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RIS
RIS
No. 89 April 2020
1
— Research shaping the development agenda
Policy Brief
Introduction
The global health crisis on account of Corona
Epidemic has rekindled debate on use of IPRs
as incentives as well as constraints for access to
medicines. There are parallels with the debate
on access to medicines and right to health on
account of HIV/AIDS but this time the issues
are not that simple. While research teams across
the globe are racing against the time to find a
cure whether with vaccines, use of drugs used
to treat HIV/AIDS or through a combination
of drugs, the crisis is worsening day by day,
hour by hour. Right now, there are rays of hope,
promising pathways of discovery and treatment
and renewed thrust in terms of investment and
efforts. According to one source more than 41
research groups and companies are working to
produce vaccine.1As of now there is no vaccine
available as a protection against Covid-19.
There are identified therapeutics and WHO
has listed them under different categories.2At
the same time, it is important to understand
that we do not know everything about Covid-19
and whether this will result in seasonal diseases
like flu or will be contained successfully to such
an extent, or that itwill not be a menace in the
future is not yet known. Whatever it is, there is
no doubt that this a pandemic and has emerged
as a major public health issue, particularly
because of its spread across the globe and rapidly
increase in deaths. Recently many NGOs and
academics have urged the Director-General of
World Intellectual Property Organization to
show leadership and ensure that IP rights and
regulation do not become barriers to access and
innovation. 3
WHO lists, inter alia, products/
candidates that were used for, other diseases
such as, Malaria, HIV infection, including,
Corticosteroids, Chloroquine, Ritonavir +
Lopinavir (Kaletra), Ribavirin + Ritonavir +
Lopinavir, Emtricitabine + tenofovir (Truvada),
and, Baricitinib (Olumiant or Baricinix). Under
the large scale global trial, called SOLIDARITY,
WHO is giving emphasis on four therapies
that are considered as most promising. These
are Remdesivir, an antiviral compound,
chloroquine and hydroxychloroquine used
in treatment for Malaria, combination of
lopinavir and ritonavir (HIV drugs), and, a
combination of lopinavir and ritonavir with
interferon-beta.4 Gilead developed Remdesivir,
initially for viral infections including Ebola
and Marburg virus. According to Knowledge
Ecology International (KEI), it was developed
with significant support from US government.
It has been extensively patented, including in
India. Which among these is the best from a
public health perspective depends upon the
context and the status of patents and patent
applications. Just as Covid-19 is making us
rethink many assumption and policies on our
capacity to handle pandemics, this issue of
innovation and access also calls for a rethink and
imaginative solutions. In this policy brief, an
analysis of the issues and approaches in finding
solutions is provided.
Intellectual Property Rights
and Innovation in the Times of
Corona Epidemic
RIS Policy Briefs are prepared on specific policy issues for the policymakers.
This Policy Brief has been prepared by Dr Krishna Ravi Srinivas, Consultant, RIS. Author is grateful
to Professor Sachin Chaturvedi, Director General, RIS for his initiative, guidance and support for
preparing this policy brief.
2RIS Policy Brief # 89
TRIPS, Patents and Compulsory
Licensing
With TRIPS becoming the de facto standard
for IP rights in most countries of the world,
the options for regulators and policy makers
are circumscribed by TRIPS.5 Although TRIPS
does provide flexibilities, these are subject to
conditions. But more important is that for
countries that have limited manufacturing
capacity and regulatory capacity, their availability
under the law alone will not guarantee that access
to medicines will be enhanced. Rather countries
should have the capacity to make the best use
of them and translate that in terms of strategies
that will result in better access to medicines at
affordable prices. Among the TRIPS flexibilities,
use of Compulsory Licensing is the most relevant
measure and the one has been used before and
after TRIPS extensively.6 According to WTO;
“Compulsory licensing is when a government
allows someone else to produce the patented
product or process without the consent of
the patent owner. It is one of the flexibilities
on patent protection included in the WTO’s
agreement on intellectual property - the TRIPS
(Trade-Related Aspects of Intellectual Property
Rights) Agreement.”7
Compulsory Licensing is an option when
patent holders are unwilling to supply the
requisite goods in adequate numbers or are not
interested in commercialising the innovation
despite there is a need or the patent rights are
abused to maximise profits. The Trade Related
Intellectual Property Rights (TRIPS) Agreement
enables governments to issue Compulsory
Licenses (CL) subject to certain conditions, as
specified in Article 31. Many countries have used
CL under different circumstances and there is
enough case law and there are enough laws to
show that CL has been effective, particularly
in enhancing access to drugs in HIV/AIDS.
Basically, by issuing CL government ‘breaks’
the rights of the patent holder but ensures
that royalty is being paid. Although terms and
conditions vary, many nations have provisions
on issuing CL and government use.8
Israel issued CL on 23 March for lopinavir/
ritonavir, used as HIV medicine and now used in
many countries to treat patients suffering from
Covid-19. Under this, the import of lopinavir/
ritonavir from a generic producer is permitted.
The Parliament of Chile passed a resolution
requesting the Government to declare that CL
for a wide range of medicines, products and
devices useful in, inter alia, prevention, diagnosis
treatment and detection of the virus in Chile.
Similarly, the National Assembly of Ecuador
has passed a resolution requesting the Health
Minister to bypass patents related to medicines
for Covid-19. UK and Germany are some of
the other countries that may use provisions
that grant the right to limit the rights of the
patent holders or permit the government to
use the patents. But companies are also facing
the pressure to respond responsibly and not to
use the current crisis to maximise their profits.
Facing the heat, Gilead requested the FDA,
to drop the special status for Remdesivir, as
an orphan drug. Giving up that status means
that it will forego the exclusivity for seven years
that was granted earlier.9 On the other hand,
how Gilead will ensure affordable access is yet
to be known. In the days to come, as many
governments may contemplate measures such
issuing CL, industry may face more pressure to
prioritise public health over profits and work
with governments in ensuring affordable access.
Although CL is an option under TRIPS,
there are limits to its usage and scope for
invoking it. Governments can declare the
Covid-19 as a public health emergency and
invoke CL and also allow parallel imports of
the needed medicines, diagnostic kits, medical
devices and vaccines. But the larger question
is whether there is adequate capacity among
the producers of generics to meet the demand
within the country as well as to export. For many
countries that have limited capacity and rely
largely on imports of generics, the Paragraph
6 solution, which since has been incorporated
in TRIPS as, Article 31bis, will be useful and
invoking it they can import generics. As Article
31bis relates to export-oriented CLs its use is
an opportunity for many developing countries/
LDcs to enhance access.
In case of HIV/AIDS, CL was used by many
countries and it could be used as an effective tool,
on account of factors like the world recognising
the gravity of the situation in many countries
and availability of generics from many sources.
Moreover, most of the countries that issued CL
1 https://sciencebusiness.
net/news/race-covid-
19-vaccine
2 https://www.who.int/
blueprint/priority-
diseases/key-action/
Table_of_therapeutics_
Appendix_17022020.
pdf
3 http://infojustice.org/
archives/42220
4 https://www.
sciencemag.org/
news/2020/03/
who-launches-global-
megatrial-four-most-
promising-coronavirus-
treatments.
5 Cynthia Ho 2011,
Access to Medicine in
the Global Economy:
International
Agreements on Patents
and Related Rights,
Oxford: Oxford
University Press
6 Reto M. Hilty , Kung-
Chung Liu (Eds) 2015
Compulsory Licensing:
Practical Experiences
and Ways Forward
Cham: Springer
7 WTO http://www.
wto.org/english/
tratop_e/trips_e/
public_health_faq_e.
htm
8 WIPO 2019
COMPILATION OF
VARIOUS LEGAL
PROVISIONS ON
COMPULSORY
LICENSES AND
GOVERNMENT
USE Geneva: WIPO
https://www.wipo.
int/edocs/mdocs/scp/
en/scp_30/scp_30_3-
appendix1.pdf
9 https://www.gilead.
com/-/media/gilead-
corporate/files/pdfs/
company-statements/
remdesivir-orphan-
drug-designation.pdf?
3
RIS Policy Brief # 89
also had capacity to produce generics. But how
effective will CL be, when there is no vaccine
against Covid-19 and there is lack of clarity
on using lopinavir/ ritonavir for treatment?
The treatment regarding HIV/AIDS was well
established and the efficacy of the medicines and
their combinations were known. This in turn
helped both countries and generics industry
to know the demand and produce/import
medicines in adequate quantities. As these
medicines have to be taken continuously, the
demand and supply aspects can be anticipated
and production and distribution can be planned.
In case of Covid-19 these aspects are not clear
and more importantly what combination of
medicines will be more effective is yet to be
ascertained.
Still not withstanding such uncertainties,
countries should focus on using CL as an effective
tool and explore all the options available to them
under TRIPS and under national laws on health.
In these times of crises and health emergencies,
CL should be used to the maximum so that
treatment and availability/supply of medicines
is not hit by TRIPS or IP regimes. To encourage
use of CL, all countries can pledge that while
they will support application of CL, they will
not use any other trade instrument or policy to
discourage use of CL or as a factor in assessing
adherence to IP rules, whether under TRIPS or
under any other bi-lateral/ multilateral treaty.
In other words, there should be a waiver on
all restrictions on use of CL for use in actions
relating to Covid-19. G20 should take a lead in
this and arrive at a consensus.
Another key issue is that of TRIPS Plus
provisions in Free Trade Agreements/Regional
Trade Agreements/Bi-lateral Trade Agreements
and these have the potential to reduce affordable
access.When combined with Investment
Protection Treaties, wherein IP is covered under
Investment, there can be adverse impact on
access to affordable medicines as well as to local
production.10
Compulsory Licensing in India
CL can be issued invoking the powers vested
through Section 84. Section 84 states that an
interested party can apply to the patent office
seeking CL on any one of the three grounds,
viz. unmet demands, lack of local manufacturing
and unmet demand. Such an application can be
made from three years after the date of grant of
patent, if the efforts to obtain a voluntary license
do not fructify.
The Patent Act provides three more options:
1 Government can acquire the relevant patents
under Section 102 for public purpose. The
price of the patents has to be negotiated
between the government and patentee.
However, if they fail to agree on this, the High
Court can fix the price for the patent(s).
2) Under Section 100, Government can
authorise use of any patent or patent
applications for “purpose of government” by
specific companies. Under this authorisation,
manufacturing can be commenced without
waiting for negotiations with patent holders
to be completed. If no agreement is reached
with the authorised user or government, the
high court can fix the royalty payable.
3) Under Section 92, the Government can
declare a national emergency and in these
circumstances on account of Covid 19.
It can notify the relevant patents and any
interested person who intends to manufacture
can apply to the Controller of Patents to
issue a Compulsory License without going
through the regular procedure and thereby
get the License and start manufacturing.
The reasonable royalty will be fixed by the
Controller of Patents. In 2012, a CL was
granted to Natco to produce an anticancer
drug (Sorafenib) on the ground that the
patent holder (Bayer AG) was found wanting
in making it available to citizens of India. The
generic version was just one fourth of the price
of Sorafenib sold by Bayer.
While issuing CL seems to be the best option,
it need not be so in some circumstances,
particularly when the period between
application for issue of CL and that of grant
of patent is less than three years. Taking in
to account the patents granted in India and
patent applications pending on Remdesivir,
and, Favipiravir, Gopakumar and Prathibha
argue that the Government will have to
choose from the above mentioned, last three
options and act.11
10 Gleeson et al.
2019, Analyzing
the impact of trade
and investment
agreements on
pharmaceutical
policy: provisions,
pathways and
potential impacts,
Globalization and
Health 15(Suppl
1):78 https://
doi.org/10.1186/
s12992-019-0518-2
11 Drugs That Could
Be Used to Beat
COVID-19
Have Another
Barrier – Patents
https://thewire.
in/law/remdesivir-
favipravir-covid-
19-patents-indian-
patents-act-ustr
4RIS Policy Brief # 89
But under Section 157A the Government
is empowered to take any action in the
interest of security of India. According to
this section:
“Notwithstanding anything contained in this
Act, the Central Government shall:
(a) not disclose any information relating
to any patentable invention or any
application relating to the grant of
patent under this Act, which it considers
prejudicial to the interest of security of
India;
(b) take any action including the revocation
of any patent which it considers
necessary in the interest of the security
of India by issue of a notification in the
Official Gazette to that effect.
Explanation. For the purposes of this
section, the expression “security of
India” includes any action necessary for
the security of India which-
i. relates to fissionable materials or the
materials from which they are derived;
or
ii. relates to the traffic in arms,
ammunition and implements of war
and to such traffic in other goods
and materials as is carried on directly
or indirectly for the purpose of
supplying a military establishment; or
iii. is taken in time of war or other
emergency in international
relations.”12
Security can be broadly defined and the
Government can invoke this section also. The
Government can incentivise the patent holders/
drug companies to manufacture in India for
export.13
Invoking CL citing public health emergency
and making amendments through an ordinance
to enable issue of CL even in cases when the
period between application for CL and date of
grant of patent is less than three years may be a
better option. This is because in terms of theory
and practice CL has been a preferred solution
and there are rulings and precedents on this.
The objective of enabling generics production
quickly will be better served. Acquiring patents
will send wrong signals to innovators, while
invoking “purpose of government” will also
be seen as a step that will be perceived as a bad
precedent. In case of CL the rights of the patent
holder are impacted but only in a limited way.
On the other hand, issue of CL to more than
one party and issue of more than one CL can
effectively incentivise production of generics.
Another option is to use the Competition law
so that there is no monopoly and unfair pricing
coupled with anti-competitive practices and
there is competition. In invoking competition
law, governments can use them in conjunction
with rights available under Patent law. For
example, a government can use the provisions to
issue CL and also use competition law provisions
to probe anti-competitive behaviour. But as not
many countries have strong laws on competition
and restriction of monopoly, this crisis may be
used to revisit this issue.
Thus, there are options available under the
IP and Competition Law regime to ensure that
medicines are produced and made available.
In combination with DPCO, the prices can
be fixed and competition can be ensured. If
necessary, in order to meet urgent needs and to
assure regular supply, the government can even
permit imports of these drugs and as a matter
of policy, can exempt them from rules of tariffs
and customs duties.
Many countries allow IP protection for
second use of a drug, it is not surprising that
second use claims have been applied for. For
example, it has been reported that The Wuhan
Institute of Virology of the China Academy
of Sciences, has applied a patent for using
Remdesivir, as a treatment for Covid-19.
Remdesivir was originally developed by Gilead
as an antiviral drug. If granted such patents can
constraint access to the much-needed treatment
as even if the earlier patent for the first use, say
as an antiviral drug has expired, the second use
claim will still be enforceable. Moreover, even
if CLs have been issued in the case of the drug,
those would be applicable only for the patent(s)
covering the first use claim(s). The global status
of such claims on the chemicals/compounds
that are potential therapeutics is not clear. On
the other hand, as India does not recognise such
claims as patentable claims, there will not be
any constraint on that ground. However, the
problem may be acute for countries that allow
12 http://ipindia.nic.in/
writereaddata/Portal/ev/
sections/ps157a.html
13 I thank Dr.V Siddhartha
for pointing out this
option and on invoking
Section 157(a).
5
RIS Policy Brief # 89
such claims and do not have indigenous capacity
for production of generics. So even if they want
to use CLs that may not be the perfect solution.
In such cases, depending upon the national
laws and regulations, grounds like government
use, public health emergency have to be used
to authorise imports.Whether to apply for a
patent for second use is a good strategy or not
is being debated. According to Enrico Bonadio,
this is a flawed strategy and instead of that, The
Wuhan Institute should have insisted on CL as
a solution, rather than applying for a second
use patent.14
Thus, even as the scientists are racing to find
solutions, IP is becoming keenly contested topic.
Whether IP will emerge as a major constraint
in providing affordable access or not is not yet
known. However, as there are precedents like
HIV/AIDS crisis, which alerted the world on
the issue of affordable access, lessons learnt from
them will be useful in addressing the issues and
finding solutions.
Patent Pools
In wake of this epidemic, seeking to widen access
to products and treatments, the Costa Rica
government has proposed that World Health
Organization should create a voluntary pool for
patent rights, test data and information that can
be shared for developing drugs, diagnostics.15
This proposal envisages: “This pool,
which will involve voluntary assignments,
should include existing and future rights in
patented inventions and designs, as well rights
in regulatory test data, knowhow, cell lines,
copyrights and blueprints for manufacturing
diagnostic tests, devices, drugs, or vaccines.
It should provide for free access or licensing
on reasonable and affordable terms, in every
member country. Given the urgency of this
matter, Costa Rica proposes that the WHO
develop an initial concise memorandum of
understanding on the intent to share rights in
technologies funded by the public sector and
other relevant actors, and reach out to WHO
Member States, non-profit institutions, industry
and others, to sign such a MoU. The specific
technologies and the terms of the assignments
can be determined later, in the implementation
stage of the pool, in consultation with R&D
funders and rights holders.”
Patent pools have a long history and been
used in different industries/sectors, either
on a voluntary basis or by the order of the
government. According to WIPO: “Patent pools
can be defined as an agreement between two or
more patent owners to license one or more of
their patents to one another or to third parties.
Often, patent pools are associated with complex
technologies that require complementary patents
in order to provide efficient technical solutions.
Generally, these patent pools cover mature
technologies. Pools also frequently represent the
basis for industry standards that supply firms with
the necessary technologies to develop compatible
products and services. In that case, they rather
concern technologies that are yet to be fully
developed.”16
In the last decade or so, a successful example
of patent pooling has been Medicines Patent Pool
(MPP). MPP is an initiative backed by United
Nations. Initially it was focussing on creating
patent pools for enhancing affordable access to
HIV/AIDS medicines and later diversified its
work to diseases like Hepatitis C. MPP has been
able to offer affordable access with co-operation
of industry, governments and other stake holders
including philanthropic foundations. In light of
the current epidemic MPP has decided to work on
patent pooling to cover treatment for Covid-19.
MPP has decided to support the call given by
Costa Rica government. Earlier UNITAID has
announced that it would commit, to begin with,
$30 million investment in treatment, diagnostics
and tools.17 Recently, Director General of WHO
has indicated in the media briefing on 6April “I
support this proposal, and we are working with
Costa Rica to finalize the details.”18
Both are positive developments. The earlier
experience with HIV/AIDS indicates patent
pooling works and can expand affordable access.
When MPP was established, the treatment for
HIV/AIDS was well established and the issue
was that of expanding access and to make it
affordable. In case of Covid19, how this work
out is not clear. Although the MPP is a global
patent pool, there can be other patent pools at
national level and perhaps at the regional level.
The different patent pools can complement each
other and expand scope for affordable access. But
a major challenge would be financing the pool.
Given the adverse economic impacts of Covid19,
14 https://www.sixthtone.
com/news/1005210/
why-patent-laws-
matter%2C-even-in-
times-of-crisis
15 https://www.
keionline.org/wp-
content/uploads/
President-MoH-
Costa-Rica-Dr-Tedros-
WHO24March2020.
pdf
16 https://www.wipo.
int/export/sites/www/
ip-competition/en/
studies/patent_pools_
report.pdf
17 https://unitaid.org/
news-blog/with-special-
investment-unitaid-
bolsters-covid-19-
response/#en
18 https://www.who.int/
dg/speeches/detail/
who-director-general-
s-opening-remarks-at-
the-media-briefing-
on-covid-19---6-
april-2020
6RIS Policy Brief # 89
it cannot be expected that the traditional donors
and supporters of MPP will give this the first
priority in funding. Moreover, for governments
the first priority could be to find affordable
solutions in health care than to finance a global
patent pool.
Given the lack of wider options in terms
of treatment, the governments may prefer to
directly negotiate with the innovators and
explore options like CL, patent pooling than
enhancing access through a patent pool at the
global pool. For countries that have both the
financial resources and capacity to innovate this
may be a preferred option as this enables them
to address the problem directly and quickly.
Another factor that is in favour of allocating
resources for national level initiatives is that it
sends a signal to the people that the government
is taking the bull by horns. So, while some
nations may prefer to work on their own and
create pools at the national level, such an
option may not be feasible for many countries,
particularly LDCs.One solution to address
the dilemma between supporting national
pools and global pool is that governments
can treat national pools and the global pool as
complementary sources than as competitors.
Open Science and Open
Innovation and Patent Pledges
Given the urgency to find effective solutions
to the epidemic, governments and other
stakeholders are focussing on accelerating
the on-going efforts to find solutions and to
fund and support new research and initiatives.
In this there are discussions on using the
solutions proposed earlier such as Health
Impact Fund, Prizes and Advance Market
Commitments. Using Open Source and
Open Innovation, including Open Science
approach and promoting freer flow of data and
information among research groups have been
suggested. It is worth pointing out that some
of the solutions have been discussed earlier and
the WHO
Similarly, options like patent pledges have
been proposed now and using patent pledges are
not new. In the last two decades are so, many
such proposals have been made to address the
need for newer approaches in incentivising
innovation for enhancing access to drugs and to
develop and deploy technologies to address the
climate change. For reasons of space we will not
discuss them in detail but the point is despite
many articles and reports, and, discussions not
much has happened in these, in the sense that
there have not been significant and large-scale
initiatives based on these. Hence the possibility
that discussions and proposed initiatives today
may not get sufficient support in terms of
financial and other resources is very much there.
Still, this crisis also gives an opportunity to revisit
the earlier proposals and modify them suitably.
According to Matt Apuzzo and David D.
Kirkpatrick: “But the coronavirus has ignited
the scientific community in ways that no other
outbreak or medical mystery has before. That
reflects the scope of the pandemic and the
fact that, for many researchers, the hot zone
is no longer an impoverished village in the
developing world. It is their hometowns”.19 They
point how researchers are collaborating and as
they have realised that this is not a problem
of developing countries or LDCs, only , the
thrust is substantial although the vaccine may
be years away. This thrust has been further
strengthened by enhanced funding on R&D
related to Covid-19. Developing countries like
India have also launched special programmes to
fund R&D and to incentivise commercialisation
of relevant products. Thirtythree members
of European Parliament have suggested that
European Commission should prohibit exclusive
licensing for Covid-19 products developed using
grants from EU, besides asking for transparency
in R&D so that affordability becomes a reality. 20
Patent pledges and covenants guarantee that
innovators and users of technologies covered by
the patents that are made available under the
patent pledge and will not be sued for patent
infringement as long as they fulfil certain terms
and conditions. In this the patent holder neither
puts the patents in public domain for free access
and use to all and thereby abandons the rights,
nor uses the patent solely for commercialisation
purposes only. In the recent decades, the types
of patent pledges have expanded and diversified
and are now being practiced in, inter alia,
software, green technologies and electronics.21
According to Chang and Stach: “Companies
today increasingly are looking for ways to
19 https://www.nytimes.
com/2020/04/01/
world/europe/
coronavirus-science-
research-cooperation.
html
20 https://www.
healthpolicy-watch.
org/european-
parliament-members-
urge-open-licensing-
for-covid-19-products-
financed-through-eu-
grants/
21 See Jorge L. Contreras
PATENT PLEDGES
543 Ariz. St. L.J 2013,
SSRN Electronic
Journal. 10.2139/
ssrn.2309023
Ehrnsperger JF,
Tietze F (2019)
Patent pledges, open
IP, or patent pools?
Developing taxonomies
in the thicket of
terminologies.
PLoS ONE 14(8):
e0221411. https://doi.
org/10.1371/ journal.
pone.0221411
7
RIS Policy Brief # 89
maximize the value of their patents, and some
are employing alternatives to the traditional
direct monetization methods of patent licensing
and assertion. These alternatives include
agreeing not to assert patents offensively or
to provide free patent licenses. … In 1959,
Volvo shared its three-point seat-belt patent. In
1974, General Motors similarly allowed others
to use innovations in its catalytic converter.
Tesla’s move differs in that it made all of its
patented technologies widely available, not just
technology for any specific vehicle component”22
In the context of Covid-19, an “Open
Covid Pledge” has been launched so that IP
related to Covid-19 is made widely available and
is used extensively. Under this pledge companies,
universities and others would provide free
licenses to their patents, copy rights and few
other property rights, to anyone for developing
technologies related to diagnosis, prevention or
treatment to Covid-19. The pledge is:
The pledgor grants to every person and
entity that wishes to accept it, a non-exclusive,
royalty-free, worldwide, fully paid-up license
to fully use, practice and exploit all patent,
copyright and other intellectual and industrial
property rights (other than trademarks and trade
secrets) that we have the right to license, for the
sole purpose of ending the “covid-19 pandemic”
and minimising the impact of the disease,
including without limitation the diagnosis,
prevention, containment, and treatment of the
covid-19 pandemic.”23 Unified which calls itself
as a “deterrence entity” has published its
pledge which sets the terms and conditions
of the pledge ‘Open Covid Pledge”24
To what extent patent pledges will work
in this context is not clear. One issue is that if
a technology is covered by many patents with
different patent holders, more than anything
else, unless the key or most important patents
are pledged under “Open Covid Pledge” or any
other similar pledge, patent pledges may not be
an effective solution. If a major pharmaceutical
company or a government join the pledge and
make commitments then the idea of pledge
will gain acceptance. But governments may
not be keen to put patents for technologies
developed with their funding under such a
pledge as there is no incentive to join such an
arrangement. A company can derive benefit
from patents pledged by others without pledging
its own. As the pharmaceutical sector is very
different from software and electronics, how
effective this will be a question. Cross licensing
and other approaches may be preferable when
the technologies are not covered by too many
patents and number of patent holders is less.
As Richard Gold points out, there are models
for sharing and collaborating in drug discovery
and collaborative models and mechanisms
should be harnessed so that the challenge is met
effectively. 25
In mid-2000s and later, there was much
discussion on Open Source Drug Discovery
and a project in India was launched to use this
model to develop drugs for TB. Although there
is literature on Open Source Drug Discovery,
there are not many successful projects or
drugs developed through that approach.
The reasons for that need to be explored so
that we are able to find pragmatic solutions.
Collaboration and open innovation are not
uncommon in pharmaceuticals, particularly in
biopharmaceuticals. But these have not made
IP rights redundant, nor have resulted in open
source drug discovery as an important model.
Hence while there is enough scope to try open
innovation and open source models, what will
succeed is too premature to predict now.
It has been suggested that Health Impact
Fund, Prizes and Advance Market Commitments
can be used as alternative models to incentivise
innovation. These ideas are not new and
while it makes sense to recommend them as
solutions, to us, the key issue is that of financing.
Unless governments come together and form a
consortium, and collectively fund or use one
of these mechanisms, these ideas will remain
what they are. But this is also the time to test
novel approaches and schemes to incentivise
innovation. Many of these models or approaches
do not call for radical changes in IP laws and
policies, nor call for relinquishing rights by
IP holders. Hence, they deserve a relook and
review.26
Challenges for India
The global developments provide opportunities
to India but there are also challenges. A major
challenge is how India can meet the global
needs for generics and domestic need, when on
22 Maximizing a
Patent’s Value by
Pledging Not to
Assert It? March/
April 2015 By Jason
E. Stachhttps://
www.finnegan.com/
en/insights/articles/
maximizing-a-
patent-s-value-by-
pledging-not-to-
assert-it.html
23 https://www.
iam-media.com/
copyright/new-
patent-pledge-
underlines-delicate-
balancing-act-
companies-must-
strike-in-covid-19
24 https://www.
unifiedpatents.com/
open-covid-pledge
25 https://fortune.
com/2020/03/26/
coronavirus-
vaccine-drug-
development-open-
science-covid-19-
treatment/
26 As I intend to
develop this further
elsewhere, it is not
explored fully here.
8RIS Policy Brief # 89
account of various factors there are significant
constraints in availability of raw materials and
organising production. It has been argued that
“in the context of the COVID-19 pandemic,
global reliance on Indian generics is likely to
become a complex international challenge.
There are no reliable substitutes for API
supplies,nor production capacity available and
more importantly, any country potentially
capable of establishing manufacture is likely to
focus on national needs and not on export nor
development aid.”27
It is estimated that India supplies about
20 per cent of the global generics and India’s
pharmaceutical exports are critical for programs
on vaccination and on tropical diseases. While
this indicates the importance of India in global
public health, the epidemic has also shown
that supplies could be limited or affected if the
pharma industry in China is affected even for
a month or two. The recent policy initiatives
to reduce such a dependency and enhance
local capacity to produce raw materials and
ingredients like APIs could, in the long run,
make India more self-reliant. But in the short
term India has to find quick solutions.
Indian government should examine the
challenges posed by IP laws and regulations.
It should form a committee or working group
to examine the issues in depth and come out
with a policy to address them and to incentivise
innovation. For example, in light of this crisis,
the government can develop a coherent policy
on using CL for meeting needs in India and
to export drugs. Similarly, it can examine as
to whether India has fully used the flexibilities
under TRIPS and how they can be used in this
occasion.
Regarding innovation, India should promote
open innovation and open source drug discovery.
It should examine the proposals earlier made and
now, such as Prizes, Health Impact Fund, and,
Advance Marketing Commitments and analyse
which ones are suited to meet needs of India
as an innovator and as a user of drugs. With
WHO supporting the idea of Patent Pool, India
should examine how to approach this and how
it can contribute to that and benefit from that.
It is suggested that a Working Group can be
formed to monitor the developments and advice
the government. Issues on access, affordability
and incentivization have been discussed earlier
also. In this new context, it is the right time to
develop a coherent, pragmatic policy, that will
enable India to meet the multiple challenges
effectively and make significant contributions
to global public health.
Conclusion
The HIV/AIDS crisis showed that the traditional
IP rules and models of innovation do not assure
affordable access. This resulted in some changes
in IP rules and the recognition that IP and trade
rules should not become major constraints for
affordable access. The current crisis provides an
opportunity to revisit and learn from the earlier
one. This calls for a rethink of role of IP and
its use as an incentive. The Business As Usual
approach will not work. The current crisis should
be seen as an opportunity to review and rethink
and to give new models and approaches a chance.
In the race against time, what we will do on IP
and Innovation, may make a huge difference.
The question is how much the governments,
UN agencies and other stakeholders are prepared
for this.
27 Guerin PJ, Singh-
Phulgenda S and
Strub-Wourgaft N.
The consequence
of COVID-19 on
the global supply of
medical products:
Why Indian generics
matter for the world?
[version 1; peer
review: 1 approved]
F1000Research 2020,
9:225 https://doi.org
/10.12688f1000resea
rch.23057.1
Research and Information System
for Developing Countries
fodkl'khy ns'kksa dh vuqla/ku ,oa lwpuk iz.kkyh
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