with the position that states have sovereignty over 
plants and animals and can exercise exclusive rights and insist  upon prior informed consent in 
mutually agreed terms for others to use such plants  and animals.  
As regards the relationship between the TRIPS Agreement and the CBD , in past sessions of 92.  
the TRIPS Council , a number of delegat ions not ed that they believed there was a need to avoid 
erroneous patents that involve the use of genetic resources  and related traditional knowledge. We 
agree that there is a need to avoid erroneous patents , but we disagree that this disclosure of 
origins would help improve the quality of patents. In the many years that this issue has been 
discussed, we know that many  countries have imposed a disclosure requirement on applicants. If 
that disclosure requirement has in fact improved the quality of patents, then surely by now there 
will be data to support this conclusion. As noted by India in past sessions of the TRIPS Co uncil, 
traditional knowledge and cultural practices can be prior art and would be fully taken into account 
in the patent examination procedures.  
Turning to the question of the briefing by the CBD Secretariat, United States welcomes 93.  
the interventions of WTO  Members describing their recent actions to implement the convention on IP/C/M/88/Add.1  
 
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  biological diversity and the Nagoya Protocol. We believe that all WTO Members can benefit from 
a better understanding of the policy decisions  made by other WTO Members who are party to  
the CBD or are signatories to the CBD in deciding whether to ratify the protocol or in implementing 
the protocol. However, we do not support the CBD Secretariat providing an intervention at this 
time a s we have previously explained.  
5.14 Japan   
We have already discussed these agenda items at length at a series of meetings of the  TRIPS 94.  
Council. The delegation of Japan, therefore, believes that its position is well -known among 
Members, so this time it would like to focus on some major points in its intervention.  
This delegation would like to reiterate its position that the CBD, is by nature not relevant to 95.  
the IP system and , therefore, we need to seek other ways to deal with misappropriation of genetic  
resources. This means we should bear in mind that any measures taken must neither adversely 
affect the existing system nor hinder the creation of innovations utilizing genetic resources and 
associated traditional knowledge.  
This delegation is firmly convi nced that the disclosure requirement would discourage 96.  
industries from conducting research and development activities on biological materials outside 
their own countries. This is the very consequence of the disclosure requirement that Japan has 
been concern ed about. Therefore, Japan believes that the disclosure requirement is not an  
appropriate means for dealing with such misappropriation, so therefore, we have to make sure not 
to include it in the intellectual property system.  
In addition, this delegation b elieves the WIPO IGC is the most appropriate forum for holding 97.  
technical discussions on Genetic Resources, Traditional Knowledge and Folklore from the  
perspective of IP. Based on the mandate that was renewed at the last WIPO General Assembly, 
the 35th Sess ion of the IGC will be held next month and deal with issues regarding genetic 
resources. Japan remains willing to contribute to discussions on these issues in a  constructive and 
effective manner.  
5.15 Switzerland   
Our delegation would like to reiterate its conviction that, among other fields of technology, 98.  
the field of biotechnology holds particular promises for the people both in developing and 
developed countries. Investments in research and development of new  biotechnological products 
however depend on a reliable and effective patent and court system, among other critical, 
macroeconomic factors.  
While Switzerland, in the review of Article 27.3(b), cannot support measures proposed which 99.  
would ultimately lead to  the lowering of the level of patent protection for biotechnological 
inventions, it is in favour of increasing the transparency in patent applications by introducing 
a disclosure requirement.  We believe that such a requirement would be an adequate way to a dd 
legitimacy and promote a  better understanding and acceptance of the benefits of the patent 
system.  Addressing the concerns of many Members, we also believe that Art. 27.2 in conjunction 
with Art icle 27.3(b) already provides for sufficient flexibility to  opt for the exclusion of certain 
inventions as a precautionary measure that a national legislator may take - always within 
the scope of the Agreement.  
The TRIPS issues, consisting of the GI -register, the GI -extension as well as the requirement 100.  
for disclos ing the source of genetic resources and traditional knowledge in patent applications, 
remain on the table.  The three topics have been on the agenda for quite some time and draft 
modalities language was submitt ed to the TRIPS Council in 2008, in submission IP/C/W/ 52. 
Switzerland would like to reiterate that a large group of Members continues to be interested in 
substantially advancing the three issues in parallel in the WTO, and we continue assessing t he best 
way forward after MC11.  
Switzerland also supports  the proposal for an update of the factual notes.  101.  IP/C/M/88/Add.1  
 
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  5.16 Australia  
Australia considers the WIPO IGC  is the best place to address the complex intellectual 102.  
property issues relating to genetic resources and associated  traditional knowledge. We are pleased 
that the WIPO IGC will continue its mandate and work to progress these important issues over 
2018 and 2019. As we have said at previous TRIPS Council sessions, Australia considers the TRIPS 
Agreement and the Conventio n on Biological Diversity are consistent. Australia fully implements 
our obligations under both agreements which we view as mutually supportive.  
In relation to procedural matters, Australia continues to be open to a briefing by the CBD 103.  
Secretariat on the N agoya Protocol and can be flexible in relation to the Sec retariat  updating 
the three factual notes.  
AGENDA ITEM 6: NON-VIOLATION AND SITUAT ION COMPLAINTS  
6.1 India   
Opposition on this issue remains unchanged. Serious concerns remain on the debilitating 104.  
impact  non-violation complaints in TRIPS can have on the reg ulatory policy space of M embers, on 
TRIPS flexibilities as well as increasing the complexity in interpreting  the TRIPS provisions. It can 
not only have a chilling effect on Member's exercise of their IP regimes but also severely restrain 
ability of Members to achieve other public policy objectives.  
The absence of non -violation complaints in the TRIPS context doe s not in any manner 105.  
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 rights of IP right holders ver sus 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 the WTO Members. Any benefits arising from 
the Agreeme nt can be adequately protected by applying the text of the Agreement in accordance 
with accepted principles of international law, and without introducing the legally uncertain notion 
of non -violation and situation complaints.  
We look forward to work with l ike-minded Members in making non -violation complaints 106.  
inapplicable to TRIPS. We also wish to reiterate that until there is a consensus on the scope and 
modalities of the applicability of NVCs to TRIPS, NVC will not apply to the TRIPS Agreement.  
6.2 South A frica 
On this item, I think, my delegation has been consistent in the past and has indicated some 107.  
sort of flexibility to have an open -ended discussion, specifically in our last intervention in this 
particular house. We in dicated that , as articulated by the TRIPS Council Chairperson in May 2003, 
there are  four possible outcomes  to discussion of NV SCs. S ome Members have had the opinion 
that such complaints should not apply as India has indicated, other Members have indicated  that 
these types of claims should apply.  
To this delegation's thinking, there may be some basis for discussion as to possibl y 108.  
identifying how modalities could apply, should we get to a situation once again in 2019 that we 
have had two years to discuss the matter and at the last Council meeting we still do not have any 
recommendations to make to our Minister s. In this respect, di scussions should be at least amongst 
those  delegations that are situated and that are able to do so to identify possible modalities and 
what they would mean.  From this delegation's perspective, it would seem that proponents of the 
application of NVSCs  under the TRIPS Agreement have not provided concrete examples of the kind 
of scenarios under which an otherwise TRIPS consistent measure would impair or nullify benefits 
beyond those arising from the obligations set out in the Agreement. Thus, it may be useful  to 
clarify what situations proponent Members wish to avoid by having a non -violation remedy 
available under the TRIPS Agreement and , on the other hand , to ensure that non -violation 
remedies in the TRIPS context would not be so broad as to have the  effect of expanding the 
existing TRIPS obligations or nullifying flexibilities that have accrued to Members in this regard.  IP/C/M/88/Add.1  
 
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  6.3 China   
China wishes to reiterate its position on this issue. Regarding the non-violation and situation 109.  
comp laints, C hina appreciates the efforts made by delegations in Buenos Aires and welcomes the 
outcome on this issue. China would also like to thank you, Madame Chair, for your hard work 
before MC11 to help Members reach a consensus on this issue.  
China reaffi rms its position that the non -violation and situation complaints are not applicable 110.  
under the TRIPS Agreement, as elaborated in the document I P/C/W/385/R ev.1 proposed by 
16 Members including China. We welcome the discussion on this issue in accordance with  the 
decision and mandate given by the Buenos Aires Ministerial Conference.  
6.4 Brazil   
The recent decision agreed at the Ministerial Conference in Buenos Aires is the seventh time 111.  
such extension of the moratorium is approved b y Ministers, in addition to the initial five-year 
moratorium set in Article 64.2. It shows a continuous consensus by Member s that such provisions 
suffer from lack of clarity.  
Twenty -three years after the TRIPS Agreement was finalized, the ordinary dispute 112.  
settlement procedure available to Members under Article 64.1  has proved itself adequate to ensure 
compliance with the provisions of the TRIPS Agreement. It has been invoked and used with great 
success in the past and no concrete case of the necessity for e xtending the mechanism to NVSC 
was presented by demandeurs. In fact, the extension of NVSC to the TRIPS Agreement could pose 
additional and unnecessary burden on the dispute settlement mechanism, in light of the worrisome 
situation of the Appellate Body ca used by one country, which is blocking the launch of the process 
to fill the vacancies of the AB.  
Further, the applicability of NVSCs would endanger the use of flexibilities relevant to attain 113.  
the objective of the protection of intellectual property as set  out in Article 7 of the TRIPS 
Agreement.  
In short, the application of NVSC to IP disputes would generate systemic imbalances and 114.  
reduce the legal certainty of multilateral IP law. In light of the above, Brazil reiterates its 
understanding that non-violation and situation complaints should not be applied to the TRIPS 
Agreement.  
6.5 Bolivia, Plurinational State of  
Bolivia's position on this issue is well known. As far as Bolivia is c oncerned, non-violation 115.  
complain ts are not  applicable in the TRIPS environment. The nature of rights and obligations as 
well as benefits are detailed in the Agreement itself and the benefits that Governments have 
decided to grant to each other has established a delicate balance which would be negatively 
affected if we brought non -violation complaints in and that would generate a great deal of 
uncertainties. This is the feeling of the overwhelming majority of WTO Members and this Council 
should proceed according to that re ality and adopt a decision whereby non -violation complaints do 
not apply to the TRIPS Agreement.  
6.6 United States of America  
For the reasons we have detailed in our previous interventions under this agenda it em, we 116.  
continue to believe that the drafters of the TRIPS Agreement envisioned that NVNI complaints 
should be available.  
We also believe that while valid questions have arisen , they are fully and adequately 117.  
answered by the text of the TRIPS Agreement itse lf and further clarified through GATT and WTO 
adjudication as we have enumerated in our communication to the TRIPS Council, which was 
circulated to the Members as IP/C/W/599, as well as in our recent interventions.  
We also take this opportunity to confirm that while the moratorium on NVNI disputes under 118.  
the TRIPS Agreement was extended in December for an additional two years, the United States IP/C/M/88/Add.1  
 
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  continues to maintain its long -held and firm position that NVNI disputes should be applicable to 
the TRIPS Agreemen t, that they are fully consistent with the TRIPS Agreement and that the 
application of such disputes in this context was the intent of the drafters of the TRIPS Agreement.  
We took note of several issues on this topic raised by Members during recent meeting s of 119.  
the TRIPS Council , and would like to take time to briefly address them today to help dispel 
misconceptions and alleviate concerns.  
First, some Members asserted that NVNI claims could undermine regulatory authority and 120.  
limit ability of a Member from u ndertaking policies to promote ce rtain public policy objectives.  
The United States is of the view that the availability of non -violation complaints will protect 121.  
Members from intentional 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.  
Further, non -violation complaints will only be successful if they could not have been foreseen 122.  
when the Uruguay  Round negotiations we re under way. Because 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 those  goals.  
During a recent session, some Members asserted that "non-violation and situation 123.  
complaints are unnecessary to protect any balance of rights and obligations inherent in the TRIPS 
Agreement ". The application of non -violation complaints was clearly envisione d by the drafters of 
the TRIPS Agreement , as evidenced by the language of Article s 64.1 and 64.2 which explicitly 
state that , after five years , complaints under Article XXIII.1 (b) and (c) of GATT would be available 
under the  Agreement. Therefore, the Unite d States is of the view that these drafters intended for 
non-violation complaints to constitute an additional obligation to Members that is not expressed 
elsewhere in the pr ovisions of the Agreement. Disallowing Members from having recourse to this 
remedy is the action that upsets th is balance.  
Some Members have suggested that application of these complaints to IP disputes would 124.  
"generate systemic imbalances and reduce the legal certainty of multilateral IP law ". We do not 
view this to be the case and question whether the inapplicability of such complaints serves to 
reduce certainty for Members. Non -violation complaints serve an interest all WTO Members share, 
which is to assist Members in protecting against measures that nullified or impaired concessions.  
WTO adjudicatory bodies will continue to be bound by Article 3.2 of the DSU , which clearly 125.  
states that "[r]ecommendations and rulings of the Dispute Settlement Body cannot add or diminish 
the rights and obligations provided in the covered agreements ". Furthermore, past GATT and 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.  
Finally, non -violation complaints are an "exceptional " remedy. The United States considers it 126.  
unlikely that a limited remedy such as a non -violation complaint would have the destabilizing 
impact that concerns some Members. GATT and WTO panels have acknowledged the need fo r 
caution with respect to such complaints, noting that they "should remain an exceptional remedy ".  
Adjudicative bodies have also noted "[t]hat reason for this caution is straightforward. 127.  
Members negotiate the rules that they agree to follow and only excep tionally would expect to be 
challenged for actions not in contravention of those rules. "  
The United States hopes that this information has been helpful to explain our position on this 128.  
matter and address concerns raised by Members. We continue to believe t hat 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 
applicable to the TRIPS Agreement.  IP/C/M/88/Add.1  
 
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  6.7 Argenti na  
Argentina's position on this matter is well known and remains unchanged. We believe that 129.  
complaints of this type are not applicable to the TRIPS Agreement. This position is based on 
the arguments set forth 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 constructive discussions on 
this issue with a view to finding an acceptable and permanent solution.  
6.8 Haiti – on behalf of the LD C Group   
I am making this statement on behalf of the LDC Group , though we don 't expect this to 130.  
apply to all LDCs. Our group is pleased with the Ministerial decision WT/MIN17/66 
from13 December 2017 adopted by the Trade Ministers in Buenos Aires  at the conclusion of MC11 . 
The Ministerial Decision invited Members to continue their examination of the scope and modalities 
for the types of complaints provided for under subparagraphs 1(b) and 1(c) of Articl e XXIII of the 
GATT 1994 and to make recommendations in anticipation of the Twelfth Ministerial Conference.  
The LDC Group encourages Members to carry out this examination in order to prepare 
recommendations for the Ministers. To that end, it urges Members to work towards a consensus 
solution.  
6.9 Switzerland   
Despite the decision in Buenos Aires to extend the moratorium for another two years, 131.  
Switzerland continues to take the view tha t non-violation and situation complaints  also apply 
under the TRIPS Agreement. The TRIPS language is very clear in that respect.  
Non-violation complaints are an exceptional remedy to provide predictability and security to 132.  
all Members under the TRIPS Agreement, just as they do under the GATT and GATS. Having said 
that, they also preserve Members ' ability to implement legitimate social, economic, development, 
health, envir onmental and cultural policies.  
The rules for a non-violation case are strict. The principles of GATT Article XXIII:1(b) apply 133.  
and there is additional guidance from past panels. We also recal l that one key condition for a 
non-violation complaint to succeed is that the measure complained could not have been 
foreseeable.  
In Buenos Aires, Ministers once again renewed the TRIPS Council 's mandate to continue its 134.  
examination of the scope and modalities for non-violation complaints , and make recommendations 
to Ministers at the upcoming Ministerial Conference. As repeatedly stated, we believe that 
the GATT and the DSU provide appropriate gu idance on the applicability and use of non -violation 
complaints in the context of the TRIPS Agreement.  
A number of panels and the Appellate Body have con ducted significant analysis of 135.  
non-violation provisions. These decisions provide WTO Members with the n ecessary scope and s et 
of modalities applicable to non-violation complaints also under the TRIPS Agreement.  
With the objective of ending the constant renewal of the moratorium, the TRIPS Council 136.  
should eventually move ahead. The purpose of the moratorium, as stated in TRIPS Article 64.3, 
was for Members to have the time to discuss the scope and, if found necessary, special mo dalities 
for the TRIPS context.  
Switzerland is open to consider specific proposals, which allow for the concrete examination 137.  
of the sc ope and modalities for Non -Violation and Situation C omplaints under the TRIPS 
Agreement. Switzerland stands ready to participate in a constructive manner in such discussions.  
We hope that the TRIPS Council, over the next 22 months, will be able to make pro gress in 138.  
this important matter and fulfil its mandate under Article 64.3 of the TRIPS Agreement.  IP/C/M/88/Add.1  
 
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  6.10 Japan   
Regarding this issue, the delegation of Japan would like to express its sincere gratitude for 139.  
the continuous efforts ma de by the Chair and Members in the discussions before and during 
the MC11.  Meanwhile, this delegation also recognizes that the Members have not yet reached 
consensus on the applicability of non -violation and situation complaints in the area of TRIPS.  This 
delegation is willing to engage in discussions in a constructive and practical manner.  
6.11 Ecuador  
We would like to acknowledge the Buenos Aires Ministerial decision approving an extension 140.  
of the moratorium. Our delegation ma intains its well-known position that non -violation complaints 
are not applicable to the TRIPS context , as indicated in document IP/C/W/385/Rev.1  co-sponsored 
by Ecuador. However, our delegation will continue to participate proactively with a view to 
reachi ng a mutually satisfactory agreement in the run -up to MC12.  
6.12 Canada  
Our position on this issue is well -known and remains unchanged. Canada continues to have 141.  
concerns regarding to the applicability of the NVNI remedy to the TRIPS Agreement. Recognizing 
that the current moratorium exists  based on consensus , we nevertheless t rust that Members can 
continue to discuss these issues in a collegial manner in the TRIPS Council especially in light of 
the high concentration of Members with concerns in this area.  
AGENDA ITEM 7: REVIEW OF THE IMPLEM ENTATION OF THE TRIPS  AGREEMENT UNDER 
ARTICLE 71.1  
No statements were made under this Agenda item.  142.  
AGENDA ITEM 8: REVIEW OF THE APPLIC ATION OF THE PROVISI ONS OF THE SECTION 
ON GEOGRAPHICAL INDI CATIONS UNDER ARTICL E 24.2  
No statements were made under this Agenda item.  143.  
AGENDA ITEM 9: FOLLOW -UP T O THE FIFTEENTH ANNU AL REVIEW UNDER 
PARAGRAPH  2 OF THE  DECISION ON THE IMPL EMENTATION OF ARTICL E 66.2 OF 
THE TRIPS AGREEMENT  
9.1 Haiti – on behalf of the LDC Group   
The LDC Group would like to congrat ulate you on the way you conduct the business of this 144.  
Council . This issue of technological progress is key for our development, which is why 
the implementation of Article 66.2 is so important and we seek to provide incentives to facilitate  
technology transfer towards LDCs.  
Since 1999, after 15 annual reviews, a failure to fully implement Article 66 .2 has been 145.  
observed. The notifications of developed country Members do not always reflect the expectations 
of LDCs. At the last review on this i ssue, the LDC Group commented on a divergence between the 
LDCs' views of concepts such as "incentives" and "viable technological base" and those of 
developed countries.  We also took note of communications aiming to define what "technology 
transfer" is cons idered to encompass . 
With regard to this observation, the LDC Trade Ministers came to a decision, in 146.  
the Declaration they adopted in Buenos Aires on 9  December  2017, on the effective 
implementation of the letter and spirit of Article 66.2 of the TRIPS Agre ement . And on the basis of 
the foregoing , the LDC Group prepared  a proposal and circulated it to Members for their 
consideration in  document IP/C/W/640 of 16 February  2018, requesting that the Council deliberate  
on the following issues:  IP/C/M/88/Add.1  
 
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  1) that developed coun try WTO Members should mention only incentives for technology 
transfer to LDCs in their reports, thereby making the latter more specific, with a targeted 
content;  
2) on the meaning of "incentives to enterprises and institutions" found in Article 66.2, and 
agree on possible ways to provide incentives by developed country Members to their 
enterprises and institutions in order to implement the letter and spirit of that provision . 
During the discussions, Members will have to focus on the issue of whether condition s for 147.  
participating in contracts tendered by their governments, to be implemented in LDCs, involve 
incentives for technology transfer related to the commitment in Article 66.2 and provision of 
royalties as an incentive when technologies are transferred by enterprises in developed countries 
to LDCs.  
At each session of this Council, we hear that it is difficult for developed country Members to 148.  
influence the activities of their private enterprises. While it may be true that it is the enterprises 
that develop a nd own their technologies, it is no less true that governments create a favourable 
environment through purchase contracts. Mandatory and contingent clauses in these contracts 
could serve as a means of providing support within LDCs or in the context of publ ic bidding for aid 
projects in LDCs. These can include contracts similar to those described in Members' submissions, 
including the EU submission for this session of the TRIPS Council. In this case, eligibility for some 
of the contracts could be conditioned  on the enterprise's bid including a technology transfer 
component in favour of the recipient LDC.  
By means of this communication, the LDC Group aims to expand on the instructions provided 149.  
by our Ministers in Buenos Aires, in paragraph 3.7 of document WT/M IN(17)/40, and to stimulate 
discussion in order to find creative ways to effectively implement Article 66.2  
The LDC Group hopes that, after these exchanges, Members will be able to take a decision 150.  
on the scope of the obligations regarding these incentives . With respect thereto, it  invite s Members 
in this Council to prepare a precise and detailed report  on the implementation  of Article 66.2 and 
on the impact on viable and sustainable  technology transfer with a view to creating a sound and 
viable technological base in our countries.  
9.2 Bangladesh  
My delegation associates with the statement made by Haiti on behalf of LDCs.  151.  
The delegations, who attend the annual review workshop regularly, are perhaps aware of 152.  
the concerns we have raised in our submission IP/C/W/640. Article 66.2 maintains I quote  
"Developed country Members shall provide incentives to enterprises and institutions in 
their territories for the purpose of promoting and encouraging technology transfer t o 
least-developed country Members in order to enable them to create a sound and 
viable technological base"  
 In our understanding, Article 66.2 fi rst requires developed country M embers to provide 153.  
incentives to enterprises and institutions in their territori es and second, purpose of such incentives 
must be promoting and encouraging technology transfer to l east-developed country Members.  
We are thankful to the WTO membership for agreeing to a mechanism on implementation of 154.  
Article 66.2 through notification and  annual review 15 years back. During the last 15 year s, 
developed country M embers made notifications on regular basis informing us various initiatives, 
they have taken during this period. According to an estimate, we already have more than four 
thousand pa ges of notifications.  However, we are not sure whether the measures and initiatives 
they have referred to in those notifications fall under the Article 66.2. We have not found any 
provision for incentive to the enterprises in the territory of developed cou ntry targeted towards 
promoting technology transfer to LDCs.  We have raised our concerns in each annual review 
workshop, but we have not received any satisfactory response. For this reason, in order to bring 
clarity in the  implementation of Article 66.2 , more specifically incentives to enterprises and 
institutions in the  territory of developed country M embers for promoting technology transfer to 
LDCs, our Trade Ministers in the meeting held in Buenos Aires  have instructed us to raise  the issue IP/C/M/88/Add.1  
 
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  in the TRIPS Council. Accordingly, we have submitted our proposal. We  sincerely hope that the 
TRIPS C ouncil will have constructive discussion in identifying the incentives referred to in Article 
66.2. My  delegation is ready to engage in discussions in any format with a  view to coming up with 
a decision by the next TRIPS Council meeting.  
9.3 United States of America  
The United States attaches great importance to this review with respect to the obligations 155.  
under Article 66.2. Our submission in 2017 , IP/C/W/631/Add.2 details the IP , trade capacity 
building, training, developmental assistance, educational, financing, entrepreneurship and 
infrastructure -related programmes aimed to support LDCs and fostering the necessary 
environme nt to encourage the effective , voluntary transfer of technology to LDC Members.  
The United States continues to believe that the effective functioning of Article 66.2 of 156.  
the TRIPS Agreement requires a robust dialogue between de veloped country and LDC Member s in 
order to target incentives in a way that is most responsive to the self -identified technology transfer 
interests and needs of LDC Members. We look forward to future opportunities to continue this 
important conversation.  
At the same time, United States  cannot support the Article 66.2 implementation proposal 157.  
communicated on behalf of the LDC Group by Cambodia and presented this morning by Haiti. In 
terms of the proposal as it pertains to the scope of annual implementation reports, we are not 
persuaded th at there is a problem in need of a solution or that the solution proposed is workable. 
In terms of the perceptions of an existing problem, the annual reports of the United States clearly 
identify programmes benefitting LDC Members and specifying which LDC s have been beneficiaries 
in the prior year. Accordingly we are not aware of a problem inhering  in the scope of the US 
reports. Without a clear understanding of the perceived problem, the United States is unable to 
lend support to the proposal to limit the scope of future reports.  
In terms of workability, we recall that the decision of the TRIPS Council calls for 158.  
"an overview of the incentives regime put in place to fulfil the obligations of Article 66.2, including 
any specific legislative, policy and regula tory framework ". In the experience of the United States, 
such frameworks may not be strictly limited in  eligibility or benefits to least developed country 
Members , yet the full scope of relevant incentives for LDC Members cannot be conveyed without 
such a discussion . It therefore appears unworkable for a report to be strictly limited in some way 
to programmes only benefiting LDC country Members. In fact, such a requirement could interfere 
with the ability of the developed country Members to describe the ful l scope of their incentive 
legislative , policy , and regulatory frameworks. From the perspective of the United States,  
therefore, the LDC proposal would undermine long -standing and beneficial reportin g requirements 
of the  decision.  For these reasons, the sc ope-related portion of the LDC proposal appears unclear 
in terms of the problem being addressed and unworkable in its application.  
Additionally, the LDC Group propos es that the TRIPS Council deliberate on the meaning of 159.  
the phrase "incentives to enterpris es and institutions " with the apparent intention of reaching 
recommendations to developed country Members on such incentives. The LDC Group additionally 
proposes that this deliberation include an  examination of particular terms  of contractual 
arrangements,  including on royalties entered into by participants. As consistently indicated by the 
United States and others, technology transfer can proceed most effectively if it is had on voluntary 
and mutually agreed terms. Such terms must be arrived at by the invo lved parties , and not terms 
recommended or imposed  by this Council.  
In addition to technology transfer being a voluntary effort, mutually agreed between parties, 160.  
the environment in which the parties are seeking to operate cannot be overlooked. For example, 
a company may be willing to work with the US Agency for Internation al Development to transfer 
a manufacturing technology to an LDC that has an intellectual property system in which their 
technology could be protected , but no amount of incentive s or encouragement would result in 
them transferring the technology to a countr y in which those rights would not be protected. As a 
result, there is no one  size fits all approach that can be agreed upon at an international level.  
For these and other reasons, the United States does not support the proposal of the LDC 161.  
Member countries  on the implementation of the Article 66.2.  IP/C/M/88/Add.1  
 
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  9.4 Japan   
The delegation of Japan would like to express its sincere gratitude for the efforts made by 162.  
the LDC group to prepare the document (IP/C/W/640) for consideration. In particula r, this 
delegation would like to appreciate and welcome the intention of LDCs to discuss the issue of their 
interest in a practical manner in the body of the WTO which is the most relevant to the issue.  
Needless to say, this delegation recognizes the impor tance of Article 66.2 of TRIPS for LDCs, 163.  
particularly when, taking into account their economic, financial and administrative constraints.  
This delegation believes that any measures that enable LDCs to create a sound and viable 164.  
technological base would be recognized as "incentives to enterprises and institutions ", as 
stipulated in Article 66.2. In this regard, training programs and fundamental -administration 
enhancement such as capacity -building to run sound intellectual property systems  are good 
examples o f the incentives.  
Moreover, as to the point mentioned in the report about implementing Article 66.2, 165.  
the delegation of Japan would like to mention that Japan has prepared its report specifyi ng 
incentives provided to LDCs.  
This delegation would like to high light that this TRIPS Council and, in particular, the annual 166.  
Workshop dedicated to discussing Article 66.2 would provide us with useful platforms for practical, 
evidence -based discussions on this topic. This delegation looks forward to fruitful exchange of  
views on this important issue using such occasions  
9.5 Switzerland  
Switzerland would like to thank the LDC Group for its proposal IP/C//W/640 on the 167.  
implementation of Art icle 66.2 which raises important questions to be loo ked into.  We will yet need 
to analyse it  in more detail.  Thank you also for the query that we received as follow -up to our 
2017 report which we will take up with our lead  agencies in charge of the relevant matter in 
capital.  
9.6 European Union  
The EU's report of last year once more confirms that the EU and its member States take 168.  
their commitments and obligations under Article 66.2 TRIPS seriously and fulfil them. Moreover, 
both the EU and its member States gave proof to p romptly react to natural, social, health, climate 
and economic changes by putting in place projects specifically tailored to the current needs of 
LDCs and their regional organizations.  
Technology transfer refers to the ways and means through which companie s, individuals and 169.  
organizations acquire technology or know -how from third parties, whether such technology is IPR -
protected or not, including know -how. 
However, technology transfer is often one component of a more complex project, rather than 170.  
a stand -alone activity. The acquisition by LDCs of a sound and viable technological base does not 
indeed depend solely on the provision of technology or equipment, but also on acquisition of know -
how, management and production skills, improved access to know ledge sources as well as on 
adaptation to local economic conditions.  
Therefore, training and education of university graduates, exchanges of qualified staff, and 171.  
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 countries. Several 
projects put in place  by the European Union and its m ember States are accordingly aimed at 
providing such training and education.  
One of the most important pre -conditions of technology transfer is the improvement of 172.  
the absorption capacity of LDCs. Absorptive capacity can be defined as availability of human IP/C/M/88/Add.1  
 
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  capital and presence of technological capability and other factors, such as a ccess to finance and 
infrastructure, which helps assimilate and replicate knowledge gained from external sources. 
Absorptive capacity is key for diffusion of any knowledge, originating domestically or abroad, and 
thus for determining how technology can con tribute to economic transformation and "catching -up" 
of a country. It can also influence technology holders' incentives to promote transfer and diffusion 
of knowledge. Policies aimed at improving absorptive capacity can help to remove some of the key 
bottlenecks to technology transfer, particularly in least developed countries.  
Aimed at increasing the ability to absorb, internalise and utilise new knowledge, absorptive 173.  
capacity policies encompass a wide range of measures addressing 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.  
Most projects that deal with sectors such as energy, water, agric ulture, governance and 174.  
infrastructure result in transfer of know -how and technology. Moreover, their prolonged duration 
reflects the goal of helping local forces to develop independent systems in the concerned sectors.  
In our efforts to encourage and promo te technology transfer, as governments we are limited 175.  
by two factors:  
 First, we do not own the vast majority of such technologies. It is clear that the private 
- and particularly the commercial - sector is nowadays the main source of technologies.  
 Second, we cannot force the private sector to transfer its technologies. Incentives can 
therefore  only take the form of encouragement, promotion and facilitation of projects 
which are part of a global and comprehensive approach to development.  
However, by making p ossible through public money and public -private partnerships 176.  
the numerous projects cited in the EU 's 2017 report, the EU and its m ember States facilitate and 
encourage technology transfer in line with its obligation of Article 66.2 of the TRIPS.  
Finally, i t should be noted that EU actions usually target groups of countries or regions. 177.  
The reason is because the EU supports regional integration as often specific development problems 
can best addressed region -wide. Those problems do not always stop at borders.  In addition, such 
a regional approach fosters better understanding and political and economic links between 
neighbouring countries. That is why many technology tra nsfer programmes of the EU and m ember 
States target regions including both LDCs and also oth er developing countries.  
9.7 Australia  
We were pleased to present Australia's report at the Article 66.2 workshop at our last 178.  
meeting in 2017. Australia has participated in these workshops since their inception in 2008. They 
are useful forums for exchanging views and have positively influenced how Australia prepares our 
reports and shares information. Australia notes the communication circulated by the delegation of 
Cambodia on behalf of the LDCs Group regarding the implementa tion of Article 66.2. Australia is 
committed to assisting least developed countries through technology transfer pursuant to 
the Council's decision on the implementation of Article 66.2. Australia fulfils its commitment in this 
regard by providing its repor t in the preferred template and participating actively in the workshop.  
9.8 Banglad esh 
We are grateful for t he initiative s taken by developed countries , which help us in many 179.  
areas . The question is , first,  whether the measur es to which they have referred are all measures  
that facilitate technology transfer . We need to know what types of incentives they are providing to 
the enterprises and institutions in their territories . While notifications may  amount to  more than 
5,000 pages, we see  technical assistance  projects but not incentive s provided to the enterprises 
and institutions in their territories. The second question is that t here is no specificity regarding to 
LDCs. IP/C/M/88/Add.1  
 
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  You provide incentives to importers by exempting import ers from custom dut ies when you 180.  
import from LDCs or developing countries. That is the type of incentive we are talking about. 
That's why we request Members to have a discussion to bring clarity in the incentives mechanism . 
9.9 Haiti on behalf of the LDC Gr oup 
The Group of LDCs would like to thank the delega tions who have taken the floor on 181.  
the proposal that I have presented. Having heard the interventions of Members and particularly 
the intervention of t he United States, I believe that the group of LDCs has not requested the TRIPS 
Council to deliberate on what could occur between an institution in a developed country, and an 
institution in an LDC. The group of LDCs is only requesting that the Council deli berate on two 
points.  
The first is simply the concept of technology transfer, because the way in which the reports 182.  
are represented sometimes prevents some understanding exactly what is and what is not 
technology in technology transfer.  
Secondly, the group of LDCs is requesting that the Council deliberate on this concept of 183.  
incentives. What is an incentive for the developed countries? Because sometimes in some reports, 
what is being provided as an incentive is not even mentioned. During the last workshop whe re this 
issue came up, we didn't really find any replies or responses to whether there were incentives 
there or not. It has been noted that certain Members mix everything together in a certain way, 
between the implementation of Article 67 and Article 66.2,  which sometimes makes the reports 
not so user -friendly. So what the group of LDCs would like is not so much what is happening 
between an enterprise in a developed and developing countries, knowing if there is an incentive 
there. Everything else is somethi ng that should occur between the enterprise and  the LDC in 
question.  
The group of LDCs remains engaged with regard to this matter and we stand ready to 184.  
discuss and have dialogue with any concerned Member or any Member that wishes to discuss this 
matter with the group on the implementation of Article 66.2 in order to gain a better 
understanding and an  effective implementation of this provision.  
9.10 Benin  
The delegation of Benin would like thank all the developed and developing partners who by 185.  
various initiatives are trying to encourage transfer of technology to LDCs. We really would like to 
express our appreciation to them, but also to say that we can do better than what has been done 
up until now.  
Bangladesh and Haiti have clea rly highlighted that for 15 years we have received  reports 186.  
consisting of thousands of pages, we have each time had to go through all of these reports and we 
should recall that , in 2016 and 2017 , we did highlight that there were many items in the reports 
where there was mention of cases of developing countries , namely  that middle -income countries 
or even higher -income countries appear ed in the reports as beneficiaries of projects targeting 
technology transfer.  
This poses a problem for us as LDCs and we have requested that these reports be targeted . 187.  
Haiti has tried to demonstrate earlier that this targeting would allow us to identify exactly what the 
specific projects are looking to LDCs which would allow for the transfer of know -how and 
technology that we do not possess and to also to know how viable this transfer of technology and 
know -how is to LDCs. Here we completely agree with the European Union, where they have 
highlighted that an environment should be established with infrastructure, absorption capacity , 
know -how and transfer of technology, and we also agree with Japan, where they have stated that 
this should be a healthy environment established with regard to regulatory and administrative 
capacity. This should be established and strengthened and this co uld go some way to responding 
to the United States to ensure that technology that is transferred is secured . We agree that this is 
part of the incentive that we are speaking about. The  incentive has to be upstream and 
downstream, on the LDC -side, putting i nto place the capacity building capacity of LDCs, training 
personnel on the ground . You can take ownership of this know -how effectively and take ownership 
effectively of this t echnology that is transferred, b ut then on the other side, there is also an IP/C/M/88/Add.1  
 
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  important incentive to grant and it is to this that we are referring to in our second point, looking to 
what is the specific content behind the  concept of an incentive. What specifically are we doing is 
being done by our developed and developing partners who a re able to do so. What are they doing 
to allow their enterprises in the private sector who have developed in hold this technology they to 
be able to voluntarily transfer this technology and knowhow which is essential for the development 
of LDCs.  
I would like to give an example , which comes under the Tokyo International Conference of 188.  
African Development (TICAD) . This saw the establishment of a triangular partnership environment 
for the development and the production of rice. This partnership , for example, allowed a developed 
country, Japan in particular, to place finance at their disposal, but the implementation project had 
to be done by a country which had proven technology for the production at scale of rice. When 
that country was chosen by call for tende r, it was clearly stated in the terms for the 
implementation of the project that  she must be in a position to state that you have transferred 
techno logy to African countries, and w hat we call "Africa Rice ". 
Currently, all African countries beneficiaries of this project are capable of producing and 189.  
increasing their production by hectare in the rice sector. And today, the African continent in less 
than 15 years has been able to more than double its rice production. This is a concrete example, 
and it is what w e are asking for, we are not asking for a miracle, we are not asking for the private 
sector to be forced to transfer, we are not asking for enterprises to be obliged, but setting up 
these incentives consist of leading these companies to develop and possess  technology to do so 
via contracts, via concrete projects to incentivise them to do this.  
A second example is the case of South Korea. In order to develop the TGV in South Korea, 190.  
they did not have the technology there for high -speed trains. There were two service providers in 
place who declared that they stood ready to construct and provide high -speed trains for South 
Korea. South Korea chose one over the other because France which was the second was ready to 
transfer technology when constructing. Now South  Korea has become a constructor  and that is 
what we want. It is examples like that which are so important to highlight to allow our developed 
and developing partners to know that there is a way of encouraging technology transfer and we 
have to reflect on t his as Switzerland has stated. We have to reflect on how we can transfer via 
start-ups, via SMEs, via projects with the private sector from developed countries or developing 
countries in a position to do so. Where they can develop these projects in LDCs an d say to 
enterprises if you want to do this, if you accept these conditions, we would choose you. But at the 
end of the project you have to be in a position to transfer the technology and that is what we are 
asking for. And we hope that precise, targeted d ebates can take place to really allow LDCs to 
access to technology and to really be able to boost their development.  
9.11 Brazil  
Technology transfer is one of the expected benefits of the protection of IP and is contained in 191.  
Article 7 of TRIPS, as well as in its Pr eamble.  Recognizing the necessity of special and differential 
treatment of LDCs, Article 66.2 contains an  obligation for developed countries to provide incentives 
to enterprises and institutions in their territory for p romoting and encouraging tech transfer to 
LDCs.  My colleague from Benin has just illustrated that these concrete examples are what is 
intended with this Article.  
While our capital is currently analysing  the proposal of the LDC Group contained in document 192.  
IP/C/W/640, we view it as a good basis for advancing the discussions regarding 
the implementation of this important Article. We already heard today delegations from developed 
countries and LDCs providing their views on the matter . We hope we can continue wi th this fruitful 
exercise in future sessions of the Council. As our colleague from Benin has just stated, "nous 
pouvons toujours faire mieux ". 
9.12 India  
Preamble of the TRIPS agreement reflects a particular balance of rights and  obligation s and 193.  
it clearly recognizes the underlying public policy objectives, including developmental and 
technological o bjectives. Article 66.2 is specific and it cle arly entails developed country M embers to 
provide incentives to enterprises and institutions in their territories for the purpose of promoting IP/C/M/88/Add.1  
 
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  and encouraging technology transfer to least -developed country Members. The Doha Declaration 
on TRIPS and Public Health reaffirmed the commitment  of developed -country Members to provide 
incentives to their enterprises and institutions to promote and encourage technology transfer to 
least developed country Members. In this we second the  view of Brazil and w e welcome 
deliberations here on effective a nd meaningful implementation, in letter and in spirit of this 
important provision.  
9.13 European Union  
At TRIPS Council meetings and in connection with developed Members ' presentation s of the ir 194.  
numerous projects under Ar ticle 66.2, we have often heard the question of what actually qualifies 
as an incentive . When European and European member States' public money is used to finance 
projects by companies and institutions that bring technology to LDCs, it is very difficult fo r me to 
understand why  that cannot be interpreted as an in centive to transfer technology. In my view , 
that would be an  incentive to technology transfer , but I would be open to learn how that is seen 
differently.  
9.14 Benin  
We would like to thank the European Union for that question. We would also like to thank 195.  
them for all their efforts and the public funds from European tax payers that enable this 
technology transfer to happen as we said just a moment ago. You do it so well , but it must be 
done better. Doing it better simply means not compelling enterprises or forcing them to do 
the transfer but when you provide the public funds, please ensure that the enterprises chose n 
from the private sector are in a position to do that t ransfer and that they are accountable to you 
for that transfer because that is where the real problem lies.  
My colleague from Bangladesh said that we can list all these projects , the object of which is 196.  
to transfer technology but ultimately we don't see wha t technology has actually been transferred. 
So incentives can go beyond that money that you are providing and that is what we are trying to 
get at. Even prior to having an  enterprise chosen to go and carry out a project in an LDC of 
developing country, it needs to be established perhaps via some sort of conditional clause that 
says "you will be chosen provided you agree to technology transfer in terms of what you have 
done and whatever country ". For instance, say you build a highway, in a country where the 
technology for that is not in place, you carry out the project, we finance it, but the private sector 
enterprises need to hear from you whether you need to ask them whether they are prepared to 
hand over that technology to the experts in the  country , Benin , Burkina Faso, Burundi , any LDC 
and ensure and ask them whether they agree to transfer their technology to the experts and 
technicians in whatever country. If they say no, then there might be a challenger out there , a 
competitor that might agree.  
There ne eds to be a condition in th at context that would prompt these firms to want to do 197.  
the technology transfer and that takes place throughout the project. Because otherwise you can 
free up billions for projects aimed at technology transfer ultimately, but in a ctual fact, that will 
never happen. And in fact , the heart of the issue is not necessarily the money . You are already 
doing a good job, but let us do a better job together. In fact, we can discuss this together and see 
to what extent we could do this and t hat is why it is so necessary for us to carry on with these 
deliberations here for recommendations to be presented at the Council and to be adopted by 
developed and developing countries in a position to do so to set up th e framework for  technology 
transfe r that way.  
AGENDA ITEM 10: TECHNICAL COOPERATIO N AND CAPACITY BUILD ING 
No statements were made under this Agenda item.  198.  IP/C/M/88/Add.1  
 
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  AGENDA ITEM 11: INTELLECTUAL PROPERT Y AND INNOVATION: SU MMARY OF THE 2017 
THEME ON INCLUSIVE I NNOVATION AND MICRO,  SMALL AND MEDIUM -SIZED 
ENTERPRISES (MSMES):  COLLABORATION, GROWT H AND TRADE; AND 201 8 IP AND 
INNOVATION THEME: TH E SOCIETAL VALUE OF IP IN THE NEW ECONOM Y 
11.1 Japan  
Thank you Madam Chair and colleagues for giving us the opportunity to introduce 199.  
the summary paper of the 2017 theme on Inclusive Innovation and MSME s: Collaboration, Growth 
and Trade (IP/C/W/638) , which was prepared by co -sponsors namely Australia; Canada; 
the European Union; Japan; S ingapore; Switzerland; the Separate Customs Territory of Taiwan, 
Penghu, Kinmen and Matsu; and the United States. The summary paper highlights some of 
examples raised in this council last year and reiterates the value of IP, inclusive innovation and 
MSMEs.   
Regarding the MSME Collaboration, it is mentioned that MSME collaboration is 200.  
multidimensional, and can occur in various ways. In this context, a number of WTO Members 
provide programs or platforms to stimulate partnerships and other cooperative/collabora tive 
undertakings among a variety of entities, and try to enable MSMEs to more readily engage in 
innovation collaborations.  
Regarding the MSME Growth, it is mentioned that MSMEs can achieve sustainable growth by 201.  
using IP. Based on such an idea, several WTO  Members provide means for supporting innovative 
MSMEs to develop effective IP strategies. Moreover, it is also mentioned that establishing 
favourable  IP conditions has positive effects on local growth potential in middle and low income 
economies.  
Regardin g the MSME Trade, it is mentioned that IP rights can help create and maintain value 202.  
added and export opportunities to MSMEs. Therefore, supportive activities for formulating 
appropriate IP strategies overseas are undertaken by many WTO Members.  
In addition , at the Friends of IP and Innovation sponsored side -event on the margins of 203.  
the October meeting, we heard directly from four MSME stakeholders from South Africa, Israel, 
Indonesia and Colombia on the benefits of IP to promote MSME development. The stakeho lder 
presentations highlighted the importance of IP to MSME growth and the pivotal role that 
a government can play as a catalyst for the private sector to grow their businesses and take 
advantage of global opportunities.  
Overall, discussions held during th e three meetings of the TRIPS Council in 2017 provided 204.  
a robust and thorough overview of WTO Members ' national and international IP strategies, both 
from developing and developed countries. WTO Members provided examples of programs and 
policies designed to  promote inclusive innovation and trade opportunities for MSMEs, as well as 
examples of MSMEs applying individual IP strategies which enable them to collaborate, grow, and 
engage in national and international trade.  
Finally, we would like to add that we are looking forward to continuing our discussion and 205.  
sharing our experiences this year on the new theme.  
11.2 European Union   
It is a pleasure to introduce the 2018 IP and Innovation overarchi ng theme "The Societal 206.  
Value of IP in the New Economy". This year we propose that the discussion on IP and Innovation 
could take a new angle examining how IP helps create conditions that encourage investments in 
innovations of all kinds, helping to create new businesses and expand opportunities for individuals 
and societies. IP  protection and enforcement can help promote conditions that encourage risk -
taking , whether in the development of new technologies, new solutions to business challenges, 
new cultural and artistic expressions , and the means to distribute such work to the public. The 
TRIPS Council Members are invited to take part in a three -part exchange this year on how their IP 
intensive industries continue to be a major and an integral part of their l ocal economies and share 
their success stories on how  IP improves everyday lives, builds new businesses and contributes to 
the economic prosperity of our economies.  IP/C/M/88/Add.1  
 
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  The first subtheme is IP intensive industries and their economic impact on society which we  207.  
are proposing to discuss today. Future topics will include IP improving lives, and IP and new 
businesses. And now I would like to hand over the word to Paul Maier, he is the Director of the EU 
Observatory on Infringements of Intellectual Property Rights i n Alicante, to share with us in the 
name of the EU the presentation of the paper.1 
I would like to present a certain number of economic results based on studies which we re 208.  
performed together with a number of other international organisations among which th e European 
Patent Office. The title of the presentation is Intellectual Property Rights Intensive Industries and 
Economic Performance in the European Union. I will actually try to give you as briefly as possible 
the results of three different studies which  deal with the value of the intellectual property in 
Europe.  
The firs t study is an update d study that we had presented already back in 2013 and that 209.  
looks at IP intensive industries as such. It tries to determine the value of intellectual property 
rights in the economy of the European Union. In other words, how trademarks, designs, patents, 
copyrights, geographical indications and plant and variety rights contribute to employment, GDP, 
remuneration and trade. This study was published, this second round, in 2016. 
Then we will look at the second st udy which goes into the firm level as such and we have 210.  
made a specific study also of small and medium -sized enterprises to try to determine their 
approach to intellectual property. Economic study means talking first a little about methodology, 
because it is vital. If you look at the study that I mention now, you will find an  annex of thirteen 
pages and extensive explanations on the methodology , it is important to try and explain how we 
did it, these studies are based on what we call serious data crunching. It is not just subdivided to 
macroeconomic figures and multiplying by some factor , rather the effort was made  to go into the 
filing data of the European Patent Office, our own office where trademarks and designs are 
registered and the plant variety rights , and we looked at all the filings that we had in our 
database . Then the idea was to cut this through a commercial database which is the ORBIS  
database which is a database which includes more than 22 million companies  that are obliged to 
report officially their results. On the basis of this and on the matching of the data between there 
various databases we have managed to obtain solid data, the most solid that you can actually 
have.  
For copyright the situation is a bit  different, because for copyright of course there is no 211.  
registration system , as you well know, so we have based ourselves under WIPO work on 
the definition of the sectors of industry which are considered to be copyright intensive. When it 
comes to geograph ical indications, we took the figures from our colleagues in DG Agriculture which 
simply mention all the sector s exhaustively that live with geographical indications. Again, if you 
want to look at the methodology you have the link here directly so look at this. 
I think it is important to say that these figures are based also , and were compared to 212.  
macroeconomic studies of Eurostat from the year 2011 to 2013, so the averages cover three entire 
years to make sure that eventual incredible drops or incredible increases were wiped out. 
The other element , I would like to say here , is that of course we determine what are the IP 
intensive industries that those in which the sectors in which mor e trademarks than average are 
filed, more patents than average are filed . It is important to say that all sectors of industry and 
agriculture live with and use intellectual property. IPR is essential in the free  market economy . 
Nobody puts on the market a product that has not a trademark to differentiate it from the 
competitor,  nowadays you would not even buy a product which is not well designed, and therefore 
design and trademarks are everywhere.  
You will see that out of the more than 600 sectors of industry as they exist in the NACE 213.  
Classification which is an international cla ssification, 342 were considered to be IP intensive, for 
one intellectual property rights or several. What is interesting to see is the huge overlap of 
intellectual property rights between the various sectors. A  number of these sectors are IP intensive 
in four different areas of intellectual property. There is one which is intensive in GIs, in designs 
and trademarks , that is the distillers' sector for example. Of course, a number of the 
manufacturing sector s would be intensive in designs, in patents, tradem arks and very often as well 
in copyright. In other words, intellectual property rights are all -important, they are all needed for 
                                                
1 This PowerPoint presentation is available in Room Document RD/IP/21.  IP/C/M/88/Add.1  
 
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  industry depending on the type of innovation that we are talking about and the type of marketing 
strategies that want to be pu t forward.  
Let us look now at the results. The results that we found were staggering, 28% of all 214.  
the jobs in the European Union are directly generated by IPR intensive industries during the period 
2011-2013. That is 60  million jobs. In addition, some 10% of these jobs were generated indirectly 
by the industry that supplies goods and services to the IP intensive industries. So, all in all, we 
consider that 82 million jobs in the European Union are directly or indirectly generated, 
safeguarded and made alive by IP intensive industries. As you can see on the right, you have this 
broken down by type of intellectual property right. From the figure that we saw before you can of 
course draw the conclusion that if you add this all up, it will be more than the 38% .  
Trademarks are first intellectual property right in terms of the wideness of its use. In a free 215.  
market economy if you want to go and be competitive, you have to differentiate your product , 
therefore most products, if not all of them that go directly to a c onsumer, bear trademarks. Design 
is number two and patent is number three, when it comes to the contribution to employment. If 
you talk about the GDP, the Gross Domestic Product, 42% of total activity is generated by IP 
intensive industries and there it is  interesting to see that actually patents go above designs. In 
other words, the GDP contribution of patent is higher than the employment in comparison.  
Contribution of IPR -intensive industries to remuneration . Not only do these sectors 216.  
contribute, not only  are they a huge part of the EU economy, but these sectors also , to a large 
extent , provide a much better remuneration to the persons who work fo r them. The average wage 
premium  is by 46%, patent intensive industries being by far the one where the wages ar e the best 
and then followed by copyright. In other words, these jobs are not only many, they are also 
formidably  important, they constitute the future of our economy and the well-paid part of it.  
IP intensive industries contribute to a large extent to the  trade balance of the European 217.  
Union. 86% of what we import in the European Union corresponds to these sectors of industry, but 
93% of what we export corresponds to it. And actually the EU, as well known , has a  trade deficit, 
but thanks to the IP intensive  industry, this deficit is somewhat alleviated. Until now, I spoke of 
the European average, without going into detail, of course this study has all the  details for each 
member  State of the European Union. I wanted to give you just a brief view of what are the 
member States that are above the average and the ones that are below. It is important to say that 
what we look at when we look at employment of IP intensive industries, we  look indeed at the 
entire sector , and there it is interesting to see that Eastern European countries, the newer member 
States of the European Union do particularly well. We will see that patent filing, design and 
trademark filing is higher per capita in t he other countries in the EU, but the production takes 
place to a large extent in the newer member States. This is a sign for us that  the internal market 
of the EU functions well. Everybody protects intellectual property well, intellectual property is 
protected in all the countries, but of course when it comes to production, you would go to lower 
cost zones and this is what this figure actually shows.  The same when it comes to GDP, there are 
some differences though. The countries are not necessarily the sam e, but again , the contribution 
to GDP is higher in average in the Eastern European countries.  
Who files most trademarks? Who files more designs? Who files most patents? Actually here  218.  
what you have is a per capita average of patents filed. So number one is  Luxembourg, country of 
around 400 ,000 inhabitants, of course they are not the number one filer in terms of volume. 
Actually number one filer in the EU of trademarks is Germany, followed by the  United States and 
number three is China now. Same for designs,  again Luxembourg is way in front but in terms of 
volume; it will not be number on e. Number one of course in terms of patents is, in volume, 
Germany and the U nited States, by the way.  
I invite you to look at  this, it is a more detailed figure from the one I showed before with 219.  
the map. It looks at the job creations that can be considered another positive IP R contribution to 
the EU. If you look at Hungary, close to 40% of the jobs in this country are generated by IPR 
intensive industry which do not originate in the country. In other words, 40% of the jobs in 
Hungary are imported, because they correspond to investments to a large extent to IP intensive 
industries from the EU, that is the dark blue  but also other third countries of the EU. And you will 
have the entire list going down to the bottom. Again, this shows that the internal market of the EU 
functions well that where protection is broad is solid in the entire zone, what you will you obtain is 
a transfer of investment towards lower cost parts of the geogr aphical zone.  IP/C/M/88/Add.1  
 
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  The second element I would like to talk about is a second study that we have made, while 220.  
we look ed at individual firms, what we have heard so far is the sectors, now we look ed at the 
individual firms that are part of these sectors. There you  should know that we have actually looked 
at individual firms again , we have made sure that every element of the calculations that we made 
was verified. We started with a sample of more than 2,300.000 companies that are companies that 
pertain to these sect ors. In order to make sure that we have a randomized sample we have 
cleaned this up, we have made sure that the outliers  are taken out, we have made sure that at 
least 50% of these companies also are companies that indeed have patents, trademarks, and 
designs. We have checked that individually.  
On these bases, what are the results? Little more than 10% of these companies are really IP 221.  
intensive, they are not using only one of the IPs, many times several of them. There you have the 
figures of the large comp anies on the right bottom and the small - and medium -sized enterprises, 
because as you will see in a second, we do focus a lot on small - and medium -sized enterprises. 
Only 9.1% of small and medium sized enterprises are really using registered intellectual p roperty 
rights. This may sound small, in fact it is not, you should know that among approximately 
21 million companies that are included in the database, you will have local butchers, the pastry 
shops, these are people who have companies, who are listed, b ut who do not necessarily invest 
heavily  in innovation.  
What are the main results by the number of employees? This is based on a randomized 222.  
sample. In principle non -IP owning companies have an average of 94 employees. This number for 
companies that use int ellectual property jumps to 547. This is considerable, it clearly shows that 
companies that want to grow, have to have intellectual property rights. There is no demonstration 
of causality  here, causality is almost impossible to demonstrate in economic term s, but 
the correlation is ver y solid and difficult to put in to question.  
Let us look at the revenue per employee in the firm. The revenue per employee during 223.  
the year is on average in the EU is €225.000. That is the revenue of the company per employee, 
that is not the payment to the employee. This is increased by 28.6% when it comes to companies 
that use intellectual property rights and even 32% for small and medium -sized enterprises. Again, 
IP owning companies generate much more, significantly more revenue  than those that who do not 
have I ntellectual Property  register ed. Now, if we look at the wages, this is what is payed to 
the employees. There too, the blue bubble in the middle, 19 .8% better pays to the employees for 
these companies. You always have the b reaking down by patent where it is almost 41% , 
trademarks 19% and designs 23%. Clearly, the figures, going into the detail of the companies that 
we have in the EU, show that the revenue of the companies and the revenue, the salaries payed to 
the employees,  are significantly higher in  IP intensive industries.  
I will finish now with small and medium sized enterprises and intellectual property. Small 224.  
and medium sized enterprises correspond to 99% of the companies in the EU and probably 
something like 96% of th e economy of the EU. We wanted to explore if and how innovative SMEs 
position themselves  towards  IPR. We wanted to know what the level of awareness is, 
the relevance of IPR, why some SMEs register or not intellectual p roperty rights, as we saw, only 
9.1% h ave registered IPRs. What types of IPR are used and what are the  constraints? In other 
words, we wanted to understand better the positioning of intellectual property. There we had to 
proceed by a telephone survey, there you cannot obtain data directly from  any database. We 
interrogated close to 9000 small and medium -sized enterprises all over Europe to try to obtain 
results and answers to our questions. From those that we have used in the  sample, 66% do not 
use IPR, 34% do. When it comes to the very small S MEs, small and medium ones, there the 
figures correspond a bit differently.  
What are the key findings? The majority of small and medium -sized enterprises believe that 225.  
they are innovative , so entrepreneurs think they are innovative. It is a good thing to kn ow. The 
level of innovation does not always match their perception though, a  bit of optimism. The  majority 
of small and medium sized enterprises are not familiar with intellectual property rights , and t his is 
one of the major challenges that we have to fac e in the EU Observatory. Now, why would SMEs 
actually register IPRs? To prevent copying, gaining better legal certainty and increase their value 
and image. However, a strong majority of companies that have registered IPR believe that it has 
had a very posi tive or positive attitude and impact on their businesses.  IP/C/M/88/Add.1  
 
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  The usage of I ntellectual Property Rights as it is measured in the study. The main problem 226.  
for small and medium sized enterprises, that do not use IP is that they consider that the  cost and 
the leng th of procedure is too important, which is why our I ntellectual Property  Office is making 
such efforts to make sure that everything can be filed online, that the fees for registrations are as 
low as possible. And we have lowered the fees for an EU trademar k from €2500 back in 1996 to 
€850 now.  
Reasons for registering, the five reasons, I mentioned three of them earlier. I would like to 227.  
finish with the last slide here, which is the perceived impact of registering IPRs. There are three 
main impacts:  
1) increased  reputation or image of reliability of the company that is 78%.  
2) 58% of the leaders of these companies think that s trengthening the long-term business 
prospects is essential a nd therefore they need to have IPRs. 
3) and in 57% of the cases, these people consider that filing IPRs has directly i ncreased their 
turnover.  
These are the links of the three studies that I have mentioned. You can find them in our 228.  
website together with another 38 studies of economic s or legal issu es on intellectual property 
rights in the EU.  
11.3 Japan  
First of all, the delegation of Japan would like to express its sincere appreciation for 229.  
providing an opportunity to share experiences on Japan' s policy tools in order to foster IP -based 
businesses for economic growth.2 
Just for your information, handouts of the slides of this presentation are available just 230.  
around  the entrances of this room.  
Slide 1  
Firstly, this delegation would like to explain the importance to foster IP -intensive industries. 231.  
This delegation would like to thank the EU for making a wonderful presentation on the interesting 
studies. According to the report published by EUIPO and EPO, the IP -intensive industries have 
potential to g enerate jobs, tend to provide higher wages, and contribute to economic output. In 
addition, the bar graph on the right side indicates the correlation between patent rights possession 
and operating profit on sales in Japan. According to this bar graph, the operating profit on sales of 
MSMEs without patent rights is merely 1.8 percent, while that of MSMEs possessing patent rights 
amounts up to 3.5 percent. Therefore, the fact that companies with patent rights achieve good 
business performance indicates that i ntellectual property has a positive effect on corporation 
results.  
On the other hand, however, as shown in the map on the bottom -left side, in Japan, there is 232.  
regional imbalance in the ratio of MSMEs which have experience to file patent applications. In light 
of the aforementioned positive effect of intellectual properties in economic growth, there is 
potential to further stimulate local economic growth by fostering growth of IP -intensive industries.  
Therefore, the Japan Patent Of fice provides various policies, including individual support for 233.  
new IP businesses in local industries, taking into consideration regional characteristics.  
Slide 2  
In this slide, this delegation would like to introduce the "Business Producers," as one poss ible 234.  
approach, in order to promote IP -based businesses.  
With the commission from the Japan Patent Office, Business Producers are dispatched to 235.  
several specific regions. They identify potential local needs and seeds, which are the core of 
innovations and h ave potential to be further commercialized, through utilizing their local networks 
and special knowledge or skills about IP management. More specifically, with linking industry 
seeds with potential local needs, the Business Producers provide various busine ss ideas based on 
                                                
2 The rep resentative of Japan made a PowerPoint presentation, ava ilable in Room Document RD/IP/22.  IP/C/M/88/Add.1  
 
- 33 - 
 
  intellectual properties, including , for instance, seeking cooperation for fund -raising, product -
development, manufacturing and marketing.  
Furthermore, through analyzing and publicizing various cases of business activity, including 236.  
both s uccessful and less successful ones, the Business Producers aim to stabilize their activities in 
local industries even after their support is finished.  
Slide 3  
Now, this delegation would like to introduce a successful example of the Business Producers.  237.  
The Start-up Company in this slide is a "seeds -holder" based in Tokai region in Japan, which has 
newly developed micro -sensing devices for physical movement and placement. This technology, 
for instance, may be used to remotely monitor various data for infrastr ucture in real -time, such as 
oscillation and inclination levels of roads, and is expected to reduce, such as, frequency of 
necessary roadworks by promptly detecting the damage, and also reduce the cost of maintenance.  
However, in order for commercializati on of its technology, the company lacked knowledge on 238.  
how to apply its innovation to the actual business activities. Specifically, although the company 
had to place the products on the road in a certain interval to each other and conduct 
demonstrative expe riment or big -data analysis, the company had difficulty in finding the regional 
partner that could provide experimental fields, and also lacked knowledge in coordination with 
various parties, such as road maintenance companies.  
A Business Producer supporte d the company in consulting with a city government and a road 239.  
maintenance company that had needs in such experimental activity, and as a result of the 
consultation, the company was able to carry out the experiment. Additionally, the  Business 
Producer also supported the company in finding potential business partners that would be 
interested in using its innovations. Consequently, a drone manufacturing company decided to 
apply the sensing devises, i.e. seeds innovated by the Start -up company. This "seeds -holder" 
successfully commercialized the products also to construction companies and university 
laboratories.  
Slide 4  
As seen above, since there is potential for local industries to enhance their growth by 240.  
developing new IP -based businesses, this delegation bel ieves that one possible approach may be 
to individually support local industries through the "Business Producers," linking industry seeds 
with potential local needs.  
This delegation looks forward to hearing about unique experiences of interesting informati on 241.  
under this topic from other delegations.  
11.4 United States of America  
I would like to start by thank ing Australia, Canada, the European Union, Japan, Switzerland, 242.  
and Chinese Taipei for co -sponsoring this theme for 2017 and or all of the delegations that took 
the time to prepare interventions on it throughout last year.  I would additionally like to thank 
Japan for the presentation summarizing work under last year's  theme , to the EU for introducing 
this year's theme and to both of them for their very comprehensive interventions today . We look 
forward to continuing helpful exchanges under the 2018 IP and Innov ation theme as well.  
The United States welcomes this opportunity to make its first presentation under the new IP 243.  
and Innovation theme of Soci etal V alue of IP in the New Economy.  
We turn our attention to empirical data and present studies on the economic impact of IP or 244.  
IPR-intensive industries to employment, GDP, and trade.  
Patents, trademarks, and copyrights are the principal means for establishing ownership 245.  
rights to inventions and ideas, and provide a legal foundation by which intangible ideas and 
creations generate tangible benefits to businesses and employees.  IP/C/M/88/Add.1  
 
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  Intellectual property protection affects commerce throughout the economy by: providing 246.  
incentives to invent and create; protecting innovators from unauthorized copying; facilitating 
vertical spe cialization in technology markets; creating a platform for financial investments in 
innovation; supporting start-up liquidity and growth through mergers, acquisitions, and IPOs; 
making licensing -based technology business models possible; and, enabling a mo re efficient 
market for technology transfer and trading in technology and ideas. On  September 26, 2016, 
the US Commerce Department released a comprehensive report entitled "Intellectual Property and 
the US Economy: 2016 Update, " which found that IP -intensi ve industries support at least 
45 million U.S. jobs and contribute more than $6 trillion to, or 38.2% of, US gross domestic 
product (GDP). The report explains that IP incentivizes the creation of new goods and services by 
conferring excl usive rights to the ir creators.  
While inventions typically are a product of ingenious endeavours  that require long, 247.  
persistent, and meticulous effort, subsequent duplication and use of such inn ovations are often 
less costly.  
Patents add to the incentive that inventors have t o invest in costly research and 248.  
development (R&D) by providing the opportunity to reap the rewards of their innovations. In  the 
words of Abraham Lincoln, the patent system "added the fuel of interest to the fire of genius in the 
discovery and production of  new and useful things. "  
Similarly, copyrights provide the framework that incentivizes authors to create literary, 249.  
artistic, musical, dramatic, cinematic, and other works by granting them the exclusive right to 
engage in the activities that derive economi c benefits from their work. Thus, patents and 
copyrights serve as tools to stimulate individual, firm, and industry level entrepreneurial ventures 
that feed into economic activities nationwide.  
To further exploit the potential of their competitive advantag e, producers need effective 250.  
ways to indicate to consumers the reliability of their products ' source. A trademark "makes 
effective competition possible in a complex, impersonal marketplace by providing a means through 
which the consumer can identify product s which please him or her and reward the producer with 
continued patronage. " 
The Report examined 313 industries and identified 81 as those using patent, copyright, or 251.  
trademark protections most extensively.  
Some of the most IP -intensive industries include:  software publishers, sound recording 252.  
industries, audio and video equipment manufacturing, cable and other subscription programming, 
performing arts companies, and rad io and television broadcasting.  
I'll now summarize the findings of the report as to the e ffects of these industries on 253.  
employment, gross domestic product, and trade.  The Report indicates the critical role that IP -
intensive industries play by each measure in the United States.  
Starting with employment, the study found these "IP -intensive industries" to be the source - 254.  
directly or indirectly - of 45 million jobs, or roughly 30%  of all the jobs in the United States 
in 2014.  
Breaking the data down more finely, the report indicates that IP -intensive industries directly 255.  
accounted for 27.9 milli on jobs either on their payrolls or under contract in 2014, they also 
indirectly supported 17.6 million more in supply chain jobs throu ghout the economy.  
Examining the data by type of intellectual property, the report found that Trademark - 256.  
intensive industr ies are both the largest in number and that they contribute the most employment 
with 23.7 million jobs in 2014.  
Copyright -intensive industries supplied 5.6 million jobs followed by patent -intensive 257.  
industries with 3.9 million jobs.  Similarly to the results  found in the EU study, n ot only is the 
number of jobs attributable to IP -intensive industries high, but so too is the quality of those jobs.  IP/C/M/88/Add.1  
 
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  Examining average weekly wages, workers in IP -intensive industries earned 46% higher 258.  
than workers in other industr ies in 2014.  That wage premium was even higher for patent -intensive 
industries – at 74% – and highest in IP -intensive copyright industries – at 90% – in 2014.  
Turning to Gross Domestic Product, the share of total US GDP attributable to IP -intensive 259.  
industr ies reached 38.2 % in 2014.  And in terms of absolute value added by IP -intensive 
industries, the 2014 total was 30 % higher than just four years before.  
28 of the 81 industries under study derived revenues from IP licensing, in the am ount of 260.  
$115.2 billion in 2012.  
In terms of trade, IP -intensive industries accounted for over half the share of U.S. 261.  
merchandise exports in 2014.  In absolute terms, the total merchandise exports of IP -intensive 
industries increased to $842 billion in 2014.  
Exports of service -providing IP -intensive industries totalled  about $81 billion in 2012 and 262.  
accounted for approximately 12.3 % of total US private services exported in 2012.  
In conclusion, the 2016 update confirmed the critical beneficial contributions of IP -intensive 263.  
industries  to the United States in terms of employment, GDP, and trade.   
An economy that is prosperous and growing may provide increasing opportunities for its 264.  
citizens to find good paying jobs, be rewarded for their hard work, and to offer a brighter future to 
their children.  And innovation offers the opportunity to address challenges and share creative 
works and other products with an expanding audience.  
In the United States, IP intensive industries contribute to a prosperous and growing 265.  
economy, and thus to the at tendant benefits for citizens, as described today.  
11.5 Switzerland  
I would like to thank the previous speakers for their interventions and interesting 266.  
presentations. We welcome the opportunity t o exchange experiences and views on IP -intensive 
industries and their economic impact on society. We hope to add some further aspects of this issue 
to the discussion.  
"IP-intensive industries " can be defined as branches of economic or commercial activity that 267.  
use intellectual property rights more intensively than the average industry. They may for example 
use more patents, trademark s or designs when compared to other industries using IPR s, or 
generate most of their re venue from licensing IP rights.  
For the purposes of our discussion, IP -intensive industries should be understood in broad 268.  
terms. They should certainly not be limited to cutting edge technology -producing industries or 
companies. In S witzerland, many of the major economic sectors are IP -intensive industries, which 
include the three most important export industries: the chemical and pharmaceutical industry, the 
mechanical and electrical engineering industry, and the watch industry. The number of IP -intensive 
industries has increased over recent decades. This has ultimately led to higher economic welfare, 
as IP-intensive industries tend to be more export -oriented and have increased productivity; they 
pay higher wages and generate more job s. 
Today, we are witnessing an ongoing digital revolution that affects the highly competitive 269.  
sectors which use IP intensively. The digital revolution is not much different from the industrial 
revolution in the 19th century, yet there are indeed differences in the dimension, the pace and 
the level of complexity. The 4th industrial revolution, known also as the digital revolution, is 
a global rather than a local phenomenon. It is thus a much more trade -related issue, affecting 
the whole world. The technologies of the impending industrial revolution should enable everyone to 
access new business opportunities, which benefit the national and international economies, and 
the challenges to public interest.  IP/C/M/88/Add.1  
 
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  What is the role of the IP -System?  
New approaches and solutions have been significantly facilitated by the IP system and the 270.  
incentives it offers for investment in creative ideas, innovation, research and development of new 
products and services. An adequate protection and  enforcement of intellectual property rights 
brings forth new businesses, in particular, but not limited to new businesses in high technology 
industries; it helps and advances our societies, and it contributes to long -term economic growth 
and development.  
What role does the Swiss government play in supporting IP -intensive industries and thereby 
fostering innovation and growth?  
Switzerland aims to provide and maintain an attractive political and economic framework for 271.  
businesses and researchers. Within this framework, economic operators, individuals and 
companies, should be free to pursue their ideas. Government agencies can play an important role 
in helping businesses and researchers to connect and in providing advice. In the area of IP, 
the Swiss approach i s to motivate businesses to create appropriate IP -strategies which always take 
into account their individual business models.  
The following are some successful governmental programmes and projects that support IPR - 272.  
intensive industries in Switzerland. They reflect the value that the government attributes to 
branches that heavily rely on IP.  
The Swiss Federal Institute of Intellectual Property, the Swiss IP Office IPI, has established 273.  
some measures tailored to the special needs of SMEs, start -ups and inventor s. The measures 
mainly focus on raising awareness of IP, the opportunities it brings and the challenges companies 
need to be vigilant about. The Institute offers so -called "patent searches ". During a half -day 
assisted patent search, IPI experts provide fir ms and inventors with information on protection 
possibilities, their pros and cons, explain the different application procedures, search together with 
the clients in patent databases and provide them with an initial overview of the state of the art. 
Firms and inventors previously in touch with the IPI, benefit further from a free initial  consultation 
from some patent attorneys. The IPI also designed a website -portal that is specially geared to 
the needs of SMEs, showing them how to avoid infringing others' products and protect their own 
innovations and creative work. Moreover, the Institute has a "Contact Center " working as 
a centralised point of entry for companies seeking information about IP.  Finally, the IPI offers 
a broad range of IP -courses for firms a nd interest groups.    
With the availability of new technologies, counterfeiting is reaching alarming proportions; 274.  
among other industries, in the watch and health sectors. The problem of counterfeiting can 
threaten existing jobs, harm the environment. Count erfeiting activities often finance criminal 
organisations and – in particular relation to drugs and replacement parts – it endangers the health 
and lives of people.  According to the Swiss watch industry's association, sales of counterfeited 
products are wo rth an estimated 400 billion dollars annually. Tens of millions of fake Swiss 
watches are offered for sale every year, while the Swiss watch industry produces around 30 million 
original watches. To fight against counterfeiting and piracy at the national le vel, Switzerland has 
adopted a range of measures. The Swiss Anti -Counterfeiting and Piracy platform, called STOP 
PIRACY, constitutes such an instrument. It allows for enhanced coordination and cooperation 
among competent government agencies as well as betw een the public and private sectors. It acts 
as a networking platform and provides educational and awareness campaigns to consumers. STOP 
PIRACY helps IP -intensive industries to persist, grow and add value by supplying the society with 
innovative, cutting -edge and high quality products and services.  
A major programme at government level is Innosuisse, the Swiss Innovation Agency. Its  role 275.  
as a federal entity is to support and promote innovating projects in Switzerland. Innosuisse 
promotes the partnership be tween academia and the market via innovation projects. It provides 
networking, training and coaching for innovative firms. Experienced business coaches advise and 
support start -ups and those interested in setting up a business, providing them the ability t o 
implement their own strategy for growth. Innosuisse also has the task of giving an overview of the 
innovation landscapes ' numerous public and private stakeholder s, and is funding R&D -projects.  
The three examples of governmental programmes and projects sh ow the public sector 's 276.  
strong engagement in the fostering of IP -intensive and innovative industries.  IP/C/M/88/Add.1  
 
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  Let me illustrate the economic impact of IP -intensive industries on society with a case 277.  
example from a traditional industrial sector, which also wrote indu strial history in Switzerland.  The 
Federation of the Swiss Watch Industry, FH, is the Swiss watch industry's leading private, 
professional and non -profit association with headquarters in Bienne, Switzerland. The FH currently 
represents around 500 members, which represents more than 90% of Swiss firms active in the 
production and sale of watches. The association aims to support the Swiss watch industry and to 
represent the watch sector as a whole in Switzerland and internationally. The watchmaking 
industry i s one of the sectors in Switzerland which has a broad IP portfolio, and it is considered to 
be the country 's third largest exporter, behind the chemical and pharmaceutical industry, and 
the machine and electrical engineering industry. Switzerland is the la rgest exporter of watches in 
terms of value.  
In 2015, around 59,000 people in Switzerland were employed in this sector, generating 278.  
1.5% of the country 's gross domestic product. According to the FH, the workforce in the 
watchmaking and micro -engineering sec tor has risen by a third in the last few years, representing 
nearly 20,000 additional jobs. This industry still has a significant market potential, despite the fact 
that Swiss watches have a long history and consist of a mechanical construction. Traditiona lly 
made products can indeed endure in the ongoing digital revolution. This is perceived as 
an opportunity, in particular for peripheral regions such as Bienne. With its 55,000 inhabitants, 
Bienne serves as the headquarters of numerous watchmaking factorie s, among others 
the Swatch  Group.  
Other cities well -known for their watchmaking factories, apart from Geneva, are 279.  
La Chaux  de-Fonds, Neuchâtel or Schaffhausen. All their traditional manufacturing enterprises rely 
heavily upon the protection of their intellectual property. They protect their innovations with 
patents, successfully manage and maintain valuable trademarks and designs, and are able to 
count on copyright protection. Another important IP right for Swiss watch makers are geographical 
indicati ons. 
Thanks to all those IP rights, the watch making enterprises can constantly reinvest and 280.  
create added value, keeping abreast of stiff market competition and significantly contributing to 
the prosperity of their places of business. The watchmaking indus try was also able to recover from 
difficult times and to overcome structural and economic crises, e.g. in the 1970 's. This was due not 
least to their innovative spirit, the incentives provided by IP rights, and some other favourable 
economic framework cond itions. Just like other IP -intensive industries, the watchmaking industry 
constitutes an essential pillar of the local economy, society and culture.  
We hope that the examples presented have provided Members a brief and useful overview of 281.  
some of the measur es taken by Switzerland to support IP -intensive industries, and an overview of 
the benefit that those industries provide to their place of business, region,  and to the society as 
a whole.  
In conclusion  it can be noted that IP -intensive industries serve an important function in 282.  
the international community. Innovation, creative processes, research and development of new 
technologies - in short the investment into new and better products and services - creates 
opportunities, but at the same time requires a sol id IPR regime and protection. We look forward to 
hearing the contributions of other Members. We will also be interested in learning more about 
aspects of New Economy in the upcoming Council meetings this year.  
11.6 Norway  
Norway would like to thank the proponents for the communication contained in document 283.  
IP/C/W/641, and for interesting presentations and interventions. An examination of the societal 
value of IP in the new economy, including how IP hel ps create conditions that encourage 
investments, should give Members relevant information on the positive contribution of IPRs to the 
prosperity of individual businesses as well as to the economy at large.  
The Norwegian Government is currently undertaking several studies in this area in order to 284.  
refine our policies. And today I would like to mention two examples:  IP/C/M/88/Add.1  
 
- 38 - 
 
   A study on the value of IP both at the business level (micro) and the level of society 
(macro), where we can see that it is methodologically more challenging to measure 
effects at the macro  
 An external review of all our Government policies in the area of industrial rights.  
 
These and other initiatives are a follow -up to the Government's white paper (Report No. 27 285.  
to the Storting) on industrial policy, which was issued in March 2017: A Greener, Smarter, and 
more Innovative Industry.  
These studies are still a work in progress, but we hope to be able to come back to 286.  
the Council with concrete findings and examples later this year. We look forward to  the discussion.  
11.7 Chinese Taipei  
The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu is pleased to co - 287.  
sponsor the two papers under this agenda item. We thank the introductor y remarks made by 
Japan and the EU, as well as all the informative interventions before me. My delegation views this 
is a useful forum for Members to share experiences on the value of IP.  
On the 2018 theme: As I'm sure we are all finding, in this era of th e digital economy, IP 288.  
investment is playing an increasingly greater role in driving both economic growth and structural 
change. And at the same time, innovation is fast becoming a critical factor in the competitiveness 
of global businesses.  
Our own economy  is certainly no exception. In 2016, IP investment reached a total of 289.  
US$25.6 billion, which accounted for 4.42% of our G DP. 
If we break that down by the two main industry sectors, the manufacturing industry, 290.  
comprising mostly of IT industries, took up close to 62% of the investment. Service industries took 
up the other 38%.  
As far as numbers of patent applications are concerned, according to the USPTO's data, in 291.  
2015 we ranked 5th in the world, with 11,693 granted inventions. In terms of patent strength , we 
ranked No.6. The main technical fields to which these inventions apply are, firstly IT 
optoelectronics, then mechanical transport, and finally materials chemistry, all of which are 
indicative of our strong innovation capacity. These types of IP invest ment are our main sources of 
expansion in overall demand, and in driving productivity growth.  
However, despite this strong innovation capacity, we are still failing to generate higher 292.  
economic values overall because of our continuing high technology trade deficit over recent years. 
This is vividly illustrated by the fact that the effective use of inventions by universities and 
research institutes remains at a mere 12%. So, these are the real priority issues that  our 
government has to address.  
We look forwar d to hearing from other Members' about their experiences, and how they are 293.  
dealing with these priority issues in particular.  
11.8 Colombia  
I would like to share Colombia's experience with you in thi s area. The National C opyright 294.  
Directorate of Colombia together with the World Intellectual Property Organization WIPO 
conducted  a study on "The Economic Contribution of C opyright –Based I ndustries in Colombia" . 
The purpose of the study was to  quantify  the economic contribution of copyright -based industries 
(CBIs)  to value added, foreign trade  in exports and imports and employment in Colombia during 
the period 2000 -2005.  
Based on  the methodology proposed by WIPO, the study focused  on identifying copyright - 295.  
based industries and quantifying their contribution  to value added, employment and the external 
sector . These industries include  companies contributing to the production and marketing of works  
protected by copyright at different points in the value chain . They can be grouped into four 
categories : IP/C/M/88/Add.1  
 
- 39 - 
 
  a. Core copyright industries : This group brings together all industries wholly dedicated to the 
creation, production, representation, exhibition, communication, distribution and sale of 
copyright protected material,  for example music, literature,  theatrical productions, film, 
communication media, visual arts, advertising services and collective management 
societies . 
b. Interdependent copyright i ndustries : These are industries that contribute to the 
production, manufacture  and sale of equipment . Their purpose is to facilitate  the creation, 
production and use of copyright protected material, for example the  manufacturing and 
sale of appliances  such as televisions, CD recorders  and computers , musical instruments  
and photograp hic equipment . 
c. Partial copyright industries : These involve certain  activities that are related or linked  to 
copyright protected materials, such as jewellery, architecture and handicraft s. 
d. Supporting Industries : This category relies indirectly and marginall y on copyright protected 
material, as the industries in this group also deal with other type s of activit y unrelated to 
copyright such as telephony , transport and sales in general . 
Now on the contribution of the CBIs to value added . The total gross value added of 296.  
copyright -based industries in Colombia was COP 9.5 trillion , approximately US$4.8 billion in 2005. 
And COP 5.7 trillion  in 2000, each figure representing some 3.3% of GDP. In other words, 
discounting price increases, the gross value added of the  CBIs grew from COP 2.4 trillion  in 2000 
to COP  3.1 trillion  in 2005  (in constant 1994 pesos) . 
During the period analysed, these industries saw an average share of GDP of 3.3%, a rate 297.  
similar to the share of  electricity and gas, slightl y higher  than the contribution  of crude oil and 
natural gas and more than double that of coffee and coal. The latter comparison is significant in 
a country with a  substantial  global market share in these two products.  
The c ore industries represent  55.9% o f the total value added generated by these economic 298.  
activities, followed by interdependent  industries 23.7%, supporting industri es with 12.7% and then 
partial  copyright  industries with 7.6%.  
With regard to the contribution of CBIs to employment. In 2006 , copyright -based  industries 299.  
generated 1,097,430 jobs representing 5.8% of the country's workforce  and 12.7% of 
employment  in the 13 major  cities. This gave these industries a higher share in national 
employment than traditional sectors such as construction, coffee and finance.  
Breaking down the contribution of CBIs for that year, the core industries accounted for  1.7% 300.  
of national employment, the interdependent  industries 0.7%, the partial  copyright industries 1.9% 
and the support  industries 1.5%.  
Between 2003 and 2006, the copyright -based  industries created around 156.000 additional 301.  
jobs, representing  8.8% of new jobs throughout the country and 16.5% of those created in the 13 
major  cities and their  metropolitan areas.  
With regard to the contributi on to the external trade. In 2005 , CBI exports were worth  302.  
US$2.138 million,  while imports amounted to  US$4.8 billion, t he net balance showing  that imports 
more than double d exports while copyright export s represent ed 17.3% of the country's industrial 
expor ts and 10% of total exports, imports had a  more substantial share  with 24% and 22.6% 
respectively.  
This initial  result indicates that in 2005 the country was a net importer of copyright material 303.  
with $2.662 million. However , the result is mainly  determined  by imports of the  interdependent  
industries. If the group of core industries alone had been taken into account, the balance would 
have been reversed, that is, the country would have been a net exporter of copyright material . 
The purpose of quantifying  the economic contribution of copyright industries to value added , 304.  
national employment and foreign exchange  earnings  was to make these industries "visible " to the  
public and to potential investors and financ iers (the public sector, firms and private invest ors). 
From the p ublic policy point of view, this study was designed to guide specific measures to 
promote the consolidation and expansion  of the CBIs . In other words , it aimed to highlight the fact IP/C/M/88/Add.1  
 
- 40 - 
 
  that, beyond the ir role in the  cultural heritage framework , these industries  constitute a potential 
source of economic growth and development.  
Copyright -based industries in Colombia have extensive production of their own and are 305.  
characterized by their heterogeneity and different levels of development. They includ e dynamic 
sectors associated with information and communication technology , which will not only open new 
fields of application for copyright and related rights but will also generate new investment to raise 
CBI participation in the economy in the immediate  future.  Nonetheless, t he expansion of these 
sectors  will not necessarily mean increase d GDP or employment in copyright -based  industries , at 
least in the short term . 
In coming years,  the CBIs will, in line with global trends, benefit from  greater private 306.  
investment and will  increase their productivity and competi tiveness , as long as the  investment 
climate is sound, which depends on copyright  and related rights  being protected . 
11.9 El Salvador  
We appreciate the inclusion of this item in the agenda, as requested by the delegations of 307.  
the United States, Japan, Switzerland, the European Union and Chinese Taipei, as well as the 
summary presented by the delegation of Japan on the important discussions h eld over the past 
year on "inclusive innovation and micro, small and medium enterprises (MSMEs): collaboration, 
growth and trade".  
We would like to share some ideas on this point, particularly taking into account "the social 308.  
value of Intellectual Property in the new economy", the theme proposed for this year.  
The Central American Region has now a valuable instrument. The first phase of an economic 309.  
study on the impact of the Use of Intellectual Property in Central America and the Dominican 
Republic was compl eted in August last year and is an element of guidance for the design and 
implementation of appropriate measures. The conduct of this study represented a significant effort 
on the part of the competent authorities in the seven countries of the region and i ts results are still 
of a preliminary nature.  
The main objectives of the Study were to support the formulation of IP policies in the Central 310.  
American region based on empirical data, as well as to cover the specific technical need for the 
development of eco nomic and statistical instruments for continuous monitoring and evaluation of 
the impact of IP, innovation and trade policies in general and, in particular, the recently formulated 
national policies and strategies on IP. According to this Study, which has linked the trade and IP 
industrial property registers' data:  
 The majority of patents in the region have been requested by foreigners (95%), especially 
from the US (50%). The inventors of the region have made limited use of the patent 
system. The few times they have resorted to this system, they have sought protection in 
their own country or outside the region (mainly in the United States), but very rarely in 
other countries of the region.  
 Utility models have served as an alternative for the inventors of the  region, who have 
submitted 61% of applications. However, in 85% of cases, protection has been limited to 
the national level, being hardly used at regional and international level.  
 Foreigners have been the main users of industrial design protection in the region (81%). 
However, they have resorted to it to a much lesser extent than in the case of patents.  
 Trademarks are the IPR mostly used in the region, in which use by nationals (42%) is 
similar to the use by foreigners (51%). The United States is the main user of registered 
trademarks in the region (33%). The region (excluding national use) is the second most 
important foreign origin of registered trademarks in the region (12%). On the contrary, 
the region makes little use of trademark protection in the Uni ted States (less than 2%). Of 
the marks that originate in the region, the proportion of those for which protection is 
requested in the United States with respect to those for which protection is requested in 
the region (excluding national ones) is from 1 t o 9 (that is, less than 10%).  
 IP/C/M/88/Add.1  
 
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  One of the main conclusions of the Study is that there is potential in the region for the 311.  
formulation of policies that stimulate a better use of the IP system in support of commercial 
strategies.  
In addition to the integrated  data for the region, the study has a chapter of individual data 312.  
and statistics for each of the seven countries.  
Amongst other challenges, it was possible to detect a gap in the production of copyright data 313.  
that allows us to measure the impact of the use o f intellectual property, as well as other support 
measures, in the promotion of the creative industries. As a country and at the regional level, we 
have begun work to strengthen our institutions and to meet this need, in order to implement 
consistent and c omprehensive policies and measures. We hope to count on an extension of the 
Study with global Intellectual Property data.  
At the national level, as mentioned on previous occasions before this Council, we have a 314.  
National Intellectual Property Policy.  
I quot e the initial paragraph of the policy: "In a vision of inclusive development, the greatest 315.  
wealth of the country and the most important potential of the Salvadoran nation is in its people, 
the aforementioned raises the commitment to raise the quality of li fe of the Salvadoran population 
and overcome poverty in the route to good living. The future and the progress of the country are 
directly linked to the capacities and talents of people, to the development of their imagination and 
creativity, their entrepre neurial quality, their innovative skills, their ability to create knowledge and 
increase the productivity of their work."  
Since its adoption in November 2014, one of the great challenges for its implementation has 316.  
been to integrate intellectual property el ements systematically and transversally in the 
development policies of the country's social and economic sectors as an instrument with social 
impact.  
In addition to the aforementioned programs and actions and others developed by the 317.  
Intellectual Property O ffice and the Ministry of Economy, to which our delegation has referred on 
previous occasions as part of this agenda item, the national export promotion agency PROESA is 
working jointly with the Intellectual Property Office to support exporters with strate gies that 
involve elements of intellectual property.  
Our Government is supporting the development of creative industries, especially in the area 318.  
of application development and videogames. In this sense, the Ministry of Economy has developed 
sectoral progra ms to support these industries.  
11.10 Australia  
Australia is pleased to co -sponsor discussions on intellectual property and innovation 319.  
understanding that these frameworks can play a role in trade, investment and business confidence 
and development.  
Under the topic of The Societal Value of Intellectual Property in the New Economy, we will 320.  
take this opportunity to share our national experience on how balanced and effective intellectual 
property framew orks can contribute to business development, creative endeavour and 
employment under this meeting's topic of Intellectual Property Intensive Industries and their 
Economic Impact on Society.  
Rather than focus on large studies and statistics, we will highlig ht a couple of specific 321.  
example s. The first is a copyright related example and the second is an example of regional, 
technical cooperation regarding intellectual property valuation.  
The rapid growth of the internet and advancements in technology has  create d both positive 322.  
and negative effects for copyright intensive industries and its consumers.  IP/C/M/88/Add.1  
 
- 42 - 
 
  Advancements mean that it has become easier to enjoy lawful content online. Australians 323.  
are embracing online streaming services more than before, according to a copy right consumer 
survey conducted in 2017.  
Of those surveyed, the number of Australians paying for streamed content has increased by 324.  
almost 10% overall since 2015. Pricing and availability continue to be key factors for people when 
accessing copyright materi al online.  
Recognising the importance of protecting copyright material  from infringement online , in 325.  
June 2015 Australia introduced a website blocking scheme for copyright owners and internet 
service providers to work together to disrupt large scale online copyright infringement.  
The Australian Federal Court has ordered blocking of infringing video streaming, torrent and 326.  
other websites hosting film, television and music.  
Research shows a correlation between the introduction of the website blocking scheme and  327.  
a reduction in online copyright infringement. Australia is monitoring evidence closely to better 
understand the impact of the scheme over time.  
Secondly, under the WIPO -Australia Funds in Trust development assistance prog ram. 328.  
Australia funded a program  for universities and research institutions in Indonesia to better 
understand the full cycle of intellectual property commercialisation.  
For example, Australia supported a national training workshop on intellectual property in 329.  
Jakarta in July 2017 to assist t echnology managers with valuing intelle ctual property and 
technologies . This has been a positive example of technical cooperation within the Indo -Pacific 
region . 
11.11  Brazil  
Brazil thanks the sponsor s of the present agenda item. We have submitted to our capital 330.  
the document IP/C/W/641, circulated on February 21st. As initial comments, let me stress that 
Brazil continuously strives to provide an environment conducive to innovation and we appreciate 
opportunities for the exchange of views and experiences that enable mutual understanding. Our 
first innovation law was approved back in 2004 and during its drafting we carefully studied 
the legal framework of other countries and their concrete results achieve d. As recent as February 
7th, a new decree was approved with additional initiatives to encourage innovation and scientific 
and technological research in Brazilian universities. We hope to come back with further comments 
in the next session of the Council.  
The dynamics of intellectual property protection in a market economy and their role in 331.  
relation to creativity and innovation provide the background to this discussion. In our view, this 
implies that a well -crafted and balanced IP system is able to stimulat e innovation while addressing 
the potential anticompetitive effects, avoiding that IP themselves become a barrier to access to 
technology and dissemination of information. It is thus important to deepen understanding of 
features of the intellectual propert y system related to the achievement of the objective set in 
Article 7 of the  TRIPS Agreement.  
I would also add the importance that industrial property offices issue patents of high quality 332.  
that enhance legal certainty and provide clear boundaries of the ri ghts granted. Patents of low 
quality can represent an additional barrier to entrepreneurs, in special to MSMEs.  
In this sense, public databases containing information on the legal status of patents would 333.  
further help companies to determine the freedom to o perate, and to what extent and with whom, 
licences need to be negotiated. They would also be able to access the vast amount of information 
contained in patent applications, thereby assisting their efforts to innovate and creating 
opportunities for further cooperation.  IP/C/M/88/Add.1  
 
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  11.12  Canada  
Canada is pleased to present some of its analysis and findings on the role of IP -intensive 334.  
industries in the Canadian economy, as part of the broader three -part discussion on  "The Societal 
Value of IP in the New Economy ". Canada looks forward engaging on these issues during 
the current and upcoming TRIPS Council meetings in 2018. We would like to thank the 
co-sponsors for their communication on this topic, as well as the delegations that have provided 
insights so far.  
In examining the relationship between IP -intensive industries and economic activity, one of 335.  
the key questions facing policy makers is in identifying the influence that IP protection may have 
on economic outpu t. While it is broadly understood that the outputs of innovation and creation – 
such as new products, technologies and processes – can drive commercial success (a point made 
in last year 's discussion on the topic of IP and micro, small and medium -sized ent erprises), 
the exact role played by IP protection is not always linear. In other words, a patent does not 
always necessarily lead to a given ratio of economic activity. Nor for that matter, is innovative 
economic output necessarily accompanied by a given l evel of IP protection.  
Nonetheless, we can identify the impact that specific IP -intensive industries have on 336.  
economic activity, which in turn, can help inform policy decisions on how IP can support and 
facilitate the growth and contribution of these indus tries to overall economic activity. Along these 
lines, Canada has recently conducted a number of studies on the contribution of specific 
IP-intensive industries in the Canadian marketplace, with a view to further clarifying 
the relationship between IP and economic output.  
For instance, in 2014, a study commissioned by the Canadian Department of Innovation, 337.  
Science and Economic Development (ISED), entitled "Intellectual Property and the Canadian 
Economy: IP -Intensive Industries and their Economic Contributi on", measured the level of 
employment, wages, and economic contribution of 75 IP -intensive industries to Canadian GDP and 
trade. The study drew upon a range of data sets, including patent and trademark filing data 
available through WIPO, as well as data fr om the Canadian Intellectual Property Office (CIPO) and 
Statistics Canada, to identify a set of patent and trademark -intensive industries across 
the Canadian economy. In terms of methodology, this involved linking the listing of industries in 
the North Ame rican Industry Classification System (NAICS) to the classes of trademarks used in 
the Madrid System as well as the Nice Classification System under WIPO, as well as to patent 
classes under WIPO 's International Patent Classification. Using patent grant and trademark 
registration data, the study then calculated patent and trademark intensity ratios (e.g. total 
number of patents granted and trademarks filed divided by the average payroll employment by 
industry) for a set of industries, to identify a subset of IP-intensive industries for each type of IP. 
Using the WIPO definition of "core" copyright industries (e.g. those industries that are "wholly 
engaged in creation, production and manufacturing, performance, broadcast, communication and 
exhibition, or distri bution and sales of works and other protected subject matter "), the study also 
identified a subset of IP -intensive industries in this area.  
Using this data, researchers were able to estimate that the 75 IP -intensive industries in 338.  
the study accounted for 25  percent of Canadian GDP in 2010 ($332 million in Canadian dollars, or 
roughly $262 million in US dollars). These industries also contributed to 40% of Canada 's total 
exports for 2010. In cross -referencing the set of IP -intensive industries with Statistics  Canada 
data, the researchers were also able to identify the total Canadian employment in IP -intensive 
industries, which stood at 13.6% in 2010, with the majority of employment found in trademark -
intensive industries, followed by copyright and patent -intensive industries. Researchers also found 
that weekly earnings in IP -intensive industries were 16% higher than the national average, with 
the highest weekly earnings found in patent -intensive industries.  
Going a step further, CIPO has also more recently turn ed its investigation to the relationship 339.  
between IP -intensity and economic performance at the firm level. For instance, CIPO 's most recent 
"IP Canada Report " for 2017 examines the economic impact of industries designs on firm 
performance. Using financial d ata from the years 1990 -2014 from 723 publicly -traded Canadian 
firms, of which 70 held at least one industrial design, CIPO 's study found a 16% increase in 
revenue per employee associated with holding industrial designs. More interestingly, the study 
found  a 0.46% increase in revenue per employee from each additional industrial design registered 
to a firm . IP/C/M/88/Add.1  
 
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  Of course, one of the questions raised in examining IP -intensity and economic output is 340.  
the role played by IP -protected assets. To get at a better unders tanding of this relationship, CIPO 's 
study on industrial designs also investigated the impact of the "design orientation " of a firm, which 
aims to capture whether the industrial designs are directly responsible for higher performance, or 
whether this corre lation is due to other activities associated with the industrial design. Using a new 
model to get at this question, CIPO found that a firm having ever held an industrial design resulted 
in a 13% increase in revenue per employee and a 17% increase in net in come per employee, in 
additional to the marginal effect of each industrial design currently held by that firm. At the same 
time, the relationship between industrial design ownership and economic performance is not 
definitive. While the presence of industri al designs is associated with higher levels of firm 
performance, future research on data on associated variables, such as R&D spending, marketing 
expenses, and firm age, will be instructive in getting a clearer sense of this relationship.  
Building on this research, CIPO has also begun investigations on emerging Canadian 341.  
industries, with a view to using patent data to highlight areas of innovation. Two ongoing studies, 
in the areas of climate change mitigation technologies and space technolo gies, draw upon patent 
data to identify areas where Canada may have relative advantages in respect of certain 
technologies within each industry. Using keywords from patent documentation to cluster patents 
together, CIPO has developed "patent landscapes ", which serve as visual representations of 
climate change mitigation technologies, as well as space technologies, in respect of patents applied 
for by Canadians. In clustering patents together in this way, patents are organized in common 
themes and grouped to gether as "contours " on each patent landscape map to show areas of high 
and low patenting activity by Canadians. In doing so, the patent landscapes provide insights into 
the areas of each industry where Canadian innovators are relatively specialized. For i nstance, 
when compared to other top patenting countries in the area of climate change mitigation 
technologies, patent landscape maps in this area indicate that Canada is relatively specialized in 
areas such as carbon capture, buildings, smart grids and tra ditional energy. Similarly, with respect 
to space technologies, the patent landscape in this area indicates that Canadian innovators are 
active in areas such as antenna technology, communications, and navigation satellite systems. 
This research, which is c ontinuing in 2018 (and is detailed further in CIPO 's most recent "IP 
Canada Reports " for 2016 and 2017) will provide further insights into the technology areas where 
Canadians are patenting, with a view to identifying some of the key innovations in these f ields.  
These are just some of the approaches that can help identify and measure the impact of IP - 342.  
intensive industries on economic output. Canada would be pleased to provide additional 
information on any of these studies with other Members upon request, as well as updates on 
ongoing studies as this research continues. We would like to once again thank other Members for 
sharing their national experiences and information on the role of IP -intensive industries on 
the economy, and look forward to continued discu ssion under the theme of "The Societal Value of 
IP in the New Economy " today and in the coming months.  
11.13  India  
Please allow me to refer to my statement at the previous TRIPS council meeting in 343.  
October  2017 under this agenda item and summarize that intellectual property is only one element 
in a larger innovation ecosystem and IP laws alone do not promote technology development. A  
national innovation survey conducted in India in 2011 -12 in MSME se ctor identified: availability of 
finance and in general the cost of innovation, availability of skilled manpower, access to market 
information and availability of information technology, infrastructure, domination of established 
player in the market, regul atory requirements etc. as important barriers to innovation. Evidence 
does not support that increasing patent monopolies would drive greater innovation. On 
the contrary, the view gaining ground is that increasing patent monopolies would actually stifle 
innovation.  
The history of evolution of IP rules in developed countries suggests that the design of IP 344.  
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 count ries 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. IPRs cannot boost innovation if the required conditions – skills, information, capital, 
market prospects – do not exist. Therefore, the strength of IP rules should be calibrated to IP/C/M/88/Add.1  
 
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  the levels of development in country. In countries where the required conditions to benefit f rom 
strong IP protection do not exist, IP protection may be more costly than beneficial.  
11.14  Israel  
Israel wants to thank for the introduction of this paper, since Israel is a strong believer and 345.  
supporter of innovation and IP and the role it plays in economic and societal development.  
Our country has many initiatives that support this innovation and IP agenda, some of which 346.  
we have shared in this forum, as well as in others. We thank the Members who  shared their 
experience and we will continue to listen carefully to the experiences of others.  Israel looks 
forward to continuing sharing some of our experiences in future meetings.  
11.15  South Africa  
This delegation would like to thank the proponents for their communication titled 347.  
"Intellectual Property and Innovative: Inclusive Innovation and MSME Growth". While there is no 
doubt that IP may be valuable and may contribute to economic developme nt and growth, there are 
many factors that determine whether IP protection may create appropriate conditions that enable 
MSMEs to effectively exploit IP. MSMEs are a hot topic globally, but especially in South Africa, 
where the National Development Plan (N DP) stipulates that 11 -million jobs need to be created by 
2030 – 90% of these by SMEs.  
From a definitional perspective, there is no common understanding of what constitutes 348.  
MSMEs. There is no common global or regional definition in this respect. Generally , developed 
countries' definitions of MSME generally encompass much larger enterprises than developing 
countries' definition of MSMEs. In the European Union for example, any company with less than 
250 employees is considered a MSME. In most African countri es, a company with more than 
100 employees is a large company. MSMEs are almost by definition registered enterprises. In 
other words, the informal sector is usually not covered. However, large parts of economic activity 
in developing countries occur in the informal sector. South African o rganisations are classified as 
'small' when they have fewer than 50 employees and 'medium' when they have fewer than 200 
employees  
IP rights are important, however MSMEs are affected by a whole host of factors that put 349.  
them at a disadvantage with larger f irms, especially in the developing world. Moreover, IP rights 
are only useful to businesses if they can use IP protection to generate innovation, this requires 
financial resources that MSMEs might not possess. In this way, IP may only serve the largest 
firms, unless complementary policies are in place. Furthermore, IP rights can only be realised if 
firms have access to critical ingredients for innovation such as finance, human capital, knowledge 
and infrastructure.  
Strengthening and extending IPR regimes a nd enforcement are strongly advanced by 350.  
countries at the cutting edge of innovation globally. One can understand that, for those countries, 
it is of strategic value to use IP protection as a mechanism to preserve the rent -generating and 
other advantages th at arise from the technological capabilities built up by their firms.  
In the history of development and 'catching up', successful strategies always appear to have 351.  
involved 'emulation' that requires measures that are targeted at acquiring knowledge in incre asing 
returns activities. Furthermore, all successful catching -up episodes occurred under condition of 
weak IPR regimes that permitted easier access to  knowledge and acquisition and imitation. During 
the 19th Century, today's advanced economies used the IP  system and the flexibility it accorded 
as they pursued their industrialisation objectives. This allowed those countries to strengthen their 
IP regimes at their own pace, and in support of overall progress in their economic development.  
There are arguments  that patents are unlikely to foster innovation in developing countries at 352.  
early stages of industrialisation. The evidence on the extent to which patent protection, which is of 
particular relevance in the context of industrial policies, contributes to enco uraging innovation is, 
at best, inconclusive.  IP/C/M/88/Add.1  
 
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  South Africa has had a long history of IPR protection and, as signatories of the WTO, we 353.  
have adopted and implemented all our obligations under the TRIPs Agreement. As we review our 
IP policy, we are seeking to  ensure that appropriate balances are struck in providing protection for 
innovation and ensuring that benefits are shared in society. In particular, we are interested in 
ensuring that the IPR regime in South Africa supports our wider development objectives  and 
underpins our efforts at industrial development objectives.  
AGENDA ITEM 12: INTELLECTUAL PRO PERTY AND THE PUBLIC  INTEREST: REGULATORY 
REVIEW EXCEPTION  
12.1 Brazil  
I would like first t o thank Bolivia, Chile, China and South Africa for cosponsoring document 354.  
IP/C/W/639.  
In the session of this Council held in May of last year, Brazil, China, Fiji, India and South 355.  
Africa circulated document IP/C/W/630, with the goal of expanding the discuss ions on the complex 
interplay between intellectual property and public interest . With a view to continuing discussions 
on the topic, the sponsors of the agenda item invite delegations to share their experience 
regarding the existence and use of the regulat ory review exception, also known as "Bolar 
exception ", under their national or regional frameworks.  
The issue before us relates directly to the core goal of intellectual property: to promote 356.  
technological innovation in a manner conducive to social and econ omic welfare. The attainment of 
such goal is a constant concern of policy makers and demands an unceasing and careful analysis 
of the boundaries of IP rights.  
As a rule, companies invest in innovation to obtain a competitive edge in the relevant 357.  
market, in  the form of increased productivity of its industrial processes or by developing new 
products. Countries grant patent protection with the goal of incentivizing innovation by avoiding 
free-riding behaviour  of competitors, since this could lead to sub -optima l investment in R&D. 
At the same time, the strong market power granted by a patent allows the right  holder to exclude 
competitors from manufacturing the patented invention, thus restricting competition  during 
the term of the patent.  
In economic terms, the temporary exclusivity on the market granted by a patent is expected 358.  
to generate long -term dynamic procompetitive innovation at the cost of short -term anticompetitive 
effects. Considering this theoretical background, policymakers strive to design an efficie nt and 
balanced patent system, avoiding a situation in which patents lead to inefficiencies, high prices or 
the under -provision of goods.  
In the field of medical products, it  is of particular importance to assure that the exclusive 359.  
right granted to the pat ent holder is not extended beyond what is intended in the patent legislation 
and becomes itself a hindrance to technological innovation and access to medicines.  
If patents become barriers, the development process of new medicines is slowed and other 360.  
manufa ctures may refrain from entering the market, generating increased costs for patients and 
uncertainty  in the market.  
Under this framework, the Bolar  exception provides a valuable tool for stimulating 361.  
competition and ensuring adequate treatment for those suffering from diseases.  
Data from a study by the United States ' Congressional Budget Office indicate that 362.  
the average delay in generic entry after pa tent expiration fell from more than three years to less 
than three months after the approval of a Bolar -like exception in that country. The average 
number of generic entrants in the market also increased, stimulating competition.  
In other words, without th e Bolar exception, generic entry would be delayed by three or 363.  
more years in economies with generic pharmaceutical manufacturing capability, affecting 
the supply of life -saving medicines. The exception thus guarantees that the term of protection of IP/C/M/88/Add.1  
 
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  a patent  produces the optimal effect, in terms of creating incentives to both innovation and 
competition.  
Now turning to the guiding questions listed in our communication, I would like to provide 364.  
a brief overview of the regulatory review exception under Brazilian legislation.  
The Industrial Property Law, in its article 43, paragraph 7, provides that acts carried out by 365.  
unauthorized third parties related to a patented invention are safeguarded from enforcement, if 
the goal of such acts is the production of informati on, data and test results necessary for obtaining 
marketing registration afte r the expiration of the patent.  
The provision covers any act by third parties, such as making and using the invention. It also 366.  
allows such acts if the end purpose is to obtain reg ulatory approval in other countries. Our 
legislation does not limit the use of the exception to the health industry, as other technological 
sectors may also benefit from the expeditious entry of new competitors. Furthermore, third parties 
may rely on the e xception at any time during the l ength of the patent protection.  
Reports from manufacturers, both in Brazil and abroad, indicate two potential challenges for 367.  
its full implementation. The first one, not related to intellectual property, is access to precursors, 
that is, the chemical compounds necessary for the production of the ac tive pharmaceutical 
ingredient.  
Another potential challenge is the insufficient disclosure of the invention as contained in 368.  
the patent application, creating an obstacle for t he reproduction of the invention even by an expert 
in the field. The solution for this lies in adequate implementation of the disclosure requirement in 
the course of the patent examination by industrial property  offices.  
The Bolar provision is one of the k ey tools to ensure an efficient and balanced patent system 369.  
by safeguarding against the artificial extension of patent protection. It is a very useful health -
related patent flexibility for promoting public health objectives and maintaining dynamic 
competiti on between companies.  
The undue extension of such privilege would go against the very goal that justifies 370.  
the existence of patent protection. Past Government reports in the pharmaceutical sector ha ve 
shown that the anti -competitive use of patents not only reduces the welfare of society by 
restricting access to off -patent medicines, but also affects innovation activities in 
the pharmaceutical sector, damaging the generation of new life -saving medicines.  
The recent entry into force of the Protocol of Amendmen t to the TRIPS Agreement 371.  
demonstrates the need to have mechanisms that ensure adequate remuneration to intellectual 
property rights holders while allowing governments to adopt measures necessary to protect 
the public interest.  
Yesterday the Director s-Gener al of WTO, WIPO and WHO joined together to discuss 372.  
challenges and opportunities to ensure that innovative technologies are developed and reach 
patients in order to realize the fundamental human right to health. During those discussions, 
intellectual proper ty had a prominent role, underlining the importance of a balanced IP regime for 
promoting the public interest.  
Let me conclude by inviting other delegations to the debate, enabling a rich exchange of 373.  
views and experiences that enhances the mutual understan ding of the matter. The discussion 
would also benefit from the comments of international organizations here with us today, such as 
WIPO and WHO.  
12.2 South Africa  
As a co-sponsor of document IP/C/W/639, we thank Brazil for introducing it and for sharing 374.  
the specific experiences. Its paragraph 1 refer s to a document circulated earlier . The co -sponsors 
felt that an on -going discussion on matters related to compulsory licensing and issue s raised in the 
High-Level Panel report was important. Paragraph 3  references the Canada – Pharmaceutical 
Patents  case where it was held that Canada's regulatory review exemption is fully in compliance IP/C/M/88/Add.1  
 
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  with the TRIPS Agreement , in particular with Article 3 0, which pertains to exceptions to rights 
conferred . Following the panel decision , numerous Members have introduced similar  regulatory 
review exceptions in their national legislation. It is also important for delegations to note the 
questions which have been posed in paragraph 6.  
The intersection of IP and public health has long been an issue of contention not only in 375.  
South Africa but the world over, and one without resolution to date.  
The e arliest legal recognition of the problem began as early as 1997, with amendments to 376.  
the Medicines Act, and the subsequent case, PMA v the President of the Republic of South Africa. 
In this case a consortium of multinational pharmaceutical companies sought to block amendments 
to the Medicines Act in 1997 that would expand access to medicines. As a result of the legislative 
amendment, the USTR placed South Africa on the section 301 "Watch List " and urged the South 
African government to repeal its law. In June  1998, the White House announced a suspension of 
South Africa 's duty - free treatment under the US Generalized System of Preferences program. 
While hindsight is 20:20, this aggressive campaign actually hastened the mobilization of opposition 
to it. This cas e was a key factor leading to global dialogue around the potentially negative impact 
of IPRs on public health, culminating in the Doha Declaration on TRIPS and Public Health.  
South Africa has been a key driver of the now global recognition that the duty ow ed by 377.  
states to safeguard public health is not inconsistent with their concomitant responsibility to honour  
international treaty obligations. Paragraph 4 of the Doha Declaration on TRIPS and Public Health 
states as follows:  
"We agree that the TRIPS Agreem ent d oes not and should not prevent m embers from 
taking measures to protect public health. Accordingly, while reiterating our 
commitment to the TRIPS Agreement, we affirm that the Agreement can and should 
be interpreted and implemented in a manner supporti ve of WTO Members' right to 
protect public health and, in particular, to promote access to medicines for all. " 
In addition to this, the state 's duty to progressively realize the right to health is captured in 378.  
international instruments which South Africa ha s ratified such as the International Covenant on 
Economic, Social and Cultural Rights (ICESCR), the Convention on the Rights of the Child (CRC),  
the Convention on the Elimination of all Forms of Discrimination against Women and Girls 
(CEDAW), the Conventio n on the Rights of Persons with Disability (CRPD), and regional treaties 
such as the African Charter on Human and Peoples ' Rights.  
In order to expedite the availability of generic medicine on the market post patent, 379.  
the South African Patents Act was amende d in 2003 to include Section 69A, making provision for 
a statutory licence available for generic companies to access products  under a patent in specific 
circumstances, effectively introducing a "Bolar" type exception. This amendment was made 
following the decision in Stauffer Chemicals v Monsanto 1988(1) SA 805(T), which held that 
the experimental use of an invention amounted to infringement. The Court confirmed 
the interpretation of section 45(1) – in its form then – by finding that it entitled the patent owner 
to have and enjoy the whole profit and advantage of the invention, but that it does not prohibit 
the mere possession of an infringing article/product without an intention to use or dispose of it. 
The Court stated obiter that even experimental use of a patented invention will amount to 
an infringement in that the experiment uses the patented invention. In the Stauffer case 
the alleged infringer used the patented invention during the term of the patent to prepare for 
marketing registration of its own si milar product, and the Court found that such activity in fact 
used the patented invention as a springboard to obtain an improper advantage. This could be 
viewed as gaining a commercial advantage; such use was found to constitute infringement. In 
order to a ddress this situation, South Africa amended its Patent Act and introduced Section 69A.  IP/C/M/88/Add.1  
 
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  Section 69A provides as follows:  380.  
"69.A(1) It shall not be an act of infringement of a patent to make, use, exercise, 
offer to dispose of, dispose of or import the paten ted invention on a non -commercial 
scale and solely for the purposes reasonably related to the obtaining, development 
and submission of information required under any law that regulates the manufacture, 
production, distribution, use or sale of any product.  
(2) It shall not be permitted to possess the patented invention made, used, imported 
or acquired in terms of subsection (1) for any purpose other than for the obtaining, 
development or submission of information as contemplated in that subsection. " 
It will be noted that the exception is not limited to pharmaceutical products; it applies to any 381.  
invention (in any field of technology) in respect of which any law requires the submission of 
information for the manufacture, distribution or sale of a produc t. This would for example cover 
pharmaceutical and agrochemical products which require marketing authorization before such 
products may be put on the market. Stockpiling of patented products is not allowed under 
section  69.A(2).  
The main import of this sec tion is that it is permissible for a generic manufacturer of 382.  
pharmaceutical, veterinary or agricultural products to obtain registration of generic equivalents of 
patented products with the registration authorities in South Africa, prior to the expiration o f 
the relevant patent.  
South Africa is currently conducting a review of existing IP laws. Discussions around 383.  
the "Bolar" exception have  focused on whether the narrow marketing exception should also be 
extended to a broader category of activities, including  early experimental research. Some 
stakeholders advocate  an approach as exemplified by the US Patent Act regulatory review 
exception, which covers both regulatory review and early research e.g., pre -clinical  pathway. 
Reference is often made to Merck v. Integra Lifesciences, 545 U.S. 193 (2005) where the US 
Supreme Court found that exempts uses of patented inventions in preclinical research from 
infringement even when the research results are not eventually in cluded in a submission to 
the FDA. 
While South Africa 's IP Policy Review is still continuing, there are broad practices in various 384.  
jurisdictions that allow countries who have not yet implemented this flexibility to do so with 
confidence and prior examples of sound regulatory practice. In this regard a valuable resource can 
be found on the WIPO website, "WIPO Lex ", contains a comprehensive database with national IP 
laws and international agreements. On this point, during the December 2017 meeting of 
the Standing Committee on the Law of Patents, the WIPO Secretariat was requested to review 
a draft reference document on exception regarding acts for obtaining regula tory approval from 
authorities contained in document SCP/27/3 . 
Since the Secretariat has been doin g some work in the area of exception regarding acts for 385.  
obtaining regulatory approval from authorities, it would be very useful for the Secretariat to report 
what it has b een doing in this respect. The p roponents would greatly value such a contr ibution as 
an add -on to our outreach and experience sharing on exception regarding acts of obtaining 
regulatory approval from authorities.  
Before  I end this intervention, I would like to pay tribute to a global hero and the father of 386.  
post-apartheid South Africa, name ly Nelson Mandela . As mentioned in the introduction, it was his 
administration that took steps to address issues of access to medicine. Many of us would not 
realize that this year marks a century since his birth. I mention this because I regard him as 
a universal standard bearer. He is a peak of moral authority, rising above the soulless wasteland of 
the 20th century; he is a universal symbol for goodness and wisdom, for the ability to change, and 
the power of reconciliation.  May he rest in peace.  
12.3 El S alvador  
We would like to thank the delegations of Brazil, Chile, Bolivia and South Africa for 387.  
introducing this item on the agenda and for document IP/C/W/639.  IP/C/M/88/Add.1  
 
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  We recognize the importanc e of the debate on the balance that should exist between 388.  
intellectual property rights and the public interest, so we appreciate the debate in this Council. My 
Delegation takes the invitation made by the proponents in point 6 of the cited document.  
Regardin g the general characteristics of the "Bolar" exemption or its equivalent in the case of 389.  
El Salvador, the exemption regarding the regulatory examination, is not expressly part of the 
general exception for research purposes, but rather it is considered an in dependent assumption of 
abstraction of the rights conferred by a patent that is regulated in Article 116 paragraph e) of the 
Intellectual Property Law (LPI).  
In line with the above, the Regulation for the Protection of Test Data of New Pharmaceutical 390.  
Produ cts, which regulates the protection of information on safety and efficacy of products 
containing new chemical entities, in its Article 8 expressly, refers to the "Bolar" exception.  
Regarding the measures taken by legitimate third parties that are excluded from the 391.  
enforcement of patent protection under this exemption, the Intellectual Property Law in its 
Article  116, allows generic manufacturers to investigate, develop and submit information to the 
competent authorities to authorize the marketing of a produ ct before the expiration of the validity 
of the patent, with a view to entering the market immediately after the patent expires.  
With respect to the neutrality of the exemption as regards its application, according to what 392.  
the law establishes, the exemptio n covers the sanitary registrations of pharmaceutical or 
agricultural chemical products. This is determined inasmuch as the uses contemplated must be 
aimed at specifically meeting the marketing approval requirements for this type of product.  
 Regarding the  difficulties faced in applying the exemption, our national authorities do not 393.  
report difficulties, but rather highlight the importance of this mechanism as it saves time, mainly, 
for the producers of generic pharmaceuticals.  
12.4 Costa Rica  
Costa Rica appreciates the opportunity given by proponents of this agenda item to share our 394.  
experience regarding the application of the "Bolar  Exception" in our legislation.  
First of all, we would like to state that compulsory licensing exceptions, parallel imports, and 395.  
the Bolar exception, are not restricted by our international commitments and domestic legislation. 
Costa Rica has kept these provisions as part of its intellec tual property rights framework, since 
they constitute a significant guarantee of access to pharmaceuticals in line with international 
standards.  
The Bolar exception included in the DR -CAFTA enables a third party to develop a generic 396.  
product (whether pharma ceutical or agricultural chemical) in order to be obtain marketing 
approval and then enter the market as soon as the patent has expired.  
Article 6.3 of the Regulation to our Law of Undisclosed Information (No. 34927 -J-COMEX -S- 397.  
MAG) allows for generic drugs producers to use a patented invention to obtain marketing approval 
without the patent owner's permission and before the patent protection expires. Regarding 
agricultural chemicals, said agreement provides that registry can only be granted once data testing  
protection period is over, unless the right holder grants authorization.  
However, Costa Rica maintains an adequate protection for all patents registered and generic 398.  
manufacturers can only enter the market once the patent expires.  
Costa Rica firmly believe s that this exception is important to balance the interests of 399.  
inventors with public interest.  
12.5 Chile  
As a co -sponsor of this document Chile would like to share its experience in the us e of this 400.  
important flexibility under the TRIPS Agreement. In Chile, the so called Bolar exception is 
contained in Article 49 of Law No. 19.039 on industrial property. In addition to establishing IP/C/M/88/Add.1  
 
- 51 - 
 
  the effects of a patent, the Article indicates that "the pat ent for an invention shall not confer 
the right to prevent third parties from importing, exporting, manufacturing or producing 
the subject matter protected by a patent with the purpose of obtaining the sanitary registration or 
authorization of a pharmaceut ical product. The above shall not allow the marketing of said 
products without the authorization of the patent holder". The exception thus covers patent 
protected pharmaceutical products and allows the protected subject matter to be imported, 
exported, man ufactured or produced for the purpose of obtaining sanitary registration or 
authorization.  
The use of this exception helps pharmaceutical companies that hope to market generic 401.  
products on the Chilean market to lay the groundwork and reduce the time needed to launch 
generic medicines and bring them to market, thereby expanding access to health for the entire 
population. Chile therefore considers the use of this flexibility to be a part of the balanced 
intellectual property system that the country has sought to implement.  
12.6 Singapore  
I thank you and the co -sponsors of the agenda item on IP and the Public Interest for 402.  
the opportunity to share Singapore's perspective on the use of a regulato ry review or "Bolar" 
exception.  
The "Bolar " exception can be found in Section 66(2)(h) of the Singapore Patents Act, and 403.  
was introduced in 2004. The use of the Bolar exception is specific to the pharmaceutical industry, 
and applies to clinical test ing necessary to meet the requirements for marketing approval in 
Singapore.  
Under our legislation, the "Bolar" exception applies only to acts performed in relation to 404.  
the subject matter of the patent to support an application for marketing approval for 
a pharmaceutical product provided that anything produced to support the application is not: 
(i) made, used or sold in Singapore; (ii) exported outside Singapore; or (iii) for any purpose other 
than for meeting the requirements for marketing approval for that  pharmaceutical product. There 
is no specific procedure needed to make use of the Bolar exception.  
The legislation was introduced to facilitate the manufacture, sale and distribution of generic 405.  
versions of patented drugs immediately after the patents for t hose drugs have expired. Singapore 
consumers stand to benefit as they can gain access to generic versions of a drug as soon as 
the patent expires.  
We hope this brief snippet has been useful, and look forward to hearing about how other 406.  
Members frame and imp lement regulatory review exceptions in their own jurisdictions.  
12.7 Canada  
Canada would like to thank Bolivia, Brazil, Chile, and South Africa for their communication on 407.  
this issue, and t o provide a brief overview of the regulatory review exception in our domestic 
regime.  
Canada provides a regulatory review (or "early working ") exception under section 55.2 of 408.  
the Patent Act. This exception, which reads as follows, provides that "[i]t is not an infringement of 
a patent for any person to make, construct, use or sell the patented invention solely for uses 
reasonably related to the development and submission of information required under any law of 
Canada, a province or a country other than C anada that regulates the manufacture, construction, 
use or sale of any product. " 
For instance, under this exception, manufacturers of generic drugs in Canada may use 409.  
a patented invention to obtain regulatory approval for marketing purposes – such as from h ealth 
regulatory authorities – without the patent owner 's permission before the patent expires. This 
allows the generic manufacturer to be in a position to enter the market as soon as possible after 
patent expiry.  IP/C/M/88/Add.1  
 
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  It is also important to note that Canada 's early working exception is drafted without 410.  
prejudice to the field of technology. In other words, it is not limited to pharmaceutical patents.  
As Members may be aware, Canada 's early working exception was upheld by a WTO Dispute 411.  
Settlement panel in 2000, u nder the dispute "DS114: Canada – Patent Protection of 
Pharmaceutical Products. " Specifically, the Panel found that Canada 's early working exception was 
not inconsistent with Article 27.1 of the TRIPS Agreement, and was covered by the exception in 
TRIPS Ar ticle 30.  
12.8 China  
China is glad to state that it would like to co -sponsor the proposal under this agenda item 412.  
and we support the discussion of this topic. During the second and third mee tings of the TRIPS 
Council in 2017, Members actively discussed the issue of intellectual property and the public 
interest, good results have been achieved.  
Bolar exception was introduced in the third revision of the patent law of China in 2008. 413.  
Article 69. 5 of the patent law provides that it shall not be deemed to be patent right infringement 
in the situation where any person produces, uses, or imports patented drugs or patented medical 
apparatus and instruments, for the purpose of providing information req uired for regulatory 
approval, or where any other person produces or imports patented drugs or patented medical 
apparatus and instruments especially for that person mentioned above.  
China believes the protection of IP should contribute to the mutual advant age of producers 414.  
and users and to a balance of innovation and public interest.  
China also believes the discussion on intellectual property and public interest should be open 415.  
and inclusive. And Members could share views and experience on how to take advanta ge of 
flexibility of TRIPS Agreement including Bolar exception, and effectively solve the public interest 
problem.  
12.9 Australia  
Australia notes  the communication from the Plurin ationa l State of Bolivia, Brazil, Chile and 416.  
South Africa regarding Intellectual Property and the Public Interest Regulatory Review Exception.  
Australia's Patents Act provides infringement exemptions for the purpose of obtaining 417.  
regulatory approval of pharmaceuti cals (sl 19A).  
This permits generic manufacturers to obtain regulatory approval during the term of 418.  
the pharmaceutical patent so they can enter the market when the patent term expires.  
We look forward to hearing other Members' examples.  419.  
12.10 Argentina  
My delegation would like to thank the co-sponsors  of this agenda item for the communication 420.  
in document IP/C/W/639.  
A wide range of policy options are built into the international intellect ual property regime 421.  
that can be used to pursue public policy objectives, including public health and innovation.  
These options are not self-actuating  at the international level, though, and attention and 422.  
action are needed at the domestic level as to how best to implement such flexibilities, so that 
the national IP regime responds to each country's individual needs and policy objectives.  
This is why we agree with the thrust of document IP/C/W/639: indeed, Argentina is 423.  
a country which has made use of the TRIPS flexibilities in drawing up its legislation, for instance 
the well-known  "Bolar " exception.  IP/C/M/88/Add.1  
 
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  We need to maintain a balance between intellectual property rights and public interests, 424.  
bearing in mind the importance of Articles 7 and 8 of the TRIPS Agreement in the light of 
document IP/C/W/639.  
12.11 India  
We would like to thank the p roponents of the communication Bolivia, Brazil, Chile, China, 425.  
and South Africa for bringing this important issue of regulatory exemption for discussion today. I 
also thank the delegations of El Salvador, Singapore, Canada, Australia and Argentina for shari ng 
a national experience of using this important regulatory exemption.  
The TRIPS Agreement attempts to strike an appropriate balance between the interests of 426.  
rights holders and users. The TRIPS Agreement also recognizes that the principles of IP protection  
are based on underlying public policy objectives. In furtherance of the objectives and principles of 
TRIPS enshrined in Articles 7 and 8, a number of safeguards or flexibilities have become an 
integral part of the TRIPS framework. These flexibilities have  been clarified and enhanced by the 
2001 Doha Declaration on TRIPS and Public Health that WTO Members have the flexibility to 
interpret and implement the TRIPS provisions in a manner supportive of their right to protect 
public health.  
The regulatory review  exception or the Bolar Exception is an important example of what 427.  
would be covered by Article 30 of the TRIPS Agreement. Bolar Exceptions in India are covered 
under Section 107A of the Indian Patent Act. Report of the Joint Committee of the Indian 
Parliame nt, when this amendment was introduced  states the objective behind such insertion of 
Bolar Exemption via 2002 Amendment to the Patents Act and I quote  
"This clause seeks to insert a new section 107 -A in the 'principal Act, relating to 
certain acts which a re not to be considered as infringement. This provision has been 
made to ensure prompt availability of products, particularly generic drugs, 
immediately after expiry of the term of the patent. The amendment in this clause has 
been made to make a provision in consonance with the Bolar provisions at the global 
level". 
Bolar exemption originated from Section 202 of the Drug Price Competition and Patent Term 428.  
Restoration Act of 1984 of USA with an objective to provide for a specific exemption for 
experimental tr ials conducted on patented drugs in order to generate clinical data and obtain 
regulatory approval that would facilitate early entry of generics as soon as the term of the patent 
expires.  
In India the application of Bolar exceptions as covered by Section 1 07 A is technology and 429.  
sector agnostic. These exceptions are valid for any industry where development and submission of 
information is required under any law in force in India or when such information is required in 
a country other than India for regulator y purposes. While the application of the exception is 
technology neutral, it has been of particular benefit in ensuring early availability of more affordable 
generic medicines which in turn has positively affected access to medicines and treatments  in 
India and all over the world . 
Under the Indian law, acts such as manufacture of the product that includes a patented 430.  
technology, export of Active Pharma Ingredient (API) or finished formulation by a generic 
company, conduct of clinical trials, or import of the  API or formulation by a third party are not 
considered to infringe a patent provided the purpose of these acts is to seek relevant regulatory 
approvals or for generation of a regulatory dossier in other countries . 
Bolar exceptions have an important link w ith compulsory licensing. The absence of the Bolar 431.  
exceptions can severely affect the ability of a country to effectively utilize compulsory license 
provisions when considered necessary. In India, the Bolar exception played a vital role in the entry 
of a m ore affordable generic of a cancer drug when the Indian Patent Office had issued the first -
ever compulsory license in India to a manufacturer in 2012 on the drug sorafenib tosylate, used to 
treat kidney and liver cancer.  IP/C/M/88/Add.1  
 
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  We look forward to listening from o ther delegations on their experiences on using this 432.  
important TRIPS flexibility.  
12.12 Indonesia  
Indonesia welcomes the inclusion of this agenda item in the TRIPS Council meeting and 433.  
supports continuing discussion this issue of great importance which relates the balance between 
intellectual property and public interest, especially the Bolar Exception.  
The need for protection of IP in encouraging innovation is the most important element i n 434.  
TRIPS Agreement. However, there is a need to balance the rights of IP holders and the right for 
people to get access to affordable medicines. Article 30 of the TRIPS Agreement allows exceptions 
to the exclusive rights of patent holders. With such flexibi lity, "Bolar Exception " or the regulatory 
exception of the patent objects can be used without the patent owner 's permission and before 
the patent protection expires. Such exception may become national legal exception and need to be 
set out in the national Patent Law. Our Patent Law has already accommodated the use of Bolar 
Except ion as stated in Article 167.  
In line with the TRIPS Agreement a nd the flexibilities contained therein, the Indonesian 435.  
Government also enacted regulation to allow such flexibility to be put in practice with the primary 
aim to strengthen Indonesia 's capacity to provide medicines to people in need.  
The Food and Drugs Sup ervisory Agency of Indonesia enacted Regulation Number 24/2017 436.  
on Criteria and Drug Registration Procedure as a legal basis to implement the Bolar Exception. 
Based on Article 21 of the aforementioned Regulation, registration of drug which is still under 
protection of patent, may be utilized by applicants which are not the holder of the patent.  
Indonesia would like to reiterate that this agenda item be maintained for the next meeting of 437.  
the TRIPS Council, especially with regard to discussions on patent prot ections and its possible 
conflict with the right to health, and how it relates to the issue of encouraging new inventions and 
patent applications, as well as for WTO Members to achieve sustainable development goals of 
2030.  
12.13 Switzerland  
Switzerland would like to thank the delegations of Bolivia, Brazil, Chile and South Africa for 438.  
their paper on public interest, in particular on the regulatory review exception;  
We recognize the imp ortance of this discussion and the sharing of national experience in this 439.  
area;  Public interest is fundamental to this delegation. The current system of intellectual property 
protection should and does integrate  a balance between private and public interes ts; 
The TRIPS Agreement foresees exceptions and limitations to the scope assigned through 440.  
private rights. Such limitations were put in place to strike a balance between the private interest of 
the IP holder and the public interest in general . 
The regulator y review exception, also known as the Bolar exception, is fully compliant with 441.  
the TRIPS Agreement. The Panel in DS114 Canada – Patent Protection of Pharmaceutical Products , 
which the distinguished delegate of South Africa mentioned before , ruled that: pot ential 
competitors of a patent owner are permitted to use the patented invention, without 
the authorization of the patent owner during the term of the patent, for the purposes of obtaining 
government 's marketing approval, so that they will have regulatory permission to sell in 
competition with the patent owner by the date on which the patent expires . 
It is noteworthy to also highlight that the Panel further ruled that stock -piling of those 442.  
medicines in anticipation of market entry was generally in violation  of the TRIPS Agreement . 
In 2008, Switzerland introduced the Bolar exception in its patent law. All acts with regard to 443.  
a patent -protected pharmaceutical product that are required to obtain a pharmaceutical marketing 
authorisation are outside of the scope of patent protection . The Swiss Bolar exception applies to IP/C/M/88/Add.1  
 
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  marketing authorisation in Switzerland or in countries with comparable control of pharmaceutical 
products . 
A further aspect should also be considered. The duration of the patent and the calculation  of 444.  
the effective patent term are essential for all stakeholders: the patent holder, the competitors and 
for the public. It should thus be handled in a balanced manner.  For that reason, Switzerland also 
partially compensates patent owners for their time lo st due to regulatory requirements; the 
effective patent term can in fact be drastically shortened due to marketing approval procedures 
and the time and effort it takes to generate necessary test data required by the authorities.  
Applicants undertake expens ive clinical trials which entail a major commercial risk and normally 
take years to compile and submit for marketing authorisation;  
Switzerland encourages Member states to analyse their relevant regimes and ensure that 445.  
they can strike a fair balance between the public and private interest, i.e. between the right 
holders making available innovative products and services and the users to have their needs met.  
12.14 United States of America  
The laws of the United States provide for a limited patent exception allowing certain 446.  
patented invention to be made, used, offered for sale, or sold within the United States or imported 
into the United States solely for uses reasonably  reliably related to the development and 
submission of information under a U.S. law which regulates the manufacture, use, or sale of such 
inventions, facilitating rapid introduction of generic medicines in the U.S. market once patents, 
including any patent term extensions and any mar ket exclusivity periods expire.  
In fact, U.S. intellectual property and innovation policies have not only helped encourage 447.  
investments in pharmaceutical innovation, but also facilitated the approval and utilization of 
generic drugs. According to recent data, generic medicines account for 89% of all prescriptions 
dispensed in the United States.  
In fact, the most recent estimates are that a vast majority of medicines on the WHO Model 448.  
List of Essential Medicines  Patents are off-patent.  
I share this relevant information to help illuminate the perspective that IP and patents 449.  
should not be viewed a s intrinsic barriers to access.  
To properly address barriers to access, we must look at factors outside the IP system.  These 450.  
includ e pricing and procurement policies, taxes, markups and tariffs, and other national policies (or 
lack thereof) that ultimately result in higher costs for consumers and for health systems.  
Unfortunately, the theme of today's agenda item does not explore thes e critical factors.  451.  
12.15 Chinese Taipei  
We would first like to thank the proponents for continuing discussions on the relationship 452.  
between IP and public interests. The issues of p ublic health and how to promote h ealth technology 
are important.  
Regarding the "Bolar exception ", it is prescribed by Article 60 of our Patent Act. 453.  
The applicable acts include: exploiting a patent for trials per se, as well as manufacturing, offering 
for sale, selling, using, or importing anything that  is directly related to trials.  
The effects do not extend to acts other than for the purpose of obtaining registration and 454.  
market approval, such as trials of drugs conducted by hospitals. According to the rele vant laws 
and regulations, the pharmaceutical industry is the only industry where this aforementioned 
provision is applicable.  
12.16 Japan  
The delegation of Japan would like to mention that  Members, including Japan, have been 455.  
aiming to balance the interests of patent rights holders and third parties by, for example, providing IP/C/M/88/Add.1  
 
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  the option to extend the term of patent rights as a measure to compensate for the loss of a part of 
the term resultin g from regulatory reviews.  
Therefore, this delegation would like to ask other Members to note that it might be better to 456.  
take more comprehensive approach, taking into account not only the interests of third parties but 
also those of patent right holders. W hen regulatory review is discussed, a  comprehensive and 
evidence -based approach should be taken.  
In addition, this delegation would also like to point that, as South Africa mentioned, the 27th 457.  
session of WIPO/SCP has just decided its future work which inst ructs the WIPO Secretariat to 
prepare a second draft reference document on exception s regarding acts for obtaining regulatory 
approval from authorities, and to submit it to WIPO/SCP/28. Given this situation, the delegation of 
Japan is of the view that WIPO /SCP is the most appropriate forum to discuss this matter.  
Generally speaking, we have the need to protect intellectual property to encourage 458.  
development of new and effective drugs so that new essential drugs will continuously be 
developed.  
12.17 European Union  
It is the position of the European Union that a balanced system of intellectual property 459.  
rights, which takes into account legitimate interests of users and right holders, doe s serve 
the public interest. It is for this very reason the national and international systems of intellectual 
property rights have been created. In the European Union, according to Article 17(2) of the 
Charter of Fundamental Rights of the European Union, IPR is a fundamental right.  
Intellectual creations need protection if creativity and innovation are to flourish, and this is 460.  
the role of IPRs, which play an important function in promoting development and in addressing 
today's global challenges.  
The European Union fu rther believes that TRIPS generally, although only being minimum 461.  
standards, provides a reasonable balance and its rules and flexibilities allow not only least 
developing countries a pragmatic and flexible approach that can help Members maximise 
the potenti al of their own intellectual assets and further their integration into international trade, 
while achi eving broader societal welfare.  
We think that the compatibility of the so -called "Bolar" or regulatory review exemption with 462.  
the TRIPS is one more example  showing that TRIPS allows for flexibilities to the benefit of research 
for new pharmaceutical products and earlier to market timing for generics in full compatibili ty with 
the relevant IP rights.  
In our view, it also shows that the carefully balance strok e at the time of conclusion of 463.  
the TRIPS allows the WTO system, including its dispute settlement mechanism, to react to legal 
questions app ropriately and proportionately.  
The EU took note of the outcome of the case Canada – Pharmaceutical Patents (DS114) a nd 464.  
in fact, a regulatory review exemption was introduced in EU law in 2004 by Article 10(6) of 
Directive 2004/27 amending Directive 2001/83 on the Community code relating to medicinal 
products for human use.  
Under this rule, conducting studies and trials n ecessary to gain regulatory approval for 465.  
generic medicinal products and "the consequential practical requirements " do not constitute acts 
infringing patent rights or supplementary protection certificates for medicinal products.  
We believe that if the regulatory review exemption is applied in that concrete, specific and 466.  
limited way, it can both allow for the necessary flexibility in the marketing approval context as well 
as providing legal clarity on what constitutes a n IP infringement and what not.  
At the same time, the EU would however be cautious in supporting a too broad interpretation 467.  
of the regulatory review exemption that could amount to weakening the underlying IP rights for 
other purposes, such as for industrial policy reasons.  IP/C/M/88/Add.1  
 
- 57 - 
 
  On a final note, we would like to welcome the constructive tone of the paper submitted by 468.  
Bolivia , Brazil , Chile and South  Africa . We also welcome the interesting topic chosen that shows 
how the IP system is successfully integrating and supporting the public interest.  
In such a context, the EU, for its part, stands ready to continue to contribute positively to 469.  
the debate.  
AGENDA ITEM 13: INFORMATION ON RELEV ANT DEVELOPMENTS ELS EWHERE IN THE 
WTO  
13.1 WTO Secretariat  
Many thanks for giving the Secretariat an opportunity to provide an update of IP -related 470.  
issues as they have come up in the mos t recent trade policy reviews. As at previous sessions, this 
update concentrates just on those aspects of IP -related trade policy  matters that other Members 
actively chose to address in the course of the review of Members' trade policy settings. Since the 
last TRIPS Council meeting in October 2017, the trade policy reviews of the West African Economic 
and Monetary Union3, the Plurin ational State of Bolivia, Cambodia, The Gambia, Malaysia and 
Egypt have taken place.  
These recent reviews covered a wide range of IP -related trade policy matters; a full account 471.  
of these matters would be particularly lengthy.  Following, therefore, for the sake of brevity, is a 
representative list of some of the areas on which other members have expressed concrete interest 
in the form of follow -up questions during these reviews:  
 incentives for firms to a cquire foreign owned IP rights;  
 mechanisms to foster tr ading in IP rights and for realising their financial value;  
 collective management of licenses on copyright content;  
 reduction of "red tape" associated with obtaining and protecting  IP rights ; 
 policies of exhaustion of IP rights, specifically patents, trade marks, copyright and plant 
varieties ; 
 procedures for registration of trademarks and for opposition to trademark registration;  
 geographical indications;  
 compulsory licenses on pharmaceutical patent;  
 acceptance and domestic implementation of the Protocol Ame nding the TRIPS 
Agreement;  
 a constitutional right to access to medicines in relation to the patent system ; 
 protect ion of undisclosed information;  
 enforcement of IP rights online and at the border ; 
 ex officio  authority to take enforcement action in cases of  infringement of business and 
entertainment software copyright;  
 administrative measures for the enforcement of IP rights;  
 the structure, hierarchy and competence of specific courts on IP matters within the 
domestic judicial system;  
 the function of a regist ry of importers as a mechanism in supporting the enforcement 
of IP rights;  
 cooperation agreements between completion and IP authori ties; regional IP 
organizations ; and ratification of WIPO Treaties (including Marrakech) and accession to 
the UPOV Convention.  
                                                
3 WAEMU includes Benin, Burkina Faso, Côte d'Ivoire, Guinea -Bissau, Mali, Niger, Senegal and Togo.  IP/C/M/88/Add.1  
 
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  The IP section in the latest WTO Director-General Monitoring Report4, issued in mid - 472.  
November 2017, reported on the entry into force of the Protocol Amending the TRIPS Agreement; 
and highlighted certain trade -related IP policy initiatives undert aken by Canada, China, Paraguay 
and South Africa.  
AGENDA ITEM 14: OBSERVER STATUS FOR INTERNATIONAL INTERG OVERNMENTAL 
ORGANIZ ATIONS  
14.1 ARIPO  
On behalf of the African Regional Intellectual Property Organization (ARIPO) and on my own 473.  
behalf I want to express my appreciation for the decision made by this Council in its last session 
held 19-20 October 2017 to grant to ARIPO the status of permanent observer.  
As you may all be aware, ARIPO is an inter -governmental organization responsible for 474.  
the administration  of IP on behalf of its member States. There are currently 19 m ember States of 
ARIPO, 13 of which are least developed countries. Therefore, the  debates happening at the TRIPS 
Council are of tremendous importance to our organization.  
We believe that granting a permanent observer status to ARIPO is a clear recognition of 475.  
the role that the organization can play in shaping the global debates related to IP and especially in 
contributing to a more balanced IP system.  
The governing bodies of ARIPO received with great satisfaction the granting of 476.  
the Permanent status to the organization and encouraged its Secretariat to participate actively in 
the work of  this Council with the view to adequately and systematically voic ing the concerns, 
aspirations and needs of its member s, especially the LDCs and explore opportunities that can 
benefit them in the development of the IP system.  
Therefore, ARIPO commits itsel f to continue engag ing constructively with the WTO and its 477.  
Members during the debates happening at the WTO forums, especially at the TRIPS Council.  
In concluding, Madam Chair, allow me thank all the Member States that supported our plead 478.  
to be admitted on a permanent basis in this Council.  
14.2 India  
India supports granting of permanent observer status to three intergovernmental 479.  
organizations - South Centre, the CBD Secretariat and the International Vaccine Institute. All 
the three organizations fulfil the requisite criteria laid down by the General Council with regard to 
Observer status.  
India requests M embers opposing the three organizations to provide a valid reason for their 480.  
stand given that all the three organizations fulfil the requisite criteria laid down by the General 
Council with regard to observer status.  
14.3 United States of America  
Our position has not changed and we are not able to support additional observers . 481.  
14.4 China  
China supports that the CBD Secretariat and the South Center should be granted observer 482.  
status, at least on an ad hoc basis.  
__________  
                                                
4 Overview of Developments in the International Trading Environment, Annual Report by the Director -
General, document WT/TPR/OV/20  of 16 November 2017.