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PATENT POLITICS AND THE COVID-19 VACCINE:

WHAT NEEDS TO BE DONE?

SUBMITTED BY: SUBMITTED TO:


NAME: ADITI BHAWSAR DR. M.R. SREENIVASA MURTHY
ROLL NO.: 728
SEMESTER: VII
SECTION: A

NATIONAL UNIVERSITY OF STUDY AND RESEARCH IN LAW, RANCHI


TABLE OF CONTENTS

INTRODUCTION .......................................................................................................................... 3

HURDLES FOR COVID-19 VACCINE........................................................................................ 4

PATENT RIGHTS FOR COVID-19 VACCINE ........................................................................... 7

COVID-19 VACCINE AND THE BARRIERS TO EQUITABLE ACCESS..............................11

CONCLUDING REMARKS.........................................................................................................14

BIBLIOGRAPHY..........................................................................................................................15

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INTRODUCTION

The current COVID-19 pandemic is the most serious worldwide infectious event since the
influenza pandemic of 1918. So far, the number of infections and deaths has not reached levels
seen during the ''Spanish flu'' pandemic. However, modern travel and global trade (and new
factors such as social media, whether for good or ill) have increased risks, and awareness of
those risks, throughout the world. The economic and social consequences of the COVID-19
pandemic are also much more serious today than they were a century ago. Although some
naysayers might disagree, the economy is global, and disruptions in one country or one part of
the world tend to affect some or all others. Equally, the pandemic has created a need for research
into better ways of detecting infections, preventing them by vaccines, and treating them more
effectively. The adage that ''an ounce of prevention is worth a pound of cure'' applies critically to
the COVID-19 pandemic.

In the global economy driven by technological advances, Intellectual property plays a vital role
in providing a conducive business and trade environment. A Patent is a form of legal right
granted to the owner or inventor of certain products against third parties to prevent them from
manufacturing, selling, using or making for certain periods of time1. Under global intellectual
property rights, an inventor or owner has the sole responsibility of manufacturing and retailing of
newly invented drugs. In most countries, the term of standard patent right is for 20 years. The
most effective way to fight this Covid-19 pandemic is through the invention of a vaccine. The
social need for distribution of vaccines worldwide may take a backseat when the IPR's comes in
conflict with social needs.

Throughout most of the world, and particularly in the United States, patents provide incentives
for the development of medicines, including vaccines, and protect the developers' investments of
time and resources2. The severity of the COVID pandemic, and the concomitant need for both
treatments and vaccines, has increased the need for the US patent system to respond to the
disruptions created by the pandemic. Some have voiced concerns that intellectual property (IP)
protection for COVID-19 vaccines and therapies would inhibit their development or availability.

1
https://www.wipo.int/patent-law/en/developments/publichealth.html
2
https://www.wipo.int/wipo_magazine/en/2020/02/article_0002.html

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Advocates for IP protection for COVID-19 vaccines and therapies counter that IP protection will
be vital to the development of innovative treatments, tests and vaccines. They also point out that
the federal government is empowered to prevent any inhibition of vaccine and treatment
availability.

The concern of fairness and equality in vaccine distribution was also seen during the 2009 H1N1
pandemic, where developed countries placed large advance orders and almost bought all the
vaccine companies. Thus, the developed countries secured themselves with a huge supply of
H1N1 vaccines. When developing countries and the World Health Organization came to know
about this, they entered into talks with manufactures and developed countries, to provide supply
for Low-Income Countries. But the end result was not very satisfactory. The race to develop
vaccines for COVID-19 has edged closer to its finishing line with at least three candidates
announcing positive results from their vaccine trials. While this may appear to be the light at the
end of the tunnel, the focus now shifts towards equally challenging issues of availability,
accessibility, and affordability of vaccines.

The global intellectual property system allocates the rights of the vaccine to the inventor or
owner. These rights are granted for a limited period – 14 years for design rights, 20 years for
patent rights in most places. During this time, the owner has a monopoly over the product and
can demand a price they see fit. However, this provision has often been used by the inventors to
limit access to essential goods to people who need them or to smaller companies that could
manufacture the product at affordable prices. This article will explore the hurdles for granting
patent rights, the issues with the availability, accessibility, and affordability of vaccines and the
politics associated with it.

HURDLES FOR COVID-19 VACCINE

Governments, non-governmental organisations, universities and pharmaceutical companies have


started collaborating worldwide for the production of Vaccine. The World Health Organization
and the European Union are exploring ways to make the vaccine available worldwide. The IP
hurdles faced by Covid-19 vaccine will be in the form of a barrier of access. IP rights are mostly
vested with the private funders and to overcome the cost price they can fix rates which can be a

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burden on developing countries. The concern of fairness and equality in vaccine distribution was
also seen during the 2009 H1N1 pandemic, where developed countries placed large advance
orders and almost bought all the vaccine companies. Thus, the developed countries secured
themselves with a huge supply of H1N1 vaccines. When developing countries and the World
Health Organization came to know about this, they entered into talks with manufactures and
developed countries, to provide supply for Low-Income Countries. But the end result was not
very satisfactory. The infrastructure for drug development mostly lies with the high-income
countries and if they develop any vaccine there will be a chance that low and middle-income
countries may not be able to afford it. The free market system may dictate the value of patented
products. Due to high demand, there will be a surge in price which will make it unavailable for
low income and developing countries. Government may prioritize its citizens by signing pre-
purchase agreements and banning the exports of the vaccines. This may prove to be detrimental
as other countries will suffer.

The vaccine market has many parallels to the market for therapeutic drugs, with similar legal
institutions incentivizing and regulating access to new products. Several Universities and
Companies have signed the Open Covid-19 pledge to encourage the development of vaccines to
find a solution to this pandemic. They have pledged to develop and deploy technologies on a
massive scale by curbing the hurdles of Intellectual Property Rights. There has been international
cooperation in sharing medicines. To make the COVID-19 vaccine available to all, many
countries have encouraged compulsory licensing and an open patent pool. Several right holders
like AbbVie have pledged to not exclude others from using their invention. They have
announced that they will not use their patent rights on Lopinavir, an antiviral drug. Similarly, the
Serum Institute of India has announced that it will not file patent rights on the researching and
manufacturing of Covid-19 vaccine. Gilead Sciences also announced that it will provide its entire
1.5 million dose supply of Remdesivir, at no cost to patients with most severe symptoms. Many
countries have started laying a legislative framework for compulsory licensing of the vaccine.
Compulsory Licensing is when the government allows someone else to produce a patented
product or process without the consent of the patent owner or plans to use the patent-protected
invention itself. These rights not only apply to new drugs but also to existing medications whose
patents have been extended because pharmaceutical companies made minor changes to

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formulations or discovered a new use for the medication. The countries that have adopted this are
Chile, Israel, Ecuador, Germany, Canada and France.

On October 8, Cambridge-based biotech company Moderna, Inc., a leading contender in the race
to develop a COVID-19 vaccine, publicly pledged not to enforce its COVID-19 related patents
against ''those making vaccines intended to combat the pandemic.'' It also expressed willingness
to license its intellectual property for COVID-19 vaccines to others after the pandemic. In
making this pledge, Moderna refers to its ''special obligation under the current circumstances to
use our resources to bring this pandemic to an end as quickly as possible.'' Moderna holds seven
issued U.S. patents covering aspects of an mRNA-based candidate vaccine directed to COVID-
19 which entered Phase III clinical trials in July. The potential market for a COVID-19 vaccine
is potentially enormous. As of this writing, the U.S. government has committed approximately
$1.5 billion to acquire 100 million doses of Moderna's vaccine if it proves to be safe and
effective (with an option for 100 million more), and the Canadian government has agreed to
purchase 20 million doses for an undisclosed amount. In the high-stakes market for COVID-19
vaccines, it is worth considering the full range of factors that might motivate a private firm to
relinquish valuable intellectual property rights for the public good. A better understanding of
these factors could help policymakers to secure additional pledges from firms that have not yet
volunteered their intellectual property in the fight against the pandemic.

Moderna could face patent invalidity challenges from competitors. According to a report3, there
are five other mRNA-based COVID-19 vaccines currently under development by other firms.
Such firms could have incentives to seek to invalidate one or more of Moderna’s patents
claiming this technology. Moderna’s pledge not to assert its patents, assuming that it is binding
and enforceable (see this article discussing how patent pledges can be enforced), could obviate
any threat of infringement that might otherwise give rise to a declaratory judgment action
seeking to invalidate Moderna’s patents.

There is a growing need to balance Intellectual property interests and the public good for fighting
this pandemic. An advanced market commitment mechanism can be adopted where international
organizations commit to purchase specific amounts of drugs to distribute in Low to Middle-
Income Countries at the asking price. There is a need for compulsory licensing in more and more

3
https://www.ipwatchdog.com/2020/11/11/breaking-modernas-covid-19-patent-pledge/id=127224/

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countries so that the vaccine production does not get entangled in the web of Intellectual
property rights. Providing Universal Patent rights can also be a way to fight the IP hurdles
around COVID-19 vaccine.

PATENT RIGHTS FOR COVID-19 VACCINE

Among the many issues raised during the COVID-19 pandemic, there is increasing attention on
how intellectual property rights, particularly patents, are put into practice. Patent rights exist
everywhere around viral pandemics, as seen in simple Google searches for face masks,
ventilators, therapies, diagnostics, and vaccines. Globally, many of these patents remain active,
and many new applications are being filed. The rationale for patents is that they encourage
innovation. By granting temporary time frames of exclusivity around uses of new technologies,
innovators are encouraged to embark on the process of commercial development. Pharmaceutical
companies have always guarded their patents over new chemical and biological medicines. Their
rationale is that the high expense and risk of taking therapeutics through the regulatory hurdles to
prove they are safe, effective and useful means there needs to be a period of exclusivity once
they are on the market. Difficulties will arise if patent holders refuse to permit repurposing
investigations to be undertaken by others. This is particularly concerning now, given that many
of the patented chemical or biological medicines for the treatment of viral infections such as
SARS, MERS, influenza, HCV, and Ebola may be suitable for repurposing. Many of the
patented chemical or biological medicines for the treatment of viral infections such as SARS,
MERS, influenza, HCV, and Ebola may be suitable for repurposing.

Building on existing World Health Organization (WHO) and United Nations initiatives, the
WHO launched the COVID-19 Technology Access Pool (C-TAP) at the end of May with the
aim of accelerating discovery of vaccines as well as other treatments. A key element of the
initiative is transparency, including in relation to disclosure of gene sequences and data, and
results of clinical trials. Linked to this, two elements are of particular interest from a legal
perspective: Governments and other funders are encouraged to include clauses in funding
agreements with pharmaceutical companies and other innovators about equitable distribution,
affordability and the publication of trial data. Potential vaccines, treatments and technologies

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developed in response to COVID19 should be licensed on non-exclusive and global bases to the
UN’s Medicines Patent Pool, and/or made available through other public health research and
development mechanisms, consortia or initiatives that facilitate global and transparent access,
and/or voluntary non-enforcement of intellectual property rights. Predictably enough, there is
scepticism about whether a voluntary initiative of this nature can succeed. One might say that it
is easy enough for the pharma giants to support the initiative in principle without ever giving
access to their IP in the manner envisaged.

Some of the major patent holders are taking the pragmatic approach of temporarily suspending
enforcement of their patent rights for the duration of the pandemic. In some countries, such as
Germany, Israel, Chile and Canada, governments are taking pre-emptive steps to ensure that uses
for COVID-19 purposes remain open4. A group of scientists and organisations have pledged to
make their intellectual property free of charge for use in COVID-19 research. Not all patent
holders are taking this benevolent approach and organisations such as Médecins Sans Frontières
(Doctors Without Borders) are calling for others to do the same. Recently, India and South
Africa, expressed their concerns about specific provisions of the Agreement on Trade-Related
Aspects of Intellectual Property Rights (TRIPS), which they argue obstruct the global fight
against the COVID-19 outbreak. The joint submission said that patent laws have restricted access
to several pharmaceutical products and medical equipment, including N-95 masks, and will
continue to create such hurdles unless the institution formally waives certain obligations. They
also expressed concern about the TRIPS provisions limiting the availability of a COVID-19
vaccine.

Pfizer and its partner BioNTech have said their vaccine will cost $19.50 a dose in the US. That’s
likely to be too much for many poorer countries, even if discounted, especially given the cost of
the vaccine’s deep-freeze storage requirements. But AstraZeneca’s vaccine costs $4 to $5 a dose
and is the big hope for the developing world right now. India's proposed WTO waiver faces stiff
opposition from the US and EU. In South Africa, the Patents Act does not define an invention
but rather lists a number of exclusions as to what could constitute a patentable invention. In
particular, the act specifies that a scientific discovery is not an invention. The difficulties faced
by these governments highlight the importance of diluting the legal provisions to deal with the
4
The Wire, Will the COVID-19 Pandemic Change the IP Domain for the Better, available at:
https://science.thewire.in/health/covid-19-pandemic-research-collaborations-intellectual-property/.

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unprecedented public health emergency posed by the COVID-19 outbreak. Consequently,
several countries have introduced laws to soften their existing patent laws and increase
accessibility to pharmaceutical products and medical equipment.

Grant of a patent gives the patentee a twenty-year exclusivity to make and sell the patented
product. This exclusivity, however, is qualified. The patent can be challenged by any interested
person at any point of time on the ground that it should never have been granted i.e. it does not
meet the requirements of grant of a patent. Granted patents are frequently challenged on the
ground that they are not novel or are obvious or that they fail to meet procedural requirements.
Therefore, one of the first lines of attack against a Covid-19 patent is likely to be on the merits of
the patent itself. advanced stage of development. National governments are looking to use a
practice called ''Compulsory licensing'' whereby they can authorise a third-party to make, use, or
sell the vaccine without the permission of the patent owner5.

The patent exclusivity can be subjected to a Compulsory License under Section 84 of the Patents
Act (hereinafter ''CL''). A person interested can apply to the Patent Office to grant a license for a
patented product, even without the consent of the patentee, on any one or more of three grounds:

 that the patentee is unable to satisfy the reasonable requirements of the public with respect to
the patented product;
 or that the patentee has not made the patented invention available at a reasonably affordable
price,
 or that the patented invention is not worked in India.

As per my view, Ground (a) which pertains to failure to meet public demand for the drug is most
likely to be invoked. Given the widespread nature of COVID-19, depending on the efficacy and
the recommended dosage regimen, the worldwide demand of a COVID-19 is bound to be
extremely high, possibly running into millions of tablets. Patent law typically requires that a CL
can be sought only after three years of the grant of a patent. However, there are special
provisions (such as Section 92) dealing with a national emergency or other circumstances of
extreme urgency under which the Government has the power to declare the grant of a CL even if

5
Arnab Acharya, Opinion: The Debate around Intellectual property rights and the COVID-19, available at
https://www.devex.com/news/opinion-the-debate-around-intellectual-property-rights-and-the-covid-19-vaccine-
97609.

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this mandatory 3-year period has not expired. In my view, a pandemic causing thousands of
deaths will almost certainly be considered a ''circumstance of extreme urgency''. One could argue
that in this case the patents arising from the collaboration should not be treated as a private asset
for exploitation but rather as a public asset to be licensed freely. But that may not be feasible,
particularly given the number of vaccines under development and the consequential disincentive
to continue funding research if similar work is already being advanced by other collaborative
(independently) or that competing IP is available or at a more

The Government has the power to use the invention for its purposes and sell the same on a non-
commercial basis under Section 100 of the Act. Under this special provision, sometimes referred
to as ''march-in rights'', the Government or any entity authorized by it can use an invention by
paying the patentee adequate remuneration for such use. This remuneration is determined taking
into account the economic value of the use of the patent. The Government has broad powers to
revoke a patent in public interest under Section 66 of the Act. The Central Government can
revoke a patent if the patent itself or the mode in which it is exercised is mischievous to the State
or generally prejudicial to the public or for the ''security of the State'' (under Section 157A of the
Act). In a land mark decision of Natco Pharma Ltd., India v. Bayer Corporation, USA6, the
Controller of Patents issued the order of grant of first compulsory license for patents in India.
The compulsory license was issued to Natco Pharma Ltd. in patent number 215758 granted to
M/S Bayer Corporation. This patent relates to drug Sorafenib tosylate sold under the brand name
Nexavar by Bayer. Nexavar is indicated in Renal Cell Carcinoma - RCC (kidney cancer) and
Hepatocellular Carcinoma – HCC (liver cancer).

Judicial precedents also provide adequate flexibility to Courts to fashion remedies to ensure that
COVID-19s are available to patients. As readers may be aware, the exclusivity of a patentee is,
in practice, exercised through the Courts which can and, often do, grant injunctions restraining
unauthorized use7. The Delhi High Court in Merck v Glenmark 8
has found that this public
interest factor will be more significant in cases of life-saving drugs. If a patentee does move the
Court to seek an injunction against manufacture and sale of COVID-19s, the public health, social

6
Natco Pharma Ltd., India v. Bayer Corporation, USA, 238(2017) DLT 701.
7
G. Nair Gopakumar, Fernandes Andreya, & Nair Karthika, Landmark Pharma Patent Jurisprudence in India, 2013.
8
Merck v Glenmark, 2015(6) SCALE 665.

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and economic emergency arising out of this pandemic may justify the refusal of an injunction on
this ground. In the alternative, the Court can award reasonable damages or fix a reasonable
royalty, which would in effect function as a license to the generic drug makers to manufacture
and sell COVID-19s.

The TRIPS Agreement allows for exceptions to the exclusive rights conferred by a patent, such
as the right to license, sell and distribute a patented vaccine. Significantly, the compulsory
licensing provision of TRIPS is optional9. Some countries have opted separately to allow for
compulsory licensing, while others have not. Most European countries provide for compulsory
licensing of some sort, as do India and Canada to name a few. These countries permit
compulsory licensing to encourage public access to inventions and vaccines, and naturally this is
promising in the fight against COVID-19.

Admittedly, watering down patent rights can provide scope for exploitation. However, with a
unique threat like the COVID-19 pandemic, the measures, too, need to be unprecedented and
extreme. However, without an expedited international response to the issue, we risk stretching
out the pandemic and its consequent impact on the world’s economy far longer than necessary10.
Hence, the international community must put political differences and international politics
aside, and countries must abandon their inward-looking policies and unify in the global fight
against the virus before it is too late.

COVID-19 VACCINE AND THE BARRIERS TO EQUITABLE ACCESS

Intellectual property owners of critical healthcare products could consider balancing their
Intellectual Property Rights along with the public good. For example, the vaccine patent owners
could be given transferable or roaming intellectual property rights11. This would not impede the
rights of a patent owner. Instead, would ensure easy availability at affordable prices in addition

9
Andrew Green, COVID-19: Countries race to strengthen compulsory licensing legislation, available at:
https://www.devex.com/news/covid-19-countries-race-to-strengthen-compulsory-licensing-legislation-97595
10
Anjitha Santosh, Ip Hurdles For Covid-19 Vaccine, IP Assisto, 2020.
11
Joe. C. Mathew, Coronavirus: Will intellectual property be a hurdle in India’s fight against COVID-19, available
at: https://www.businesstoday.in/latest/trends/coronavirus-will-intellectual-property-be-a-hurdle-in-indias-fight-
against-covid-19/story/400200.html

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to keeping royalties flowing12. Finally, Search for the vaccine has come to a halt. Governments,
industry and philanthropists have been pouring funds into a multitude of vaccine development
and manufacturing projects. Both conventional as well as less-explored technologies have been
applied to develop a vaccine. But will the Covid-19 vaccine become freely available and be
affordable?

A strong need for equitable and inclusive access to innovations for the research community is the
need of the hour13. The ability to import and export critical technologies will be the deciding
factor. Intellectual property navigations should not slow down these processes. Previous
experiences such as the HIV epidemic in Africa have shown that patent ownership can
drastically influence global access to healthcare. Since the beginning of the COVID-19
pandemic, concerns have been raised regarding the implications of enforcement of patents held
over potential COVID-19 treatments. This has brought the patent landscape of the vaccine-
manufacturing companies under scrutiny.

Public Citizen has identified 13 patents claimed by BioNTech on its vaccine technology.
However, the status of rights over the vaccine is complicated. While the development of most
vaccines has been significantly funded by governments, Pfizer has claimed that they have taken
no money, neither from the US government nor from anyone else (perhaps as an explanation
behind why it has not made any no-profit or non-patent enforcement pledges like other
developers). As the companies stand poised to make $13 billion from their vaccine by next year,
these multiple claims over the ownership of the technology can lead to complicated battles
between the public and private players involved. (Knowledge Ecology International maintains
this page containing copies of the US government’s contracts with pharmaceutical companies for
COVID-19 related technologies.)

Moderna, which has received huge sums from the US government, has so far published seven
US patents it claims protect its vaccine. he company has been accused of failing to disclose vast
amount of funds received from US Defense Advanced Research Projects Agency (DARPA) for
its vaccine patent filings. The developers of the Oxford vaccine, which has relied on the UK
12
https://www.who.int/bulletin/volumes/98/12/20-021220/en/
13
Anjula Gurtool and Rahul Patil, When a Covid-19 vaccine is discovered, will it be freely available and be
affordable to all?, available at: https://scroll.in/article/966877/when-a-covid-19-vaccine-is-discovered-will-it-be-
freely-available-and-be-affordable-to-all.

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government’s funds and other donations, had been lauded initially for suggesting a possible open
licensing framework. In April, Oxford entered into an exclusive licensing agreement with
AstraZeneca. While they too have pledged to sell the vaccine at cost price till the pandemic lasts,
AstraZeneca’s definition of “pandemic” has recently been called into question.

The equitable distribution of vaccines depends largely on the availability of vaccines in sufficient
quantities. The past few months have seen frenzied attempts at vaccine stockpiling by higher-
income countries through numerous bilateral pre-purchase agreements. Also, cross-country cold
storage transportation requires timely infusions of dry ice to maintain temperature, which is all
the more difficult to ensure in tropical regions with torrid climates. This risks spoilage of
expensive vaccines which are already limited in number.

As the physical procurement of vaccines clearly presents a multilayered challenge, an alternative


way of ensuring wider, equitable distribution is by sharing technological know-how with local
manufacturers across the world to pump up total supply. Earlier, an attempt by WHO to facilitate
a COVID-19 Technology Access Pool for the sharing of know-how and IP in order to allow
companies to manufacture vaccines and treatments had fizzled out with only 40 countries
(excluding India) joining the Solidarity Call for Action – most of which were lower income
countries. In October, when India and South Africa made a proposal to the WTO to allow the
suspension of patents linked to Covid-19 treatment till global immunity is achieved, this proposal
was widely supported by other lower and middle income countries, WHO, and leading UN
experts. At the same time, the higher income countries, which have reportedly already pre-
booked 51% of the world’s vaccine supply, refused to concede.

COVAX is also heavily funded and controlled by the Gates Foundation, which has been
criticized for constantly siding with Big Pharma in the IP rights suspension debate. With these
concerns persisting, more and more countries are joining the call for suspension of patent rights
which have not only allowed pharma companies to make profits by free-riding on largely public-
funded vaccine research, but also pose a serious impediment in achieving the goal of equitable
access.

To ensure that there is accountability and transparency in the allocation of COVID-19 vaccines
the Framework proposes that an Allocation Mechanism be established. This would comprise of
firstly a Joint Allocation Taskforce, made up of WHO and the Office of the COVAX Facility,

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that would be responsible for preparing a proposal regarding vaccine allocations for COVAX
Facility participants, and secondly an Independent Vaccine Allocation Group, made up of
independent experts, that would validate this proposal. The threat posed by the novel coronavirus
knows no borders. Only a well-coordinated global plan that harnesses the best science and
delivers it to everyone in need can effectively counteract the COVID-19 scourge and future
pandemics.

CONCLUDING REMARKS

The lack of protection for product patents in pharmaceuticals and agrochemicals had a
significant impact on the Indian pharmaceutical industry and resulted in the development of
considerable expertise in reverse engineering of drugs that are patentable as products throughout
the industrialised world but unprotect able in India. It has now become very important to look at
our IP laws from the perspective of public health as modern laws are not equipped to deal with a
global pandemic. Immediate action is required to halt the COVID-19 pandemic and treat those
affected. The most important need right now is the availability of the COVID-19 vaccine in fair,
reasonable and non-discriminatory terms. India is slowly moving into global markets and
competing with international quality standards and prices. As COVID-19 is causing chaos
around the globe, the world’s largest economies are competing to be the first to find a cure to this
new pandemic and taking measures to ensure that their citizens will have access to any vaccines
or treatments once available. COVID-19 has introduced a whole new global arms race, the race
to own patent rights to a COVID-19 vaccine.

Patents and scientific innovation are intended to operate independently of politics. In the face of
a global pandemic, political conflicts should never threaten public access to essential medicines
and treatments. It remains to be seen, however, how the global arms race for a COVID-19
vaccine patent will unfold in light of these recent events. Making a new drug and introducing it
in the market is a very expensive job. The company who are making new drugs always look to
protect their business and financial interest by patenting the products. For better growth of the
industry, it is important that the investors feel secure in investing their money into that sector.

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BIBLIOGRAPHY

A. STATUTES

1. Patents Act, 35 U.S. Code Title 35.


2. The Patents Act, 1970.
3. The South African Patents Act 57 of 1978.

B. BOOKS

1. Ahuja V. K., Law Relating to Intellectual Property Rights (3rd ed. 2017).
2. Wadehra B.L., Law Relating to Intellectual Property (3rd ed. 2017).

C. CASE LAWS
1. Merck v Glenmark, 2015(6) SCALE 665.
2. Natco Pharma Ltd., India v. Bayer Corporation, USA, 238(2017) DLT 701.

D. ARTICLES

1. Arnab Acharya, Opinion:The Debate around Intellectual property rights and the COVID-19,
available at https://www.devex.com/news/opinion-the-debate-around-intellectual-property-
rights-and-the-covid-19-vaccine-97609.
2. The Wire, Will the COVID-19 Pandemic Change the IP Domain for the Better, available
at:https://science.thewire.in/health/covid-19-pandemic-research-collaborations-intellectual-
property/.
3. Arnab Acharya, Opinion: The Debate around Intellectual property rights and the COVID-19,
available at https://www.devex.com/news/opinion-the-debate-around-intellectual-property-
rights-and-the-covid-19-vaccine-97609.
4. G. Nair Gopakumar, Fernandes Andreya, & Nair Karthika, Landmark Pharma Patent
Jurisprudence in India, 2013.

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5. Andrew Green, COVID-19: Countries race to strengthen compulsory licensing legislation,
Available at:https://www.devex.com/news/covid-19-countries-race-to-strengthen-
compulsory-licensing-legislation-97595
6. Anjitha Santosh, Ip Hurdles For Covid-19 Vaccine, IP Assisto, 2020.
7. Joe. C. Mathew, Coronavirus: Will intellectual property be a hurdle in India’s fight against
COVID-19, available at: https://www.businesstoday.in/latest/trends/coronavirus-will-
intellectual-property-be-a-hurdle-in-indias-fight-against-covid-19/story/400200.html
8. Anjula Gurtool and Rahul Patil, When a Covid-19 vaccine is discovered, will it be freely
available and be affordable to all?, available at: https://scroll.in/article/966877/when-a-covid-
19-vaccine-is-discovered-will-it-be-freely-available-and-be-affordable-to-all.

E. WEBLIOGRAPGY

1. Manupatra.com
2. Scconline.com
3. https://www.wipo.int/patent-law/en/developments/publichealth.html
4. https://www.wipo.int/wipo_magazine/en/2020/02/article_0002.html
5. https://www.ipwatchdog.com/2020/11/11/breaking-modernas-covid-19-patent-
pledge/id=127224/

6. https://www.who.int/bulletin/volumes/98/12/20-021220/en/

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