Blended LL.

M in Intellectual Property and Technology Law

Course 8 - TRIPS and Public Health

Module 4 - Summary

Global efforts for access and distribution

GISAID

● The first global institutional mechanism that we would be discussing is that of Global
Initiative on Sharing All Influenza Data, known as GISAID. GISAID is a
collaborative initiative that has enabled the timely sharing of genetic sequencing data
related to COVID-19 in a freely accessible database. The fast and open sharing of
genetic sequences of the covid-19 virus has allowed researchers to continuously track
the spread of the virus, which is extremely important and useful when such a virus has
reached the pandemic level of global proportions. In addition to this, GISAID had
also catalysed the development of diagnostic kits, prototype viruses for research, and
medical countermeasures like vaccines and antibodies. The real-time sharing of the
genetic sequencing data was very crucial, especially during the initial months of the
Covid-19 pandemic when there was quite a lack of clarity about its various specifics.
● GISAID has a Database Access Agreement. As the centerpiece of GISAID’s open
science mechanism, the DAA provides a set of rules to providers and users to share,
access, and use the data. According to these rules, GISAID’s data is open to access
and fully accessible by anyone, thus fulfilling a longstanding demand of scientists and
researchers, subject to a number of conditions. First, users and recipients are required
to credit the originating (and submitting) labs in any research output. Second, the
DAA encourages users to collaborate with the originating laboratory and involve
them in analyses and further research involving the data. Some other provisions even
provide recourse to arbitration in case a user fails to abide by these rules. In addition
to this, to ensure transparency, GISAID also offers an electronic tracking system that
allows anyone to see who has sent and/or received virus samples. So, for example,
technologically superior countries like the US that obtain sequences from other
countries can’t apply for patents without the permission of the country that provided
the data. This way, GISAID also, at least formally, tries to make sure that resources
developed using open science methods and philosophy are not appropriated and
monopolised.

C-TAP
 Blended LL.M in Intellectual Property and Technology Law
Course 8 - TRIPS and Public Health

● The basic idea for C-TAP, as is evident, is based on the concept of patent pooling.
Patent pooling allows several patent holders to voluntarily share their patented
inventions, which are then made available for others to use and produce. At least in
the global context, usually there is coordinating agency or institution that manages the
pooled patents and takes care of the various issues like licensing terms, royalty
determination, etc. The main, aim, in theory, is to facilitate efficient sharing of
technological innovation by reducing transaction costs and facilitating mediated
sharing as well as avoiding the problems of patent thickets, where multiple patent
holders have various overlapping and related patents which could hinder the further
development of a particular technology.

COVAX

● COVAX is co-led by the Global Alliance for Vaccines and Immunization (GAVI), the
World Health Organization, and the Coalition for Epidemic Preparedness Innovations
(CEPI) and is one of the three pillars of the Access to COVID-19 Tools Accelerator,
(known as ACT Accelerator) which was launched in April 2020 by the World Health
Organization, France and the European Commission.
● The ACT Accelerator promotes global collaboration with the objective of, inter alia,
facilitating equitable distribution of tests, treatments and vaccines. COVAX, within
this framework, is dedicated entirely to accelerating the development and manufacture
of COVID-19 vaccines and ensuring said vaccines reach poor countries.
● Let us now look at how COVAX tried to do so and what has been the overall working
of the mechanism. As just mentioned, COVAX in simple terms, acts as a pooling
mechanism, combining the resources of all participating countries, which will share
the risks and benefits associated with an investment in vaccines for COVID-19. For
this, COVAX tried to intervene and support the various stages of vaccines. First,
COVAX aims to offer funding and financial resources for vaccine development. This
includes grants for research and development of vaccines as well as for clinical trials
and regulatory approvals. All of this is done via another international public-private
initiative known as Coalition for Epidemic Preparedness Innovations.
 Blended LL.M in Intellectual Property and Technology Law
Course 8 - TRIPS and Public Health

● Launched in 2017 at the World Economic Forum in Davos, CEPI’s primary aim is to
offer an innovative model for financing vaccine development for epidemics. This
innovation is to be achieved, “through pooling resources from several investors”. It
cuts across the spectrum and includes, public, private, philanthropic, and
non-governmental organisations and actors.
● CEPI aims to step in to remedy the market failures by “bringing together sustained
long-term funding from governments and philanthropies to encourage collaboration”
between relevant actors. As a collaborative global partnership, CEPI has taken lead in
ensuring that research and development for Covid 19 vaccine can be facilitated. In
pursuance of this, CEPI has disbursed substantive grants to many of the leading
vaccine developers like AstraZeneca, Novavax, CureVac, and Moderna.
● with this comes the question that if such a global fund which has funding from public
as well as private sources, and provides very crucial grants for vaccine development,
what kind of consideration for equitable access must govern such grants and the
overall mechanism itself.
● On the specific issue of intellectual property rights, CEPI generally maintains that it
does not seek to own any intellectual property rights that are developed by the funded
partnerships. According to CEPI’s Equitable Access Policy, CEPI’s approach is to
require awardees to manage their IP in such a way that equitable access can be
realized, i.e, in case of the Covid-19 vaccines, doses are made available to the
COVAX Facility for fair allocation and procurement. This, according to CEPI’s
policy, is the most effective way of delivering accessible vaccines as quickly as
possible, without stifling innovation or delaying the urgent vaccine development
process”.
● Many commentators and public health groups have shown concern with relatively lax
obligations on vaccine developers and manufacturers in return for important and
considerable funding received by them. In fact, despite contractual provisions that
have public health safeguards aspects in many of the funding agreements, (like an
assured supply of a certain percentage of vaccines to COVAX and even step-in rights
to share technology with other manufacturers), by and large, CEPI has been
ineffective in ensuring utilising these provisions to promote equitable access to
COVID-19 vaccines.
 Blended LL.M in Intellectual Property and Technology Law
Course 8 - TRIPS and Public Health

● So, this was about the first stage of vaccine development. Apart from this, the
COVAX mechanism also provides for the later stages in vaccine production process,
like assistance with expansion and scaling of manufacturing capacity and providing
at-risk investment (meaning enabling manufacturers to prepare for production even
before the vaccines are developed and approved).
● The overarching aim for COVAX was to ensure that 20% of the population in all the
countries must have been vaccinated by end of 2021. This 20% mark was said to
cover the most vulnerable sections of the population including frontline workers and
other at-risk individuals. For this, COVAX estimated that it would deliver around 2
billion doses of vaccines. The way in which countries participate in the COVAX
Facility depends on which group they fall into, based on their financial resources.
Higher Income Countries and upper-middle-income countries (UMICs) are classed by
COVAX as “self-funded,” whereas low-income countries and Lower Middle-Income
Countries are designated as “funded”. Self-funded countries finance their vaccine
supply using their own public finance budgets (as upfront payments) and are
guaranteed a sufficient number of doses to vaccinate 20% (in later rounds to be
increased to 50%) of their populations. On the other hand, the funded countries were
to be offered vaccines at no or low cost to be financed through aid funding received
through donor organisations of various kinds as well as different countries.
Low-income and lower-middle-income countries had to make formal applications and
based on certain criteria were to be designated as eligible countries. As of now, 92
countries have been declared as eligible countries for COVAX. As per the COVAX
allocation framework, vaccine distribution would occur in rounds and subsequent
allocations would only happen once 20% population in all countries had been
vaccinated.

TRIPS Waiver

Claims and Arguments

● One of the main claims made about intellectual property and its relation to Covid-19
access issues is that there is no relevance of intellectual property rules. To elaborate,
the argument here is that the main issue with lack of equitable vaccine access has to
do with other issues like supply chain constraints, significant amount of nationalistic
 Blended LL.M in Intellectual Property and Technology Law
Course 8 - TRIPS and Public Health

hoarding of vaccines in the initial days, and demand-side issues like improper vaccine
administration.
● In addition to this, it is also generally argued, which seems to be setting the
contemporary context of advanced TRIPS waiver negotiations, that the global
intellectual property regime already had requisite solutions and policy options that are
enough for balancing public health concerns
● Lastly, it is also argued that relaxations and affordances via global intellectual
property rules would not be relevant and won’t lead to a solution because it is just not
feasible, on many grounds, to boost the production of vaccine in the global south
countries.
● The proponents of the TRIPS Waiver, on the other hand, highlight the centrality of
intellectual property rules and the overall legal regulatory framework they set up in
the context of access to Covid-19 health products and technologies.
● On the issue of intellectual property waivers negatively harming the incentives for
medical and pharmaceutical research and development and consequently reducing
innovation in these sectors, the proponents of the waiver point out that the linkage
between patents and incentives is not as straightforward as it is generally considered.
● Moreover, specifically on the question of TRIPS waiver and vaccines, intellectual
property regime being insufficient, something that we discussed while talking about
CEPI, is also raised. For instance, as Siva Thamibsetty and others note in their recent
work. “Notably, in the past, the market has not been very good at responding to calls
for pandemic preparedness, in part because of the way Intellectual Property incentives
operate. There have been prominent examples of market failures with respect to
producing vaccines for Lower Middle-Income Countries. Failures also occurred in the
responses to Zika and Ebola. Precisely because the conventional incentives provided
by IP tend to fail to meet the needs of the poor, we must resist calls to defend
uncritically such incentives now, amid a global pandemic”
● Lastly, the proponent of the TRIPS waiver also questions the arguments that raise a
concern about the ability of global south countries in producing vaccines. As
Thambisetty and others note “The claim that there is no spare HIC/LMIC production
capacity has largely been debunked. Companies in both HICs and LMICs – Canada
(Biolyse), Israel (Teva), Denmark (Bavarian Nordic), and Bangladesh (Incepta) –
 Blended LL.M in Intellectual Property and Technology Law
Course 8 - TRIPS and Public Health

offered manufacturing capacity and were rebuffed and/or were unable to obtain a
licence.

Compromise Draft Text

● In paragraph 1, the compromise draft text provides that “Notwithstanding the

provision of patent rights under its domestic legislation, an eligible Member may limit
the rights provided for under Article 28.1 of the TRIPS Agreement by authorizing the
use of patented subject matter required for the production and supply of COVID-19
vaccines without the consent of the right holder to the extent necessary to address the
COVID-19 pandemic, in accordance with the provisions of Article 31 of the
Agreement, as clarified and waived in paragraphs 2 to 6 below”.
● In paragraph 2, the draft text provides “For greater clarity, an eligible Member may
authorize the use of patented subject matter under Article 31 without the right holder's
consent through any instrument available in the law of the Member such as executive
orders, emergency decrees, government use authorizations, and judicial or
administrative orders, whether or not a Member has a compulsory license regime in
place. For the purpose of this Decision, the " law of a Member" referred to in Article
31 is not limited to legislative acts such as those laying down rules on compulsory
licensing, but it also includes other acts, such as executive orders, emergency decrees,
and judicial or administrative orders”. This provision seems straightforward and
basically offers a clarification that any legal or administrative instrument or means
might be used by a particular country to issue and authorise compulsory license.
● Paragraph 3 of the Draft text provides a number of specific clarifications with respect
to different procedural aspects of the compulsory licensing framework. In
sub-paragraph a, it provides “With respect to Article 31(a), an eligible Member may
issue a single authorization to use the subject matter of multiple patents necessary for
the production or supply of a COVID-19 vaccine. The authorization shall list all
patents covered. In the determination of the relevant patents, an eligible Member may
be assisted by WIPO's patent landscaping work, including on underlying technologies
on COVID-19 vaccines, and by other relevant sources. An eligible Member may
update the authorization to include other patents”. This provision allows the issuance
of a single authorization applicable to multiple patents necessary for the production or
supply of a COVID-19 vaccine. In addition to this, it imposes an obligation on the
 Blended LL.M in Intellectual Property and Technology Law
Course 8 - TRIPS and Public Health

members utilising the waiver, to list out all the patents that have been covered in such
authorization.
● Subparagraph b states that “An eligible Member need not require the proposed use of
the patented subject matter to make efforts to obtain an authorization from the right
holder for the purposes of Article 31(b)”. As it is evident, this provision clarifies that
prior efforts to get a voluntary authorization from the patent holder by a potential
applicant for compulsory licensing, which is one of the standard requirements in the
compulsory licensing provision, could be dispensed with. It must be noted, however,
this seems more like a restatement of the TRIPS flexibility already present in the
current framework as it is explicitly stated in Article 31 that the prior negotiation
requirement can be waived by a member in view of a national emergency or other
circumstances of extreme urgency, which Covid-19 pandemic clearly qualifies for.
● Subparagraph c states that “An eligible Member may waive the requirement of Article
31(f) that authorized use under Article 31 be predominantly to supply its domestic
market and may allow any proportion of the authorized user to be exported to eligible
Members and to supply international or regional joint initiatives that aim to ensure the
equitable access of eligible Members to the COVID-19 vaccine covered by the
authorization.”
● In subparagraph d, the draft text states that “Eligible Members shall undertake all
reasonable efforts to prevent the re-exportation of the COVID-19 vaccine that has
been imported into their territories under this Decision. All Members shall ensure the
availability of effective legal remedies to prevent the importation into their territories
of COVID-19 vaccines produced under, and diverted to their markets inconsistently
with, this Decision”. This provision introduces an obligation on eligible importing
countries to make sure that the vaccines, produced under the specific compulsory
licensing framework, that they receive are not exported and diverted to other countries
and regions. In addition to this, all WTO members are also obligated to provide
effective legal remedies so that the importation of vaccines, that is inconsistent with
the conditions of the waiver, in their territories could be avoided.
● And lastly, sub-paragraph e, provides that “Determination of adequate remuneration
under Article 31(h) may take account of the humanitarian and not-for-profit purpose
of specific vaccine distribution programs aimed at providing equitable access to
COVID-19 vaccines in order to support manufacturers in eligible Members to
 Blended LL.M in Intellectual Property and Technology Law
Course 8 - TRIPS and Public Health

produce and supply these vaccines at affordable prices for eligible Members. In
setting the adequate remuneration in these cases, eligible Members may take into
consideration existing good practices in instances of national emergencies,
pandemics, or similar circumstances”.
● paragraph 4 of the Draft text, provides that obligations of Article 39.3 with respect to
test data may not be adhered to by a country so as to enable utilisation of a
compulsory license granted under the waiver.
● According to Para 5, this provision obligates countries to notify the TRIPS Council
about any measure they have introduced or adopted in pursuance of the waiver.
Footnote to paragraph 5 specifies what kind of details are to be included in the
notification. It says that “The information provided shall include the name and
address of the authorized entity, the product(s) for which the authorization has been
granted, and the duration of the authorization. The quantity for which the
authorization has been granted and the country to which the product is to be supplied
shall be notified as soon as possible after the information is available”. These
requirements are on similar lines to what we came across in our discussions on Article
31bis.
● Paragraph 6, is about the duration for which such a waiver would be effective and
states that “An eligible Member may apply the provisions of this Decision until 3 or 5
years from the date of this Decision. The General Council may extend such a period
by taking into consideration the exceptional circumstances of the COVID-19
pandemic. The General Counsel will review annually the operation of this Decision”.
● Paragraph 7 states that “Members shall not challenge any measures taken in
conformity with this Decision under subparagraphs 1(b) and 1(c) of Article XXIII of
the GATT 1994. And lastly, paragraph 8 states that “No later than six months from the
date of this Decision, Members will decide on its extension to cover the production
and distribution of COVID-19 diagnostics and therapeutics”.

TRIPS Plus FTAs

● The recourse to bilateralism, especially by countries like the United States and the
European Union, in form of free trade agreements, bilateral investment agreements,
etc has raised significant concerns.
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Course 8 - TRIPS and Public Health

● As Ellen t’oen notes in this context. “Countries expected that by agreeing to the
TRIPS standards they had struck a bargain protecting them from pressures to further
ratchet up national levels of IP protection. The same expectation was reinforced when
World Trade Organization (WTO) members agreed to the Doha Declaration on TRIPS
and Public Health, which affirmed the importance of countries' right to use the
flexibilities written into TRIPS. That bargain has been broken by the plethora of trade
agreements containing TRIPS-plus provisions that have been concluded in the last
decade, including after the adoption of the Doha Declaration on TRIPS and Public
Health. The US and the EU are systematically seeking higher levels of IP protection
in agreements with developing countries that affect access to medicines and seriously
hamper the full implementation of the Doha Declaration.

Patent term linkage

● One of the most discussed TRIPS-plus standards which is definitely problematic with
respect to the issue of access to medicine is what is known as patent term linkage. As
German Velasquez, a well-known IP scholar notes in his recent book. “Several
bilateral trade agreements have included provisions that prevent national drug
regulatory authorities from granting marketing approval for generic pharmaceutical
products without ‘consent or acquiescence’ of the patent holder when there is a
relevant patent in force.
● This ‘linkage’ between patent protection and marketing approval may prevent
approvals for generic products during the lifetime of a patent. This clearly goes
beyond the basic minimum obligations imposed by the TRIPS Agreement as the
TRIPS Agreement permits generic producers to seek regulatory approval during the
life of a patent without conditions. Moreover, we discussed a similar issue in the
WTO dispute, Canada – Pharmaceutical where the regulatory review exemption of
Canadian Patent law was found to be TRIPS consistent.

Data exclusivity

● Data exclusivity refers to the market exclusivity that a pharmaceutical manufacturer

who is an originator drug company, is granted, by prohibiting the medicine and drug
regulatory authority to refer to the originator’s clinical trial data when reviewing an
application for a generic product.
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Course 8 - TRIPS and Public Health

● So what are the implications of these additional rights in form of data exclusivity that
pharmaceutical companies have, on the issue of access to medicines? In effect, data
exclusivity standards add an additional layer of protection over the exclusive rights
granted by patents. Data exclusivity makes the development of generic medicines
onerous, expensive and time consuming.
● Even within industrialised nations, especially the European Union, which has
well-developed, centralised, and extensive data exclusivity standards, recently there
have been serious discussions about the impact of these on the pricing of medicines
and drugs.
● In addition to this, in many cases, data exclusivity standards could also pose problems
for the public health safeguards in patent law such as compulsory licensing. This is
because, even if a compulsory license is granted on a pharmaceutical drug, data
exclusivity can render such a compulsory license practically ineffective or at the very
least delay its execution of it.

ISDS Mechanism

● Investor-State Dispute Settlement mechanism basically refers to the system of

international arbitration where foreign investors could institute legal proceedings
against a particular country that is party to the investment agreement. ISDS
mechanism is generally provided as an explicit provision in FTAs and Bilateral
investment agreements that sets out the various details and specifics of the dispute
settlement mechanisms.
● many commentators consider this a significant limitation on the sovereign rights of
countries as the ISDS mechanism allows private legal persons to bypass the national
judicial systems as well as multilateral legal frameworks. ISDS mechanism, in effect,
creates a lopsided system that favors the legal interests of foreign investors at the
expense of sovereign states.
● The second concern, which is somewhat related to the first one is that the ISDS
mechanism definitely limits the domestic regulatory space for many countries and
constraints their ability to introduce measures for a number of social-economic
concerns that may have an effect on the rights of the foreign investors. The threat to
recourse to the ISDS mechanism by foreign investors has a constraining effect where
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Course 8 - TRIPS and Public Health

it is more reasonable for a country to refrain from changing its legal policies ( or, in
certain cases, when it has introduced a legal policy to reverse it). This is generally
known as regulatory chill.
● Lastly, it has also been pointed out ISDS proceedings could directly limit TRIPS
flexibilities. The dispute known as Eli Lily v Canada is a prime example of this. Eli
Lilly was the proprietor of two pharmaceutical patents for commercially successful
drugs called Strattera and Zyprexa. Both of the patents were revoked in court
proceedings after being challenged by competing generic producers. Having lost both
cases in the final court instance Eli Lilly started the investment arbitration
proceedings under NAFTA Investment Chapter in 2012. Both of Eli Lily’s patents,
which were essentially claiming patent protection for new use of already known
substances, had been revoked on the ground of lack of utility. More specifically, the
applicable legal rule here was that of the promise utility doctrine. According to this
doctrine, in essence this doctrine posits that when it is not possible for the utility of
the patent to be demonstrated at the moment of the filing, the patent applicant can
“promise” such utility. However, he or she must provide ample evidence that indicate
the possibility that the utility will be proved in the future.
● For instance, in the case of the Straterra Patent “The trial judge found that, at the time
of the filing of the patent, the evidence provided by Eli Lilly did not suffice to show
that atomoxetine would fulfill the promise disclosed in the patent. The judge
determined that the clinical study used as evidence of the utility of the patent was not
enough to establish a promise of utility at the time of the filing”. Similar judicial
decision was made for Zyprexa. Once the Supreme Court of Canada dismissed Eli
Lily’s appeal, started the arbitration proceedings and claimed that the reliance on
“promise utility doctrine”, based on which the Canadian courts had invalidated its
patents, had resulted in improper expropriation of its patent rights and denied fair and
equitable treatment. In 2017, the Investment Tribunal issued its award and dismissed
Eli Lilly’s claims, and confirmed that Canada was in compliance with NAFTA
Obligations. More specifically, the Tribunal ruled that the law as applied to the
promise utility doctrine did not constitute a violation of either Articles 1105 or 1110
of the NAFTA.
● Despite this success, many commentators and scholars have shown concerns about
how investment tribunals has assumed authority over intellectual property rules and
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Course 8 - TRIPS and Public Health

standards that are generally consistent with the TRIPS Obligations. Prof James Gathii
and Prof Cynthia Ho, note in this regard “Canada's promise doctrine is a type of
TRIPS flexibility. TRIPS flexibilities give WTO members discretion to define key
patentability requirements which in turn allows them to limit patents to truly
deserving inventions and promote access to lower-cost drugs. Although proponents
of these flexibilities typically suggest interpreting the terms "invention" or "new," any
core patentability requirement such as Canada's unique promise doctrine can provide
flexibility. Accordingly, Eli Lilly's case seeking $500 million in damages against
Canada may make South Africa and Brazil hesitant to enact domestic laws that
embrace these flexibilities even though policymakers have encouraged them to do so.