RESTRICTED  
  
IP/C/M/91/Add.1  
 
2 April 2019  
(19-2044) Page: 1/58 
Council for Trade -Related Aspects of  
Intellectual Property Rights    
 
MINUTES OF MEETING  
HELD IN THE CENTRE W ILLIAM RAPPARD ON 13 FEBRUARY 2019  
Chairperson: H.E. Ambassador Dr Walter Werner (Germany)  
Addendum  
The present document contains the statements made during the Council for TRIPS meeting held on 
13 February  2019.  
 
_______________  
 
Table of Contents  
 
1   NOTIFICATIONS UN DER PROVISIONS OF TH E AGREEMENT  ................................ ........  5 
2   REVIEW OF NATION AL IMPLEMENTING LEGI SLATION  ................................ ................  8 
3   REVIEW OF THE PR OVISIONS OF ARTICLE 27.3(B)  ................................ .....................  9 
4   RELATIONSHIP BET WEEN THE TRIPS AGREE MENT AND THE CONVENT ION ON 
BIOLOGICAL DIVERSITY  ................................ ................................ ................................ .. 9 
5   PROTECTION OF TR ADITIONAL KNOWLEDG E AND FOLKLORE  ................................ ..... 9 
6   NON-VIOLATION AN D SITUATION COMPLAIN TS ................................ .......................  14 
7   REVIEW OF THE IM PLEMENTATION OF THE TRIPS AGREEMENT UNDE R 
ARTICLE 71.1  ................................ ................................ ................................ .................  16 
8   REVIEW OF THE AP PLICATION OF THE PRO VISIONS OF THE SECTI ON ON 
GEOGRAPHICAL INDICAT IONS UNDER ARTICLE 2 4.2 ................................ ....................  16 
9   FOLLOW -UP TO THE  SIXTEENTH ANNUAL RE VIEW UNDER PARAGRAPH  2 OF 
THE DECISION ON THE IMPLEMENTATION OF AR TICLE 66.2 OF THE TR IPS 
AGREEMENT  ................................ ................................ ................................ ...................  17 
10   TECHNICAL COOPE RATION AND CAPACITY BUILDING  ................................ ............  24 
11   INTELLECTUAL PROPER TY AND INNOVATION: S UMMARY OF THE 2018 
THEME – THE SOCIETAL  VALUE OF IP IN THE NEW ECONOMY, AND 201 9 IP AND 
INNOVATION THEME: PU BLIC -PRIVATE COLLABO RATIONS IN INNOVATIO N ................  24 
12   INTELLECTUAL PR OPERTY AND THE PUBLI C INTEREST: PROMOTIN G PUBLIC 
HEALTH THROUGH COMPE TITION LAW AND POLIC Y................................ ......................  48 
13   INFORMATION ON RELEVANT DEVELOPMENT S ELSEWHERE IN THE W TO ...............  56 
13.1   Dispute Settlement  ................................ ................................ ..............................  56 
13.2   Amendment  to the TRIPS Agreement  ................................ ................................ ... 56 
13.3   IPR-Related issues in Trade Policy Reviews  ................................ .........................  56 IP/C/M/91 /Add.1  
 
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  14   OBSERVER STATUS  FOR INTERNATIONAL I NTERGOVERNMENTAL 
ORGANIZATION S ................................ ................................ ................................ ...........  57 
15   OTHER BUSINESS  ................................ ................................ ................................ .... 58 
16   ELECTION OF THE  CHAIRPERSON  ................................ ................................ ............  58 
  IP/C/M/91/Add.1  
 
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  INDEX OF THE STATEMENTS MADE  
AT THE MEETING OF COUNCIL FOR TRIPS 13 FEBRUARY 2019 * 
 
 
 
African Regional Intellectual Property 
Organization  
Article 66.2  ................................ ........  24 
Argentina  
Non-Violation  ................................ ...... 16 
Australia  
Article 66.2  ................................ ........  21 
Biotech, Biodiversity, TK  ......................  14 
IP & Innovation - Public -Private 
Collaborations in Innovation - Research  & 
Development  ................................ ... 29 
Technical Cooperation  ..........................  25 
Bangladesh  
Article 66.2  ................................ ........  21 
Observer Status  ................................ .. 59 
Bolivia, Plurinational State of  
Biotech, Biodiversity, TK  ......................  12 
Brazil  
Biotech, Biodiversity, TK  ......................  13 
IP & Innovation - Public -Private 
Collaborations in Innovation - Research  & 
Development  ................................ ... 45 
IP & Public Interest - Promoting Public 
Health Through Competition Law  & Policy
 ................................ ......................  51 
Non-Violation  ................................ ...... 16 
Canada  
Article 66.2  ................................ ........  23 
Biotech, Biodiversity, TK  ......................  13 
IP & Innovation - Public -Private 
Collaborations in Innovation - Research  & 
Development  ................................ ... 39 
Non-Violation  ................................ ...... 16 
Central African Republic  
Article 66.2  ................................ ........  19 
Chad, on behalf of the LDC Group  
Article 66.2  ................................ ........  18 
Chile  
Biotech, Biodiversity, TK  ......................  14 
IP & Innovation - Public -Private 
Collaborations in Inn ovation - Research  & 
Development  ................................ ... 35 
China  
Biotech, Biodiversity, TK  ......................  11 
IP & Innovation - Public -Private 
Collaborations in Innovation - Research  & 
Development  ................................ ... 48 
IP & Public Interest - Promoting Public 
Health Through Competition Law  & Policy
 ................................ ......................  53 
Non-Violatio n ................................ ...... 17 
Observer Status  ................................ .. 58 
Costa Rica  
IP & Public Interest - Promoting Public 
Health Through Competition Law  & Policy
 ................................ ......................  50 Dominican Republic  
IP & Innovation - Public -Private 
Collaborations in Innovation - Research  & 
Development  ................................ ... 49 
Ecuador  
Biotech, Biodiversity, TK  ......................  11 
Non-Violation  ................................ ..... 16 
Observer Status  ................................ .. 58 
European Union  
Article 66.2  ................................ ........  23 
IP & Innovation - Public -Private 
Collaborations in Innovation - Research  & 
Development  ................................ ... 43 
IP & Public Interest - Promoting Public 
Health Through Competition Law  & Policy
 ................................ ......................  55 
Hong Kong, China  
IP & Innovation - Public -Private 
Collaborations in Innovation - Research  & 
Development  ................................ ... 37 
India  
Biotech, Biodiversity, TK  ......................  10 
IP & Innovation - Public -Private 
Collaborations in Innovation - Research  & 
Development  ................................ ... 49 
Non-Violation  ................................ ..... 15 
Indonesia  
Biotech, Biodiversity, TK  ......................  14 
IP & Public Interest - Promoting Public 
Health Through Competition Law  & Policy
 ................................ ......................  53 
Japan  
Article 66.2  ................................ ........  21 
Biotech, Biodiversity, TK  ......................  12 
IP & Innovation - Public -Private 
Collaborations in Innovation - Research  & 
Development  ................................ ... 41 
IP & Public Interest - Promoting Public 
Health Through Competition Law  & Policy
 ................................ ......................  55 
Notifications  ................................ .........  6 
Korea, Republic of  
IP & Innovation - Public -Private 
Collaborations in Innovation - Research  & 
Development  ................................ ... 45 
Mexico  
IP & Innovation - Public -Private 
Collaborations in Innovation - Research  & 
Development  ................................ ... 43 
Montenegro  
Article 24.2  ................................ ........  17 
Myanmar  
Article 66.2  ................................ ........  20 
New Zealand  
Article 66.2  ................................ ........  23 IP/C/M/91 /Add.1  
 
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  IP & Innovation - Public -Private 
Collaborations in Innovation - Research  & 
Development  ................................ ... 33 
Norway  
Article 24.2  ................................ ........  17 
Article  66.2 ................................ ........  23 
Notifications  ................................ .........  6 
Russian Federation  
Non-Violation  ................................ ...... 16 
Senegal  
Article 66.2  ................................ ... 20, 24  
Singapore  
IP & Innovation - Public -Private 
Collaborations in Innovation - Research  & 
Development  ................................ ... 28 
South Africa  
Biotech, Biodiversity, TK  ......................  10 
IP & Innovation - Public -Private 
Collaborations in Innovation - Research  & 
Development  ................................ ... 36 
IP & Innovation – The Societal Value of IP in 
the New Economy  .............................  35 
IP & Public Interest - Promoting Public 
Health Through Competition Law  & Policy
 ................................ .................  49, 56  
Non-Violation  ................................ ...... 15 
Observer Status  ................................ .. 58 
Switzerland  
Article 24.2  ................................ ........  18 
Article 66.2  ................................ ........  22 
Biotech, Biodiversity, TK  ......................  13 IP & Innovation - Public -Private 
Collaborations in Innovation - Research  & 
Development  ................................ ... 31 
IP & Public Interest - Promoting Public 
Health Through Competition Law  & Policy
 ................................ ......................  54 
Non-Violation  ................................ ..... 16 
Chinese Taipei  
IP & Innovation - Public -Private 
Collaborations in Innovation - Research  & 
Development  ................................ ... 34 
Non-Violation  ................................ ..... 16 
Notifications  ................................ .........  6 
United States of America  
Article 66.2  ................................ ........  22 
Biotech, Biodiversity, TK  ......................  12 
IP & Innovation – Public -Private 
Collaborations in Innovation - Research  & 
Development  ................................ ... 25 
IP & Public Interest - Promoting Public 
Health Through Competition Law  & Policy
 ................................ ......................  54 
Non-Violation  ................................ ..... 15 
Notifications  ................................ .........  7 
Observer Status  ................................ .. 58 
Vanuatu  
Article 66.2  ................................ ... 21, 24  
Venezuela, Bolivarian Republic of  
Observer Status  ................................ .. 58 
WTO Secretariat  
Information on Developments in WTO  ... 57 
Notifications  ................................ .........  8 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
_______________  
*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/91/Add.1  
 
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  1  NOTIFICATIONS UNDER PROVISIONS OF THE AG REEMENT  
1.1  Japan  
1.  This delegation is pleased to inform the Council that Japan recently amended its Unfair 
Competition  Prevention Act, Patent Act , and Trademark Act. The amendments have been notified to 
this Council in accordance with Article 63.2. The reference numbers are IP/N/1/JPN/U/2, 
IP/N/1/JPN/P/14 and IP/N/1/JPN/T/9., We would like to take this opportunity to briefly explain some 
major points about the amendment s. 
2.  First, the Unfair Competition Prevention Act was revised to enhance regulation on acts of unfair 
competition that interfere with the technological restriction measures. For example, the revised Act 
newly covers regulations on the act of providing services of circumventing technological restriction 
measures to users.  
3.  Secondly, the Patent Act was revised to be compatible with the Comprehensive and Progressive 
Agreement for Trans -Pacific Partnership (hereinaf ter CPTPP), in particular with adding a new 
provision regarding the extension of duration of patent right s. Concretely, due to the revision, the 
duration of patent right s has turned to be extendable if the establishment of a patent right is 
registered after the date either five years since filing, or three years since a request for examination, 
whichever is later. The new system will be applicable t o patent filing s after 1 0 March 2020.  
4.  Lastly, the Trademark Act was also revised to be compatible with the CPTPP, in particular with 
adding a new provision regarding the presumption of amount of damage s. Specifically, the new 
provision enables a trademark holder to claim the dama ges with the presumption that it is the 
amount equivalent to the expenses which are normally required for the acquisition and maintenance 
of the trademark right.  
5.  The Government of Japan will continuously fulfil its obligation to ensure the accessibility an d the 
transparency of the Japanese intellectual property system.  
1.2  Chinese Taipei  
6.  The amendments to the Regulations Governing the Determination of Patent Term Extension and 
the Enforcement Rules of the Trademark Act were notified to the TRIPS Council on the 
29 November  2018, contained in documents IP/N/1/TPKM/P/11 and IP/N/1/TPKM/T/9.  
7.  With regard to the Regulations Governing the Determination of Patent Term Extension, it is aimed 
at streamlining the application process. T his means, for example, that in the case of a request for 
extension of the patent term based on a clinical trial or field test conducted in a foreign country, the 
document proving that the trail time has been claimed and approved for patent term extension by 
the foreign country will no longer be required.  
8.  As far as the Enforcement Rules of the Trademark Act are concerned, the Schedule attached to 
Article 19 - the list of goods and services – is now deleted. According to our understanding, this 
means that th e Enforcement Rules of the Trademark Act will not anymore be subject to amendments 
in response to the updated versions of WIPO International Classification of Goods and Services.  
1.3  Norway  
9.  The notifications from Norway contained i n the mentioned documents include amendments made 
to the Designs Act, the Patent Regulations, the Regulations on Fees payable to the Norwegian 
Industrial Property Office and the Board of Appeal for Industrial Property Rights, the Trademarks 
Act, as well as  a corrected translation of the Patents Act.  
• The amendments to the Trademarks Act are due to the entry into force of the Penal Code 
(Act no 28 of 20 May 2005) and include updating provisions on criminal sanctions and 
correcting references to the Penal Cod e. IP/C/M/91 /Add.1  
 
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  • The amendments to the Designs Act include a change in the provision on criminal sanctions 
and corrected references to the Penal Code. The provision in Section 54 concerning the 
priority between third party rights in a registered design is also amended.  
• The amendments to the Patent Regulations concern provisions of a technical character 
complementing the changes made to the Patents Act (Act no. 9 of 15 December 1967) and 
the Act on Security Interests (Act no 2 of 8 August 1980) introducing the possibility  of 
establishing security interests in patents and plant variety rights.  
• The amendments also include provisions on the processing of applications for and handling 
of extensions of supplementary protection certificates for medicinal products for paediatric  
use.  
• The amendments in the Regulation on Fees concern changes necessary for the introduction 
of the possibility to create security interests in patents and plant variety rights. The 
amendments include changes of a technical nature and introduces a fee fo r the extension of 
supplementary protection certificates for medicines for paediatric use.  
• The translation of the Patents Act is updated, correcting errors in the previous translation.  
1.4  United States of America  
10.  The United States has notified three legal amendments: the Study of Classes Chasing 
Engineering and Science Success (hereinafter SUCCESS Act 2018) (IP/N/1/USA/P/15), Music 
Modernization Act (IP/N/1/USA/C/7), and the Marrakesh Treaty Implementation Act 
(IP/N/1/USA/C/8 ). 
11.  First, the SUCCESS Act 2018 amends the Leahy -Smith America Invents Act to extend by eight 
more years the authority granted to the USPTO to effectively adjust, with public input and oversight, 
the fees it charges for the services it provides  to patent and trademark applicants.  Extension of the 
authority helps ensure that those fee collections fully recover the costs of USPTO 's operations and 
services provided to innovators.  The law also provides for a report that identifies publicly availabl e 
data on the number of patents annually applied for and obtained by women, minorities, and 
veterans, and small businesses owned by women, minorities and veterans, and includes legislative 
recommendations for how to increase participation in entrepreneuria l activities and patenting by 
women, minorities, and veterans.  
12.  Next, t he Orrin G. Hatch –Bob Goodlatte Music Modernization Act, or MMA, addresses the 
United  States ' determination that copyright law has not kept pace with changing consumer 
preferences and te chnological developments in the music marketplace. It was signed into law on 
11 October 2018.  
13.  Title I of the MMA, or the Music Licensing Modernization Act, among other things, modifies the 
existing section 115 "mechanical " license for reproduction and dist ribution of musical works in 
phonorecords (which was previously obtained by licensees on a per -work, song -by-song basis).  
• This Title establishes a new blanket license for digital music providers to engage in specific 
covered activities (namely, permanent d ownloads, limited downloads, and interactive 
streaming).  
 
• Licensing of physical configurations ( such as  CDs, vinyl) will still operate on a per -work, 
individual song license, basis. Title I establishes a market -oriented "willing buyer, willing 
seller " rate standard that will apply to all licensees of musical works under the section 115 
mechanical license.  
 
• Also, under Title I of the MMA, the Register of Copyrights will designate an entity as the 
mechanical licensing collective to administer the blanket license and distribute collected 
royalties to songwriters and music publishers.  
 
• The newly created mechanical licensing collective will be tasked with developing and 
maintaining a database of musical works and sound recordings, which will be publicly IP/C/M/91/Add.1  
 
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  available and is expected to become the most comprehensive database in the music 
industry.  
 
• There will be a transition period to move to the new blanket license, allowing digital music 
providers to limit copyright infringement liability so long as the provider engages in 
good-faith, commercially reasonable efforts to identify and locate musical work copyright 
owners.  
 
• The legislation also modifies the process for selecting federal district court judges to 
adjudicate rate -setting disputes regarding performance r ights organizations that are subject 
to consent decrees with the Department of Justice.  
 
14.  Title II of the MMA, o r the Classics Protection and Access Act, among other things, brings 
pre-1972 sound recordings partially into the federal copyright system by ext ending remedies for 
copyright infringement to owners of sound recordings fixed before 15 February 1972.  
• The federal remedies for unauthorized use of pre -1972 sound recordings shall be available 
for 95 years after first publication of the recording, and are  subject to certain additional 
periods, which provide varying additional protection for pre -1972 sound recordings, based 
on when the sound recording was first published.  
 
• Title II applies a statutory licensing regime similar to that which applies to post -1972 sound 
recordings.  
 
• It also establishes a process for lawfully engaging in non-commercial  uses of pre -1972 sound 
recordings that are not being commercially exploited.  
 
• Finally, Title II of the MMA applies certain existing limitations on exclusive rights  and 
limitations on liability to uses of pre -1972 sound recordings, such as, sections 107, 108, 
109, 110, 112 and 512.  
 
15.  Title III of the MMA, or the Allocation for Music Producers Act among other things, will allow 
music producers to receive compensation from royalties collected for uses of sound recordings under 
the section 114 statutory license.  
16.  The Marrakesh Treaty Implementation Act was signed into law on 10 October 2018.  It revises 
the Copyright Act to meet the terms of the 2013 Marrakesh Treaty to F acilitate Access to Published 
Works for Persons Who Are Blind, Visually Impaired, or Otherwise Print Disabled.    
17.  The Marrakesh Treaty requires its contracting Members to create limitations and exceptions to 
copyright law that will make it easier for those with certain kinds of print disabilities to access printed 
works in accessible formats such as Braille and digital audio files.  
18.  The United States confirms that it deposited the US Marrakesh ratification materials with WIPO 
on 8 February 2019.  
1.5  WTO Secretari at 
19.  The Secretariat appreciates the opportunity to provide a further regular update to the TRIPS 
Council on the e -TRIPS project. Delegates will recall that the e -TRIPS project aims at streamlining 
and bringing up to date the information services the Secretaria t provides for Members, while 
remaining fully within the framework established by the TRIPS Agreement itself and the decisions of 
this Council. It comprises three elements – first, a means of receiving TRIPS notification and review 
material, the e -TRIPS No tification Submission System (the e -TRIPS NSS); second, a complete 
Information Management System, now the backbone of our TRIPS information services; and, third, 
an e-TRIPS Gateway which will be integrated with the WTO website and provide a wide range of 
opportunities for delegates to access and make use of TRIPS information.  
20.  Today, we are pleased to announce that the first element, the e -TRIPS Notification Submission 
System (the e -TRIPS NSS) is now open and ready for your use.  IP/C/M/91 /Add.1  
 
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  What is the e -TRIPS NSS?  
21.  The e-TRIPS NSS is an optional online tool for submitting:  
• TRIPS notifications , such as newly passed laws and regulations relevant to TRIPS;  
• TRIPS review materials , such as responses to the questionnaires established by the TRIPS 
Council; and  
• TRIPS -related  Reports , such as regular reports on technical assistance and measures for 
technology transfer filed by some Members and some international intergovernmental 
organizations.  
22.  Traditional methods of notifying to the TRIPS Council will, of course, remain avai lable. However, 
we have endeavoured to make the e -TRIPS NSS easy to use, and trust that it will become the 
preferred means for submitting notifications, review materials and reports to the Council for TRIPS. 
As we approach 25 years of operation of TRIPS no tification and review processes, we are very 
conscious that it can be difficult to track existing notifications and to update submissions accordingly. 
We are also conscious that there are some extensive gaps in coverage of material provided. Our 
immediate emphasis, therefore, is on supporting delegates and capital -based officials to become 
familiar with this tool and to assist them in its practical use.  
Next STEPS  
23.  In the coming weeks, therefore, the Secretariat will send an email to all Missions to the WTO 
with guidance on how to access and use the e -TRIPS NSS. User names and passwords for using the 
system will be provided to delegations. We will also provide a user guide, which will explain how the 
e-TRIPS NSS works, and what can (and cannot) be submitted t hrough the e -TRIPS NSS. In addition, 
delegations will also be able to access an online training environment, which is, in effect, a test site 
reproducing all of the functions of the e -TRIPS NSS. Any practice entries made when using this 
training tool will go no further than the test site and will not, of course, be formally notified to the 
TRIPS Council.  
24.  We are also available at any time to demonstrate the NSS to any interested delegations, or to 
assist in its use in submitting notifications and review mate rials. 
25.  Additionally, on the margins of the Council meeting in June, the Secretariat will provide an 
informal training session for interested delegations on how to use the new system.  
26.  The e -TRIPS NSS will be available in the three official WTO languages. T he initial version that 
will be made available in the coming weeks will, however, only be available in English. The site is 
currently being translated and it will be made available in French and Spanish as soon as possible.  
27.  We are deeply grateful for the feedback and collaboration of many delegates who have helped 
to shape and refine this new tool in line with your actual practical requirements, during an extended 
development process. This initiative truly could not have come to fruition without this valua ble input. 
We continue to welcome any feedback on how you think the e -TRIPS NSS could be improved in the 
light of practical experience.  
The broader e -TRIPS Gateway  
28.  I would like to turn now to a brief update on the broader e -TRIPS Gateway – in other words,  
the online information portal that will allow you to search and extract the full range of TRIPS 
information managed by the Secretariat. Work is progressing steadily. As reported earlier, we will 
be engaging with delegates and other stakeholders on the des ign and layout of this Gateway, again 
with a view to building it around the practical needs and requirements of Members. We hope to 
provide a more substantive update at the June meeting, including information on an initial release 
version for trial by dele gations, and look forward to your guidance on this stage of the project as 
well. 
2  REVIEW OF NATIONAL I MPLEMENTING LEGISLAT ION 
29.  No statements were made under this agenda item.  IP/C/M/91/Add.1  
 
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  3  REVIEW OF THE PROVIS IONS OF ARTICLE 27.3 (B)  
4  RELATIONSHIP BETWEEN  THE TRIPS AGREEMENT  AND THE CONVENTION ON 
BIOLOGICAL DIVERSITY   
5  PROTECTION OF TRADIT IONAL KNOWLEDGE AND FOLKLORE  
5.1  India  
30.  There is no change in India 's position on the issues of review of the provisions of Article 27.3 (b), 
relationship between the TRIPS Agreement and the CBD, and protection of traditional knowledge 
and folklore. However, India would take this opportunity to highlight some of the important points 
from our last submission. India is an ancient civilization with a rich body of traditional knowledge 
associated with biological resources. In India 's case, this traditional knowledge is both coded, as in 
the texts of Indian systems of medicine, such as Ayurveda, Unani and Siddha; and non -coded, which 
exists in the oral  undocumented traditions. India is also amongst top 20 identified mega diverse 
countries in the world.  
31.  Countries have adopted various methods to protect traditional knowledge and associated 
genetic resource s at the national level. However, in the absence of an enforceable international 
regime, such domestic/national regimes on their own cannot address misappropriation of existing 
knowledge in foreign patent offices and biopiracy.  
32.  Therefore, it has been one of our long -standing demand that there should be an international 
enforceable regime that makes patent offices the checkpoint to contain such misappropriation. As 
in fact, patents should not be granted for existing traditional knowledge and associated genetic 
resources, and where traditional knowledge an d associated genetic resources form the basis of 
scientific development, patent applications must disclose source or origin of the resource and 
disclose whether the access was on mutually agreed terms. The TRIPS /CBD linkage is, therefore, 
important for dev eloping countries because it seeks to address biopiracy.  
33.  India is also of the view that a briefing by the CBD Secretariat on the latest developments in 
the implementation of the Nagoya Protocol would be very useful for a large majority of the 
Membership o f this Council. India also supports updating of three factual briefs by the Secretariat 
on these issues.  
5.2  South Africa  
34.  South Africa is a Contracting Party to the Convention on Biological Diversity (CBD) and rat ified 
the Nagoya Protocol on Access to Generic Resources and Fair and Equitable Sharing of Benefits 
Arising from their Utilization in 2013 which came into force October 2014.  
35.  The Access Benefit Sharing  (ABS) legal framework for South Africa is contained in  Chapter 6 of 
National Environmental Management: Biodiversity Act No 3, 2003 . This Act regulates , inter alia , 
bioprospecting involving indigenous genetic and biological resources; the exportation of indigenous 
genetic and biological resources for purposes of bioprospecting or any other research purpose; and 
provides for a fair and equitable sharing by stakeholders in benefits arising from bioprospecting.  
36.  South Africa also requires disclosure of the use of traditional knowledge or biological resources 
in pat ent application s. Sections 30 (3A) of the Patents Act No. 37 of 1952  as amended by Act No. 
20 of 2005  require that:  
• "(3A) Every applicant who lodges an application for a patent accompanied by a complete 
specification shall, before acceptance of the application, lodge with the registrar a statement 
in the prescribed manner stating whether or not the invention for which protection is claimed 
is based on or derived from an indigenous biological resource, genetic resource, or traditional 
knowledge or use ." 
 
37.  These amendments to the Patents Act came into force on 14 December 2007 by proclamation 
and with the publication of Regulations for the Patents Amendment Act. As a result, every applicant 
for a patent (with the exception of provisional patent applicati ons) filed in South Africa on or after IP/C/M/91 /Add.1  
 
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  14 December 2007 is required to lodge a declaration or statement in respect of traditional knowledge 
or use of indigenous biological resources, irrespective of the nature of the invention sought to be 
protected.  
38.  The S outh African National Recordal System (NRS) is a defensive anti -appropriation strategy 
which was launched on 24 March 2013 by the Department of Science and Technology (DST) in 
response to the Indigenous Knowledge System (IKS) Policy adopted by the South Af rican 
government in 2004. The Recordal System, which is loosely modelled  upon India 's Traditional 
Knowledge Digital Library (TKDL), seeks to capture, preserve, manage and disseminate traditional 
knowledge  in digital format, while simultaneously enabling pr ocesses to derive benefit from the 
traditional knowledge . The NRS, which has been developed in phases, currently focuses on 
traditional knowledge  of both African traditional medicine and indigenous foods, while the protection 
of traditional knowledge relating to arts, crafts and farming practices will be developed at a later 
stage.  
39.  Despite the already extensive legal regime that applies in South Africa, we still experience 
significant instances of biopiracy and misappropriation. National regimes are therefo re necessary, 
but insufficient steps to protect traditional knowledge or the use of indigenous biological resources. 
A multilateral system within the context of the TRIPS Agreement that regulates disclosure and access 
remains the best guarantee against mis appropriation of genetic resources and traditional knowledge.  
40.  In respect of procedural issues, South Africa once again calls on the Secretariat to update the 
three factual notes contained in documents IP/C/W/368/Rev.1, IP/C/W/369/Rev.1 and 
IP/C/W/370/Rev.1 . We further reiterate our support for a briefing by the CBD Secretariat on the 
Nagoya Protocol and subsequent developments.  
5.3  Ecuador  
41.  Ecuador would like to confirm the views it expressed at previous meetings regarding these 
issues and the need to review Article 27.3(b) of the TRIPS Agreement.  
42.  We reiterate our position that patents for all life forms and parts thereof should be prohibited, 
as life forms and parts thereof cannot be considered tradeable goods sub ject to possible inventions. 
Viewing them as such would endanger or negatively affect them.  
43.  It is important that the TRIPS Agreement and the Convention on Biological Diversity are 
mutually supportive in their objectives, in particular as regards access to genetic resources and the 
fair and equitable sharing of benefits arising from their utilization, and prior informed consent.  
Regarding the utilization of genetic resources and associated traditional knowledge, it is vital to 
disclose both the origin and so urce in the country that provided the genetic resources and associated 
traditional knowledge.  In this context, it is important to have multilateral legal instruments that can 
improve the utilization and protection of genetic resources, traditional knowledg e and traditional 
cultural expressions, since the absence of clear regulations on intellectual property rights over living 
organisms has allowed for the proliferation of practices such as biopiracy and bioprospecting.  
44.  Lastly, we would like to insist on our  request that the Secretariat update the factual notes on 
the relationship between the TRIPS Agreement and the Convention on Biological Diversity, the 
review of the provisions of Article 27.3(b) of the TRIPS Agreement, and the protection of traditional 
knowledge , which were last updated in 2006.  As you already know, the aim of this request is to 
ensure that Members have updated elements of analysis that can enrich the discussions on these 
issues, without prejudice to each Member 's individual position.  We ca ll on the delegation of the 
United States to show flexibility in its position so as to enable the Secretariat to update the 
aforementioned factual notes and, in this way, advance the work of this Council.  
5.4  China 
45.  The r elationship between the TRIPS Agreement and the CBD is an important issue in this 
Council. Over the years, Members have conducted a lot of useful discussion on this issue. China 
attaches great importance to the issue of TRIPS -CBD and hopes that Members could constructively 
involve in this discussion. As a large country for genetic resources, China attaches great importance 
to these issues. China joined the CBD as early as 1983 and  joined the Nagoya Protocol in 2016. At IP/C/M/91/Add.1  
 
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  the same time, China makes e fforts to improv e domestic legislation . The Patent Law stipulates the 
disclosure of genetic resources, requiring that the direct and original resource should be illustrated 
when  inventions and creations are based on genetic resources.  
46.  Regarding the substan tial issues, China notes that the majority of Members support  to amend 
the TRIPS Agreement to ensure the mutual support iveness  between  the TRIPS Agreement, the CBD 
and the Nagoya Protocol.  As to the issue of disclosure, China ha s provided detailed suggesti ons on 
negotiation modes, improving the transparency on genetic resources utilization, preventing 
misappropriation of genetic resources and traditional knowledge, and preventing the grant of 
erroneous patent s in documents TN/C/W/52 and TN/C/W/59 co -sponsor ed by China and other 
Members. China also believes that setting up a reasonable system for prior informed consent and 
benefit sharing could make better protection of genetic resources.  
47.  As regard to the procedure, China supports to invite the CBD Secretari at to brief on the Nagoya 
Protocol and hopes that the Secretariat could re vise three  factual notes （IP/C/W/368/Rev.1, 
IP/C/W/369/Rev.1  and IP/C/W/370/Rev.1 ) which can contribute greatly to our discussion. China 
believes that discussion and negotiation in WIPO  IGC could not hinder Members from finding 
solution s in the WTO as the Ministers ha ve given the Council the mandate to examine the relationship 
between the TRIPS Agreement and the CBD. The WTO and WIPO are different platforms for 
discussion and research . Discussion s in both platforms are conducive to solution -finding.  
5.5  Bolivia, Plurinational State of  
48.  The Plurinational State of Bolivia wishes to reiterate the relevance of document IP/C/W/545 of 
26 February 2010, in which it submitted a contribution to this Council. We would like to emphasize 
the importance of keeping this item under discussion and on this Council 's agenda. We also support 
the idea to update the three factual notes. The review of Article 27.3(b) is an issue within the 
mandate of the Doha Development Agenda under Paragraph  19 of the 2001 Doha Ministerial 
Declaration. Article 27.3 (b) must be clarified in order to prohibit the patenting of all life forms and 
to protect all the rights of farmers, genetic resources, traditional knowledge and traditional practices 
in developing countries.   
5.6  United States of America  
49.  Regarding genetic resources, traditional knowledge and folklore, we continue to believe that 
WIPO serves as the best forum to address these issues. The WIPO IGC is looking at addressing 
unresolved issues and working on a common understanding of core issues, using an evidence -based 
approach and examples of national experiences.  The United States will continue to engage in 
technical discussions at WIPO IGC and looks forward to hearing more from the demandeurs  
regarding dat a supporting their position s on this issue.  
50.  With respect to the various requests made in the meeting , the United States is not in a position 
to support them, but remains open to discussions, including bilaterally with delegations in between 
and at the marg ins of the TRIPS Council meetings.  
5.7  Japan  
51.  We have discussed this agenda  item at length during a series of meetings of the TRIPS Council. 
This delegation, therefore, believes that our position is well -recognized among Members, so we 
would like to make our intervention brief  by highlighting some major points.  
52.  The delegation of Japan  would like to reiterate our position that the Convention on Biological 
Diversity  is by nature not relevant to the intellectual property system. Therefore, we need to seek 
appropriate ways to deal with misappropriation of genetic resources. This means that  we should 
bear in mind that any measures taken must not adversely affect the existing intellectual property 
system or hinder the creation of innovations utilizing genetic resources and associated traditional 
knowledge.  Japan  is firmly convinced that to in clude the disclosure requirement in the IP system 
would discourage industries from conducting research and development activities on biological 
materials. This is the very consequence of the disclosure requirement that Japan has been concerned 
about. The s ame holds true for not only developed countries but also emerging and developing 
countries. Therefore, Japan believes that the disclosure requirement is not an adequate means for IP/C/M/91 /Add.1  
 
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  dealing with the  misappropriation of genetic resources.  In line with the above-mentioned  position, 
we firmly believe that the protection of  genetic resources , traditional knowledge and folklore , and 
traditional cultur al expressions should be designed in a manner that supports creativity and 
innovation.  
53.  In addition, this delegation believes that the WIPO IGC is the most appropriate forum for holding 
technical discussion on genetic resources, traditional knowledge and folklore from IP aspects, and 
the 39th and 40th sessions of the WIPO IGC are planned to be held in the first half of this year. This 
delegation has been actively contributing to the discussion at the IGC meetings, making various 
proposals, and remain willing to contribute to evidence -based discussion on these issues in a 
constructive and effective manner.  
5.8  Brazil  
54.  Brazil has a well-known  position on the importance of promoting the neutral support iveness  
between the TRIPS Agreement and the Convention on Biological Diversity (CBD), which  is contained 
in document TN/C/W/59.  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 reinfo rce the view that IP rules can work for the 
benefit of all countries and stakeholders.  
55.  Biopiracy and misappropriation of traditional knowledge and traditional cultural expressions 
continue to occur. An amendment to the TRIPS Agreement would ensure cooperation between 
countries, reduce uncertainty for stakeholders and curb illegal activities related to th is matter.  
5.9  Canada  
56.  Canada continues to firmly believe that the TRIPS Agree ment and the Convention on Biological 
Diversity are complementary, and that there is therefore no need to amend the TRIPS Agreement 
in this regard.  
57.  Canada welcomes the ongoing work of the WIPO Intergovernmental Committee on Intellectual 
Property and Genet ic Resources, Traditional Knowledge and Folklore (IGC). Canada views the IGC 
as the best and most appropriate forum for discussion on these complex issues. It is an important 
venue to bring together expert views to discuss IP  related issues in order to ide ntify evidence -based, 
balanced, appropriate and mutually -beneficial approaches. Canada has been, and continues to be, 
an active and committed participant to this important work, and welcomes the concrete discussions 
and exchanges of national experiences at  the IGC, which  are so important to  identify the  issues  at 
hand.  In this regard,  Canada looks forward to the upcoming 39th session of the IGC in March  2019.  
58.  With respect to procedural matters at the TRIPS Council, as Canada has previously noted, and 
without prejudice to our position on substantive matters, Canada can support from a procedural 
standpoint a briefing from the CBD  Secretariat  to the TRIPS  Council, should  there  be sufficient interest 
from other Members on the matter. Canada could also supp ort the compilation of the three factual 
notes on the TRIPS Agreement and the CBD , review of Article 27.3(b) , and protection of traditional 
knowledge (documents IP/C/W/368 /Rev.1 , IP/C/W/369 /Rev.1 , and IP/C/W/370 /Rev.1 ) by the WTO  
Secretariat.  Canada  remain s of the understanding that  this would  remain  an information  collating 
exercise, and in both cases, this is without prejudice to national positions on these issues.  
5.10  Switzerland  
59.  The relationship between the TRIP S Agreement and the Convention on Biological Diversity 
(CBD), including the question of a disclosure requirement for genetic resources , has been on the 
agenda of the TRIPS  Council and the WTO as outstanding implementation issues for many years. 
Switzerland  recognizes that these are important concerns for many biodiversity rich countries. 
Switzerland,  being a Party to both the CBD and the TRIPS Agreement, remain open to continue 
exploring ways to further enhance the mutual supportiveness of both international agreements.  
60.  Transparency is inherent to the patent system. Transparency is also of key importa nce in the 
utilization of genetic resources and associated traditional knowledge . If an invention is directly based 
on genetic resources or traditional knowledge , transparency could be further enhanced by disclosing IP/C/M/91/Add.1  
 
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  information on the source of the respect ive genetic resources  or traditional knowledge . Such a 
disclosure requirement must be adequate, practical, non -burdensome and non -prejudicial to an 
expeditious and effective patent application, examination and granting procedure. By working out a 
solution along these criteria for the specific context of the TRIPS regulatory framework, the WTO will 
not only enhance transparency but also legal certainty at the international level.  
61.  Switzerland is of the view that such a solution will serve the advancement and  promotion of the 
patent system, in particular in relation to inventions in the field of biotechnology. These are some  
reasons why Switzerland is one of the coalitions  of 109 Members that tabled document TN/C/W/52. 
It contains modalities proposals for such  a requirement to disclose the source of genetic resources  
and traditional knowledge  in patent applications as well as for enhanced protection of geographical 
indications, thus combining working proposals on these two outstanding implementation issues.  
62.  Finally, Switzerland supports the request to the Secretariat to update its factual compilation 
notes on the discussions under these three agenda items and to  invite the CBD  Secretariat to brief 
the TRIPS Council on the Nagoya Protocol.  
5.11  Australia  
63.  Australia believes that the WIPO IGC is best placed, with appropriate technical expertise, to 
consider the important and complex issues relating to intellectual property and genetic resources 
and associated traditional know ledge , and cultural expressions. Australia hopes WIPO Members will 
adopt a spirit of compromise when the issue of genetic resources is next considered in 2019.  
Australia will continue to be an active and constructive participant in the IGC process .  
64.  Austr alia believes the TRIPS Agreement and the Convention on Biological Diversity are fully 
consistent, and that the TRIPS Agreement therefore does not need to be amended. Australia fully 
implements its obligations under both agreements, which we view as mutual ly supportive.  
65.  In relation to procedural matters, Australia is open to a briefing by the CBD Secretariat on the 
Nagoya Protocol, and can be flexible in relation to the Secretariat updating the three factual notes.  
5.12  Indonesia  
66.  Indonesia 's position is well-known,  and we are in the process of incorporating the CBD 
provisions in our IP system . We believe that the TRIPS -CBD issue is important for most Members of 
the WTO and for this reason we would like to emphasis the following: we need to ensure the 
consistency and mutual supportiveness between the TRIPS Agreement and the Convention on 
Biological Diversity . We need to take neces sary measures to ensure fair and equitable sharing of 
benefit arising from the utilization of genetic resources , traditional knowledge  and folklore  through 
the establishment of a disclosure requirement for patent application s. We also need assume  
substanti ve discussion in this Council as complementary to the discussion in other fora, such as 
WIPO  with the view of achieving a fair and balanced trading system with regard to intellectual 
property.  Indonesia also support s the suggestion that the CBD Secretariat  be giv en an opportunity 
to brief the Council on any development related to the CBD and also urge s the WTO Secretariat to 
update the factual notes .  
5.13  Chile  
67.  Regarding this agenda item, our delegation would like to reit erate the importance of the 
flexibilities contained in the TRIPS Agreement. In this respect, we understand that the flexibilities 
provided for in Article 27 of the Agreement enable each Member to take into account its own ethical 
and public health standard s, among other criteria, when developing its intellectual property system. 
For Chile, it is important that such flexibility can be preserved insofar as it allows each Member to 
rethink and modify its intellectual property model in the light of its own soci al, cultural and economic 
changes.  
68.  In Chile 's view, intellectual property systems are not an end in themselves, but are tools for 
promoting innovation and development while also facilitating access to information and health. This 
vision is reflected in Law  No. 19.039 on industrial property, which excludes the patentability of plants 
and animals.  IP/C/M/91 /Add.1  
 
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  69.  Chile, like other delegations, considers that the TRIPS Agreement and the CBD are 
complementary instruments. We therefore believe that there is no need to make any amendment s 
to the TRIPS Agreement to ensure that they are consistent with each other. We wish to highlight the 
important work being done at the W IPO on genetic resources, traditional knowledge and traditional 
cultural expressions, and reaffirm Chile 's comm itment to continue working and facilitating discussion 
in that forum.  
70.  Finally, we would like to express our support for the proposal that the CBD Secretariat provide 
a briefing to this Council. We believe that a factual description could shed light on this  topic for 
Members and promote dialogue.  
6  NON-VIOLATION AND SI TUATION COMPLAINTS  
6.1  South Africa  
71.  South Africa is not a proponent for the application of draft modalities in respect of Non-Violation 
and Situation Complaints ( NVSCs). However,  we remain open to discuss any ideas that delegations 
may have in this regard. At the last TRIPS Council meeting we identified a few useful elements that 
can inform any debate that Member s may wish to have on the subject of non -violation and situation 
complaints as they pertain to the TRIPS Agreement.  
6.2  India  
72.  India's position on the issue of non-violation and situation complaints  (NVSCs)  under the TRIPS 
Agreement remains unchanged. Serious concerns remain on the debil itating impact that NVSCs  in 
TRIPS can have on the regulatory policy space of Members, on TRIPS flexibilities as well as increasing 
the complexity in interpreting the TRIPS provisions.  
73.  The absence of NVSCs  in the TRIPS context does not in any manner threat en or dilute the 
enforceability of TRIPS -related rights and obligations. Introducing NVSCs  into the TRIPS Agreement 
is unnecessary and inconsistent with the interests of WTO Members. As such, any benefits arising 
from the Agreement can be adequately protec ted by applying the text of the Agreement in 
accordance with accepted principles of international law, without any need for introducing the legally 
uncertain notion of NVSCs . 
74.  India looks forward to working with like -minded Members in making NVSCs  inapplica ble to 
TRIPS.  
6.3  United States of America  
75.  The United States ' position on this issue remains unchanged. We reiterate our support for 
allowing the current moratorium to expire so that Members may bring NVNI complaints in the future, 
as appropriate.  
76.  In the previous TRIPS Council  meeting , some Members raised concerns over the application of 
NVNI complaints to the TRIPS Agreement. We believe that while valid questions have arisen, they 
are fully and adequately answered by the text of the TRIPS Agreement itself and further clarified 
through GATT and WTO adjudication, as we have enumerated in our communication to the 
TRIPS  Council, which was circulated to Members as IP/C/W/599 . 
77.  The United States has provided detailed and extensive analysis in each of our statements under 
this item over the past several years. We have expla ined the legal basis for such claims in the GATT 
and TRIPS Agreement texts, the panel and Appellate Body jurisprudence involving NVNI disputes, 
the extensive safeguards that exist to protect Members rights and obligations under the TRIPS 
Agreement, and con crete descriptions regarding how such disputes would work in practice.   
78.  As we have detailed in past interventions, NVNI claims have a long lineage in the WTO and in 
international trade law generally. The applicability of such claims to the WTO Agreements is the rule; 
their non -application is the exception. The TRIPS Agreement moratori um is the exception.  IP/C/M/91/Add.1  
 
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  79.  We continue to believe that WTO Members are being deprived of an important tool to enforce 
their rights under the TRIPS Agreement, which is why we support  the expiration of the current 
moratorium so that complaints of this type may be applicable to the TRIPS Agreement.  
80.  While we remain of the view that the text of the WTO Agreements and dispute settlement rulings 
provide Members with sufficient guidance on t he application of NVNI disputes to the 
TRIPS  Agreement, the United States remains open to considering specific proposal from Members 
wishing to further examine the scope and modalities for complaints of these types.  
6.4  Brazil  
81.  Brazil's position on this matter is well -known and remains unchanged. Brazil reiterates its 
understanding that NVSCs should not be applied to the TRIPS  Agreement.  
6.5  Ecuador  
82.  Under this item, Ecuador wishes to reiterate its view that NVSCs  do not apply to the TRIPS 
Agreement as this Agreement does not seek to protect market access, as there is no exchange of 
tariff concessions.  
83.  We expressed this position in document IP/C/W/385/Rev.1, which we co -sponsored. The 
document refers to the sc ope and modalities for complaints of the types provided for under 
Article  XXIII:1(b) and (c) of the GATT 1994, which are not applicable in th is area of dispute 
settlement.  
6.6  Russian Federation  
84.  The Russian Delegation would like to reiterate our position on the issue of non -violation 
complaints. We consider that non -violation and situation complaints shall not be applicable to 
disputes under the TRIPS Agreement. Such disputes are unnecessary and inconsistent with the 
interest of the WTO Membership since it  is going to disrupt the balance of rights and obligations 
under the Agreement. Any benefits arising from the Agreement can be adequately protected by 
applying the text of the Agreement in accordance with established pr inciples of international law, 
without recourse to legally imprecise notion of non -violation and situation complaints.  
6.7  Switzerland  
85.  For the details of Switzerland 's position regarding the application of NVSCs under the TRIP S 
Agreement and the expiration of the moratorium, I refer to the interventions of my delegation in 
past Council meetings. I therefore limit myself to reiterating that we stand ready to discuss any 
proposals of Members, should they consider specific modalit ies for such complaints necessary in the 
TRIPS context beyond those already contained in the DSU and those that can be derived from WTO 
jurisdiction.  
6.8  Argentina  
86.  Argentina 's position on this matter is well -known and remains un changed. We believe that 
complaints of this type are not applicable to the TRIPS Agreement, as explained in document 
IP/C/W/385/Rev.1, which Argentina co-sponsored  together with a large number of other Members.  
6.9  Chinese Taipei  
87.  My delegation recognizes  the concerns of Members on the applicability of NVSCs to the 
TRIPS  Agreement. We are looking forward to having substantive discussion with Members in this 
Council on this issue.  
6.10  Canada  
88.  Our positi on on this issue is well-known and  remains unchanged. Canada continues to have 
concerns regarding the applicability of the NVNI remedy to the TRIPS Agreement.  IP/C/M/91 /Add.1  
 
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  89.  Recognizing that the current moratorium exists based on consensus, Canada wishes to express 
its continued interest in participating in any consultations that take place on this issue amongst other 
interested Members.  
6.11  China  
90.  China reaffirms the position that non -violation and situation complaints are not applicable under 
the TRIPS Agreement, which has been elaborated in document IP/C/W/385/R ev.1 proposed by 16 
Members including China. We also welcome the discussion on this issue in accordance with decision 
and mandate given by Buenos Aires Ministerial Conference.  
7  REVIEW OF TH E IMPLEMENTATION OF THE TRIPS AGREEMENT UNDER ARTICLE 71.1  
91.   No statements were made under this agenda item.  
8  REVIEW OF THE APPLIC ATION OF THE PROVISI ONS OF THE SECTION O N 
GEOGRAPHICAL INDICAT IONS UNDER ARTICLE 2 4.2 
8.1  Montenegro  
92.  The protection of geographical indications in Montenegro is governed by the Law on Indications 
of Geographical Origin, the Law on Quality Schemes for Agricultural and Food Products, the Law on 
Wine and the Law on Spirit Drinks.  
93.  The Law on Indications of Geographical Origin does not apply to products and services where 
the acquisition, legal protection and the exercise of rights in respect of the use of the indication of 
geographical origin is regulated by a specific regulation.  
94.  Protection of geographical indications is conditioned on registration.  Geographical indications 
for agriculture and food products, spirit drinks and wines are registered in the Ministry of Agriculture 
and Rural Development, while GIs for all other products are registered in the Int ellectual Property 
Office of Montenegro – Ministry of Economy.  
95.  In accordance with the aforementioned legislation, foreign natural or legal persons, or foreign 
associations may apply for the registration of a geographical indication, if the geographical in dication 
was recognized in the country of origin, when it stems from the international agreements.  
96.   Recognition of a geographical indication does not need to be renewed or reaffirmed, also a 
geographical indication does not need to be used in order to maintain rights.  
97.  The decision on registration of the designation of origin, or geographical indication shall be 
cancelled in case s where no product protected with the designation of origin or geographical 
indication has been marketed for at least seven years.  
98.  "Njeguški pršut ", "Pljevaljski sir ", "Crnogorska goveđa pršuta ", "Crnogorska stelja " and 
"Crnogorski pršut " are some of the Agricultural and Food Products labelled with a protected 
geographical origin, and I invite you if you have opportunity to try some of them. Unfortunately, I 
could not find them on the market in Geneva.  
8.2  Norway  
99.  Norway has updated its review of the application of the provisions of the section on geographical 
indications under TRIPS Article 24 .2, the so -called checklist of questions. Our answers to the 
checklist are contained in IP/C/W/117/Add.7/Rev. 1.  
100.  The updated review takes account of the established sui generis -system for registration of 
geographical indications, designations of origin and traditional specialities for foodstuffs. The sui 
generis system offers protection at the same level as provi ded for wines and spirits under Article 23 
of the TRIPS Agreement.  IP/C/M/91/Add.1  
 
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  101.  We invite Members to have a look at the mentioned document for detailed answers to the 
questions. We also encourage other WTO Members to provide their answers or updated answers to 
the che cklist.  
8.3  Switzerland  
102.  Switzerland would like to thank Montenegro for submitting its answers to the checklist of 
questions and Norway for up -dating its initial set of responses. I would also like to thank both 
delegates for gi ving a brief account on the responses and the up -date submitted.  
103.  Switzerland encourages other Members to follow suit. Comprehensive and up -to-date 
information from Members is the basis needed for the Council to usefully undertake the review 
stipulated in A rticle 24.2 of the TRIPS Agreement.  
104.  In this context, Switzerland would like to inform the Council that in the English translation of 
Switzerland 's up-dated answers to the checklist, a number of corrections were made to make it 
comply with the French origi nal as submitted to the WTO at the end of 2017.  
105.  Switzerland thanks the WTO Secretariat for carrying out these corrections and for making the 
amended English translation available on the WTO database.  
9  FOLLOW -UP TO THE SIXTEENTH ANNUAL REV IEW UNDER PARAGRAP H 2 OF THE 
DECISION ON THE IMPL EMENTATION OF ARTICL E 66.2 OF THE TRIPS AGREEMENT  
9.1  Chad, on behalf of the LDC Group  
106.  On behalf of the WTO LDC Group, I would like to take this opportunity to express our sin cere 
thanks to the Chair for  his leadership over the course of the Workshop on the Implementation of 
Article  66.2 of the Agreement on Trade -Related Aspects of Intellectual Property Rights (TRIPS) held 
on 11  and 12 February at the WTO.  
107.  The LDC Group would also like to thank and congratulate all the workshop participants for 
their enthusiastic and constructive involvement throughout the event. The LDC Group welcomes the 
opportunity provided for representatives from the capitals to give detailed presentations  on items 
related to the priority areas in technological development under consideration. This was also an 
opportunity for individual LDCs to share their experiences with respect to priority projects – 
particularly those set out in the reports on Article 6 6.2 of the TRIPS Agreement.  
108.  We would also like to express our gratitude to our developed country Members  
(the United  States  of America , Japan, Australia, the European Union, Canada, Norway, Switzerland 
and New  Zealand) and all the other Members that took a n active part in the workshop. The developed 
country Members presented a comprehensive summary of their reports and responded to some of 
our questions regarding observance of Article 66.2 of the TRIPS Agreement.  
109.  The LDC Group also warmly welcomes the WTO S ecretariat 's commitment to supporting the 
efforts of LDCs to promote their economic and trade priorities through its organization of this 
workshop under a new format, which  include s the increased involvement of multilateral and regional 
partner organizatio ns. 
110.  The preliminary assessment that we have conducted shows that some of the programmes 
mentioned by the developed country Members seem to improve the level of information and lead to 
technology transfer and incentives. However, it also appears that other programmes mentioned in 
the reports do not relate to Article 66.2 and are not consistent with it, even though what is required 
of developed country Members in this context is to specifically address and report on technology 
transfer and incentives under th e article in question.  
111.  There were two sides to the workshop held over the last two days. First, LDC participants had 
the opportunity to discuss their priority areas with respect to technological development and provide 
their views on the projects under Art icle 66.2 included in the reports of certain developed country 
Members. Second, developed country Members were able to present their 2018 reports specifically 
on the implementation of Article 66.2 of the TRIPS Agreement.  IP/C/M/91 /Add.1  
 
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  112.  In the follow up on this issue, we would encourage our partners to be more explicit and focused 
on technology transfer under Article 66.2 of the TRIPS Agreement. One thing is certain, and that is 
that this year 's workshop has allowed for enhanced dialogue between LDCs and their developed 
country Member s, which is very positive and likely to foster a more effective implementation of 
Article 66.2. LDCs need to develop a sound and viable technological base, not only under Article  66.2 
but also in accordance with Article 66.1, taking into accoun t both the development of a technological 
base and the UN Sustainable Development Goals.  
113.  LDCs have a genuine need for incentives put in place by developed country Members to 
promote and encourage technology transfer to LDCs. We need to understand how the p rogrammes 
developed actually contribute to technology transfer and incentives for transfer. We need Members 
to work actively alongside us in this area.  
114.  As we end this workshop on technology transfer to LDCs under Article 66.2, the LDC Group 
supports the conclusions that have been drawn, particularly with a view to improving communication 
on the issue between LDCs and developed country Members. Access to relevant information will 
allow us to better gauge the implementation of and follow up on Article 66.2.  
115.  It would therefore be useful to designate focal points among the LDCs to monitor technology 
transfer and ensure appropriate follow up. It seems to us that this is an important suggestion that 
should be made operational.  
116.  Likewise, designating focal points among developed country Members to engage in the same 
follow up would be particularly relevant and help meet the expectations of LDCs.  
117.  The LDC Group appreciates these direct and productive exchanges with developed country 
Members and thanks them for their flexibility in taking into account the LDCs ' suggestions with 
respect to the priority projects raised. We fully support maintaining the new format for discussions.  
118.  Technology transfer to LDCs is a key and decisive factor in our countries ' economic growth. It 
is therefore important to emphasize that applying Article 66.2 and improving the use of the 
transparency mechanism on incentives for transfer of technology will undoubtedly contribute to 
improving relations between LDCs and our developed country Members  in the short, medium and 
long term.  
119.  On behalf of the LDC Group, we remain committed to a productive discussion on the 
implementation of Article 66.2 of the TRIPS Agreement and the continued involvement of our 
partners.  
120.  We should continue to pursue these j oint efforts to support LDCs in building institutional and 
human capacity so that they are able to integrate and develop technology that is appropriate to their 
economic growth.  
9.2  Central African Republic  
121.  The Cen tral African Republic supports the statement made by the LDC coordinator. It wishes 
to thank the WTO Secretariat for organizing th e Workshop on the Implementation of Article  66.2 of 
the TRIPS Agreement. The Workshop is important not only for enabling a cle ar understanding of this 
Article but also for highlighting the willingness of developed country Members to support our 
countries in implementing technology transfer.  
122.  To this end, we urge developed countries to facilitate these transfers of technology to ou r 
countries for the purpose of improving the economic situation and thereby enabling active 
participation in the multilateral trading system. In addition, developed Members can favour 
endogenous technologies that meet the needs of LDCs.  
123.  Lastly, the delegat ion of the Central African Republic would like to thank countries which are 
open to discussions on this matter.   IP/C/M/91/Add.1  
 
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  9.3  Senegal  
124.  Senegal  would like to join the LDC coordinator in thanking the WTO Secretariat for organizing 
the Workshop on the Implementation of Article 66.2 of the TRIPS Agreement.  
125.  This workshop, which brought together LDC delegates (both capital and Geneva -based) and 
delegates from developed countr y Members that had submitted reports, provided a good forum for 
discussion on the relevance and effectiveness of technology transfer under Article 66.2 of the TRIPS 
Agreement. It enabled LDCs to indicate the priority areas for technology transfer, to report on the 
results of the implementation of technology transfer proje cts and to make recommendations on the 
steps to take to improve the evaluation process.  
126.  The recommendations made include the following:  
a. The setting up of focal points at LDC and developed country Members level in order to 
coordinate and report on the incen tives provided by developed countr y Members  to 
enterprises and institutions in their territories for the purpose of promoting technology 
transfer to LDCs, and the results achieved in LDCs.  
b. Ensuring the compatibility of technology transfer projects with the  needs and priorities 
expressed by LDCs.  
127.  Improving reports so as to make them more specific and consistent with the letter and spirit 
of Article  66.2. 
128.  We hope that all the recommendations emanating from the workshop will help to improve the 
review under pa ragraph 2 of the decision on implementation of Article 66.2 of the TRIPS Agreement. 
In this respect, Senegal  encourages the Secretariat to pursue this initiative further in the context of 
the Council's  future work.  
129.  Lastly, Senegal  wishes to thank the devel oped countr y Members  for their reports.  
9.4  Myanmar  
130.  It is a pleasure to have the opportunity to speak this morning at this important meeting. First 
of all, on behalf of Myanmar, I would like to express special thanks to the WTO for its assistance to 
hold the Workshop on the Implementation of Article 66.2 of  the TRIP  Agreement, and also express 
thanks to the LDC participants  for their presentations  despite the ir busy schedules and finally thanks 
to all Members which presented at  the Workshop and in this Council  meeting.  
131.  The Government of Myanmar is exerting its best efforts for all -round development of the 
country by undertaking a series of political and economic reforms to achieve the vision of becoming 
a modern, democratic and developed country Member  by 2030. Although Myanmar is a 
least developed  country a nd lacks enough capacity building to fulfil its obligation as a Member of 
WTO, it is making every best effort.  
132.  Myanmar is also continuously working in the area of legislation on trade -related laws and 
policies such as FDI law, company law, IP laws, competitive policy, etc. Concerning IP  laws, the 
Industrial Design Law and Trademark law have already been approved by the Union Parliament and 
were signed by the President in January 2019. The remaining two IP laws , on patent and copyright , 
will also come  out soon.  
133.  In such a situation, it is also extremely grateful to the develope d country Members  for assisting 
technical assistance  and technology transfer  according to the Article 66.2 , both of  which are very 
much beneficial for Myanmar people. Technical a ssistance  and capacity building are essential for 
Myanmar to be able to overcome the big challenges it faces, especially regarding  trade and 
technolog ical development.  
134.  Article 66.2 of the TRIP Agreement is very supportive for the development of LDCs like 
Myanmar. Encouraging technology transfer in one country will provide technology promotion there. 
This will, in turn, create an environment  for innovation,  and will benefi t not only the host country , 
but also the development partner. Therefore, we should con sider this Article to be applied IP/C/M/91 /Add.1  
 
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  continuously for mutual interest. In Myanmar, we  have already setup our S ustainable Developing 
Goals, Economic Policy and Development Assistance Policy, etc. for carrying out country 
development. In this connection, we woul d like to refer our Myanmar Development Assistance Policy, 
2018 in building an effective cooperation between us.  
135.  In conclusion, we would like to inform you that we are ready to  constructive ly engage and to 
closely work together with the Members of WTO to enabling ourselves to build a sound and viable 
technological base in order to meaningfully improv e Article 66.2 implementation.  
9.5  Bangladesh  
136.  The delegation of Bangladesh sincerely thanks the Secretariat for organizing the Workshop on 
Implementation of TRIPS Article 66.2. It was a great opportunity to hear both the development 
partners and the targeted LDCs, particularly from their capital -based delegates. However, we should 
be honest to admit that not all assistance programmes are technology transfer as stated in 
TRIPS  Article 66.2 that aims to ensure sound and viable technological base in the LDCs. But we must 
acknowledge that many technical assistance programmes , a large portion of which falls under TRIPS 
Article 67 , by the development partners are helping the LDCs in capacity enhancement in different 
areas. Many projects and programmes cited in the workshop by the LDC delegates are virtually the 
examples of technical assistance programmes.  
137.  The delegation of Bangladesh support s the proposals by the delegation of Chad and Central 
African Republic that we need regular dialogues on the TRIPS Article 66.2 implementation. We 
encourage the Secretariat to arrange such workshops on regular intervals involving more LDC 
Members. We also welcome the proposal of appointing a focal point on the implementation status of 
TRIPS Article 66.2.  
9.6  Vanuatu  
138.  Vanuatu support s the statement s made by Chad on behalf of the LDC Group and the previous 
LDC Members.  
139.  In addition, Va nuatu thanks the WTO Secretariat for organizing this workshop and for allowing 
our LDC capitals -based  officials to participate and share experiences.  
140.  Secondly, Vanuatu  fully support the establishment of the focal points in both LDC and 
developed countr y Members  to facilitate coordination and information sharing.  
9.7  Japan  
141.  Japan thanks the Secretariat for organizing the W orkshop on the Implementation of Article 
66.2 of the TRIPS Agreement, which  was held back -to-back to this Council. The Workshop worked 
to advance cooperative activities and enhance mutual understanding between developed country 
Members and LDC Members.  
142.  Japan will continue to make its utmost efforts to improve the business environm ent and make 
it even more conducive to transfer technology. We look forward to working further with LDC Members 
in this context.  
9.8  Australia  
143.  We warmly welcomed the opportunity to discuss Australia 's technology transfer activiti es with 
LDC Members over the past two days at the Workshop on the Implementation of Article 66.2 of the 
TRIPS Agreement.  
144.  We would like to register our appreciation for the hard work of the Secretariat in organising 
this important event. We also thank all p articipants for this productive exchange.  
145.  At the workshop we presented some specific examples of Australia 's compliance with its 
Article  66.2 obligations, including the Cambodia Agricultural Value Chain Program (CAVAC), which IP/C/M/91/Add.1  
 
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  has given farmers in four Camb odian provinces access to cutting edge agricultural technology and 
improved seed varieties, helping them to improve yields and make their rice more competitive.  
146.  We paid close attention to the questions and feedback provided by LDC Members on our 
Article  66.2 reporting, and welcomed the opportunity presented by the Workshop to engage on these 
issues.  
9.9  Switzerland  
147.  Switzerland was pleased to participate in this year 's Workshop on the Implementation of Article 
66.2 of the TRIPS Agreement  and to learn about LDCs priority sectors for technology transfer. We 
thank the Secretariat for its organization and for leading the workshop in an efficient manner.  
148.  It was particularly helpful to see some concrete examples of technology transfer that have 
effectively worked in practice. This serves developed countr y Members  as an orientation when 
developing incentives measures and planning tailor made projects together with LDC partners.  
149.  We believe that the presentations of the LDCs during the wor kshop should not only contain 
examples of past or current projects. We encourage LDCs to also present planned project outlines 
as concretely as possible. The presentation of Myanmar was very helpful in this regard to understand 
what is concretely needed. W e encourage other LDCs to present similar concrete project outlines in 
the future.  
150.  Switzerland remains committed to engaging in the Council 's discussion on Article 66.2 and to 
further developing its incentive measures to enterprises and institutions in Swi tzerland for the 
purpose of promoting and encouraging technology transfer to LDCs.  
9.10  United States of America  
151.  United States  also thank the Secretariat for its efforts in organizing the Workshop. We also 
found it to be an excellent program me that, in particular, benefited from the participation of 
capital -based officials from LDCs.  
152.  The United States appreciated the opportunity to present and share details on our most recent 
Article 66.2 submission IP/C/W/646.  
153.  At the workshop w e gained insight into the perspective and needs of LDCs and hope that the 
LDC Members also left the workshop with a better understanding of our extensive program mes and 
activities.  
154.  We took note of the idea shared during this week 's workshop of the designation of focal points 
on 66.2 reports for both LDC and developed country Members.  
155.  We understand that LDC focal points could play an important role in disseminating information 
or reports about technology transfer program mes and thei r effectiveness to broader audiences, so 
technology transfer projects could be better leveraged in the country.  
156.  However, with respect to the United States, the nature of our program mes and technical 
assistance do not immediately seem to lend themselves to such a structure under the WTO.  
157.  It is quite an undertaking each year to take stock of the program mes we report to the 
TRIPS  Council. As you can see from our recent reports, there is not one coordinating body that 
undertakes all of these programs. We theref ore view it best to continue to implement these 
program mes and these reports as we have.  
158.  Of course, we are always willing to meet with interested Members to discuss ways to ensure 
that our program mes and reports are as helpful as possible.  IP/C/M/91 /Add.1  
 
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  9.11  Norway  
159.  Norway thanks the Secretariat for its hard work in putting together the very comprehensive 
Workshop on the Implementation of Article  66.2 of the TRIPS Agreement in which we attended  these 
past two days.  The Workshop was an excellent oppo rtunity for exchange between LDC Members and 
developed country Members.    
160.  Norway already gave a brief presentation of our report in the meeting of the TRIPS Council in 
November. In the interest of time, we will therefore refrain from doing so again in this  meeting.  
161.  The TRIPS A rticle 66.2 report from Norway is contained in document IP/C/W/646/Add.5.  
162.  Norway presented its report at the Workshop on the Implementation of Article 66.2 of the 
TRIPS Agreement  and had a useful discussion afterwards. We would like to  thank the LCDs for their 
interest in our report and the questions and comments we received. We aim to respond to these in 
writing as soon as possible.  
9.12  New Zealand  
163.  New Zealand also wants to thank the Secretarial for organi zing what was a very effective 
workshop. Was a pleasure to engage in a dialogue on which assist us all to an understanding on 
what Article 66.2 provides. The basis for my remarks today is report which New Zealand submitted 
on its Implementation of Article 66.2 covering the period from June 2017 to June 2018. We  have 
lodged this with the Secretariat and you 'll find this at document reference IP/C/W/646/Add.6.  
9.13  European Union  
164.  The E uropean Union and its Member s take their commitments and obligations under Article 
66.2 of the TRIPS  Agreement very seriously and try to deliver technology transfer programmes to 
LDCs in a way that reacts to natural, social, health, climate and economic changes. The programmes 
are spe cifically tailored to the needs of least developed countries (LDCs) and their regional 
organizations. The programmes listed in the EU report are provided by the European Commission or 
other European institutions or the EU Members. The main incentive for th e EU companies or 
organisations to voluntarily transfer technologies to LDCs is that they get funding from the European 
Commission or the EU Members for these activities. The high number of programmes shows that 
this incentive has proven to be effective.  
165.  We would like to thank the Secretariat and also in particular the LDC participants for the very 
detailed and useful Workshop. We saw a lot of common ground and always stand ready for any 
fruitful exchanges.  
166.  The EU had presented it report at the last meetin g and actively participated in the Workshop 
held from 11 to 12 February. In the interest of time, we therefore refrain from presenting our long 
list of exemplary projects again.  
9.14  Canada  
167.  Canada  would like to thank the Secretariat  for organizing the thematic discussions and panels 
and Members for sharing their important insights on the implementation of Article  66.2 of the 
TRIPS  Agreement . Canada places great importance on the implementation of Article 66.2, and on 
the annual works hop as an opportunity to exchange national experiences and practices, particularly 
with a view to ensuring that our continued implementation of the TRIPS Article 66.2 commitment 
remains responsive to the needs and priorities of LDCs over time in enabling t hem to create a sound 
and viable technological base.  
168.  In our experience, the clear identification and articulation of priority needs by LDCs is 
particularly important in ensuring that the outputs of Canada 's tech transfer incentives are tailored 
to these o bjectives. Ensuring that our LDC partners have an opportunity to provide feedback on 
specific projects, as well as on their needs and priorities over time, will help provide that the 
incentives provided under our Article 66.2 commitment continue to enable LDCs to address new and 
emerging development challenges in creating a sound and viable technological base. We similarly IP/C/M/91/Add.1  
 
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  benefit from hearing the experiences of other developed country Members , in sharing and identifying 
best practices and commonalities, wi th a view to better informing Members of how future incentives 
in the area of technology transfer might best respond to LDCs ' evolving priorities and needs over 
time.  
169.  In turn, these discussions can inform developed country Members in refining and tailorin g the 
range of incentives provided to enterprises and institutions, in order to continue to meet the 
development needs of LDCs going forward.  
170.  In this spirit, Canada would be pleased to discuss any aspect of its 2018 report which can be 
found in document IP /C/W/646/Add.4 with interested LDC Members and looks forward to further 
dialogue through the annual workshop and at TRIPS Council. We once again thank the Secretariat 
for convening th e Workshop on the Implementation of Article 66.2 of the TRIPS Agreement , and all 
Members for their constructive engagement on these important issues.  
9.15  Senegal  
171.  Senegal would like to react to a few observations made by the European Union and the United 
States on the idea of having focal points at the developed and LDC level. We are fully aware that it 
is not easy to ensure coordination of the whole set of structur es and projects carry out for the 
implementation of Article 66.2. This require even more efforts in regard of payments. Some 
delegations mentioned during the Workshop experiencing some difficulties verify ing the whole set 
of projects that were listed in th e reports. But we think that this is a good starting point and it would 
be useful in this context to have focal points so that we can centralize  and also to be able to respond 
at the WTO level.  
172.  In the workshop, during the Q&A session, some delegations tha t presented reports were not 
always able to reply to the questions following the presentation of the reports. Perhaps information 
was not available or the entities responsible for implementation at country level would have to be 
addressed directly . For exa mple, there is Japan and other entities that are relevant to those contexts. 
It is our view  that having focal points could help  us resolve these challenges. LDCs stand ready to 
establishes this and we think that will be easier for developed countr y Member s who have greater 
mean s for coordination than the LDCs do. To ensure that this happen , we would happily discuss this 
in an agreed date with the concerned delegations. On this proposal, and to improve our efforts . 
9.16  Vanuatu  
173.  Vanuat u took note of the report submitted by developed countr y Member s during the 
Workshop  and is  wondering whether it could be possible to include in the reports some inputs from 
the beneficiary's  countries. The LDCs are benefitting in general terms but there i s a lack of 
coordination between beneficiary's and developed supporting countries . 
174.  Vanuatu suggests that , in order to have a better coordination and see what benefits LDCs are 
actually  receiving from developed countries , it would be wise to adopt a format where the inputs 
from the beneficiaries  could help in terms of moving forward.  
9.17  African Regional Intellectual Property Organization  
175.  The African Regional Intellectual Property Organizat ion (ARIPO ) would like to associate itself 
with the statement made by the delegation of Chad on behalf of the LDCs.  
176.  This delegation raises the flag to appreciate Secretariat for organizing the Workshop on the 
Implementation of Article 66.2 of the TRIPS Agr eement: Incentives for Technology Transfer that was 
held in the past two days.  
177.  This workshop allowed the LDCs to showcase their development priorities and technological 
needs that technology transfer could assist in achieving.  
178.  We especially appreciate the new format that seems to be adequate to promote the dialogue 
between developed countr y Members  and LDCs on the issues of technology transfer, especially with 
regard to the implementation of TRIPS Article 66.2.  IP/C/M/91 /Add.1  
 
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  179.  We will not delve into the very important conc lusions and recommendations emanating from 
this meeting but as this delegation is in fully agreement and support of those outputs it is our desire 
to encourage both developed countr y Member s and LDCs to implement them.  
180.  Finally, we would like to encourage S ecretariat to hold this kind of events possibly in regular 
basis and including more LDCs and relevant regional organizations. This delegation also believes 
that in future it would also be useful if sufficient time is given to capital -based delegations to g ather 
the necessary information in order to be able to provide more detailed information on current and 
future priorities and projects in which they would like to receive support.  
10  TECHNICAL COOPERATIO N AND CAPACITY BUILD ING 
10.1  Australia  
181.  Australia takes an active role in promoting technical cooperation and capacity building in the 
intellectual property field as we have highlighted in our 2018 Article 67 Report.  
182.  Since our last meeting, the ongoing work of the WIPO -Australia Funds in Trust (FIT) 
programme has continued to support least developed and developing countr y Members with the 
development and implementation of IP systems and enhancement of their IP capabilities.  
183.  We are pleased to reiterate our commitment to  technical cooperation and intellectual property 
capacity building activities.  
11  INTELLECTUAL PROPERT Y AND INNOVATION: SU MMARY OF THE 2018 TH EME – THE 
SOCIETAL VALUE OF IP  IN THE NEW ECONOMY,  AND 2019 IP AND INN OVATION THEME: 
PUBLIC -PRIVATE COLLA BORATIONS IN  INNOVATION  
11.1  United States of America   
184.  The United States is pleased to co -sponsor this agenda item and contribute to the discussion 
of "Public -Private Collaborations in Innovation - Research and Development (R&D). " 
185.  The United States would like to thank the co -sponsors for this item.  
186.  Before providing the United States ' experience with public -private collaborations in innovation, 
I would li ke to take a step back and summarize what we discussed last year under the theme - "The 
Societal Value of IP in the New Economy ". 
187.  First, under the sub -theme - "IP Intensive Industries and their Economic Impact on Society " - 
a number of WTO Members provided  empirical data from reports and case studies showing how 
intellectual property rights (IPRs) contribute to employment, gross domestic product (GDP), 
licensing revenue and trade. The discussions covered a broad range of IP -intensive industries, 
wherein the  contributing Members offered examples of government resources available to support 
the IP -intensive sector generally, and, more specifically, new and emerging businesses, including 
micro, small and medium -sized enterprises (MSMEs). Members also identified  ongoing and future 
studies to help improve their respective innovation landscapes, export strategies and IP policies.  
188.  Second, under the sub -theme - "IP and Improving Lives " - Members shared stories of how 
innovators and creators, including in partnership with governments, have used IP to address global 
challenges. Examples included healthcare products to provide faster diagnosis and better 
treatments; digital solutions to reform healthcare services; agricultural technology to help farmers 
significantly inc rease yields; and technology development projects either applied or developed in 
countries for which assistance is most needed, to name a few.  Another key discussion point was 
the need to improve the awareness of, and accessibility to, IP systems to help a wider range of 
people harness the power of IP.   
189.  Third, under the sub -theme - "Intellectual Property and New Business " - Members stressed 
the importance of creating an IP environment in which SMEs and starts -ups can thrive by using the 
benefits afforded by trade secret, patent, trademark and copyright protections. Noting the significant IP/C/M/91/Add.1  
 
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  impact SMEs and start -ups have on their economies, Members expressed the need to increase IP 
awareness and provide IP counselling  at the early stages of business developme nt and innovation.   
Research and Development (R&D)  
190.  Turning now to this session 's theme - "Public -Private Collaborations in Innovation - Research 
and Development (R&D) " - I intend to highlight the importance the United States places on research 
and develop ment to solve today 's challenges, as well as the funding levels and mechanisms that 
move innovation to commercialization for the benefit of the public.  
191.  The United States government spends upwards of USD 150 billion annually on funding research 
and developm ent conducted by universities, government research institutions, private businesses 
and individuals.  
192.  The federal government funds roughly 50% of academic research in the United States, and 
universities are the second largest performer of US R&D, after the  private sector.  
193.  University research is crucial for advancing science and for expanding the knowledge pool, not 
to mention the viability and sustainability of our economy.  
194.  In addition, the transfer of technology from universities and other research instit utions, which 
is normally early -stage research, to industry for further development and commercialization, is vital 
for maximizing the benefits of publicly funded research.  
195.  Patenting of inventions is critically important for licensing, securing investment  and forming 
partnerships that lead to the commercialization of inventions. In the absence of a strong patent 
system, most of these inventions will never see the light of day because of the significant costs 
associated with the transformation to marketable  products. In the absence of strong patent 
protection, investment in early -stage inventions would be too risky for businesses.  
196.  In the United States, technology transfer from universities to the private sector is made 
possible in large part by legislation c ommonly known as the Bayh -Dole Act, which was enacted in 
1980, and became effective on 1 July 1981. It represented a fundamental change in US government 
innovation policy.  
197.  Bayh-Dole gives universities and companies the option to own inventions they develo p with 
federal funding, and to grant exclusive licenses on those inventions.   
198.  Prior to the enactment of Bayh -Dole, recipients of federal funding, including universities, 
generally could not own title to publicly funded inventions. Federal agencies that pr ovided funding 
retained all IP rights and could only grant non -exclusive licenses to private companies. In fact, at 
the time Bayh -Dole was enacted, the federal government held title to approximately 28,000 patents, 
of which fewer than 5 % were licensed to i ndustry for development of commercial products.  
Companies were reluctant to invest in developing new products and markets, since competitors 
could later acquire licenses from the Government and then manufacture and sell the same products.  
This meant that  American taxpayers were not getting the full benefit from the billions of dollars 
invested in cutting -edge research.   
199.  The Bayh -Dole Act clearly changed that landscape. Universities are now encouraged to 
collaborate with industry to translate research res ults into products that benefit the public. Because 
the funding for the research comes from US taxpayers, by policy, preference is given to small 
businesses and to those making products in the United States.  
200.  Under Bayh -Dole, any income that universities re ceive from licensing must be used for 
rewarding university scientists and supporting the cycle of innovation.   
201.  The objectives of Bayh -Dole are to encourage maximum participation of small businesses and 
non-profits in federally funded R&D efforts, to promote collaboration between businesses and 
non-profits, to ensure that the Government retains sufficient rights fro m federally funded inventions 
to meet its needs, and to encourage the use of inventions for public benefit.  IP/C/M/91 /Add.1  
 
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  202.  Bayh-Dole also includes a number of safeguards designed to protect the public interest. They 
include:  
a. Obligations to disclose each new invention to the federal funding agency, to make a decision 
whether or not to retain title to the invention and to file an initial patent application within a 
certain time period;  
b. A government use license that confers a non -exclusive, non -transferable, irrevocable, 
paid-up right to practice or have practiced the invention on behalf of the US government 
throughout the world, and other important safeguards; and  
c. Preference for SMEs for licensing purposes.  
203.  Robust university research, coupled with the enabling legal environ ment created by the 
Bayh-Dole Act, spawned entire new industries in the United States, such as biotechnology, where 
the United States continues to have a leadership role.  
204.  In the past 25 years, more than 11,000 start -ups have formed based on the results of  
university research. A majority of these were located in close physical proximity to universities, 
contributing to the local and state economy and development.  
205.  Let me provide a brief history of one of those start -ups. 
206.  The amount of information we are abl e to harness from the Internet seems limitless at times.  
In the mid -1990s, Stanford University doctoral candidates Sergey Brin and Larry Page were working 
on an algorithm that utilized all the links of different webpages to search and rank websites from 
the World Wide Web. At the time there were roughly 250,000 websites, compared to today where 
there are close to 2 billion. They initially called the engine Page Rank, but later changed it to the 
numeral "1" followed by 100 zeroes - or Google, as we know it today.  This research was funded in 
part by a National Science Foundation grant.  
207.  Brin and Page were just a few of the many computer scientists that the National Science 
Foundation looked to for researching ways in which massive amounts of data could be man aged for 
both government and commercial purposes. The federal government identified early on the benefits 
to national security of being able to manage such large databases; and we all know what became of 
Google. It currently has a market cap of USD 771 billion, and its revenue previous  year was 
USD 136 billion.   
208.  Federally funded university research also ignited the innovative engines of Qualcomm, 
Symantec and Netscape, among many others.  
209.  In 2016 alone, 1024 start -ups were formed and 800 new products  originating from university 
research were introduced to the marketplace by companies in the private sector. Over 200 new 
drugs and vaccines were developed through public -private partnerships since enactment of the 
Bayh-Dole Act.  
210.  Moreover, university techn ology transfer creates billions of dollars of direct benefits to the US 
economy and supports millions of jobs every year.  One study found that between 1996 and 2013, 
academia -to-private sector patent licensing across all industries bolstered U.S. GDP by u p to 
USD 518 billion and supported up to 3,824,000 U.S. jobs.  
211.  Additional legislation from the 1980s sought to achieve national technology transfer goals by 
requiring federal laboratories to have a formal technology transfer program me and to actively seek 
opportunities to transfer technology to industry, universities, and state and local governments.   
212.  Moreover, a collaborative mechanism was created to encourage federal agencies and 
laboratories to work with universities and companies toward a common goal. A Cooperative Research 
and Development Agreement, or CRADA, is an agreement between a Federal laboratory and a 
non-Federal party (US or foreign) to perform joint research and development in any area that is 
consistent with the Federal laboratory 's mission.  IP/C/M/91/Add.1  
 
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  213.  Under a CRADA, a Federal laboratory may provide personnel, services, facilities, and 
equipment, but no funds, to the joint R&D effort. A non -Federal party may provide funds, in addition 
to personnel, services, facilities, and equipment.  
214.  A CRADA defines th e tasks to be undertaken within an area of collaboration and grants the 
Federal government a government -purpose license and the non -Federal party a non -exclusive, 
paid-up, royalty -free license for internal use of any patents that result from the CRADA rese arch. 
215.  The non -Federal party is also granted an option to negotiate either an exclusive or a 
nonexclusive commercial license within a field of use, subject to government -purpose rights. CRADAs 
also provide protection of proprietary information.  
216.  In practice,  a federal agency - such as the National Institute of Standards and Technology - 
solicits the research community (universities, companies, and others) for collaboration in a particular 
area of research. A recent example of a solicitation involved tattoo re cognition technology, which 
potentially has both government - law enforcement and national security - as well as commercial 
applications.  
217.  The United States ' experience with collaborative research and development has been a good 
one. Important legislation such as the Bayh -Dole Act, the Federal Technology Transfer Act, and 
others allow federal agencies and laboratories, academia, and industry to work together on worthy 
causes - whether it is a vaccine, a diagnostic tool, or the technological seed that will g row into the 
next great start -up.  
218.  We look forward on hearing other Members on this topic.  
11.2  Singapore  
219.   Singapore , on behalf of co -sponsors Australia; Canada; Chile; the European Union; Hong Kong, 
China; Japan; the Republic of Korea; New Zealand, Singapore; Switzerland; Chinese Taipei; and the 
United States of America , is pleased to introduce our paper on the 2019 IP and Innovation 
overarching theme on "Public -Private Collaborations in Innovation ".  
220.  Collaborations harness different expertise and resources across various sectors to develop new 
innovation breakthroughs that may not be possible in solo endeavours. In particular, strong 
collaborations between  the public and private sectors are important for effective innovation to help 
address global challenges. The public sector (e.g. public research and research -funding agencies) 
and the private sector (e.g. research and development (R&D), manufacturing, and  marketing and 
distribution companies) possess different resources, expertise and risk profiles that can complement 
each other to create IP and deliver useful innovative solutions that benefit society.  
221.  TRIPS Council Members are invited to take part in a three -part exchange this year and to share 
success stories on how public -private collaborations in innovation helps to improve lives, build 
resilient communities and create good jobs. As per the paper, th ree subthemes will be discussed at 
each of the TRIPS Council sessions this year, namely a) R&D – collaboration frameworks / building 
capacity and engaging in R&D; b) Innovation in Creative Industries and Branding; and c) 
Commercialisation. The latter two t opics will be expanded upon in the respective TRIPS Council 
sessions in June and November respectively.  
Public -private collaborations in R&D  
222.  Focusing on the first theme, public -private collaborations in R&D can take various forms, 
depending on the specifi c situation.  
223.  One example from Singapore for illustration is Project Wolbachia, which is spearheaded by the 
Environmental Health Institute ( "EHI") of our National Environment Agency ( "NEA"). This project 
fights dengue in Singapore by developing technologie s to control the Aedes aegypti mosquito 
population. Male Wolbachia -infected mosquitoes are released to mate with urban female Aedes 
aegypti mosquitoes, resulting in eggs that do not hatch. For this project, EHI is partnering a local 
start-up, Orinno Techno logy Pte. Ltd. ( "Orinno "), and Verily, the life sciences and healthcare 
company of Alphabet Inc. EHI worked with Orinno to develop various automated devices to count IP/C/M/91 /Add.1  
 
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  the larvae and pupae of Wolbachia -infected mosquitoes. With Verily, artificial intelligenc e 
technologies were developed to sort and release the male Wolbachia -infected mosquitoes efficiently.  
224.  In this regard, the Singapore Government has developed a standard framework on IP 
management in public -private collaborations to guide such collaborations . We also have initiatives 
to help businesses, in particular the small - and medium -sized enterprises ( "SMEs "), acquire R&D 
expertise.  
Standard Framework on IP Management  
225.  How IP created from R&D can be used would invariably depend on the ownership of the 
underlying IP rights and terms of use. In determining the allocation of IP rights in public -private 
collaborations, various considerations have to be borne in mind. For example, the private sector is 
generally better placed to further develop and commercia lise the IP to meet market needs.  
226.  Therefore, in April 2018, Singapore implemented the National IP Protocol for Publicly -Funded 
R&D. This is a standard framework for how IP generated from publicly -funded R&D should be owned, 
managed and exploited, so that t he value of the IP can be fully exploited to benefit Singapore. This 
framework allows public agencies the flexibility to grant licences or assign IP to the industry, with 
the goal of facilitating IP commercialisation.  
Helping Businesses Acquire Expertise  
227.  In some cases, businesses may not have the technical expertise to conduct further R&D to 
develop solutions to meet the needs in the industry or community, but such expertise can be found 
in public sector R&D agencies.  
228.  Singapore 's public research agency, th e Agency for Science Technology and Research 
("A*STAR "), has a few programmes to help the private sector acquire and develop R&D expertise. 
One such programme is the Technology for Enterprise Capability Upgrading ( "T-Up") Scheme, where 
A*STAR will second r esearchers to companies to help build up their in -house R&D capabilities. Since 
the launch of the scheme in 2003, over 678 SMEs have benefited. Another programme is Tech 
Access, where A*STAR helps SMEs access expert training. This enables enterprises to pr ototype new 
products and improve their manufacturing capability. Since the launch of this programme in 2017, 
over 30 companies have been supported.  
Conclusion  
229.  Singapore values public -private collaborations in R&D. Done well, they deliver innovative 
soluti ons to benefit society and create good jobs.  
230.  We look forward to hearing from other Members on their experiences in facilitating 
public -private collaborations in R&D.  
11.3  Australia  
231.  Australia has long recogni zed the value of collaboration between the public and private sectors 
in promoting innovation, and the Australian government has in place a number of program mes 
aimed at helping the two sectors work to gether.  
232.  One example is the Cooperative Research Centres Program, or CRC.  
233.  The CRC Program provides grants for up to ten years to support industry -led partnerships 
between industry and research bodies.  It is organised along sectoral lines and  is designed to address 
specific challenges identified by individual industries.  
234.  To qualify for funding, Cooperative Research Centres must include at least one Australian 
industrial entity and one Australian research organisation. There is no set funding limit for the  
Centres.   IP/C/M/91/Add.1  
 
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  235.  A second stream of the program, known as CRC -Projects (CRC -Ps), provides funding of up to 
AUD 3 million for a maximum of three years for industry -led collaborative research. CRC Projects 
must involve at least two Australian industry entities (i ncluding at least one SME) and one Australian 
research organisation.  
236.  The Australian Government has committed AUD 731 million to the CRC Program over the next 
four years, and there are currently 113 collaborative projects under way. Over the program me's 
lifetime, the government has provided AUD 4.6 billion in funding, while program me participants 
themselves have contributed a further AUD 14.1 billion, supporting a total of 316 projects.   
237.  The CRC Program has paid handsome dividends, with an independent eval uation conducted in 
2012 concluding that it delivered a 3:1 return on investment.  
238.  Examples of the program me's more notable success stories include:  
a. The development of longer -lasting insulated rail joints (devices used to monitor trai ns and 
detect damage to railway tracks) that have produced annual savings of AUD 30 million for 
the rail industry;  
b. Productivity improvements of AUD 65.3 million resulting from the use of products developed 
by a cooperative research centre for polymers; an d  
c. Approximately AUD 120 million in additional earnings flowing to Australian hearing aid 
pioneer Cochlear, after it adopted new technology developed by yet another Cooperative 
Research Centre.  
239.  Another important program me is the Research and Development T ax Incentive. This 
program me lowers businesses ' R&D costs by offering annual tax offsets of up to AUD 100 million for 
eligible R&D expenditure and providing eligible small and medium -sized enterprises with a cash 
refund if they make a loss.  
240.  The tax incentive program me seeks to address the obstacles that many Australian companies 
face in raising finance for R&D activities in an environment in which success is far from guaranteed, 
and innovation can inadvertently benefit competitors. It therefore susta ins a range of productive 
R&D activities that would otherwise remain on the drawing board.   
241.  I would like to turn now to some of the specific issues identified by Singapore in its discussion 
paper which Australia has co -sponsored along with other delegatio ns. 
242.  First, how do we balance our support for innovative businesses with accountability for the use 
of public funds? Australia employs a range of checks and balances to ensure that tax payers ' money 
is spent responsibly. Industry support program mes are eval uated under the Department of Industry, 
Innovation and Science 's Evaluation Strategy 2017 – 2021, which provides a framework to guide 
the evaluation and performance assessment of the Department 's program mes and policies.   
243.  As already noted, applicants for funding under the CRC Program must meet strict eligibility 
criteria, while companies claiming the R&D tax offset must also meet certain requirements.   
244.  Second, how should we manage the IP that results from collaboration between the public and 
private secto rs?   
245.  It goes without saying that collaborations of this kind can be quite challenging, due to the 
complex intersections between confidentiality, the use of pre -existing IP, the publication of research 
findings, commercialisation, and decision making aroun d IP rights. Recogni zing these complexities, 
Australia 's IP Office, IP Australia, strongly advises would -be collaborators to give due consideration 
to IP management issues before embarking on joint research projects.  
246.  IP Australia has developed a variety of  tools that are publicly available on its website, ranging 
from collaboration checklist s, to model confidentiality agr eements.   IP/C/M/91 /Add.1  
 
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  247.  Finally, how can government agencies help the private sector capture and develop expertise 
in R&D, and acquire IP?  
248.  In recognition of its growing importance to the development of innovation frameworks, 
knowledge acquisition and promotion of entre preneurship, IP Australia has introduced a number of 
initiatives aimed at supporting collaboration between research organisations and the business sector.  
249.  The Australian IP Toolkit for Collaboration (IP Toolkit) is a joint project between the 
Department of  Industry, Innovation and Science and IP Australia, designed to facilitate collaboration 
between researchers and industry.  
250.  The IP Toolkit contains background information, guides and a range of tools –such as model 
contracts - that researchers and business es can draw upon to help them manage IP arrangements 
in a collaborative setting.  
251.  Another initiative developed by IP Australia is Source IP, which connects businesses with 
Australian public sector research organisations seeking to license their patented te chnology. Source 
IP was launched in November 2015 and is particularly focused on making it easier for Australian 
businesses, including micro -, small - and medium -sized businesses, to access innovations and 
technology generated by the publicly funded researc h sector in Australia.  
252.  The Source IP site has generated a substantial amount of interest, attracting users from a 
number of countries and recording over 200 contact requests to date. While Source IP does not 
currently list international patents, IP  Austra lia has been discussing with overseas counterparts the 
possibility of expanding the platform by providing a link to their equivalent sites on Source IP or 
granting access to Source IP in their own jurisdictions.  
253.  Source IP has already made an impact. It wa s, for example, instrumental in the successful 
collaboration of a small Australian tech start -up called Forcite Helmet Systems with the University 
of New South Wales (UNSW).  
254.  Forcite is developing the world 's first smart helmet, embedding communications sy stems into 
light recreational sports helmets and streamlining communications systems used by motorcycle 
emergency services.  
255.  Through Source IP, Forcite gained access to patents held by UNSW and has now integrated a 
UNSW patent into its helmet design.  
256.  Another initiative helping Australian businesses bolster their R&D expertise is the 
Entrepreneurs Program, which consists of two strands, Accelerating Commercialisation and 
Innovation Connections:  
a. Accelerating Commercialisation helps eligible entrepreneurs, st art-ups, small to 
medium -sized businesses and researchers to commercialise their novel product, process or 
service.  By providing expert guidance, connections and financial support, it helps to bring 
fresh innovations to market as quickly as possible, incr easing their prospects for success;  
and 
b. Innovation Connections is a facilitation service that provides expert advice and solutions on 
knowledge -related issues, and a brokering service to connect businesses with knowledge 
providers and research organisation s. This may include a matched funding grant that assists 
with direct access to research facilities.  
11.4  Switzerland  
257.  Switzerland would like to thank Singapore for proposing and introducing this TRIPS Council 
agenda item. We are pleased to co -sponsor both the agenda item and submission IP/C/W/652.  
258.  We welcome the opportunity to exchange national experiences and hear about different 
approaches in the high ly relevant area of public -private collaboration in innovation.  IP/C/M/91/Add.1  
 
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  259.  The question is: How can the public and private sectors interact to establish an innovative 
environment? The role of intellectual property rights is of particular importance to this kind of 
collaboration: A well -regulated and balanced distribution of rights and obligations significantly 
enhances cooperation and innovation. The aim is to ensure that public sector research complements 
rather than substitutes private sector research. Such collabo ration should result in an enhancement 
of the social value of IP and the patent: innovation and technology are developed into marketable 
and socially useful products.  
260.  My delegation would like to present how Switzerland establishes interfaces between the pu blic 
and private sector and  point out the role that intellectual property plays in this collaboration for the 
development of new products and services.  
261.  The Swiss Constitution instructs the Confederation to promote innovation. It is for the federal 
authorit ies and the parliament to put in place the legal framework, without taking control over the 
direction of research chosen by private actors. Federal bodies may support start -ups with advice, to 
a limited extent with seed -funding, or may make available certa in infrastructure which can facilitate 
young entrepreneurs ' activities and endeavours , for example in the form of technology parks.  
262.  Platforms of public -private collaboration facilitate the exchange of knowledge and generate 
synergies. They enable innovation and access to technology across the society. Technology is 
transferred from academia and researchers to applied research and industry and from there to the 
consumers. Building the bridge between basic and applied research, public -private partner ships 
enable social and economic investment in R&D and allow for economic growth.  
263.  In the following, I will present t wo types of public -private cooperation practiced in Switzerland. 
The first type of partnership arises when a private actor has a patentable invention but lacks the 
means to develop the idea into a marketable product. This is where the public sector can come in 
as a facilitator. Let me illustrate such a collaboration with an example of the development and market 
launch of an innovative food pre servation technology.  
264.  Writing her doctorate, Olga Dubey, a young biologist, discovered a natural substance that can 
be used to combat pathogenic fungi which infest fruit and vegetable. She knew that up to that day 
there was no efficient, cost -effective or ganic treatment against moulds on the market. As Ms Dubey 
became aware of the market potential of her discovery, it was also clear that she needed help in the 
form of advice and funding in order to develop her scientific discovery into a marketable product . 
She decided to apply for participation in the federal programme called "BRIDGE ". Literally functioning 
as a bridge between research and practice, the program me was initiated in December 2016 by the 
Swiss National Science Foundation and Innosuisse, the fe deral innovation promotion agency. Today, 
more than 40 projects benefit from the collaboration platform. By means of enhancing knowledge 
transfer between research and entrepreneurship, BRIDGE supports researchers in developing their 
discoveries into concre te applications and marketable products that can be used for the benefit of 
society.  
265.  Thanks to BRIDGE 's support, Ms Dubey ventured the step from science into her own business. 
The collaboration platform allowed her to go through the process of filing for a  patent and setting 
up her own start -up, AgroSustain  SA, while further enhancing her research activities. The young 
company developed a liquid which can be sprayed or fogged on crop yields, extending their shelf -life.  
266.  The post -harvest application of AgroS ustain 's liquid in food and plant storage facilities enables 
a significant reduction of waste. This also means a major reduction of greenhouse gases, an 
additional effect of less food spoiling along the supply chain. AgroSustain 's product is going to be 
offered to major agricultural companies and retailers like Migros in Switzerland or Walmart in the 
US. Without the guidance, coaching and funding support obtained, Olga Dubey would have been 
forced to continue keeping herself busy in the university laborator y – and the product would not be 
made available to society today.  
267.  Now, let us turn to the second type of public -private collaboration: In the following example, 
it was a public sector actor that applied for a patent, but was not able to commercialise the invention. 
It is an example which shows how the help of private actors can come in for the successful completion 
of a project initiated by a public institution.  IP/C/M/91 /Add.1  
 
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  268.  The success story of the present case is the result of a partnership between EMPA, the Swiss 
Federal Laboratories for Materials Science and Technology, and Flisom Ltd, a Swiss developer and 
manufacturer of photovoltaic solar cells. In 2011, EMPA succeeded in the development of flexible 
solar cells. The thin film cells showed an energy efficiency sim ilar to that of conventional solar cells. 
Although the patented technology had great economic potential, the research team would not have 
been able to set up a production plant and launch the product on the market without the help of an 
industrial partner.  Against this backdrop, EMPA started cooperating with Flisom. Using EMPA 's 
patented technology, the research team, combining scientists and industrial experts from EMPA and 
Flisom, improved the energy efficiency to a level equal to some of the most efficie nt solar cells in 
the world.  
269.  In 2015, Flisom was eventually able to produce a prototype of the first solar module based on 
this technology. The ultra-thin solar cells are printed on a web of flexible foils which allows for a very 
space -saving and cost -effective production. The company designed a special industrial 
manufacturing technology for a so -called "roll-to-roll production " of the flexible solar modules. The 
manufacturing procedure makes use of the material 's characteristic. Compared to traditional 
large-scale solar panel windows, the new foil can easily be unwound, processed and finally rewound. 
Only one year later, in 2016, Flisom put its pilot production line into operation and started to install 
the new product on buildings, use it as an energy sou rce for means of transport and integrate it in 
off-grid installations.  
270.  This example shows how important private sector actors can be in transforming an invention 
into a marketable commodity, for the benefit of society. As important as private investors are  for 
the development of market -ready products, as in some areas of technology such development 
requires massive investments in time and resources. For small start -ups or young researchers, it is 
often difficult to raise enough money for the commercializati on of their invention. At this point, a 
private or public partner can come in and act as decisive support, so that the momentum gained in 
early-stage research and development is not lost.  
271.  There are many other BRIDGE and EMPA projects which can serve as ex amples of effective 
cooperation and mutual support, where public -private partnerships turned ideas and work into 
marketable products suitable for mass production. The registration and management of patent, 
trademark and design rights supports such public -private ventures by putting their collaboration on 
a safe legal base. They help ensure that each partner receives a fair share of what each of them 
contributed along the innovation process, and if a commercial success results, of the profits made.  
272.  Oscar Wi ld once said: "The world is divided into two classes, those who believe the incredible, 
and those who do the improbable. " Public -private collaboration in innovation can bring those two 
groups together, supporting the innovation process for the benefit of t echnological progress and 
economic development.  
11.5  New Zealand  
273.  New Zealand is pleased to be a co -sponsor of the Intellectual Property and Innovation 2 019 
Paper.  
274.  New Zealand recogni zes the importance of maintaining collaborative synergies between the 
public and private sectors in order to promote innovation and creativity for the benefit of society.  
275.  To this end, the New  Zealand Government has committed t o raising New  Zealand 's research 
and development expenditure to 2% of our GDP over the span of ten years.  
276.  New Zealand has two devoted government agencies committed to improving innovation and 
to supporting private sector businesses in establishing and main taining sustainable growth.  
277.  The first of these agencies is Callaghan Innovation. Callaghan Innovation has a domestic focus 
and offers a range of services and tailored programmes to businesses, including:  
a. Access to experts;  
b. Technology and product development;  
c. Innovation skills;  IP/C/M/91/Add.1  
 
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  d. Business collaborations; and  
e. Research and development grants.  
 
278.  Furthermore, New Zealand Trade and Enterprise is an international business development 
agency whose purpose is to help New Zealand businesses to grow internation ally. It offers a range 
of services and tailored programmes to assist businesses to export and expand into new markets.  
It also promotes New Zealand to foreign businesses and investors, as well as helping businesses and 
investors to make international con nections and mutually collaborate across international borders.  
279.  We look forward to hearing other Members ' experiences on public -private collaborations in 
innovation.  
11.6  Chinese Taipei  
280.  As the co -sponsor of this proposal, we would very much like take this opportunity to share 
with you our own particular thoughts and experiences on this subject.  
281.  In this age of the "knowledge -based economy ", innovation and application are the keys to 
strengthening national competitiveness and economic growth. Both the public and the private 
sectors possess different resources and expertise, which, when combined, can complement each 
other and create market -oriented IP. Th is has become a crucial issue as WTO Members strive more 
and more to develop innovative technologies.  
282.  With a view to getting colleges, universities and academic institutions to conduct R&D 
program mes together, we launched in 2013 the PIONEER Grants for AIC  (Academia -Industry 
Collaboration) project. Through providing grants for research and development, this project has 
been able, at the same time, to encourage local businesses and academic/research institutions to 
develop forward -looking technologies togeth er. And, the operative word here is "together ". 
Businesses take the initiative to form alliances, decide on the topics for the research and invite 
academic and research institutions to build teams to carry it out. In doing  so, it is hoped that they 
will ac quire the ability to expand their key patent portfolios, establish new standards for the 
industries and integrate the different systems.  
283.  Since the launch of the PIONEER Grants for the AIC Project, industry has invested up till now 
TWD 2.16 billion (that  is about USD 72 million) of R&D funds and filed as many as 515 patent 
applications. A total of 3,170 doctoral students have been trained, with 900 people obtaining new 
jobs.  
284.  In addition, in few years ago, we also launched the A+ Industrial Innovation R&D Pr ogram, 
subsidizing companies that are devoted to high -level R&D work. This includes a sub -program me on 
forward -looking technologies, which encourages companies and research institutions to develop 
leading technologies together. Our aim here has been to gre atly increase industry 's profit and 
competitiveness in the global market.  
285.  For example, the Garmin Corporation, which is a well -known tech company in GPS product, 
was awarded the project 's subsidy for its "3D City Navigation System Development and Integrati on" 
plan. It was therefore able to compile a high -quality 3D city map for in -car navigation systems. Since 
then, the value of Garmin Corporation 's production has reached TWD 1.4 billion (or USD 45 million).  
286.  Back in 1999, we launched the Small Business Inn ovation Research (SBIR) Project, to provide 
subsidies to SMEs for conducting R&D projects. The Project 's main aims were to promote the 
research and development of industry technologies, products and services among SMEs, and to 
guide SME investment in R&D a ctivities in the electronics, data communications, machinery, 
services, consumer goods/chemical, biotechnology/pharmaceutical, digital content, and design 
industries. In addition to applying for subsidies individually, SMEs are themselves encouraged to 
form R&D alliances together with universities and research institutions. The Project aims to cultivate 
R&D talent among SMEs in order to accumulate R&D capabilities, and to elevate the technological 
level of SMEs in order to increase the competitiveness of th eir businesses. It helps traditional 
industries to transform and advance as well.  IP/C/M/91 /Add.1  
 
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  287.  By 2018, on the basis of the SBIR program me, 241 projects had received a total of 
TWD 310 million (or USD 10 million) in subsidies, and this had led to TWD 520 million 
(USD 16.7 million) worth of R&D investment by our SMEs.  
288.  One such project worth mentioning here, just as an example, was for the research and 
development of decorative flame products. Before implementing the SBIR subsidized project, it was 
only the companies that  possessed the innovative technologies for flame products. But, upon forming 
technological alliances, the companies were finally able to develop advanced decorative flame 
products and have since obtained more than 30 patents in Europe, the USA, Mainland Ch ina and in 
our own territory. They have also built their own brands and made their way into the international  
market.  
289.  So, it goes without saying that IP and innovation are critical to any WTO Member 's economic 
growth. It is, therefore, a crucial task of th e government to assist their public and private sectors in 
developing innovative technologies, based on their own resources and through comprehensive 
strategies.  
290.  I hope this has given you some useful examples of what can be achieved by encouraging the 
different sectors and elements in our economies to work together on the crucial issues of innovation 
and technology facing us all in the future.  
291.  We look forward to hearing from other Members about their own related experiences and 
measures taken in similar fields.  
11.7  Chile  
292.  We thank the co proponents of this document and agenda item for providing us with the 
opportunity to share our country 's successful experiences. The Government of Chile has prioritized 
public -private partnerships as a tool to promote innovation.  
293.  The Chilean Economic Development Agency (CORFO) is a government agency with the legal 
mandate to support entrepreneurship, innovation and comp etitiveness. In order to fulfil this 
mandate, CORFO has developed strategic support plans for scientific industrial consortia.  
294.  Lastly, we would like to point out that these initiatives have highlighted the importance of 
ensuring that intellectual property management strategies are consistent with the business models 
of companies participating in such projects. The success of these public -private partnerships has 
been possible thanks to dialogue between the parties concerned, which ensures that the particula r 
needs of each project are understood and that the capacities generated are beneficial to the country 's 
innovative ecosystem .1 
11.8  South Africa  
295.  During 2018 the co -sponsors disc ussed the topic of 'Societal Value of IP in the New Economy '. 
South Africa actively participated and expressed its views on several sub -topics of this theme as 
introduced by the co -sponsors.  
296.  In respect of IP -intensive industries and their impact on societ y, co -sponsors presented 
"evidence " that IPRs contribute to employment, gross domestic product, licensing revenue and 
trade. However, a closer look at the statistics indicate that a purely economic approach to IPRs may 
be misleading given that co -sponsors focus on the societal benefit of technological innovation.  
297.  The effect of IPRs on economic growth in different countries depends upon their various stages 
of development (being measured in terms of per capita GDP growth and/or human -capital 
development); in novative capability and imitative activities; technological development; and factor 
endowments, etc. In general, due to different R&D activities, most the innovations are produced in 
high income countries. Furthermore, economic literature on the impact of IPRs is rather inconclusive. 
It remains ambivalent as to whether the social benefits of IPRs exceed their economic costs, even 
in relation to the developed world. The basic argument in favour  of IPRs is that they are necessary 
                                                
1 The PowerPoint presentation is available in Room Document RD/IP/ 31. IP/C/M/91/Add.1  
 
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  to stimulate invention and ne w technologies. The main critique against IPRs is that they increase 
the cost of patented commodities which reduces welfare. This problem is exacerbated in developing 
countries because they are net importers of technology. Indeed, innovative activities are  
concentrated in a handful of developed countr y Member s with the top ten countries accounting for 
84% of global R&D activity.2  
298.  As already noted, many developing countries are large technology importers and developing 
countries that strengthened their IPRs  protection (mainly in the 1990s) have significant negative 
balances on the royalty and license fees account. A 2016 study3 concludes that IPRs tend to raise 
income inequality by generating a more skewed distribution of wages. Stronger IPRs increase the 
demand for skilled labour  force as it raises the return on R&D activities. This causes a relative 
increase in skilled labour  wages, creating a wage bias in favour  of skilled labour  against unskilled 
labour , thus aggravating income inequality within a develop ing country. Moreover, the effect on 
inequality is more pronounced for developing countries that are experiencing higher per capita GDP 
growth rates.  
299.  Proponents also advanced the argument that in respect of education and training, a range of 
intellectual property rich materials foster social and economic contributions to society. South Africa 
pointed out that a fundamental component of the right to education is access to high quality text 
books and other learning materials. Yet in many developing countries , access to such resources can 
be prohibitive since textbook scarcity is a serious challenge affecting the quality of education. We 
cited the example of an African country, where there is approximately one reading textbook available 
for every 12 grade -two students and one mathematics text book per 14 students.  
300.  Co-sponsors argue that as more and more learning is facilitated through computer access and 
the internet, both students and teachers are able to log onto fast amounts of information. 
Unfortunately, a ccess to these technologies are both inadequately and unequally distributed between 
the developed and least developed regions in the world. The disparities experienced in the physical 
world, we pointed out, is often exacerbated in the online environment. T he UNCTAD World 
Development Report of 2018 , indicates that there are still -large gaps between developed and 
developing countries: the active broadband subscription in the developed world (at 97 %) is more 
than double that in the developing world (48 %); in A frica, only 22 % of individuals use the Internet, 
as compared with 80 % in Europe .4  
301.  While there is no doubt that IP may be valuable and may contribute to economic development 
and growth, there are many factors that determine whether IP protection may create  appropriate 
conditions that enable MSMEs to effectively exploit IP.  
302.  In conclusion, South Africa has also indicated that we are reviewing our IP Policy, ensuring 
that appropriate balances are struck in providing protection for innovation and ensuring that  benefits 
are shared equitably in society.  
11.9  South Africa  
303.  We thank the co -sponsors for introducing the item of public -private collaborations in 
innovation.  
304.  South Africa followed a global trend in the popularity of Public -Private Partnerships ( PPPs) by 
establishing a formal PPP structure within the National Treasury in 1999. Although there were PPPs 
prior to this date, these arrangements did not follo w a standardised process or receive formal 
recognition as PPPs within the Nation Treasury Department of South Africa.5 South Africa has 
implemented a regulatory framework for PPPs which came into effect in the early 2000s, enabled 
through the Public Financ e Management Act of 1999 (PFMA). The National Treasury of South Africa 
                                                
2 See Auriol, Baincini & Paillacar “ Intellectual Property Rights Protection in Developing Countries .” July 
2012 at p.2.  
3 Swati Saini & Meeta K Mehra “ Impact of strengthening Intellectual Property Rights Regime on income 
inequality:  An econometric analysis centre for international trade and development. ” 
https://mpra.ub.uni -muenchen.de/75456/  MPRA Paper No. 75456, posted 10 December 2016.  
4 UNCTAD World Development Report of 2018 , p.VIII.  
5 Walwyn and Nkolele “An evaluation of South Africa’s public –private partnership for the localization of 
vaccine research, manufacture and distribution .” Health Research Policy a nd Systems (2018) 16:30 p.3 . IP/C/M/91 /Add.1  
 
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  developed a standardised procedure for such an entity, which it defined as a "contract between a 
government institution and a private party, where the private party performs an institutional function 
and/or uses state property in terms of output specifications; substantial project risk (financial, 
technical, operational) is transferred to the private party; and the private party benefits through 
unitary payments from government b udgets and/or user fees ". 
305.  According to standard economic criteria, South Africa is a high -income country with a 
well-developed infrastructure, with nearly 70% of the population urbanised and deep and liquid 
capital markets. However, it is also one of the m ost unequal economies in the world with a post -tax 
Gini-coefficient  of 0.7, with unusually high levels of structural unemployment (around 36%) and 
poverty (around 50%).  
306.  Initial PPP projects were undertaken between 1997 to 2000 by the South African Nationa l 
Roads Agency for the N3 and N4 toll roads (national roads), the departments of Public Works and 
Correctional Services for two maximum security prisons, two municipalities for water services, and 
by South African National Parks for tourism concessions. Us ing lessons from these projects, together 
with international experience, a strategic framework was adopted by government in December 1999 
and in April 2000 in accordance with Treasury Regulations for PPPs issued in terms of the PFMA.  
Examples of PPP colla borations  
307.  It is often said that vaccines are lauded as one of the most successful public health 
interventions, providing universal prophylaxis at a fraction of the cost that would otherwise be 
incurred following the widespread outbreak of an infectious dis ease. In the case of South Africa, an 
extensive vaccination programme, known as the Expanded Programme for Immunisation (EPI) forms 
part of a health strategy adopted by the National Department of Health (NDoH). Implementation of 
the EPI requires the procur ement of approximately 46 million vaccine doses annually, at a cost of 
roughly ZAR 1.5 billion per annum (2015 values). Prior to 2003, vaccine procurement was an internal 
function of the NDoH; the department issued tenders on behalf of the provinces and se cured the 
necessary supply from successful bidders. However, since 2004, vaccine procurement and 
distribution has been undertaken by a public –private partnership  (PPP), known as the Biovac 
Institute (BI).6 
308.  Over the period 2010 to 2014, BI successfully proc ured and distributed vaccines and received 
an income of US D 86 million, equivalent to an average cost premium of 12%, as per the terms of 
its supply agreement with the NDoH. Moreover, it became increasingly able to supply vaccines to 
the public health syst em at globally competitive prices and undertook local R&D, the latter in one 
case leading to a novel conjugate vaccine that has been licensed to two international companies and 
for which the institute receives royalty revenue.7 
11.10   Hong Kong , China  
309.  Hong Kong would like to thank the United States and Singapore for introducing the papers 
under this agenda item which we are pleased to be a co-sponsor. I am also thankful to previous 
speakers sharing their experiences.  
310.  Hong Kong was glad to participate in the discussion of societal value of IP in the new economy 
in 2018.  I hope our sharing in particular on how IP improves life did give Member s some food for 
thoughts in promoting IP and innovation.  
311.  On the Public -Private Collaborations in Innovation, Hong Kong recogni zes that R&D is essential 
in promoting innovation, new technology and intellectual property. All these are drivers for economic 
growth and the key to enhancing competitiveness of our industries. Our Government has therefore 
put in place a comprehensive framework of policies and institutions to promote R&D using the 
collaborative efforts of public and private sectors.   
312.  A key aspect i s the provision of infrastructure that forms an enabling environment for R&D and 
an essential part of a strong innovation eco -system. We establish a publicly -funded statutory 
                                                
6 Ibid. 
7 Welwyn & Nkolele p.15 . IP/C/M/91/Add.1  
 
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  corporation, the Hong Kong Science and Technology Parks ( "Science Park "), offerin g one -stop 
infrastructural support to technology -based companies and activities. It provides a comprehensive 
range of services to cater the needs of industry at various stages, ranging from nurturing technology 
start-ups through incubation programme, provi ding physical space and services for R&D activities, 
and to offering industrial lands for production.  
313.  As an example of public -private collaboration, the Hong Kong Government allocated about 
USD 1.3 billion to establish two research clusters - one on healt hcare technologies, and another on 
artificial intelligence and robotics technologies - in the Science Park, in order to attract the world 's 
top universities, research institutes and technology companies in the relevant fields to conduct 
collaborative resea rch in Hong Kong. Numerous top -notch institutions e.g. Institute  Pasteur of 
France, Harvard Medical School, Stanford University School of Medicine, and University College 
London, have already expressed interests in joining the clusters. It is expected that  the first batch 
of scientific research institutions will be set up later this year.  
314.  We also have set up five publicly -funded R&D centres to drive and co -ordinate applied R&D in 
five focus areas, i.e. automotive parts; information and communications techno logies; logistics and 
supply chain; nanotechnology and advanced materials; as well as textiles and clothing. The centres 
have been working closely with the industries in conducting industry -oriented R&D and promoting 
commercialisation of the R&D results. T hese R&D centres are core initiatives to upgrade the 
technological level of our industries and stimulate the growth of technology -based industries.  
315.  Hong Kong also strives to provide adequate funding to promote R&D in a direct and impactful 
manner. In part icular, there are funding schemes to provide incentives for public and private 
collaboration. Just last month, we established a Partnership Research Programme by consolidating 
two existing funding programmes to provide matching -fund support for R&D project s undertaken by 
private companies in collaboration with public research institutions. To ensure sufficient participation 
from both public and private sectors, the public research institutions are required to be the lead 
applicant, while the private compani es are required to provide at least 50% of the project cost (or 
at least 30% with exceptional approval from the Government). The companies are required to spend 
the funds in R&D only, but not in business development or operating expenses.   
316.  To encourage pr ivate companies to undertake more R&D projects, all IPR arising from the 
project will be solely owned by the companies having contributed at least 50% of the project cost. 
In case of exceptional collaborative projects involving less than 50% company contri bution, the 
relevant R&D Centre should retain the IP ownership, and the company partner should only be 
granted an exclusive licence or exclusive right to use the R&D results for a limited period. With a 
view to boosting private companies ' contribution, the  R&D Centre would encourage its partner to 
raise the level of its contribution to at least 50% within a reasonable timeframe, say nine months, 
so that the latter could own the IPR.    
317.  We also launched another programme, the Cash Rebate Scheme, in 2010 to e ncourage private 
companies to establish stronger partnership with public research institutions. Under the scheme, a 
company will receive a cash rebate equivalent to 40% of its expenditure in projects under a major 
Government fund or other R&D projects fund ed by the companies and undertaken by public research 
institutions. As at end November 2018, around 1 ,200 companies have been granted cash rebate of 
more than USD 50 million.  
318.  While Hong Kong has a low profit tax rate (which is no higher than 16.5%), we pro vide 
enhanced tax deduction for private companies ' expenditure on R&D activities which includes 
payments made to designated local research institutions. The deduction will be 300% for the first 
USD 250 000 of expenditure, and 200% for the remaining amount.  There is no limit on the amount 
of enhanced tax deduction. We believe that this will encourage private enterprises to conduct R&D 
in collaboration with research institutions in Hong Kong.   
319.  In addition to funding, the private sector would look to talent t o drive R&D activities. Hence 
our government is committed to supporting private companies in recruiting R&D talent. We rolled 
out the Technology Talent Admission Scheme in 2018. It provides a fast -track arrangement for 
admitting technology talent from over seas and Mainland China to undertake R&D work in Hong Kong. 
To balance the development and opportunity of local talent, we would require such companies to 
employ a certain number of local employees and interns in technology -related work.   IP/C/M/91 /Add.1  
 
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  320.  We also launched  a Technology Talent Scheme to pool together and nurture more technology 
talent for technology companies and institutions.  It comprises a Postdoctoral Hub programme that 
subsidises government fund recipients and incubatees or tenants of Science Park to re cruit up to 
two postdoctoral talent. Besides, there is another programme that subsidises local companies to 
train their staff in advanced technologies.  
321.  To assist private companies to acquire IP of their innovations, we launched an "IP Manager 
Scheme " in 2015. The scheme assists Hong Kong companies to build up their IP manpower capacity 
and to increase competitiveness through IP management. The scheme encourages enterprises to 
appoint a staff Member in a managerial position as their in -house "IP Manager ". This IP manager is 
responsible for overseeing the compliance, management, exploitation and commercialisation of IP 
assets. The Hong Kong government would provide training and resources for those IP Managers.  
322.  To conclude, promoting innovation and technolo gy is one of Hong Kong 's top policy agenda. 
Our goal is to develop Hong Kong into an international innovation and technology hub. Knowing that 
the public and private sectors have different edge, we will keep devoting resources to facilitate 
public -private collaborations. We would also welcome collaborations with institutions from other 
Members.  
11.11   Canada  
323.  Canada is pleased to co -sponsor the "IP and Innovatio n" theme of "Public -Private 
Collaborations in Innovation ", and the accompanying communication on this topic. We would like to 
thank Singapore for drafting the paper for discussion under document IP/C/W/652, as well as the 
co-sponsors of this discussion and  other Members that have shared their national experiences and 
insights on public -private collaborations in innovation so far.  
324.  Before sharing some of our own recent experiences on this topic, Canada would also like to 
thank the United States and the co -sponsors of the summary paper on our recent discussions under 
the theme "The Societal Value of IP in the New Economy " (document IP/C/W/650). Canada was 
pleased to participate in the wide -ranging discussions under this theme during the three 
TRIPS  Council meet ings in 2018 and benefited from the constructive and insightful sharing of 
experiences by Members on issues such as IP -intensive industries, IP improving lives, and IP and 
new business.  
325.  On the Public -Private Collaborations in Innovation  topic, Canada  would  like to take the 
opportunity to present an overview of Canada 's recently -launched "Innovation Superclusters 
Initiative ", a new funding initiative by the Government of Canada that has been  designed to  help 
strengthen  Canada 's most promising clusters and ac celerate economic growth in highly innovative 
industries .8 
326.  In the Government of Canada 's Budget 2017, the Government put forward the "Innovation 
and Skills Plan ", an agenda to spark growth and help Canada realize its potential as a global leader 
in innovat ion. As part of this agenda, in May 2017, the Government launched the "Innovation 
Superclusters Initiative " to accelerate innovation through superclusters. Budget 2017 proposed to 
invest up to CAD  950 million (or approximately USD  725.51 million), to be provided over five years  
on a competitive  basis in support  of a small  number  of business -led innovation  superclusters that have 
the greatest potential to accelerate economic growth. Under this initiative, industry partners match 
the Government of Canada 's program me contributions dollar -for-dollar.  
327.  This initiative is a first of its kind for Canada, fostering connections between participants, from 
start-ups, small and medium -sized enterprises (SMEs) and  large anchor  firms,  to post-secondary  
institutions, rese arch and government partners. Through a small number of high -value, strategic 
investments, this initiative is co -investing with industry to strengthen Canada 's most promising 
clusters and build superclusters at scale. The initiative is a "made in Canada " approach. Working 
through a business -led partnership model, the initiative works to align the efforts of diverse 
industries, researchers, and intermediary institutions, and build ecosystem -level advantages in 
regions across Canada.  
                                                
8 The PowerPoint presentation is avail able i n Room Document RD/IP/32 . IP/C/M/91/Add.1  
 
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  328.  Supercluster strategies u nder the initiative are structured around five themes of activity, which 
are eligible for co -investment. These activities include:  
• Technology leadership , such as by way of collaborative projects that directly enhance 
Member firm productivity, performance a nd competitiveness (for instance, through 
collaborative R&D projects and private -sector -led commercialization projects).  
• Partnerships for scale , which refers to activities serving a target group of cluster firms, 
such as linking start -ups with strategic pa rtners, and supply chain development to cluster 
SMEs with anchor firms;  
• Diverse and skilled talent pools , such as by way of activities that enhance regional labour 
force skills and capabilities;  
• Access to innovation , which refers to investment in and providing access to assets, 
services or resources that benefit a range of cluster firms, such as the acquisition and 
assertion of jointly -held IP; and finally  
• Global advantage , which refers to activities that position the cluster as world -leading, 
enabling  firms to seize market opportunities, and attract international investments and 
partnerships.  
 
329.  One of the key objectives of Canada 's Innovation Superclusters Initiative is to deepen existing 
strengths where Canada is already globally -competitive. This incl udes strategies to enhance 
Canada 's capabilities, competitive advantage and leadership in commercialization. As well, the 
initiative is aimed at supporting industry -led collaborative R&D, particularly with respect to platform 
technologies, and to strengthe n public -private collaboration, including with academia, to align 
innovative ecosystems.  
330.  In fostering a critical mass of growth -oriented firms, the initiative aims to develop five 
"superclusters ", namely innovation hotbeds that benefit from strong connecti ons between firms and 
research talent, competitive advantage, global brand recognition, and a contribution to job creation 
and economic growth.  
331.  The Minister of Innovation, Science and Economic Development announced Canada 's five 
selected superclusters in February 2018. Following the national announcement, the negotiation of 
contribution agreements began between the Government of Canada and the five industry -led 
consortia selected to execute Canada 's superclusters. Contribution agreements between the 
Govern ment of Canada and all five Superclusters have been signed as of December 2018, and the 
superclusters are currently finalizing their five -year strategies, with project funding expected to 
begin before the end of the fiscal year ( 31 March 2019).  
332.  Now for a bit of a geography lesson, from West to East in Canada, the superclusters are:  
• The Digital Technology Supercluster  (based in British Columbia, with a key focus on 
technologies such as augmented reality; cloud computing and machine learning; data 
collectio n and analytics; and quantum computing);  
• The Protein Industries Supercluster  (based in Canada 's Prairie provinces, this supercluster 
will use plant genomics and novel processing technologies to increase the value of key 
Canadian crops, such as canola, whea t and pulses, as well as plant -based meat alternatives 
and new food products);  
• The Advanced Manufacturing Supercluster  (based in Ontario, this supercluster is focused on 
building next -generation manufacturing capabilities, for instance, through the develop ment 
of technologies like advanced robotics and 3D printing);  
• The SCALE.AI Supercluster  (based in the Québec -Windsor corridor, this supercluster focuses 
on artificial intelligence and robotics, with a view to helping Canadian SMEs scale up and 
become a glo bally competitive export leader), and  
• The Ocean Supercluster  (based in Atlantic Canada, this supercluster focuses on industries 
like marine renewable energy, fisheries, aquaculture, oil and gas, shipbuilding, and 
transportation, through the development of  technologies such as digital sensors and IP/C/M/91 /Add.1  
 
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  monitoring, autonomous marine vehicles, energy generation, and marine biotechnology and 
engineering technologies).  
 
333.  Together, these five superclusters represent more than 450 businesses, 60 academic 
institutions, and 180 partners in Canada 's five key regions.  
334.  Under Innovation Supercluster Initiative, funding is provided to industry -led consortia (which 
include large firms, as well as SMEs, and other organizations such as academic and research 
institutions). Under t hese arrangements, funding is provided to Entities with strategic plans to: build 
a shared competitive advantage for their cluster and attract research, investment, and talent; 
increase business expenditures on R&D and advance business led -innovation and t echnology 
leadership; generate new companies and commercialize new products, processes and services; and 
foster a critical mass of growth -oriented firms and strengthen public -private -academic collaboration.  
335.  These strategic plans are built on a shared priva te sector commitment, demonstrated through 
matched, dollar -for-dollar industry funding, to leverage strengths, address gaps, and bring 
innovation ecosystem players together to work more strategically. In doing so, it is expected that 
supercluster s will eng age in collaborative projects and activities that advance their respective goals, 
and develop innovative new technologies that address ecosystem gaps.  
336.  As part of its strategic plan, each Entity also submits an IP Strategy, which sets out its role in 
achiev ing program me objectives through IP -related activities. In particular, each Entity 's IP strategy 
sets out how protection for Entity -supported IP will be obtained, how rights will be owned and 
managed, and by whom. This also includes how background IP will be treated; if and how 
non-Entity -supported IP will be acquired; and how royalties on Entity -supported IP will be managed. 
The IP Strategy also sets out how the IP ownership and management structures furthers each 
Entity 's objectives.  
337.  In addition, the IP Strategy sets out the policies for Members ' access to Entity -supported IP, 
and how Members will be supported and mentored in respect of their IP needs. One of the key 
objectives in this regard is to provide that Entities proactively engage their Members an d provide 
access to independent expertise and mentorship concerning IP -related issues, particularly in respect 
of start -ups and SMEs. This includes assistance with IP development, registration, acquisition, 
management, ownership, royalties, and assertion o f legal rights.  
338.  In developing the Innovation Superclusters Initiative, the five superclusters are not only 
expected to contribute to economic growth in Canada, but also represent strong links in global value 
chains, which deliver high -quality Canadian prod ucts and solutions. Multinational enterprises that 
are incorporated and active in Canada are eligible to collaborate and partner with existing 
supercluster organizations, with a view to accessing Canadian innovation and technical expertise, 
with a number o f global firms already involved.  
339.  With that in mind, we would be pleased to provide further information regarding the Innovation 
Superclusters Initiative upon request, as well as by directing questions to our experts at Canada 's 
Department of Innovation, Sc ience and Economic Development.  
340.  To conclude, Canada would like to once again thank Members for sharing their national 
experiences in respect of public -private collaborations on innovation with TRIPS Council, and for the 
opportunity to present an overview of this initiative.  
11.12   Japan  
341.  First of all, this delegation would like to thank the distinguished delegation from US for 
summarizing the discussion in the previous  year. And this delegation would like to review that 
discussion briefly as well. Throughout 2018, we shared each experience and national or international 
policies, and not only developed countr y Members  but also developing countries provided empiric al 
data and case studies showing positive impact of IP on innovation. As we have seen in the discussion, 
to certain extent, we have the common perception that IP contributes to improving the quality of 
life and creates essential condition for SMEs and star t-up to succeed. This delegation believes that 
recognizing common experiences and views helps us to properly understand the role of IP system 
and to find appropriate direction of its future development.  IP/C/M/91/Add.1  
 
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  342.  This delegation would like to share our experience a nd national policies regarding 
public -private collaboration in innovation. Especially, we would like to focus on ownership of patents 
in the collaborative R&D project funded by government and show you some survey results in Japan .9  
343.  First, we will show you the collaboration framework in R&D project funded by government in 
Japan. In general, it is said that private sector tends  not to invest sufficiently under the high 
uncertainty situation. This delegation believes that public sector can play a key role in encouraging 
and supporting private sectors in such a case. Japanese government implements commissioned R&D 
projects in order to complement underinvestment on the R&D projects by using public fund. And 
commissioned R&D projects involv e private companies so as to achieve the maximum use of 
outcomes of R&D projects.  
344.  In this projects, ownership of patent rights should be considered with the view to promote 
effective utilization of the results of such a R&D project. Who should own patents obtained through 
commissioned R&D projects? Article 19 of Industrial Technology Enhancement Act in Japan stipulates 
that the national government may decide not to accept patent right pertaining to the result of R&D 
entrusted by the government from that ent rusted party.  
345.  Therefore, government may decide whether government owns patents or trustees ' own 
patents.  
346.  In this slide, this delegation briefly shows you two different scenarios regarding to 
commercialization process.  
347.  First, in case where trustees ' own patents, trustees will engage in the commissioned R&D 
projects and conduct continuous R&D after projects with expectation of return of R&D investment 
and secure profit by exclusive implementation.  
348.  On the other hand, in case where government owns patents, t rustees will engage in the 
commissioned R&D projects in expectation of obtaining know -how and first -mover advantage, and 
after the project, not only trustees but also third parties will consider pros and cons to challenge the 
commercialization of the outco mes. And each company exerts their respective strengths to utilize 
the outcomes of the project in diverse form of applied products and services. Competition among 
companies will provide inexpensive products and services as well.  
349.  In both scenarios, outcomes  of R&D project will be returned to the whole society through 
supplying products and services based on the technologies established in the commissioned R&D 
projects.  
350.  According to the survey, utilization rate of patents owned by trustees are larger than tha t of 
patents owned by government. It reveals only 2.5% of patents owned by government are utilized, 
while 20.4% of patents owned by trustees are utilized. And even definition of term "utilized " in case 
where trustees ' own patents includes present and futur e self -implementation and license, 8.0% out 
of 20.4% patents are utilized in "present " self-implements or license.  
351.  Therefore, the survey indicates clearly that the mechanism of making it possible to own patents 
foster utilization of patents  of the industri al commissioned R&D project . 
352.  Finally, this delegation would like to show you main factors affecting the utilization rate of 
patents.  
353.  In case where trustees ' own patents, possibility of owning patents incentivizes trustees to 
deeply engages in the commissio ned R&D project and  enhances an trustees ' incentive for acquiring 
patents with a view of commercialization and  ensures an incentive for commercialization after the 
end of commissioned project. In addition, trustees who own patents are likely to utilize the  outcomes 
of R&D project efficiently, that is partly because they are able to streamline technology transfer by 
licensing patents in along with relevant know -how and technical guidance.  
                                                
9 The PowerPoint presentation is available i n Room Document RD/IP/30 . IP/C/M/91 /Add.1  
 
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  354.  On the other hand, in case where government owns patents, patent appl ications are likely to 
be filed without a view of commercialization, and when government license patents, usually relevant 
know -how and technical guidance are not available for licensees.  
355.  In summary, this delegation would like to emphasize again that the m echanism of making it 
possible to own patents incentivizes trustees to engage in R&D project funded by government and 
to commercialize with continuous investment by themselves, and it improves the utilization rate of 
patents and promotes commercialization of outcomes from commissioned R&D projects. This 
delegation hopes that its information helps other delegations create their own domestic policies. And 
this delegation looks forward to hearing your active inputs on this agenda item.  
11.13   Mexico  
356.  Mexico would like to thank Australia, Canada, Chile, Hong Kong, Japan, Korea, New Zealand, 
Singapore, Switzerland, Chinese Taipei and the United States for proposing tha t this item be included 
on the agenda of the meeting; we also thank the other speakers who have already taken the floor.  
357.  Innovation is currently one of the most important issues in the field of intellectual property. 
The Mexican Industrial Property Institu te (IMPI) promotes innovation, while also ensuring the 
protection of inventions and trademarks.  
358.  In May 2010, Mexico created the Sectoral Innovation Fund (FINNOVA), which is administered 
by the Ministry of the Economy and the National Science and Technology  Council (CONACYT).  
359.  FINNOVA 's objective is to promote innovation in the country through mechanisms that help to 
convert ideas into business projects (business incubators), and to foster the linkage between 
universities, research centres and companies.  
360.  Through FINNOVA, the Ministry of the Economy and CONACYT, in partnership with IMPI, have 
developed a systemic strategy to enhance the protection and exploitation of innovation. This strategy 
includes the strengthening of patenting centres (CePat).  
361.  A patenting centre is an office that carries out activities relating to intellectual property rights 
management. Such activities range from identifying projects eligible for protection, providing advice 
on conducting prior art searches, and preparing patent applicatio ns for inventors (industrial 
property), authors (copyright) and breeders (plant varieties), to providing support for completing 
the necessary formalities before the relevant authorities. All of this is done to increase the number 
of national patent applica tions, the commercialization of patents granted through the licensing of 
rights and the transfer of technology, as well as to help build an industrial property portfolio. The 
main activities of patenting centres also include the organization of intellectua l property -related 
promotional events, workshops, courses and seminars, the training and updating of human 
resources, and the preparation of promotional materials.  
362.  Patenting centres have been promoted by IMPI with a view to building the capacities needed 
to develop the country 's patent system and to enhancing the tools and skills required by research 
centres to better protect their intellectual property.  
363.  In recent years, new patenting centres have been set up throughout the Republic. There are 
currently 10 6 centres in Mexico (46 of which are operational and 60 of which are at the start up 
stage).  
364.  In 2018, patenting centres filed 341 patent applications and 285 trademark applications and  
were granted 106 patents and 223 trademark registrations.  
11.14   European Union  
365.  The EU would like to thank the United States and Singapore for introducing the two respective 
papers for this agenda point to which we are  a co-sponsor.  IP/C/M/91/Add.1  
 
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  366.  Intellectual property rights are the main commercialisation tool of R&D activities and can be 
seen as the value R&D creates. The commercialisation of R&D is fundamental in creating economic 
growth. Two -thirds of economic growth in Europe fro m 1995 to 2007 derived from R& D.  
367.  The main umbrella programme enabling public -private research collaboration in the EU aiming 
at leveraging R&D is the Horizon 2020 programme. Horizon 2020 is delivering scientific impacts 
through the reinforcement of resear ch and innovation capabilities, scientific excellence and through 
the integration of research and innovation with as well as supporting private sector participants in 
their efforts in commercialisation. Horizon 2020 projects have the potential to generate a large 
number of scientific breakthroughs; researchers have already contributed to major discoveries like 
exoplanets, the Higgs boson and gravitational waves. At least 17 Nobel Prize research got support 
from Horizon 2020 prior or after the award.  
368.  Horizon  2020 builds cross -sectoral, inter -disciplinary, intra - and extra -European networks. The 
Horizon 2020 programme is successful in attracting and involving the private sector (33.2%), a 
necessary precondition for the achievement of innovation and economic im pact. In particular, 
Horizon 2020 attracts and involves many SMEs, the backbone of the European economy. Horizon 
2020 is creating networks between businesses, and between the business sector, universities and 
research institutions, also allowing them to ma ke better use of the IP system, which is of huge 
importance to bringing knowledge quickly to market. Horizon 2020 provides companies, and in 
particular SMEs, with access to risk finance to carry out their innovation projects. 5,700 organisations 
have been funded under the Access to Risk Finance programme part (EUR 13 billion of private funds 
leveraged; EUR 29.6 billion of investments mobilised via debt financing); numerous SMEs are taking 
part in the SME Instrument until end -2016 secured a total of EUR 481 million of venture capital 
during or after the project, also with the intellectual property rights they developed.  
369.  Horizon 2020 generates large numbers of high quality, commercially valuable patents and 
other intellectual property rights, so far mainly fro m the SME Instrument. Horizon 2020 also 
generates proofs of concept and demonstrators and supports the deployment of innovative solutions 
supporting the commercialisation and diffusion of innovation, including hundreds of prototypes and 
testing activities,  as well as numerous clinical trials.  
370.  Horizon 2020 projects produce new knowledge, strengthen capabilities, and generate a wide 
range of innovation outputs including new technologies, products, services and the related 
intellectual rights: 563 firms have b een introducing innovations new to the market (56% SMEs) and 
more than half of SME Instrument Phase 2 beneficiaries have already reached the market.  
371.  Every euro invested under Horizon 2020 brings an estimated GDP increase of EUR 6 to 8.5. 
This means EUR 400  to EUR 600 billion by 2030.  
372.  Many of the Horizon 2020 supported projects demonstrate potential in terms of generating 
breakthrough, market creating innovation. A quarter of the ongoing Innovation Actions are regarded 
as having breakthrough, market creating  potential. Let me therefore finish with two concrete 
examples that show the positive global impact of the Horizon 2020 programmes also beyond Europe:  
373.  The first Horizon 2020 project is producing bioethanol from steelmaking process emissions. 
The project ST EELANOL demonstrates the industrial production of bioethanol from emissions of the 
steelmaking process, which has the potential to significantly reduce greenhouse gas emissions 
compared to oil -derived fuels. A demonstration plant of approximately 25,000 to ns/ethanol per year 
will be built in Belgium; the largest facility built to date utilizing this technology globally. This 
high-risk/high -impact project is expected to contribute to achieving the targets of the Paris 
Agreement on climate and advancing the c ircular economy.  
374.  The second project is on public -private partnership in the pharma sector. The outbreak of 
Ebola in West Africa was one of the international health emergencies of the past few years. 
EUR 24.4 million from Horizon 2020 were urgently mobilise d. In parallel, the IMI -Ebola+ 
public -private partnership call was launched in record time. This Horizon 2020 research response, 
very significant in scale, with a total of EUR 140 million, in turn, leveraged a further EUR 101 million 
from the pharmaceutica l industry. Without the possibility to use IP, such additional private funds 
would have been very unlikely to have been mobilised. These joint efforts are already delivering, 
with trials on the ground in West Africa and with the first indication of results .  IP/C/M/91 /Add.1  
 
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  375.  We therefore would like to conclude that in the EU public -private partnerships in R&D play a 
fundamental role in support of innovation and allowing the development of intellectual property 
rights, ultimately necessary for the successful commercialisatio n of private innovation. Only when 
all forces, public and private alike, are mobilised, can we fully leverage the global innovation 
capacities needed for the desired outcome of economic development and the tackling of our joint 
global challenges.  
11.15   Korea, Re public of  
376.  As a co -sponsor of the agenda item on IP & Innovation, Korea would like to join previous 
speakers in emphasizing the importance of  the private and public collaboration in promoting IP, 
particularly R&D. The value of Private and Public Partnership is bigger for the small and medium size 
enterprises, which often lack the necessary capital and know -how in building IP. Recognizing this, 
Korean government has been carrying out various projects in collaboration with the private sector 
to help SMEs establish and promote IP.  
377.  Korea Intellectual Property Office (KIPO) provides SMES with various training opportunities 
that will help them build IP in cooperation with business associations. Through these opportunities, 
entrepreneurs or executive managers of those SMEs could learn how to better carry out R&D, and 
how to commercialize their IPs in the real market.  
378.  Close partnership between business  and academia has been promoted as well by 
government -initiated projects. KIPO has been providing a platform for collaboration between 
prestigious tech colleges and SMEs and supporting for innovative ideas brought up by tech colleges 
to serve as valuable i nput for R&D projects of SMEs.  
379.  Public -private partnership has a crucial role to play in maximizing the potential of developing 
IPs and in further promoting innovation and creativity. In this sense, Korea hopes that Members of 
the Council will continue to share their national experiences of promoting IPs through close 
cooperation between public sector and private sector under this agenda item throughout 2019. 
11.16   Brazil  
380.  We would like to thank the co -sponsors for presenting the topic "Public -Private collaborations 
in Innovation " under the item on IP and Innovation.  
381.   Brazil 's new administration has a clear vision of the key role IP can play in the economy and 
important strides will be made to improve our IP institutional framework so as to further increase 
the level of innovation of our economy.  
382.  In our view, innovation is the main driver of a country 's competitiveness and economic growth 
in the medium -long term .  
383.  IPRs help create conditions that permit and encourage individuals and businesses to 
experiment new approaches and solutions, which benefit society as a whole.  
384.  The idea of advancing knowledge and technology has been recognized from the start as a core 
goal of the intellectual property system. Indeed, the TRIPS Agreement, in its preamble, recognizes 
"the underlying public policy objectives of national systems for the protection of intellectual property, 
including developmental and technological objectives ". 
385.   In order to be sustainable, however, we have to ensure that the fruits of human ingenuity are 
enjoyed as widely as possible worldwide while preserving proper i ncentives and rewards for 
innovators and creators. This is of utmost importance to the credibility and legitimacy of the 
IP system.  
386.  Brazil welcomes the issue of public -private collaborations in innovation. We believe there are 
a number of important dimensi ons to explore in this topic. We are convinced theses type of 
collaborations contribute to boost R&D expenditures.  IP/C/M/91/Add.1  
 
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  387.  The latest data available, provided by the World Bank, shows that R&D expenditure in Brazil 
as proportion of GDP reached 1 .28% in 2015, by f ar the highest amount in Latin America, and higher 
than several OECD countries . 
388.  Notwithstanding the fact that the levels of R&D spending are an important proxy to innovation, 
we know they are not synonymous. Given our levels of R&D expenditures, we should be a much 
more innovative economy. As we all know, however, an ecosystem that fosters innovation depends 
on a variety of factors.  
389.   Our new administration intends to put in place a number of structural reforms that will not 
only improve the business environ ment in Brazil but  will also deeply integrate the country in the 
world economy. As a result, Brazil expects to develop a much more effective IP system to convert 
innovation and creativity into tradable commercial assets.  
390.  We believe a closer, balanced and fine-tuned partnership between the public and private sector 
can contribute to create such an outcome. Brazil has been implementing a number of measures to 
strengthen this collaboration to develop a dynamic and innovative ecosystem.  
391.  Brazil 's IP office has established a broad array of partnerships with different institutions, public 
and private, that are part of the Brazilian innovation system: National Confederation of Industry, 
Brazilian Development Bank (BNDES), the Brazilian Trade and Investment Promotio n Agency (Apex), 
the Micro and Small Business Support Service (SEBRAE), the Brazilian Industrial Development 
Agency (ABDI), the Brazilian Agency for Industrial Research and Innovation (EMBRAPII), the 
antitrust agency (CADE), the Association of Brazilian Te chnological Parks, and with some world class 
Brazilian universities, among others.  
392.   These partnerships will be benefit from the recently approved New Innovation Law (Law 
nº 13.243/2016  and Decree nº 9.283/2018). One of main goals of the new Law is to stimu late the 
cooperation and interaction between public and private sectors; to boost innovation in companies 
and science and technology institutions (STIs); and, mainly, to simplify procedures for the 
management of science, technology and innovation projects and the adoption of performance 
monitoring.   
393.  The New Legal Framework has broadened significantly SEBRAE 's scope of action to support 
innovation. For those not familiar with SEBRAE, our Micro and Small Business Support Service, it 
plays a major role in arti culating and promoting small business access to innovation and 
technological services. SEBRAE invests at least 20% of its annual budget in innovation and 
technology.  
394.  Another example of a successful partnership is the agreement signed between SEBRAE and 
our IP office, which created a fast track for the analysis of pending patent applications for SMES. 
36% of all small businesses that have used the program me have already had their patents granted.  
395.  Another success story in promoting IP and innovation in Brazi l is EMBRAPII, the Brazilian 
Agency for Industrial Research and Innovation, a Social Organization connected to the Ministry of 
Science, Technology, Innovations and Communications (MCTIC) and to the  Ministry of Education 
(MEC). The  agency finances innovatio n projects in partnership with research centres  (EMBRAPII 
Units) to increase competitiveness of the productive sector. Brazil has 42 EMBRAPII Research 
Centers spread around the country. EMBRAPII has already supported 650 projects, 460 companies 
and technol ogies developed have generated 140 patent applications (42% of medium enterprises, 
41% of micro and small e 17% of big companies). These patents were filed in the field of advanced 
manufacturing, biotechnology, chemistry and IoT technologies.  
396.  Some example s of projects developed by EMBRAPII:  
• Smarter city manager - the innovation, developed by the EMBRAPII Inatel Unit and the 
Ericsson company, integrates different areas of interest of public agents, such as Public 
Safety, Intelligent Transportation Systems, Intelligent Lighting, in a single platform. This 
integration allows efficiency gains, faster responses and improves the quality of services 
provided to the community.  
 IP/C/M/91 /Add.1  
 
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  • Smarter city manager - the innovation, developed by the EMBRAPII Inatel Unit and the 
Ericsson company, integrates different areas of interest of public agents, such as Public 
Safety, Intelligent Transportation Systems, Intelligent Lighting, in a single platform. This 
integration allows efficiency gains, faster responses and improves the quali ty of services 
provided to the community.  
 
• Nanoencapsulation technology - Four large competing companies, Boticário, Yamá, 
TheraSkin Farmacêutica and Natura, joined EMBRAPII Unit to share the production of a new 
nanoencapsulation technique. The innovation allows active principles to be delivered to the 
innermost layers of the skin, where products such as creams or ointments cannot reach.  
 
• Vegetal Biostimulants -Biofertilizers produced from macroalgae and cyanobacteria extract 
from the Brazilian biodiversity using 100% national technology. The project, developed by 
the EMBRAPI Agroenergy Unit and the Dimiagro company, will bring more productivity to the 
crops and savings to producers.  
 
397.  On the issue of public funds and commercialization of IP, EMBRAPII and SEBRAE have 
developed the Disruptive innovation Fund in 2017 : the program me is intended to bridge the gap 
between SMEs, large companies and Science, Technology and Innovation (STI) Institutes. In this 
model, 1/3 of every project receives EMBRAPII resources, up to 1/3 from EMBRAPII -accredited 
Technological Institutes and the rest from participating companies. SEBRAE subsidizes up to 80% of 
the small company 's contribution to the project. Through this agreement, small companies have 
access to top lab oratories and researchers in the country. Four innovation funding program mes have 
been launched so far, reaching companies from 20 different technological areas in 19 Brazilian 
states. Up to October  2018, SEBRAE committed US D 3 million in projects of 74 co mpanies, which 
were leveraged up 4.2 times, amounting to US D 13.5 million.  
398.  Universities still play an important role in the development of innovation in Brazil, thus we 
would like to mention the case of UNICAMP, a public university from the state of Sao P aulo. Some 
relevant data about UNICAMP : 
▪ Number one Brazilian university in number of patents;  
▪ Second position in the Latin America´s top ten universities rank (the first one the Brazilian 
USP);  
▪ Ninth position among BRIC universities.  
399.  UNICAMP has its own Te chnology Transfer Office (TTO), which is called INOVA UNICAMP . Inova 
promotes interaction between the University and companies through the offer and the licensing of 
technologies developed at UNICAMP and the negotiation and monitoring of collaborative rese arch 
contracts. The university interacts with companies of all sizes. Innovative small companies can 
benefit from the proximity to the university in collaborative projects and by being incubated at 
INCAMP , UNICAMP 's Technology Based Incubator. Medium and l arge companies rely on Inova to 
assist them in identifying new technologies and research groups for technological development 
partnerships and have the option of being hosted in an innovation laboratory within UNICAMP 's 
Science and Technology Park.  
400.  Inova UNICAMP in numbers (2017):  
▪ Over 100 licensed technologies; Annual income of more than US D 325.000;  
▪ Over 70 partner companies;  
▪ Average of 70 patents filed per year in Brazil; 81 patent applications filed in 2017;  
▪ 485 UNICAMP -born companies active in the mar ket with revenue of US D 750 million, 
generating more than 28.000 direct jobs.  
401.  Some examples of licensed technologies in 2018:  
▪ Sugar -cane productivity monitoring system (patent number BR0502658 -0; 
UNICAMP/Agricef) – the system is attached to harvesters and enables collection of 
productivity data. The data is used for productivity maps and production management. The IP/C/M/91/Add.1  
 
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  monitoring system uses load cells and sensors, such as accelerometers and GPS, which 
communicate with the on -board computer of the harvester via a CAN network.  
 
▪ Facial analysis method for device control (BR 102016027065; PCT/BR2017/000136; 
BR5120160013729; UNICAMP/Hoobox Robotics) – Using face analysis, the system translates 
commands and controls electronic and mechanical devices. The technology, i mplemented in 
wheelchair by the licensed company, works like a 3D camera that captures expressions, 
classifies them and carries out the desired command.  
 
▪ Unique identity method in virtual environments (patent number BR 1020120057956) – 
Method developed in partnership between UNICAMP and Kryptus, licensed in 2012, that 
creates a unique identity for each computing device in which it is implemented, providing 
more security for user data and information. The technology is being used in the financial 
sector, wit h application in virtual environments such as internet banking.  
 
▪ Microencapsulated crystals as an alternative to trans-fat (patent number 
BR 1020140279997; Noviga/Unicamp) – a method to nanoencapsulate trans -free fat 
crystals, which are similar in terms of structure, consistency, appearance and taste to 
trans-fat products. The technology provides a possible substitute to trans-fat in the food 
industry, without harm to consumer health. The new process is advantageous in terms of 
logistics, costs and final product stability.  
 
402.  Brazil remains deeply committed to encouraging, rewarding and disseminating innovation in 
the economy and society through p ublic-private partnerships.  
403.  These are some of the examples we chose to share with you. We hope we have the opportunity 
to learn from other Members ' experiences as well.  
11.17   China  
404.  China thanks Members to add this item into agenda and submit th ese documents. In 2018, 
the Societal Values of IP in New Economics has been discussed and positive results have been 
achieved. China also joined the discussion and shared  our practices.  
405.  China pays great attention on the important role of innovation and IP protection in new 
economi es. In order to encourage innovation and creativity, on one hand, the legal system of IP 
protection has been improved. Based on Patent Law, Trade mark Law and Copyright Law, China has 
set up modern regulation and law system on IP protection . Currently, China is working on amending 
the Patent Law and the Copyright Law. Besides, China continuously strengthens law enforcement on 
IPR protection. China h as set up three IPR courts in Beijing, Shanghai and Guangzhou, and special 
judicial organs at 15 intermediate courts in Nanjing, Suzhou and other cities to handle cross -regional 
IPR cases, including those related to patents. China has also strengthened adm inistrative 
enforcement and launched special campaigns.  
406.  China has taken great efforts and made great achievements on IP protection and innovation 
promotion. In 2017, China received 1.382 million invention patent applications, ranking the first in 
the world  for the seventh consecutive year. Nearly 10 % of the applicants were foreign entities and 
individuals. Invention patent applications filed by foreign entities and individuals in China reached 
136,000. According to the World Intellectual Property Organizati on, 51,000 patent applications filed 
from China through the Patent Cooperation Treaty were accepted in 2017, second only to the US. 
Besides, new technologies are also in the fields as high -speed trains, nuclear energy, new generation 
telecommunication, aer ospace and etc.  
407.  Meanwhile, it should be noted that most of the Patents in China are patents for utility models 
and design patents, patents for invention are not as much as others. According to the statistics by 
World Bank, China collected USD 4.7 billion  patent fees, amount to 1.3% of world total, while paid 
USD 28.6 billion patent fees, with USD 23.8 billion deficit.  
408.  Therefore, China hopes to draw Member 's attention to the following facts. Firstly , it is agreed 
that for generation and development of new business, besides innovation and IPR protection, capital, 
human resources and other elements are also essential, for developing Members, capital and human IP/C/M/91 /Add.1  
 
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  resources play an even more important role. Secondly, innovation cannot be achieved in one day. 
It needs huge amount of investment and primitive accumulation. Compared to the developed country 
Member s, developing country M embers suffer deficiency in primitive accumulation. Currently, there 
still exi sts wide gap between developed and developing country M embers on the level and ability of 
innovation. We hope that Members can realize this and explore effective solutions.  
11.18   India  
409.  India would like to reiterate it s statements on this issue made in earlier meeting. India is of 
the view that while IPRs may provide an incentive to innovate, they are neither necessary nor a 
sufficient condition and could only  be effective in certain contexts.  
410.  Though, India realizes importance of innovation and keeping that in view, India has taken 
many steps to improve the innovation eco system -whether it is through the quality of the human 
resource or the research and develo pment activities or strengthening of academia industry linkages 
and availability of capital. As a result, India has moved up on the Global Innovation Index from a 
rank of 76 in 2014 to 57 in 2018. During the same period India has made substantial progress in 
improving its ease of doing business ranking, reaching to rank of 77 out of 190 counties surveyed, 
making it the only country to rank among the top ten improvers for the second consecutive year. 
Since 2014, India 's ranking improved 65 places from 142nd in 2014 to 77th in 2018.  
11.19   Dominican Republic  
411.  By means of Decree No.  453-18, the President of the Dominican Republic, Danilo Medina, has 
declared 2019 as the Year of Innovation and Competitiveness. Similarly, in January  2019, the 
Roundtable on Competitiveness, which is chaired by the honourable President of the Republic and 
which brings together the country's leading entrepreneurs, discussed th e need to develop a strategy 
and schedule for the formation of public -private partnerships for innovation in the country. In this 
regard, my country is very interested in seeing what WTO Members can offer in terms of support 
and technical cooperation, and we request that the submissions made today under this agenda item 
be circulated.  
12  INTELLECTUAL PROPERT Y AND THE PUBLIC INT EREST: PROMOTING PUB LIC HEALTH 
THROUGH COMPETITION LAW AND POLICY  
12.1  South Africa  
412.  South Africa wishes to continu e the discussion  on the linkage between intellectual property 
and competition law and policy based on the documents which are contained in the circulated 
docume nt IP/C/6 51, which includes inter alia  IP/C/643; IP/C/W/649 and Add enda. 
413.  We wish to continue th is debate  with specific reference to exploitative excessive pricing and 
restrictive practices such as reverse payment agreements, strategic patenting and more la tely, the 
evolution of niche pricing of off -patent pharmaceuticals.  
414.  The discussion has gone through various phases of debate, based on underlying guiding 
questions. During the TRIPS Council meeting of 5 and 6 June 2018, co -sponsors endeavoured to 
enhance the understanding of Members of the various approaches to competition law and policy and 
how competition norms are used to prevent or deter practices such as collusive pricing or the use of 
abusive clauses in licensing agreement that unreasonably restrict access to new technology and 
prevent the entry of generic companies and may result in higher prices for medicine.  
415.  We specifically  pointed out that while the TRIPS Agreement sets "minimum norms " for 
standards of IP protection that significantly limit Membe rs' discretion on a large number of IP rights 
issues, it is however not the case with competition law.  
416.  During the TRIPS Council meeting of 8 and 9 November 2018, we intensified the debate by 
pointing out that over the course of time clearer competition po licy treatment of IPRs has evolved 
through either iterative processes or the evolving practice of competition authorities. This 
development, as we  argued, underscored the need for further debate and analysis since competition 
law and policy is no longer th e preoccupation of only a few jurisdictions.  IP/C/M/91/Add.1  
 
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  417.  A recent publication of the European Commission entitled "Competition Enforcement in the 
Pharmaceutical Sector (2009 – 2017) " sheds light on the efforts of European competition authorities 
to ensure affordable and innovative medicine.10 It should be noted that not all jurisdictions prohibit 
exploitative excessive pricing, however excessive pricing models may often be indicators of 
underlying competition problem s. Unlike the binding minimum standards of intellectu al property 
protection and enforcement contained in the TRIPS Agreement, there is no equivalent international 
legal instrument for competition law that would provide such minimum standards of protection.  
418.  Competition policy has an important role to play in ensuring fair access to medical technology 
and fostering innovation in the pharmaceutical sector. WTO Members have absolute policy space 
under international law to design their national competition laws in accordance with their domestic 
interests and needs  and the level of their development.   
419.  We want  once again to urge Members to share their national experiences and examples of how 
competition law is used to achieve public health and related national objectives. Debate and 
information exchange could serve t o enhance the understanding of Members of various approaches 
to the use of competition law and policy to prevent or deter practices such as: collusive pricing or 
the use of abusive clauses in licensing agreements that unreasonably restrict access to new 
technology, the use of measures that prevent the entry of generic companies and result in higher 
prices for medicines, reverse payment agreements and strategic patenting, patent thickets and 
product switching.  
420.  We also focus on c apacity building and technica l assistance which remain s an important means 
to enable WTO Members to increase their capacity to administer and implement policies that ensure 
access to medicines within the TRIPS flexibilities framework.  
421.  We also have a list of questions circulated in document IP/C/W/6 51. I will focus in question s 
4 and 5  only: 
(4) Have any Members recently conducted market inquiries into the pharmaceutical sector to assess 
its impact on access to medicine or more generally the impact of the pharmaceutical sector on 
competition in particular market segments? If so, what were the findings and what remedial actions 
were recommended or taken?  
(5) To what extent can technical assistance and capacity building contribute to the delivery of more 
effective policies by WTO Member s in the field of competition law to address the abuse of intellectual 
property rights? What role can international organisations play in this regard, including the WTO?  
12.2  Costa Rica  
422.  Thanks to South Africa for its communication and for introducing this topic in the agenda. As 
a means to contributing to this debate, Costa Rica would like to briefly refer to some of its experience 
in this area.  
423.  When dealing with excessive pricing in the context of anti -trust or competition enforcement in 
the pharmaceutical and medical technology sector, our competition legislation does not contemplate 
specific provisions to deal with these sectors,  but pharmaceut ical and medical technology goods fall 
within the scope of our competition law. If there is proof that lack of competition in a particular 
sector might have as a consequence high prices, temporary price regulation might be implemented 
as a remedy to deal w ith these cases.   
424.  The Ministry of Economy and Industry of Costa Rica is currently leading a market study to 
analy se the impact of possible monopolistic practices on the most sold pharmaceutical products in 
the country. The results of this study are still pending and will be made publicly available in due 
time.   
                                                
10 European Commission "Competition Enforcement in the Pharmaceutical Sector (2009 – 2017)" 
European Competition Authorities working together for affordabl e and innovative medicine. (dated 28 January 
2019). http://ec.europa.eu/competition/publications/reports/kd0718081enn.pdf  IP/C/M/91 /Add.1  
 
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  425.  Finally, with respect to technical assistance and capacity building needed to deliver more 
effective policies by WTO Members in the field of competition law, Costa Rica believes that in the 
specifi c case of pharmaceutical products, it would be helpful to have technical assistance both from 
the WTO and entities related to the field of public health such as the WHO and the PHO in a 
coordinated way, in order to reach an appropriate balance between IPR protection, trade and public 
health.  
12.3  Brazil  
426.  Brazil would like to thank the co -sponsors for including in the agenda the important topic of 
"promoting public he alth through competition law and policy " under the item IP and the Public 
Interest.  
427.  The promotion of competition and the protection of IPRs are essential cornerstones for the 
development of a modern economy, and the challenge Members face, irrespective of their level of 
development, is to find the right balance between both policies.  
428.  In a well -functioning market economy, IPRs may provide incentives for competition, based on 
the promise to grant exclusive rights to products or services that eventually bring  a benefit to society 
and, as a result, more competition in the medium -long term. For this incentive mechanism to 
function, however, it is essential that existing IPRs not be employed abusively, harming competition 
and innovation in the short term at the e xpense of IP users.  
429.  In this sense, competition laws play a key role in ensuring that the exercise of exclusive 
intellectual property rights do not give rise to anti -competitive practices, whether through the abuse 
of the IP holders´ dominant position in th e market or unlawful agreements among right holders 
themselves.  
430.  On patents and health, we believe innovation, bolstered by the patent system, has produced 
a number of important technologies that have improved health outcomes worldwide. Innovation is 
also v ital to achieving the 2030 Agenda´s goal of improving the health and well -being of all people 
at all ages , which  appears in a number of SDG targets.  
431.  While important progress has been made, significant gaps persist in health, innovation and 
access. To ment ion one example, according to WHO and the World Bank, 400 million people 
worldwide lack healthcare, including access to medicines, vaccines and medical devices. Three 
quarters of them live in middle -income countries. Furthermore, an estimated 1 .7 billion p eople in 
185 countries still need treatment and care for neglected tropical diseases.  
432.  The WTO, WIPO and WHO report on IP and Public Health highlights that: "Several potentially 
anti-competitive strategies in relation to IP rights involving medical technology have been observed 
and documented. These strategies mostly are designed to extend patent protection for originator 
drugs and to prevent market entry by generic competitors after patent expiry. "  
433.  The UNDP report, entitled "Using Competition Law t o Promote Access to Health Technologies ", 
also provides a thorough analysis of different strategies companies use to try to curb competition. 
The same document underlines the importance of competition law as one of the important tools to 
promote innovation  and access to health technologies.  
434.  In our view, the use of competition law to curb abusive conduct is in line with both the letter 
and the spirit of Article 7 of TRIPS, which states that: "The protection and enforcement of intellectual 
property rights sho uld contribute to the promotion of technological innovation and to the transfer 
and dissemination of technology, to the mutual advantage of producers and users of technological 
knowledge and in a manner conducive to social and economic welfare, and to a ba lance of rights 
and obligations ". 
435.  Article 8.1 of the TRIPS Agreement also recognizes that the principles of IP protection are 
based on underlying public policy objectives.  IP/C/M/91/Add.1  
 
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  436.  Various other provisions of TRIPS are relevant to competition law including Article  6, 
Article  31(k) and Article 40. These provisions leave broad discretion to Members in how they apply 
competition law in respect of the acquisition and exercise of IP rights.  
437.  We would like to highlight that Brazil´s approach to IP and Competition aims to  be cautious, 
balanced and pragmatic.  
438.  The Administrative Council for Economic Defense (CADE) is the Brazilian Antitrust Authority 
responsible for applying Law 12.529/2011 (Antitrust Law). The institutional dialogue between CADE 
and our IP office (INPI) ha s been intensified through a recent agreement for the exchange of 
knowledge, information and technical cooperation. The objective of this increasing collaboration is 
to ensure IP and antitrust laws are equally respected and assessments are made on a case -by-case 
basis.  
439.  Based on this cooperation, CADE found Eli Lilly of Brazil and Eli Lilly and Company guilty of 
sham litigation in order to obtain exclusive marketing rights (EMR) for a medical drug used in cancer 
treatment in 2015.  
440.  In our view, such intra -agency dialogue and cooperation ensures stability, reliability and legal 
certainty, essential elements of a conducive business environment and for attracting investment and 
innovation.  
441.  Pursuing a better alignment between IP, trade and health policies is an o ngoing, never -ending 
process. That´s why, we, Member s, have to continue working together to develop a balanced and 
effective international patent system that encourages and rewards innovation and, at the same time, 
is supportive of public policy objectives .  
442.  That is why we believe the item "IP and Public Interest " is of utmost importance and should 
be further explored in the TRIPS Council agenda in future sessions.  
443.  In the Eli Lilly Case, the Brazilian Association of Generic Medication Industries filed a com plaint 
against Eli Lilly of Brazil and Eli Lilly and Company, alleging that the defendants had practiced sham 
litigation by unlawfully enforcing patents in the medical drug market. The plaintiff claimed that the 
defendants were creating artificial barriers  to competition by filing suits against public institutions, 
such as the INPI, in order to obtain unlawful exclusivity over a medical drug used in cancer 
treatment. CADE's ruling identified an abuse of IP rights in Eli Lilly's conduct. According to CADE, 
the claims filed by the defendants fulfilled the three requirements for establishing sham litigation, 
as developed by case law: (1) implausibility of the claims, (2) provision of erroneous information 
and (3) unreasonableness of the means used. The agency h ighlighted the importance of careful 
scrutiny in sham litigation cases involving IP rights due to the high potential of such cases to cause 
very harmful effects on competition.  CADE addressed the complex interface of antitrust and IP law, 
noting that even  patents lawfully granted by the designated government agencies did not preclude 
the possibility that these IP rights could be abused in enforcement proceedings.  
444.  CADE found the defendants guilty of sham litigation for the following reasons: (i) the suits f iled 
by Eli Lilly were manifestly unreasonable in the sense that they were not credible and had no chance 
of succeeding, since the patentability of the pharmaceutical product whose IP was being enforced 
had never been analysed by INPI; (ii) the defendants omitted relevant information, such as the 
suspension of the patent review and the modification of the patent scope, from their submissions 
filed in the judicial suits; and (iii) the means used to enforce the IP rights were deemed unreasonable 
since the sam e claim had been filed in several different courts . The defendants had obtained an 
unlawful monopoly, harming competition, by filing various judicial claims to avoid the practical 
effects of the refusal to grant the requested patent in order to obtain EMR .  
445.  This ruling exemplifies an instance where CADE applied antitrust rules in a case involving the 
abuse of IP rights. The defendants' conduct in the Eli Lilly case had clearly been abusive and the 
resulting unlawful monopoly had caused serious harm to competition.  IP/C/M/91 /Add.1  
 
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  12.4  Indonesia  
446.  Firstly, we would like to thank South Africa for registering this agenda item for this TRIPS 
Council meeting. There are many ways fo r us to achieve and promote public health objectives for 
the good of public interest and one of those ways is through competition law. In this opportunity, 
Indonesia would like to share its experience related to the topic of this agenda item.  
447.  Indonesia en acted a law in 1999 which prohibits monopolistic practices and unfair business 
competition among business actors. Within that law, there is a mandate for Indonesia to establish 
an agency to implement provisions within the anti -monopoly law. The Indonesian Anti-Monopoly 
Agency was established in 1999 and since its kick -off in the year of 2000 until 2017 it has handled 
348 cases including collecting fines of up to IDR 2.07 trillion.  
448.  Based on Article 50 letter (b) of the anti -monopoly law, there is an exception concerning 
exclusive rights of intellectual property rights (IPRs). However, the exclusivity of IPRs cannot be 
considered unlimited. Based on the anti -monopoly law, if monopolis tic practices and unfair business 
competition are found through the use IPRs, the agency has an obligation make corrections.  
449.  In 2010, there was a case which was handled by the agency, Case Number 17/KPPU -I/2010 
concerning Prohibition of Monopolistic Pract ices and Unfair Business Competition Law on 
Am-lo-di-pine Therapy Class Pharmaceutical Industry. This case contained issues on the dominant 
position of cartels in determining prices for certain medicine s. Within its finding , the agency 
determined that the exclusivity of IPR s cannot be classified as a license agreement but rather as a 
supply agreement.   
450.  In the health industry of a country of about 260 million people, "pricing abuse " often occurs in 
the pharmaceutical sector, where the price of drugs and med icine tends to be very high. It happens 
because drugs are considered as inelastic goods, where prices and demand do not affect each other. 
Such condition s created a notion in Indonesia that the price of drugs must be controlled to prevent 
further abuses an d most importantly to protect consumers and the public interest.  
451.  Hence the Indonesian Government created a regulation related to drug pricing which guides 
the upper limit price for certain medicines. In addition to that, an electronic catalogue  on drugs a nd 
medicines , which is used as a tool to support the National Health Insurance System , was also 
introduced. Since the introduction of this initiative, there is a tendency for drugs and medicine prices 
to decrease in Indonesia.  
452.  This is an example on how th e anti -monopoly law is used in Indonesia to ensure public interest. 
We look forward to hearing  other Members ' experiences on this subject matter.  
12.5  China  
453.  In 2018,  Members are actively involved in the discussion of intellectual property and the public 
interest, the understanding of this issue has been deepened. In the third meeting, the relationship 
between IP and competition were discussed from the viewpoint of ant i-unjustified competition, 
although divergences still exist, the discussion were open and inclusive. China believes that our 
discussion today will further the understanding of this relationship.  
454.  China reaffirms that TRIPS Council is an appropriate forum to  discuss IP and competition 
issues. China believes the discussion will help Members to get a better understanding of this issue.  
455.  In our point of view, firstly we believe that intellectual property protection should not exclude 
the application of competitio n law. Articles 6, 8.1, 31(k) and 40 of the TRIPS Agreement are closely 
related to competition. Actually, In WIPO and FTAs, this issue already has been discussed a lot. As 
an important forum for intellectual property, the TRIPS Council should discuss this issue as well.  
456.  Secondly, China conducts investigation and law enforcement on monopoly issues in the field 
of medicine, including IP abuse excluding competition and others. In 2017, Guidelines for Operator 's 
Pricing on Deficient Medicine and Drug Materials was introduced for this purpose.  IP/C/M/91/Add.1  
 
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  457.  Finally, China emphasizes the discussion of IP and competition should be open, Members can 
exchange views and experience s on the flexibility articles in TRIPS including better understanding of 
competition laws based on thei r own legislations and practices.  
12.6  Switzerland  
458.  I thank the distinguished delegate of South Africa for introducing its submission IP/C/W/651. 
Competition la w opens a broad and challenging field. To a large extent, this field is outside of the 
responsibility of the TRIPS Council.  
459.  The goal of the IP system is to grant a time limited exclusive right for the use of intellectual 
property to its owner. The IP syst em addresses and remedies an economic market failure to ensure 
sufficient incentive for investment into and for the promotion of innovation and dissemination of 
innovative technology.  
460.  An IP right may provide one of many possible backgrounds on which anti -competitive 
behaviour or an abuse of market power may occur. Competition and anti -trust law are, however, 
concerned with that anti -competitive behaviour as such - and not with the underlying IPR.  
461.  It is, therefore, misleading, in our view, to refer to comp etition law as a TRIPS flexibility. 
Competition law is not to make inroads or provide exceptions to IPR or to their protection as 
stipulated in the TRIPS Agreement.  
462.  There is no direct or necessary link between IP and price either, be it in the pharmaceuti cal or 
any other sector. A patent does not grant the right to demand a specific price, not to mention 
excessive ones. This is illustrated by the fact that excessive pricing, whether in the pharmaceutical 
or other sectors, may occur regardless of whether re spective products are patent protected or not. 
It's practices such as collusive pricing or abusive clauses in licensing agreement that are the 
subject -matter of examination by competition law - and not IPRs.  
463.  How competition law shall address such anti-competitive behaviour is, in this delegation 's 
view, outside the purview of the TRIPS Council and not its field of competence.  
12.7  United States of America  
464.  The United States has provided its views on this agenda item during the two previous 
TRIPS  Council meetings and references , but will not otherwise repeat , its June 2018 intervention on 
this agenda item.  
465.  The United States continues to be of the view that intellectual property laws and  antitrust 
laws share the common purpose of promoting innovation and enhancing consumer welfare, but also 
that intellectual property and competition are distinct disciplines implemented and overseen by 
different administrative authorities.   
466.  The United States continues to express reservations regarding discussion of this subject matter 
in this forum, as relatively few TRIPS Council delegates can be expected to have deep expert ise both 
in intellectual property and competition law and policy.  
467.  We note that there are already established forums, including the Organization for Economic 
Cooperation and Development (OECD) and the International Competition Network (ICN), which bring 
together the appropriate experts to discuss such issues.  
468.  As we have demonstrated in the United States, IP and competition polices can and should 
coexist and complement one another.  
469.  The United States is committed to achieving public health goals in a way that upholds IP rights 
and promotes competition.  
470.  For more information on the United States ' views on IP and competition, please refer to our 
June 2018 intervention.  IP/C/M/91 /Add.1  
 
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  12.8  Japan  
471.  For the purpose of having meaningful discussions under this agenda item, the delegation of 
Japan would like to suggest other Members to note that it might be better to take a more thorough 
and cautious approach, taking into account not only the inter ests of third parties but also those of 
patent -rights holders.  
472.  We all should note that the development of new and innovative medical technologies needs so 
much cost and takes so much time as well, and therefore Japan believes that there should be an 
approp riate mechanism to incentivize the development of such technologies not only for the 
developed country Members but also for the whole world.  
473.  Taking the above -mentioned points into account, we believe the IP system is an essential 
mechanism that should work  without undue barriers to promote dynamic competition. In particular, 
the current IP system plays a significant role to incentivize the development of new and innovative 
medical technologies for several purposes, such as to overcome incurable diseases and  to lower the 
cost of production of existing medicines.  
474.  In this context, this delegation would also like to point out that provisions such as those in 
Article 31(k) and Article 40 of the TRIPS Agreement, which refer to the relationship between IP and 
compe tition policy, rest on an intricate balance. Therefore, Japan believes that we should be 
cautious, in discussing this agenda item. And, these provisions should not be interpreted too broadly. 
From this perspective, this delegation has concerns about the do cument IP/C/W/651. In addition, it 
is important to note that any measures taken under these provisions should be fully consistent with 
the TRIPS Agreement, as is stipulated in Article 8 or Article 40.2 of the TRIPS Agreement.  
12.9  European Union  
475.  Competition law and intellectual property systems are not contradictory, but complementary 
systems of law, which both strive to further welfare and growth. As already  stated at the last two 
TRIPS Council sessions, in general, we do not consider the TRIPS Council the appropriate forum to 
discuss competition policy. There are other international fora, such as the International Competition 
Network, where such internationa l exchanges and cooperation are taking place and we invite all 
WTO Members ' competition authorities to participate in those fora.  
476.  While the submission from South Africa seems to consider the use of competition policy a 
TRIPS flexibility to facilitate the market entry of generic competitors, the EU would be cautious and 
would emphasise the following: while the TRIPS agreement is obvio usly compatible with the 
application of competition policy measures, it clearly does not allow for "absolute policy space ". As 
provided for in Article 8 (1) and (2), as well as in Article 40 (2), these measures have to be consistent 
with the provisions of the TRIPS agreement and cannot be used as tools in avoiding the obligations 
under the Agreement.   
477.  Generally, of course, competition policy plays an important role in controlling and sanctioning 
anti-competitive market behaviour in any sector, including th e pharmaceutical sector.  
478.  However, competition authorities in the EU have been generally reticent to address possible 
excessive pricing conduct. In a market economy, prices and profits are generally regarded as useful 
indicators and necessary incentives fo r other firms to decide where to invest, enter a certain market 
or expand their business. Lastly, if high profits are the result of a firm 's own excellence and 
innovativeness, the incentive for such efforts should not be undermined by ex -post competition 
policy enforcement. While these reasons, which justify a cautious policy, are generally well 
understood, Treaty on the Functioning of the European Union (TFEU) Article 102 has an explicit 
abuse prohibition of excessive pricing, which has been further develo ped by the European Court of 
Justice.  
479.  However, in the EU, there were no competition cases of excessive prices related to intellectual 
property rights. EU authorities, including the Commission, have so far intervened in cases where, 
due to market failure, older, off -patent drugs saw their prices increase by up to over 2000%. In 
these cases, i.e. drugs which were no longer protected by intellectual property rights, high prices 
were not related to intellectual property rights and did not act as an incentive f or innovation, which IP/C/M/91/Add.1  
 
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  intellectual property rights aim at safeguarding. Conversely, the European Commission has never 
reached the conclusion that the pricing of an innovative medicine was excessive.  
480.  Moreover, competition enforcement should not only safegua rd static price competition, but 
also be mindful of the need to secure dynamic competition for the development of new, innovative 
drugs. Both the Commission 's recent Report on Competition Enforcement in the Pharmaceutical 
Sector as well as the Commission 's Sector Inquiry recognize the value that systemic protection of 
intellectual property rights , together with the other incentives on the pharmaceutical markets (e.g. 
incentives for development of orphan medicines) , bring by stimulating innovation and increa sing 
choice for the patients. They also recognize that many legitimate practices of pharmaceutical 
companies rely on the intellectual property framework (e.g. patent strategies, patent litigations and 
settlements, patent oppositions).  
481.  Abusive conduct of ph armaceutical companies, as any other abusive practices, can violate 
competition law in certain clearly defined circumstances, and provided that all applicable legal 
requirements are met. The Report and the reported cases that include intellectual property elements 
clearly underscore that it is not the IPR system as such that is problematic. In fact, it is the opposite, 
competition issues originate from the unlawful conduct of pharmaceutical companies, which go 
against the objectives of the IPR system, for e xample, fraud on the patent office, vexatious litigation, 
or pay for delay settlement of patent disputes. European authorities have prosecuted a number of 
such cases, notably AstraZeneca, Lundbeck, Servier, Pfizer, Boehringer / Almirall etc, all summarised  
in the report.  
482.  The Commission believes that vigilant enforcement is needed to prevent abusive 
anti-competitive practices in all sectors, including the pharmaceutical sector. To that end, EU 
competition authorities have the normal toolbox of competition p olicy remedies, in particular 
monetary fines.  
483.  However, it cannot be inferred that patenting, patent litigation or other IP -related conduct is 
generally problematic from the competition law perspective.  
484.  On the international level, the EU effectively coopera tes with other national authorities, 
including many WTO Members, on competition policy and enforcement issues of mutual interest. EU 
cooperation with competition authorities takes place at two levels. First, the Commission discusses 
competition -related mat ters in various international fora, such as the International Competition 
Network (ICN), where excessive pricing was discussed during its annual conference in Portugal in 
2017. ICN is an effective forum with a broad expert outreach and brings together comp etition 
authorities from more than 100 jurisdictions, which exchange experiences and best practices in 
several meetings every year. Second, the Commission is also regularly engaged in bilateral 
cooperation, including in the pharmaceutical sector. The natur e of the cooperation activity varies 
between countries and can cover cooperation on specific investigations, dialogue on competition 
policy issues as well as capacity building support.  
485.  Therefore, we remain to be convinced about the added value of discussin g competition policy 
here at the TRIPS Council.  
12.10   South Africa  
486.  Competition law and policy is important first for the recognition and secondly the use and 
application of IPRs. I think that the discussion we had is indicative of the progress that we have 
made in the TRIPS Council. The very name of the division that is r esponsible for intellectual property 
at the WTO contains a reference to competition and so this make s it relevant to the discussions that 
we have in this meeting. The second point that we would like to make , given the different approaches 
that we see in re spect of competition or anti -trust law enforcement , is that  we recognize that these 
different approaches are legitimate policy choices that countries make.  
487.  In respect of the EU intervention, I would like to thank  the distinguished delegate for the 
analysis and response to many issues that remain on the table and I think that the approach of the 
EU has demonstrated as an indicator to all of us that there is some sort of emerging communality 
in the way that we approach issues of competition and IP law  in general.  IP/C/M/91 /Add.1  
 
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  13  INFORMATION ON RELEV ANT DEVELOPMENTS ELS EWHERE IN THE WTO  
13.1  Dispute Settle ment  
13.2  Amendment to the TRIPS Agreement  
13.3  IPR-Related Issues in Trade Policy Reviews  
13.3.1   WTO Secretariat  
488.  As on previou s occasions, the Secretariat will provide a brief update of the IP policy issues that 
have come up in the most recent Trade Policy Reviews.  
489.  Since the last TRIPS Council Meeting in November 2018, the Trade Policy Reviews of the 
Armenia; Hong Kong, China; N epal; and the United States have taken place. Of course, we will not 
attempt to summarize the full range of issues covered in each of these reviews; we will limit the 
update to those matters on which Members, including both developed and developing countr y 
Members , actively registered an interest by posing questions during the review process. The issues 
that were of particular interest in this concrete sense included:  
• Domestic implementation of the TRIPS Agreement;  
• Implementation of national intellectual pr operty policies;  
• Profit tax deductions for the purchase of IPRS;  
• Contribution of intellectual property intensive industries to exports and imports;  
• Copyright regimes, covering online and technological protection measures;  
• Trademark regimes, including prote ction of well -known and unregistered trademarks, as well 
as requirements for prior use;  
• Geographical indications regimes;  
• Protection of industrial designs;  
• Patent regimes, including projects to improve the efficiency and quality of the patent 
application a nd examination processes.  
• Protection of undisclosed information and test data;  
• Technology transfer policy, including projects to enhance innovation technology 
commercialization and partnerships;  
• Governmental expenditures on research and development;  
• Protection of trade secrets;  
• Licensing and competition policy;  
• Enforcement, civil remedies, criminal penalties online and at the border;  
• Methodologies for calculating loss caused by infringements;  
• Procedures for settling disputes, including mediation; and  
• The Accession to, and implementation of, WIPO instruments.  IP/C/M/91/Add.1  
 
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  490.  Additionally, the Secretariat has contributed to the TRIPS -related section of the G20 and 
WTO-wide Director -General 's Monitoring Reports, which were circulated to Members in late 
November 2018.   
491.  The section on "Policy Developments in Trade and Intellectual Property " in these reports 
highlights the trade -related IP policy initiatives undertaken by the Kingdom of Saudi Arabia and 
South Africa; as well as the information on developments in domestic l egislation and administrative 
issues submitted for the monitoring exercise by Australia, Indonesia, the Kingdom of Saudi Arabia, 
Mexico and Turkey.  
14  OBSERVER STATUS FOR INTERNATIONAL INTERG OVERNMENTAL ORGANIZA TIONS  
14.1  South Africa  
492.   We would like to thank Members for the constructive debate that we have been able to have 
in this house recently. In particular, South Africa once again extends its congratulations to the 
Cooperation Council of the Arab States of the Gulf (GCC) fo r having been granted regular observer 
status.  
493.  Based on document IP/C/W/52/Rev.14, there are still several requests for observer status to 
the TRIPS Council that remain outstanding. South Africa supports the request that observer status 
be granted to the A CP Group, which represents 79 Members. There are 48 countries from 
Sub-Saharan Africa, 16 from the Caribbean and 15 from the Pacific. ACP Group´s main objectives 
are sustainable development of its Members and their gradual integration into the global economy, 
which entails making poverty reduction a matter of priority and est ablishing a new, fairer, and more 
equitable world order. At the WTO the ACP remains an influential group and will greatly benefit from 
being granted observer status either on an ad hoc  or permanent basis.  
494.  We also would like to reiterate previous calls for  Members to agree on granting observer status 
to the South Centre and the Secretariat of the Convention on Biological Diversity (CBD).  
14.2  Ecuador  
495.  Ecuador continues to support the participation of the South Centre and the Secret ariat of the 
Convention on Biological Diversity as WTO observers, or at least their participation as ad hoc  
observers.  
14.3  United States of America  
496.  The United States  position has not changed. We cannot join the Members seeking to include 
these observers, either on a permanent or ad hoc  basis.  
497.  The United States values the contributions of Members and is satisfied with the current set of 
ad hoc and permanent observers.  
498.  We do not see a gap that needs filling by add ing new observers at this time.  We also do not 
support ACP.  
14.4  Venezuela, Bolivarian Republic of  
499.  My delegation wishes to reiterate the statement it made at previous meetings of this Council, 
in which it expressed support for granting the South Centre observer status.  
14.5  China  
500.  China supports that the CBD Secretariat and South Centr e should be granted observer status, 
at least on an ad hoc  basis.  
501.  The relationship between TRIPS Agreement and CBD is an important issue in this Council, it is 
no doubt that CBD Secretariat has better understanding of specific rules and latest developments of IP/C/M/91 /Add.1  
 
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  the CBD. China believes that the invitation to the CBD Secreta riat as an observer will help Members 
better understand the CBD, thus promoting discussions and consultations on TRIPS/CBD.  
502.  South Centre plays an important role in strengthening the understanding and cooperation 
between developed and developing country M embers, so as to push the discussion and consultation 
forward.  
14.6  Bangladesh  
503.  On the observer status issue, the delegation of Bangladesh reiterates its position stated in the 
earlier meetings. We would like to support the South  Centre to be granted observer status to this 
Council.  
15  OTHER BUSINESS  
504.  No statements were made under this agenda item.  
16  ELECTION OF THE CHAI RPERSON  
505.  No statements were made under this agenda item.  
 
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