IP/C/W/673  
 
15 January  2021 
(21-0507) Page: 1/12 
Council for Trade -Related Aspects of  
Intellectual Property Rights  Original: English  
 
  
RESPONSE TO QUESTIONS ON INTELLECTUAL -PROPERTY CHALLENGES EXPERIENCED BY 
MEMBERS IN RELATION TO COVID -19 IN DOCUMENT  IP/C/W/671  
COMMUNICATION FROM THE PLURINATIONAL STATE OF BOLIVIA, ESWATINI, INDIA, KENYA, 
MOZAMBIQUE, MONGOLIA, PAKISTAN, SOUTH AFRICA, 
THE BOLIVARIAN  REPUBLIC  OF VENEZUELA AND ZIMBABWE  
1  INTRODUCTION  
1.  In document  IP/C/W/671, Australia, Canada, Chile and Mexico raised eight questions for the 
consideration of the Council for TRIPS. These questions follow communication in document 
IP/C/W/669 on Waiver from Certain Provisions of the TRIPS Agreement for the Prevention, 
Containment and Treatment of COVID -19, now co -sponsored by the Plurinational State of Bolivia, 
Eswatini, India, Kenya, Mozambique, Mongolia, Pakistan, South Africa, 
the Bolivarian  Republic  of Venezuela and Zimbabwe. This waiver proposal has received global 
support from civil society, intergovernmental organizations, human rights and other experts and 
most importantly from many WTO Members.  
2.  Shortcomings in ram ping up the manufacturing of specific COVID -19 diagnostics, equipment, 
therapeutics or vaccines are well -recogni zed by all the Members. And it is surprising that even after 
the experience of last ten months, certain Members are asking these questions. Wher eas the same 
Members are applying a sequencing or prioritising criteria for administering preventive or curative 
treatment for COVID -19 in their respective jurisdictions. So, this is beyond our comprehension that 
Members are recogni zing the issue of shorta ge in supply and at the same time asking question 
whether we are facing any challenges in ramping up production . 
3.  The Waiver proposal is to ensure that complications arising from intellectual property rights 
protection do not delay response or lead to subop timal response from the countries around the world 
affecting lives of all people. Management of a pandemic needs a swift response and it is in the 
interest of all countries that every country has the capacity to fight this through vaccines, 
therapeutics an d devices. IP had proved to be a substantive barrier during the HIV crisis and 
continues to affect access to medicines in the treatment of many diseases. The pandemic has a huge 
social cost and if unaddressed through swift and appropriate action by each co untry, will create 
negative externality for every country.  
4.  TRIPS Article 31 and 31 bis do not address the situation created by a pandemic where every 
country in the world is affected and the numbers impacted continue to rise. Article 31 mainly 
addresses cou ntry specific measures such as in situations of a national emergency, extreme urgency 
or when the medicine is required for public non - commercial use. Article 31 does not address a 
situation where the world as such is impacted.  
5.  Waiver is therefore require d because a disease like the COVID 19 needs collaborative action in 
social interest while IP protected products promote private interests only. Exercise of relief limiting 
the rights of the right holder will be time consuming and considering the extent of the crisis will have 
considerable human cost.  
6.  In this communication, the co -sponsors respond to questions raised in  document  IP/C/W/671. 
The responses should be read together with communication titled Examples of IP issues and barriers 
in COVID -19 pandemi c (document IP/C/W/670), and interventions made at the formal and informal IP/C/W/673  
 
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  sessions of the Council for TRIPS clarifying and responding to issues and concerns raised with respect 
to the waiver proposal.    
2  RESPONSES  
2.1  Question 1: Have Members, or organization s acting on their behalf, experienced IP 
challenges that have impeded or prevented the timely procurement of COVID -19 
diagnostics, equipment, therapeutics or vaccines? If so, can Members describe these 
challenges, including in relation to the TRIPS Agreeme nt. 
7.  To revisit IP challenges experienced by countries in the COVID -19 pandemic, it is critical to first 
clarify that the understanding of IP challenges needs to consider at least five aspects:  
(1) the immediate blocking effects on production and supply, such as those arising from patents 
on medicines and other IP;  
(2) the effects of restrictive IP management that limits the production, supply and procurement 
options, such as those associated with selective and exclusive voluntary licensing practic es; 
(3) the effects of legal uncertainty and delay on alternative and independent development and 
production, such as those associated with patent thickets and IP disputes;  
(4) the emerging and anticipated barriers that arise alongside the evolving product  development 
pipelines, concerning both background IP and foreground IP -related to COVID -19 health 
technologies, for instance the unpublished patents on pipeline medicines, vaccines and 
diagnostics; and  
(5) the effects of different types of IP on different  aspects of COVID -19 health technologies and 
their combined effect on availability and affordability, for instance, the combined effect of 
patents and undisclosed information on medicines, vaccines and diagnostics.  
8.  Addressing each of these IP challenges r equires either removing existing barriers or anticipating 
emerging barriers and adopting legal measures to enable quicker and easier actions when needed. 
The need to address IP challenges with a global outlook also challenges WTO Members to look 
beyond exi sting legal options under the TRIPS Agreement which adopts a product -by-product and 
country -by-country scenario.  
9.  Early in the pandemic, some developed countr y Members  (e.g., Canada, Australia, Germany, 
Hungary etc.) amended laws to enable quicker and easi er procedures for the grant of compulsory 
licenses to overcome possible IP barriers to COVID -19 technologies, without any specific instance of 
IP barriers necessitating the actual use of such a measure. These law revisions were done to enable 
and prepare t he governments to act rapidly to address IP barriers, if they were to arise.  
10.  As explained below, in the context of a pandemic, compulsory licenses offer imperfect solutions. 
But these examples clearly show the importance of measures to address any possibl e IP barriers to 
ensure timely procurement and supply of needed medical products. The revisions also demonstrate  
shortcomings in existing laws on compulsory licensing and the need for additional measures in 
responding to the new challenges of COVID -19. 
11.  We therefore stress in the TRIPS Council that the waiver proposal provides a legal option under 
the WTO framework for countries to use in addressing IP challenges (that are either present or that 
might arise) to expand global supply and facilitate access. An individual country 's legal preparation 
is insufficient to address global needs. When a country prepares its law for quicker issuance of 
compulsory licenses, and some countries have issued compulsory licenses in this pandemic, the 
measure only benefits the concerned individua l country.  
12.  In addition, the waiver proposal also goes beyond the product -by-product scenario that is 
currently embedded in the TRIPS Agreement.  
IP challenges: IP landscape and restrictive voluntary licensing  
13.  Examples of IP challenges are detailed  in docum ent IP/C/W/670, in which both the emerging IP 
landscape of pipeline medical products and exclusive and limited voluntary licensing practices have 
presented ongoing challenges for the prediction, preparation and management of procurement 
options for countri es.  IP/C/W/673  
 
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  14.  For therapeutics, in addition to examples provided in  document  IP/C/W/670, recent news 
reports1 suggest that two anti -inflammatory medicines have shown positive results in treatment. 
The two medicines – tocilizumab and sarilumab – have both been repu rposed for COVID -19 
treatment but are not widely available especially in developing countries. As mentioned in document 
IP/C/W/670, the primary patent on tocilizumab expired in 2017, but multiple secondary patents 
remain granted in many countries. While fo r sarilumab, the primary patent on the drug and 
secondary patents on its formulation have been granted or filed in at least 55 developing countries.2 
This situation poses a challenge for alternative supply of these medicines.  
15.  On vaccines, as mentioned in  document IP/C/W/670, the emerging landscape of both 
background and foreground IP on key vaccine technologies, and the IP disputes that have already 
occurred during the pandemic underline evident IP challenges in ensuring legal certainty for vaccine 
develo pment and supply, especially when some of the main vaccine producers continue to pursue 
monopolistic approaches in their IP management.  
16.  In addition to the patent landscape, exclusive and limited restrictive voluntary 
licensing practices continue to pose c hallenges for procurement options for countries.  
17.  As mentioned in  document IP/C/W/670, Gilead signed limited voluntary licenses on Remdesivir 
with a few generic companies and excluded many developing countries, including most 
South  American countries, from  being supplied under the licenses and benefiting from alternative 
generic sources. A number of countries that are excluded from the voluntary licensing have generic 
production capacities.  
18.  Regeneron also holds patent on a monoclonal antibody pipeline cand idate – 
REGN10933+REGN10987, as mentioned in document IP/C/W/670. However, the company has 
chosen only one partner for the production and supply, although there are many biologics producers 
in different countries, including in developing countries, which h ave the capacity to produce and 
supply. Such practices artificially limit competition and supply, reducing the prospect of procurement 
for countries globally.  
19.  Presently, high -income countries have bought up the majority of the existing vaccine supply 
capacity, which poses a significant challenge for COVAX, and consequently for supply to low - and 
middle -income countries (LMICs) and other developing countries. Obviously,  this is not a sustainable 
situation. One of the key reasons underlying insufficient supp ly and impacting procurement is the 
way major vaccine developers are managing their IP and technologies. If we allow ramping up of 
manufacturing, and diversifying of supply options there will be more timely and equitable 
distribution.  
20.  For instance, Oxford/ AstraZeneca 's vaccine candidate is one of the vaccines included in COVAX 
for supply. Reportedly the company has signed limited, restrictive and selective licenses, and even 
their terms and conditions are not fully available publicly. A few other vaccine de velopers, such as 
Pfizer/BioNtech, have not even indicated any plan for out -licensing their IP -protected technologies 
for production and supply.   
21.  Some Members opposing the waiver proposal argue that the issuance of voluntary licenses is a 
matter of contra ct law and not related to the TRIPS Agreement. However, it is imperative for the 
TRIPS Council to recall the objectives of the TRIPS Agreement under Article 7 on promoting the 
dissemination of technologies and the protection of mutual advantage of producer s and users, as 
well as its principles under Article 8.1 and 8.2 empowering Members to take necessary measures to 
protect public health and to prevent  the abuse of intellectual property. In light of Articles 7 and 8 
of the TRIPS Agreement, the non -interven tion of Members with respect to restrictive voluntary 
licensing practices, and the lack of sharing technology, knowledge and related IP in this pandemic 
is clearly detrimental to public health and is undoubtedly an issue of concern related to the 
TRIPS  Agreement.   
 
1 https://www.bbc.com/news/health -55574662   
2https://www.medspal.org/?product_standardized_name%5B% 5D=Sarilumab+131.6+mg%2Fml&produ
ct_standardized_name%5B%5D=Sarilumab+175+mg%2Fml&disease_areas%5B%5D=COVID -
19+(drug+candidate)&page=5   IP/C/W/673  
 
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  2.2  Question 2: With respect to the local production or manufacture of specific COVID -19 
diagnostics, equipment, therapeutics or vaccines, have Members, or organizations acting 
on their behalf experienced IP challenges that have impeded or prevented local 
production or manufacturing? If so, can Members describe these challenges, including in 
relation to the TRIPS Agreement?  
22.  Document IP/C/W/670 already provides multiple examples concerning IP challenges impeding 
production and supply. Recalling the int erconnection between procurement, production and supply 
as mentioned under question 1, it is important to bear in mind that IP challenges concerning local 
production involve the immediate blocking effects, the restrictive licensing practices of IP holders 
and other anticipated challenges associated with the emerging pipelines.  
23.  During the TRIPS Council meeting on 10 December 2020, Indonesia shared information on 
challenges it faced with respect to local production of Remdesivir, i.e., it failed to convince Gilead to 
expand its production in Indonesia through voluntary licensing to address shortages and affordability 
of the medicine. Indonesia added that importing the medicine was more costly and difficult due to 
limited supply and higher price in th e region.  
24.  In respect to vaccines, past experience has shown that under conventional IP practice, patents 
could be applied for on nearly every single step and aspect of vaccine development, production and 
use,3 ranging from starting materials, composition process and the final products to methods of 
filling and packaging, methods of vaccination and vaccine schedules. In addition to patents, trade 
secrets also are a challenge. Given the conventional trade secret and patenting practice on vaccines, 
the huge l egal uncertainty it brings to leveraging production capacities, and augmenting supply and 
use during this pandemic cannot be overlooked.  
25.  Some Members opposing the waiver proposal mentioned the example of mRNA technology as 
an important innovation. Yet, th e IP situation around mRNA technology raises clear challenges for 
leveraging the full potential of this technology in COVID -19 vaccine development and production 
although this technology is considered by the scientific community as having potential for the  rapid 
development and scale -up of manufacturing at a lower cost.4  
26.  As mentioned in document IP/C/W/670, the literature has identified more than 100 background 
patents on mRNA platform technology used for COVID -19 vaccine development that are owned by 
different entities. Several patent disputes have arisen between different COVID -19 mRNA vaccine 
developers. Thus, even if one patent -holding company has announced its decision to not enforce its 
mRNA patents during the pandemic, such an announcement has no ef fect on other holders of mRNA 
patents and provides no clarity and legal certainty for other vaccine developers using the platform. 
As mentioned above, one patent holder has indicated no plan to license -out their IP on their vaccine 
candidate, and the other  has not shared openly manufacturing know -how after its patent 
non-enforcement announcement. The remaining patent thickets, the insufficient voluntary actions 
also effectively limit the potential of scaling up manufacturing and supply of mRNA vaccines glob ally. 
27.  Some Members opposing the waiver proposal hold the view that the waiver could affect ongoing 
technology transfer under voluntary licenses when it comes to ramping up production. We consider 
this premise as lacking any basis. Do such Members have any evidence to prove this? On the 
contrary, it is evident that limited and restrictive voluntary licenses have resulted in shortage of 
essential COVID supplies. As mentioned, existing voluntary licenses have not been transparent and 
only very limited informat ion is available in the public domain for scrutiny. In any case, the proposed 
waiver does not affect terms and conditions of agreed voluntary licensing agreements; those terms 
and conditions continue to be effective and can be implemented without interrupt ion.  
 
3 https://msfaccess.org/sites/default/files/2018 -
06/VAC_report_A%20Fair%20Shot%20for%20Vaccine%20Affordability_ENG_2017.pdf   
4 https://www.nature.com/articles/nrd.2017.243   IP/C/W/673  
 
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  2.3  Question 3: Have Members formally initiated processes toward the issuance of 
compulsory licenses under Article 31 of the TRIPS Agreement in relation to any COVID -19 
diagnostics, equipment, therapeutics or vaccines, but were unable to complete these 
processes and issue any corresponding compulsory licence due to circumstances other 
than those attributable to domestic legislation, procedures, or litigation? If so, ca n 
Members identify what prevented the issuance of any such compulsory licence?  
28.  It is important to look at the merits and challenges of using compulsory licenses under Article  31 
of the TRIPS Agreement from historical contexts and from the perspective of t he public health needs 
in the present ongoing pandemic.  
Challenge in relying on Article  31 to contain COVID -19 globally  
29.  In the context of COVID -19, we recognize that Israel and the Russia n Federation  have issued 
compulsory licenses for domestic use of cer tain medicines used for treatment of COVID . However, 
Article 31 was never designed to address the global access challenge of a pandemic as its primary 
focus is to empower individual countries to solve domestic problems with production and supply. In 
this p andemic, as we have collectively experienced and witnessed to date, supply of essential 
medicines, vaccines and diagnostics requires actions beyond national borders. Using compulsory 
licensing under Article 31 will not leverage uninterrupted collaboration for countries to share 
production and supply capacity and to walk out of this pandemic together.  
30.  To ensure access, the supply of needed medical products needs to be expanded and diversified 
to the maximum level at the international level. This in turn requ ires countries and manufacturers 
to have full freedom to operate and to not be hindered by intellectual property where such issues 
exist or are emerging. In document  IP/C/W/670, the preliminary patent landscape of several priority 
therapeutic candidates an d vaccine candidates for COVID -19 has been provided.  
31.  In the current situation where every country is suffering and in desperate need of adequate 
supplies, relying mainly on Article 31 to address IP challenges in ensuring global access is seriously 
ill-advised. Article 31 offers a country -by-country, case -by-case and product -by-product solution. 
This means that for every product, wherever there is a patent barrier, each country will need to 
issue compulsory licenses either to manufacture, import or export th e product or its components.  
32.  In addition, the use of Article 31 is also subject to certain conditions, in particular that the use 
is predominantly for the supply of the domestic market of the Member authorizing the use, meaning 
its use is mainly for the p urpose of supplying domestic needs. Hence country by country compulsory 
license remains unsuitable to facilitate regional and global collaboration, and the ability of 
governments and manufacturers to freely manufacture, import and export needed products an d 
their components to curb the spread of COVID -19. Under Article 31, the legal validity of the 
authorized compulsory licence may also be challenged, hindering expeditious supply.  
33.  Further Article 31 only pertains to patents. The proposed waiver will also a ddress other needed 
IP on COVID -19 medical technologies i.e. industrial designs, copyright and trade secrets.   
34.  WTO Members, including countries opposing the waiver proposal, have repeated in various 
forums that "no one is safe until everyone is safe ". In December, we saw this come true, with the 
spread of new variants of the coronavirus that are even more transmissible, resulting in many more 
infections and deaths globally. The sooner all countries around the world receive the needed medical 
products inclu ding diagnostics, vaccines and therapeutics, the better the world, including countries 
that are opposed to the waiver proposal, will be for it.  
35.  In times of a global pandemic, what we need is to maximize sharing of knowledge, technology 
and exploiting avai lable manufacturing capacity. And this aim cannot be met by merely relying on 
Article 31 of the TRIPS Agreement. There should be full freedom to operate by waiving relevant 
TRIPS provisions.   
Pressure tactics from trading partners and patent holding corpo rations  
36.  It is also important to note that the history of use of Article 31 is fraught with pressures from 
developed countr y Members  and patent -holding pharmaceutical corporations. In document  IP/C/W/673  
 
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  IP/C/W/670, some examples of pressure tactics on developing coun tries with respect to use of 
compulsory licensing and other flexibilities have been provided.  
37.  In 2020 in the midst of a raging pandemic, the Office of the United States Trade Representative 
(USTR) issued its Special 301 Report citing "actions by trading p artners to unfairly issue, threaten 
to issue, or encourage others to issue compulsory licenses, " and specifically highlighting Chile, 
Colombia, Egypt, El Salvador, India, Indonesia, Malaysia, the Russia n Federation , Turkey, and 
Ukraine.5 The report "urges  Chile to ensure transparency and due process in any actions related to 
compulsory licenses " although ironically transparency and due process are mostly absent in 
voluntary licensing. It further adds that "Chile should use compulsory licenses only in extre mely 
limited circumstances and after making every effort to obtain authorization from the patent owner 
on reasonable commercial terms and conditions ".   
38.  The European Commission in its 2020 "Report on the protection and enforcement of intellectual 
property rights in third countries " complains that "very broad, vague and arbitrary criteria are 
applied for granting compulsory licenses, which undermine the effective patent protection in 
Ecuador, India, Indonesia and Turkey, notably for pharmaceuticals and chemi cals…. " 6 
39.  These assertions contradict the provisions of Article 31 and the 2001 Doha Declaration on the 
TRIPS Agreement and Public Health, which reaffirms that "Each Member has the right to grant 
compulsory licenses and the freedom to determine the grounds upon whic h such licenses are 
granted ". Further, Article 31 is also clear that the requirement to have first sought prior authorization 
from the right holder is waived in the case of a national emergency or other circumstances of extreme 
urgency or in cases of publi c non -commercial use, and in cases of anticompetitive practices.  
40.  Similarly, patent -holding pharmaceutical industry has consistently undermined the use of 
Article  31 of the TRIPS Agreement. The Pharmaceutical Research and Manufacturers of America 
(PhRMA) i n their Special 301 Submission 2020 states: "In its 2019 Special 301 Report, USTR rightly 
highlighted concerning actions by 'trading partners to unfairly issue, threaten to issue, or encourage 
others to issue, compulsory licenses ' and committed to 'engage,  as appropriate, with trading 
partners '. PhRMA members welcomed these statements and urge USTR and other federal agencies 
to engage to address serious and growing compulsory licensing threats across Latin America, 
Southeast Asia and elsewhere. "7  
41.  These ar e just a few examples of the immense pressure that has been placed on developing 
countries in the last 25 years, deliberately introducing legal uncertainty and limiting the scope of 
available flexibilities and discouraging efforts to improve national legis lation implementing TRIPS 
flexibilities as well as to use compulsory licensing.  
42.  In this context, it is rather surprising to expect all WTO Members to have expedited provisions 
for using compulsory licenses and to be ready and able to use such licenses efficiently. In 2020, 
Australia, Germany, Canada and Hungary amended their national laws to simplify and/or facilitate 
the use of compulsory licensing for public health purposes  (without any specific instance of IP 
barriers necessitating the actua l use of such a measure)  demonstrating that even developed countr y 
Members  found shortcomings in their national legislations to address pandemic -related challenges.  
43.  Generally we recognize the need for all WTO Members to have optimal public -health -sensitiv e 
provisions that maximize the flexibilities provided by Article 31. We condemn efforts to undermine 
and limit the use of Article 31 and support the use of compulsory licenses not as a "last resort " but 
based on national needs including public health needs  as envisaged by Article 7, Article 8 and 
Article  31 of the TRIPS Agreement and the 2001 Doha Declaration on the TRIPS Agreement and 
Public Health. While a number of delegates opposing the waiver proposal have explicitly 
acknowledged the importance of usin g TRIPS flexibilities and compulsory licensing, they however 
have not acknowledged the historical suppression nor committed to ensuring that in future 
developing countries will no longer be put under such pressures.  
 
5 https://ustr.gov/sites/default/files/2020_Special_301_Report.pdf  
6 https://trade.ec.europa.e u/doclib/docs/2020/january/tradoc_158561.pdf  
7 https://phrma.org/ -/media/Project/PhRMA/PhRMA -Org/PhRMA -Org/PDF/0 -9/PhRMA -2020-Special -
301-Submission.pdf ;  IP/C/W/673  
 
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  2.4  Question 4: Have Members formally initi ated processes toward the issuance of 
compulsory licenses under Article 31 bis in relation to COVID -19 pharmaceutical products, 
but were unable to complete these processes and issue any corresponding compulsory 
licence due to circumstances other than those attributable to domestic legislation, 
procedures, or litigation? If so, can Members identify what prevented the issuance of any 
such compulsory licence?  
44.  The question posed sidesteps issues with respect to the complexity of Article 31 bis. For more 
than a de cade, experts, civil society and even generic manufacturers have viewed the mechanism 
as unworkable, as evidenced by the fact it has only ever been used once and even this experience 
is reported to have been difficult.  
45.  Citing its experience, Canada has re peatedly asserted that the Article 31 bis mechanism works. 
However, the generic supplier involved has pointed out that the system is "unnecessarily complex 
and does not adequately represent the interests of those who require treatment ".8   
46.  In addition, Méd ecins Sans Frontières (MSF), which was also involved in Canada 's 
implementation of the 30th August 2003 decision, i.e. in the Jean Chr étien Pledge to Africa (JCPA), 
has noted in a paper on its experience with respect to the Act that it "contains over 19 s ections and 
over 100 clauses and sub -clauses ",9 adding that "[s]imply understanding the legislation requires 
legal training or support. Significant financial and human resources are necessary for a government 
to analyse and use this legislation – resources which are limited in many developing and least  
developed countries ".  
47.  We fail to see how such a mechanism can be a reliable means to deliver access in a pandemic 
of this magnitude. The requirements of Article 31 bis are cumbersome (see table below ). In addition 
to these procedures, the national laws/regulations of the exporting and importing countries may 
have additional extensive requirements, which vary from country to country.  
48.  The need for compulsory licensing in the exporting and importing cou ntries, the requirements 
for specifying quantity in each notification and the requirements of differentiating packaging and 
other characteristics in each supply are simply impractical in a global pandemic, the biggest global 
health crisis facing nearly all  countries. As we have collectively experienced, the transmission and 
spread of the virus have outpaced interventions in many countries. Hence the requirements of 
Article  31bis are not fit for the purpose of dealing with the pandemic challenge facing the 
international community where timely intervention is the essence.   
  
 
8 https://www.biospace.com/article/releases/apotex -inc-life-saving -aids-drug-for-africa -gets-final-
clearance -/ 
9 https://msfaccess.org/neither -expeditious -nor-solution -wto-august -30th-decision -unworkable  IP/C/W/673  
 
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  Table  
The requirements of Article 31 bis include:  
 
(1) notification to Council for TRIPS by eligible importing Member:  
(i) specifies the names and expected quantities of the product(s) n eeded;  
(ii) confirms that the eligible importing Member in question, other than a least developed countr ies, 
has established that it has insufficient or no manufacturing capacities in the pharmaceutical sector 
for the product(s) in question in one of the ways set out in the Appendix to the Annex of Art icle 31bis; 
and  
(iii) confirms that, where a pharmaceutical product is patented in its territory, it has granted or 
intends to grant a compulsory licence in accordance with Articles 31 and 31 bis of the 
TRIPS  Agreement and the provisions of the Annex.  
 
Least developed countr ies are deemed to have insufficient or no manufacturing capacities in the 
pharmaceutical sector. For other eligible importing Members, insufficient or no manufacturing 
capacities for the p roduct(s) in question may be established in either of the following ways: (i) the 
Member in question has established that it has no manufacturing capacity in the pharmaceutical 
sector; or (ii) where the Member has some manufacturing capacity in this sector , it has examined 
this capacity and found that, excluding any capacity owned or controlled by the patent owner, it is 
currently insufficient for the purposes of meeting its needs. When it is established that such capacity 
has become sufficient to meet the Member 's needs, the system shall no longer apply.  
 
In addition, eligible importing Members shall take reasonable measures within their means, 
proportionate to their administrative capacities and to the risk of trade diversion, to prevent 
re-exportation of the products that have actually been imported into their territories under the 
system.   
 
(2) compulsory licence by importing Member (if patent exists)  
 
(3) compulsory license by exporting country with the following conditions:  
(i) only the amount necessary to meet the needs of the eligible importing Member(s) may be 
manufactured under the licence and the entirety of this production shall be exported to t he 
Member(s) which has notified its needs to the Council for TRIPS;  
(ii) products produced under the licence shall be clearly identified as being produced under the 
system through specific labelling or marking. Suppliers should distinguish such products t hrough 
special packaging and/or special colouring/shaping of the products themselves, provided that such 
distinction is feasible and does not have a significant impact on price; and  
(iii) before shipment begins, the licensee shall post on a website the fo llowing information:  
- the quantities being supplied to each destination as referred to in indent (i) above; and  
- the distinguishing features of the product(s) referred to in indent (ii) above.  
 
(4) notification to Council for TRIPS by exporting Member: T he exporting Member shall notify the 
Council for TRIPS of the grant of the licence, including the conditions attached to it. The information 
provided shall include the name and address of the licensee, the product(s) for which the licence 
has been granted,  the quantity(ies) for which it has been granted, the country(ies) to which the 
product(s) is (are) to be supplied and the duration of the licence. The notification shall also indicate 
the address of the website referred to above.  
Scenario analysis with re spect to Article 31 and 31 bis of the TRIPS Agreement  
49.  Assume country X with manufacturing capacity decides to override the patent barriers to expand 
supply. It will have to issue a compulsory licence based on national procedures on a 
product -by-product basi s, a process that can take weeks at best, but perhaps even months or years, 
especially if national laws have additional requirements or if trading partners and/or the 
pharmaceutical industry interferes to dissuade its use. Some countries have compulsory li censing 
procedure for government use, which can help to accelerate the process, but not all countries have 
such a fast -track procedure. If this country X is required to source patented ingredients from multiple 
jurisdictions, each of these jurisdictions wi ll also need to issue a compulsory licence.  
50.  Each of these compulsory licenses will be limited by the condition of Article 31(f) that it has to 
be predominantly for the supply of the domestic market. At this juncture, country X with 
manufacturing capacity,  although able to supply, is likely to be hindered due to the number of IP/C/W/673  
 
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  compulsory licenses required, and the conditions imposed. Even if country X overcomes this 
challenge and manufactures the product under a compulsory licence, it will not be able to exp ort 
widely to supply even neighbouring countries due to the limitation in Article 31(f) that a compulsory 
licence has to be predominantly for the supply of the domestic market. Instead, the manufacturing 
country X and each and every importing country will have to issue a CL if there is a patent and utilize 
the procedures of Article 31 bis outlined in the table above. As more quantities are imported and 
exported, more notifications may be needed, in addition to other requirements such as specific 
labelling or  marking of products, special packaging and/or special colouring/shaping of products.  
51.  It is also worth noting that whether or not manufacturing takes place is very much dependent 
on whether economies of scale exist. Countries may have capacity to manufact ure but lack 
economies of scale, hence making manufacturing an unattractive option.  
52.  The country -by-country, case -by-case approach offered by compulsory licenses hinders 
North -South, South -South, regional and international collaboration to achieve economie s of scale 
and ramp up global manufacturing and supply.  
53.  On the other hand, the proposed waiver requires only a one -time implementation and, for the 
duration of the waiver, will remove legal barriers and facilitate collaboration at the regional and 
global levels, allow the inclusion of multiple technologies in its scope, allow economies of scale to be 
achieved, motivating further manufacturing, and consequently lower prices. With a waiver, the 
administrative and procedural delays and conditions linked to Ar ticle 31 and 31 bis will be avoided, 
meaning that countries will have full freedom to collaborate, manufacture and supply the required 
products.  
2.5  Question 5: Have Members experienced copyright -related challenges in specific 
instances of procurement or of se eking local manufacture or production of COVID -19 
diagnostics, equipment, therapeutics or vaccines? Specifically, have Members 
experienced any such challenges that could not be addressed through the implementation 
of the flexibilities contemplated in the T RIPS Agreement? If so, can Members describe 
these challenges, including in relation to the TRIPS Agreement?  
2.6  Question 6: Have Members experienced industrial -designs -related challenges in 
specific instances of procurement or of seeking local manufacture or p roduction of 
COVID -19 diagnostics, equipment, therapeutics or vaccines protected by industrial -design 
rights? Specifically, have Members experienced any such challenges that could not be 
addressed through the implementation of the flexibilities contemplate d in the 
TRIPS  Agreement? If so, can Members describe these challenges, including in relation to 
the TRIPS Agreement?  
54.  The responses to question 5 and 6 have been combined as they cover overlapping issues and 
designs may also be protected under copyright la w.  
55.  It is surprising that the questions seek information about specific instances wherein 
copyright -related and industrial designs -related challenges have been faced, which could not be 
addressed through the implementation of the flexibilities contemplated  in the TRIPS Agreement. For 
instance, there has been no denial regarding the instance given below, which has been widely 
reported in the media. We would be happy to receive any information from Members if such 
incidences did not handicap the global COVID response.  
56.  In March 2020 in the Lombardy region in Northern Italy, one of the areas which was hit hardest 
by the pandemic, a hospital ran out of ventilator valves (which cost USD 11,000 each), and their 
regular supplier could not produce them on time.10 Two local engineers reverse -engineered and 
3D-printed replacement valves at a cost of about USD 1.11 It is reported that the original 
 
10 https://metro.co.uk/2020/03/16/firm -refuses -give-blueprint -coronavirus -equipment -save-lives-
12403815/  and https://www.techtimes.com/articles/248121/20200317/maker -ventilator -valves -threatens -
sue-volunteers -using -3d-printed -coronavirus.htm   
11 https://www.techtimes.com/articles/248121/20200317/maker -ventilator -valves -threatens -sue-
volunteers -using -3d-printed -coronavirus.htm   IP/C/W/673  
 
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  manufacturer declined to share the blueprints and even threatened patent infringement12 and that 
potential legal implicat ions stopped the engineers from distributing the digital design file more 
widely, despite receiving hundreds of requests for the 3D -printed valves.13  
57.  Following this case, a law firm warned that "[m]anufacturers should be aware of the complex 
intellectual property issues concerned with this 3D printing technology. Parts such as valves or other 
medical devices and equipment are capable of protection by patent and/or registered design. 
Unregistered design rights and copyright will also apply to the part itsel f and/or the digital model or 
CAD file. Some or all of these rights might apply in respect of a single component ".14 The firm 
cautioned: "In scanning a component such as a valve, and manufacturing a part using 3D printing 
equipment, there is a risk that this action will infringe an existing patent, design or copyright which 
protects the component, leading to an injunction or claim from the rights holder for damages or 
other remedies (such as delivery up of infringing parts). "15   
58.  This case reveals co mplex intellectual property issues involved in the manufacture and 
procurement of needed medical technologies and their parts. Industrial design and/or copyright 
issues arise not only in the context of 3D printing (which has played a crucial role globally in 
addressing scarcity of supplies) but also with respect to other health technologies such as product 
information documents or product labelling, diagnostic kits, software for medical devices and digital 
technologies.  
59.  With regard to industrial designs, A rticle 26.2 of the TRIPS Agreement allows exceptions to the 
rights conferred on the owner of industrial designs if these are limited, do not unreasonably conflict 
with the normal exploitation of protected industrial designs, and do not unreasonably prejudi ce the 
legitimate interests of the owner of the protected design, taking account of the legitimate interests 
of third parties. According to an information note by the WTO Secretariat, some Members ' laws 
provide for exceptions such as private use, use for e xperimental or teaching purposes or prior use 
of a protected design. These exceptions are inadequate, and they also provide less clarity on the 
use for public interests, hence additional legal measures are needed to protect the use for public 
interests.  
60.  Copyright limitations and exceptions involve a three -step test under Article 13 of the 
TRIPS  Agreement: limitations or exceptions be confined to (i) special cases; (ii) which do not conflict 
with a normal exploitation of the work, and (iii) do not unreasona bly prejudice the legitimate 
interests of the right holder. The scope of these limitations and exceptions is vague and there is 
uncertainty with regard to their application for public health purposes and in situations of emergency.  
61.  In January 2020, South Africa submitted a communication ( document IP/C/W/663) highlighting 
that there is disagreement over the interpretation of the three -step test among academic scholars 
and as is reflected in state practice, adding that it would be useful to address the relat ionship 
between the TRIPS Agreement and the three -step test for limitations and exceptions to copyright in 
order to further clarify the flexibilities afforded to Members to fulfil their obligations in implementing 
the objectives and principles of the TRIPS  Agreement. The lack of clarity poses a risk for 
WTO Members.   
62.  In addition, identifying the various IP claims involved with respect to a particular product or 
technology, the IP holders, and negotiating the terms of use involve a costly, time -consuming, a nd 
complex process as products and technologies involve multiple IP holders. IP holders may also simply 
refuse to license their IP. In times of an emergency, such legal issues should not hinder an urgent 
public health response.  
63.  Hence the call for a waiver  from relevant provisions of the TRIPS Agreement for the prevention, 
treatment and containment of COVID -19. In any case, waiver is only an enabling provision that the 
Members can choose whether to implement.  
 
12 https://www.techtimes.com/articles/248121/20200317/maker -ventilator -valves -threatens -sue-
volunteers -using -3d-printed -coronavirus.htm  
13 https://www.forbes.com/sites /amyfeldman/2020/03/19/talking -with-the-italian -engineers -who-3d-
printed -respirator -parts-for-hospitals -with-coronavirus -patients -for-free/#1529841378f1  
14 https://www.shoosmiths.co.uk/insights/articles/3d -printing -social -responsibility -vs-legal-risks  
15 https://www.shoosmiths.co.uk/insig hts/articles/3d -printing -social -responsibility -vs-legal-risks  IP/C/W/673  
 
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  2.7  Question 7: Have Members experienced challenges in specific instances of 
procurement or of seeking local manufacture or production of COVID -19 diagnostics, 
equipment, therapeutics or vaccines with underlying undisclosed information? In any 
such instances, have Members experienced challenges with the app lication of the 
flexibilities outlined the TRIPS Agreement, due to circumstances other than those 
attributable to domestic legislation, procedures, or litigation? If so, can Members describe 
these challenges, including in relation to the TRIPS Agreement?  
64.  A widely publicized instance16 is the case where a pharmaceutical company initially refused to 
release the recipe for a solution, a lysis buffer, needed for the COVID -19 diagnosis tests that would 
have helped laboratories to quickly produce their own soluti on and to increase their testing 
capabilities. However, following public pressure and threat of investigation for possible abuse of 
market position, the company agreed to release the recipe for others.  
65.  As in the above case, access to proprietary test mate rials has been a challenge in other countries 
as manufacturers could not meet global demand. In April 2020, The New York Times  reported that 
"Scientists in Africa and Latin America have been told by manufacturers that orders for vital testing 
kits cannot b e filled for months, because the supply chain is in upheaval and almost everything they 
produce is going to America or Europe ".17 In South Africa as well, similar challenges have been 
reported as testing materials are protected as trade secrets.18 Most of South Africa 's diagnostic 
infrastructure requires the use of proprietary test materials, including reagents, consumables and 
cartridges, hence preventing laboratories from making their own test materials or procuring test 
materials from sources other than the diagnostic machine 's manufacturer.  
66.  Article 39 of the TRIPS Agreement deals with the protection of undisclosed information. 
Article  39.2 sets out the criteria for information that qualifies for protection. Article 39.3 outlines 
obligations to protect a gainst unfair commercial use of undisclosed test or other data the origination 
of which involves considerable effort submitted to the regulatory authorities as a condition of 
approving the marketing of pharmaceutical products which utilize new chemical ent ities. In addition, 
under Article 39.3, Members shall protect such data against disclosure, except where necessary to 
protect the public; or unless steps are taken to ensure that the data are protected against unfair 
commercial use.  
67.  There is significant c ontroversy around the interpretation of protection against "unfair 
commercial use ". Generally some developed countr y Members  have argued that this involves 
granting the originator of data exclusive rights with the effect that national authorities would not  be 
permitted during the exclusivity period to rely on data they have received in order to assess 
subsequent applications for the registration of similar products. On the other hand, developing 
countries have generally been against this position. It is aga inst this background that developing 
countries have faced constant pressure, from developed countr y Members , advocating restrictive 
interpretations of Article  39 and hampering use of flexibilities.  
68.  For instance, the 2020 EU "Report on the protection and e nforcement of intellectual property 
rights in third countries " finds that "[a]nother area of continued concern reported by right holders is 
the absence of an effective system for protecting undisclosed test and other data generated to obtain 
a marketing ap proval for pharmaceuticals […] This problem affects the European industry mainly in 
Argentina, Brazil, China, India, Indonesia, Malaysia, the Russia n Federation , the 
Kingdom  of Saudi  Arabia, Ukraine and the United Arab Emirates. "19 
69.  In addition, except in the case of data submitted to regulatory authorities, Article 39 is generally 
silent about flexibilities available in other circumstances. The lack of clarity with regard to available 
flexibility creates a chilling effect on its use.  As such, a waiver will support countries to take 
appropriate actions with respect to COVID -19.  
 
16 https://www.statnews.com/pharmalot/2020/03/27/roche -covid19 -coronavirus -netherlands/  ; 
https://www.ftm.nl/artikelen/roche -releases -recipe -after-public -pressure -while-european -commissio n-
considers -intervention -due-to-coronavirus -test 
17 https://www.nytimes.com/2020/04/09/world/coronavirus -equipment -rich-poor.html  
18 https://www.spotlightnsp.co.za/2020/05/05/covid -19-behind -sas-shortages -of-test-materials/  
19 https://trade.ec.europa.eu/doclib/docs/2020/january/tradoc_158561.pdf  IP/C/W/673  
 
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  70.  It will also support disclosure of all data and documents submitted to regulatory agencies, and 
strengthen public trust in therapeutics and vaccines developed for COVID -19.  
2.8  Question 8: In relation to the above questions, as the TRIPS Agreement is a minimum -
standards agreement that is given effect via the applicable domestic laws of its Members 
(per Article 1.1), how would the proponents envisage giving effect t o such a waiver under 
Members ' domestic IP legal regimes? Put another way, what specific legal amendments 
or actions would the proponents seek to enact for the prevention, containment, and 
treatment of COVID -19 that are not – or may not be – consistent wit h the 
TRIPS  Agreement and its flexibilities?  
71.  National implementation of the waiver depends on a country 's political and/or constitutional 
arrangement. There is no one -size-fits-all approach to national implementation. However, once the 
waiver proposal is a pproved, emergency and disaster management legislations or any other relevant 
legislative methodology may be relied upon to provide for executive action to operationalize the 
waiver at the national level. Implementation of the waiver at the national level can also be done in 
the same way as for the unprecedented steps, like lockdowns, quarantine and other measures, put 
in place to curb the COVID spread.  
72.  Each WTO Member  can decide on the modality of implementing the waiver in a speedy and 
appropriate manner.  It could be implemented through the enactment of statutory laws, amendments 
to existing laws, or administrative measures, as suitable to a country in the context of its particular 
circumstances.   
 
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