DHARMASHASTRA NATIONAL LAW UNIVERSITY,

JABALPUR

INTELLECTUAL PROPERTY RIGHTS PROJECT

(Session 2022-2023)
Topic

APOGEE OF SOCIALISM AND EXTENT OF

COMPULSORY LICENSING OF PATENT

SUBMITTED TO: SUBMITTED BY:

DR. GARGI CHAKRABARTI SANSKRATI JAIN

ASSOCIATE PROFESSOR ROLL NO: 116

DNLU, JABALPUR SEMESTER- VI’B

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 ACKNOWLEDGEMENT

The completion of this project required counselling and assistance from many

people and I am thankful towards them for their counselling in my project.

I would like to express my deep gratitude towards my teacher Associate

Professor Dr. Gargi Chakrabarti, who took acute interest in my project and
guided me all along. I am feeling extremely privileged to have her as my
instructor in the project. I owe my deep gratitude to the Vice-Chancellor (I/C)
Prof (Dr.) Shailesh N Hadli for his valuable support throughout the project.
This project helped me in gathering a lot of knowledge and becoming more
aware of things related to my topic.
I would like to extend my gratefulness to my parents and friends for their

valuable support and advice.

I am making this project not only to get marks but also to enhance my

knowledge. At the end I would like thank everyone who helped me and

invested their valuable time for this project.

Sanskrati Jain

BAL/116/20

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TABLE OF CONTENTS

Introduction..............................................................................................................................3

Background and Meaning of Compulsory Licensing...........................................................4

Compulsory Licensing in India...............................................................................................6

Terms and Conditions of Compulsory License......................................................................8

Compulsory Licensing: Boon or Bane....................................................................................8

Compulsory Licensing and Competition Law.....................................................................11

Another line of argument.....................................................................................................12

Conclusion...............................................................................................................................13

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 INTRODUCTION
We are living in the age of technology where everyday we see technological advancements
taking place in most of the sectors of economy. In the today’s world more and more people
are investing their labor and time to improvise and bring into existence a better product and a
new emerging economic system is evolving. The term "New Economy" describes the
formation of a brand-new economic system that has transitioned from a traditional
manufacturing-based economy to a service-based economy that is more and more reliant on
technology and innovation. According to the World Bank, India is transitioning from a
significant industrial economy to a knowledge economy, and as a result, there is a greater
reliance on products that are representations of ideas.1 Intellectual property innovation has
unmistakably shown to be a significant economic stimulus. India continues to have socialist
aspirations despite making enormous success in every area, which is reflected not just in the
preamble but also in the competition act, which promotes consumer welfare in the name of a
free and open market.
What the eye does not see is that intellectual property innovation drives the economy to
higher levels of productivity, which ultimately leads to consumer welfare. A snowball's
chance in hell exists that the waiver of the TRIPS agreement on June 2022 will be able to do
anything other than leave us with the ruins of the progress that the international community
has done up to this point.2
The grant of compulsory right does affect the territory of competition law regime in the
country. IPR provides the right to the inventor and put him in the dominant position in the
market, the competition law, on the other hand, strives to encourage competition as a method
of market response and customer desire in order to ensure effective and efficient resource
allocation and to provide a driving force for innovation in the economy.3
In this research paper, we explore the concept of compulsory licensing in detail, analyzing its
background and meaning in the context of intellectual property law. We also examine the use
of compulsory licensing in India, which has been at the forefront of utilizing this mechanism
to promote public health and access to essential medicines. Furthermore, we delve into the
1
World Bank. (2020). India: Transitioning from a Major Industrial Economy to a Knowledge Economy.
Retrieved from <https://www.worldbank.org/en/news/feature/2020/07/23/india-transitioning-from-a-major-
industrial-economy-to-a-knowledge-economy>
2
Sanya goel, TRIPS Waiver and Compulsory Licensing: A Socialist Dystopia, CSIPR, 25/09/2022, <TRIPS
Waiver and Compulsory Licensing: A Socialist Dystopia – Blog on Intellectual Property and Technology Law
(nliu.ac.in)>
3
Dutfield, G. (2019). Intellectual property and development: Key trends and future directions. WIPO Journal,
11(1), 7-32. https://www.wipo.int/edocs/pubdocs/en/wipo-pub-944-2022-en-world-intellectual-property-report-
2022.pdf

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debate on whether compulsory licensing is a boon or bane for society, considering the
potential benefits and drawbacks of the system. We also explore the relationship between
compulsory licensing and competition law, highlighting the role of competition law in
regulating the use of compulsory licensing and ensuring that it does not result in anti-
competitive practices. Overall, this paper seeks to provide a comprehensive analysis of
compulsory licensing, its use in India, and its implications for intellectual property law and
competition law. Through our analysis, we aim to shed light on the benefits and drawbacks of
compulsory licensing, and its potential to promote public welfare while balancing the
interests of patent holders and the public at large.
BACKGROUND AND MEANING OF COMPULSORY LICENSING
Patents provide monopoly rights to patent holders. There are safeguards in patent regime to
ensure that exclusive right of the patent holder is not misused. Compulsory licensing is one of
the safeguards provided under TRIPS using which patent granting state may allow a third
party to exploit the invention without patent holder’s consent upon terms and conditions
decided by the government. This concept existed since 1623 and was not introduced by
TRIPS for the first time. But this mechanism has undergone significant changes especially in
post-TRIPS era. History of evolution of compulsory licensing is one of the least explored
areas of intellectual property law.4
The notion of Intellectual Property Rights5 is based on the principle that the person who made
an intellectual contribution must have an exclusive right to enjoy the fruits of his labor. It
sounds quite logical, but the monopoly right provided to the inventor is not only in direct
conflict with the competition laws but also has implications with regards to human rights law.
Thus, there is a need to provide safeguards to ensure that this exclusive right of the patent
holder is not misused.
Compulsory licensing of patents is one such safeguard under which government of the state
that granted the patent could allow a third party to use the patent without consent of the
patent holder on payment of a reasonable royalty or remuneration to the patent holder. It is “a
statutorily created license that allows certain people to pay a royalty and use an invention
without the patentee’s permission”. This safeguard is particularly useful with regards to
pharmaceuticals especially in the instances of public health crisis when underprivileged states

4
Dr. Raghuvir Singh, Law Relating to Intellectual Property - A complete comprehensive material on Intellectual
Property covering Acts, Rules, Conventions, Treatise, Agreements, Digest of Cases and much more, (3rd Edn.
2010)
5
K.G Nair, Intellectual Property Rights, 301 (1st edn. 1994).

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have no other option but to dilute the patent in order to improve access to affordable essential
medicines to their poor citizens with limited purchasing power.
“Compulsory license6 is a license issued by a state authority to a government agency, a
company or other party to use a patent without the patent holder’s consent” 7. In simple words,
“compulsory license is an action of a government forcing an exclusive holder of a right to
grant the use of that right to other upon the terms decided by the government”. The
government, however, pays a royalty to the patent holder in order to compensate them for the
use of their patent without their consent. In other words, “Compulsory license means a non-
voluntary license issued by the state to a third party, without the authorization of the patent
holder, on the condition that the licensee pays reasonable remuneration to the right holder in
return”.
A compulsory license or a non-voluntary license may also be defined as “an involuntary
contract between a willing buyer and an unwilling seller imposed and enforced by the state”.
The licensee enjoys the right to manufacture, sell or import the patented product. These acts
are otherwise covered by the exclusive rights of the patent holder. No doubt, patents are
necessary to promote innovation. If the government does not ensure patent protection, no
firm would have an incentive to develop new products. If other firms are allowed to copy the
same products, there would be no monopoly and prices would automatically come down. But
this price control is at the cost of innovation. Patent is therefore an imperfect but necessary
instrument to encourage innovation.
But when monopolistic patent rights are conferred on the products which are essential for
human life, they can have adverse effects on the socio-economic development of the country
that grants patents. An obvious result of patents may be an increase in price and decrease in
supply of the patented products as the patent holder enjoys monopoly. World Trade
Organization, in its Doha Declaration,8 recognizes the right of access to affordable medicines.
Life-saving medicines may be beyond the purchasing power of common masses in many
developing and underdeveloped countries due to patent protection enjoyed by the
pharmaceutical products. The availability of life saving medicines becomes even more
uncertain in case of national emergency. In such situations, the national governments may

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The birth of the concept of compulsory licenses is linked to the obligation, introduced by the United Kingdom
(UK) Statute of Monopolies in 1623. Compulsory licensing has been reported to be popular in Britain as early
as 1850s. Later it was recognized by the international community through Paris Convention of 1883
7
Paris Convention, 1883
8
The November 2001 Doha Declaration on the TRIPS Agreement and Public Health was adopted by the WTO
Ministerial Conference of 2001 in Doha on November 14, 2001. It reaffirmed flexibility of TRIPS member
states in circumventing patent rights for better access to essential medicines.

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avail the flexibility provided under WTO regulations by using the provision of compulsory
licensing. It may, however, be noted that a national emergency is not the only ground for the
issuance of compulsory license. Doha Declaration on Public Health 2001 provides freedom to
member states to determine grounds of compulsory licensing. In the absence of international
norms and standards for this practice, the grounds for granting compulsory licensing vary
from country to country depending on laws of each state. Compulsory licensing obviously
involves breaking of the exclusive right of the patent holder. The purpose behind breaking of
the patent right is to change the terms of bargaining between the buyer and the seller. For
instance, if the government is a buyer and the patent holder is a seller, and the parties fail to
negotiate a reasonable price of the product, compulsory licensing provisions provide for an
arrangement using which the government may dilute exclusive patent right of the patent
holder and license some other firm to sell the same product. Compensation is, however, paid
to the patent holder in exchange for use of his patent. Thus, compulsory licensing, by
stimulating generic competition, strengthens the bargaining position of the government
resulting in lowering of prices. Compulsory licensing is therefore yet another necessary evil.
It is a violation of the rights of the patent holder. But this violation sometimes becomes
necessary in order to improve availability of essential products at affordable prices. It is
pertinent to note that access to drugs or to deal with emergency public health situations is not
the only reason for grant of compulsory license. It can be used as a policy mechanism to deal
with anti-competitive practices, non-working of the patent, or other undesirable behavior of
patent holders7. Compulsory license not only forces the patent holder to use his invention for
the benefit of the society but also boosts generic industry of the country granting such
license.9
COMPULSORY LICENSING IN INDIA
Sections 82 through 94 of Chapter XVI of the Indian Patent Act contain the pertinent system
of compulsory licensing. The following categories can be used to break down the grounds for
granting a compulsory license under the Act:
(i) Abuse of patent rights (dealt with broadly under Section 8410);
(ii) ‘Public Interest’ (dealt with broadly under Section 9211).
(iii) New Grounds introduced by the 2005 amendments.

9
Convention for the Protection of Performers
10
The Indian Patent Act, 1970, §84 No.39, Acts of Parliament, India (1970)
11
The Indian Patent Act, 1970, §92 No.39, Acts of Parliament, India (1970)

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 (iv) Other provisions on compulsory licensing such as Section 91, dealing with the
licensing of related patents.
According to Section 84, any person who is interested in the invention or who is already the
holder of the license under the patent may seek the Controller to award a Compulsory
License on the patent three years after the date the patent was granted, provided that the
following conditions are met:
1. The reasonable requirements of the public with respect to the patented invention have
not been satisfied
2. The patented invention is not available to the public at a reasonably affordable price
3. The patented invention is not worked in the territory of India.12
The Controller must consider several things when granting a compulsory license, including
the nature of the invention, steps already taken by patent holders or licensees to fully exploit
the invention, the applicant's ability to use the invention for the benefit of the public, the
amount of time that has passed since the patent was granted, and other similar considerations.
Additionally, Section 92 of the Act states that the Controller of Patents may grant compulsory
licenses "Suo motu" in response to a notification from the Central Government in situations
of "national emergency," "exceptional urgency," or other similar circumstances. 13
"Public noncommercial use." When the Central Government announces in the Official
Gazette that extraordinary circumstances have mandated the award of compulsory licenses in
connection to patents that assist in addressing the exigency, the system under this clause is set
in motion. A person interested must nevertheless apply to the Controller for the issuance of a
compulsory license in accordance with Section 92(2).14
There are two types of Patent Licenses:
 Exclusive license: Under an exclusive license, a patent owner transfers all indicia of
ownership to the licensee only retaining the title to the patent. From the point of view
of the patent owner, he surrenders all rights under the patent (including the right to
sue for infringement and the right to license) to the licensee.
In essence, the licensee steps into the shoes of the patent owner and acquires the right to
sublicence the patent and sue for patent infringement. However, the exclusivity can be limited
by a field of use. That means that the licensee gets a promise from the patent owner that the
patent will not be licensed to anyone else in a stipulated field of use.

12
Supra Note 10
13
Supra Note 11
14
Id

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  Non-exclusive license: By granting a non-exclusive license, the patent owner
essentially promises not to sue the licensee for patent infringement. Some people
think that by acquiring a non-exclusive license the licensee acquires the freedom to
operate in the space protected by the licensed patent, but this may or may not be the
case. It depends on whether the licensee’s products infringe other patents.15
Terms and Conditions of Compulsory License

The terms and conditions of the license can be kept confidential by the Controller on request
by licensee or the licensor.
1. Royalty and other remuneration, if any reserved to the patentee or other person
beneficially entitled to the patent.
2. Patented article should be worked to fullest extent by a person to whom the license is
granted.
3. Patented article should be made available to the public at reasonably affordable
prices.
4. License granted is non-exclusive license.
5. The right of licensee is non-assignable.
6. License is for the balance term of patent unless a shorter term is consistent with the
public interest.
COMPULSORY LICENSING: BOON OR BANE
The concept of Compulsory Licensing is not new but India’s first Compulsory licensing in
the Natco Pharma Case16. The first compulsory license under section 84 given to India was
based on what the country's patent controller regarded to be an unreasonably high cost for
consumers and regional producers. As a result, the Patent the controller failed to take the
patent holder's R&D spending into account.
The Bayer medicine Nexavar, used to treat kidney cancer, was given a compulsive license.
Nexavar was launched in India in 2008. Four years later, after Natco Pharma's voluntary
license application was swiftly denied by Bayer, Natco Pharma applied for a forced
licence.20 Natco Pharma submitted a compulsory licence application to the Patent Controller
in August 2011.
The Controller General of Patents granted Natco Pharma was granted a compulsory licence to
use Nexavar. Because to price differences, Nexavar did not reach 98% of the Indian

15
Avtar Singh, Intellectual Property Rights: Patents, Copyrights, Trademarks & Allied Rights (7th ed. 2019).
16
Natco Pharma Ltd. v. Bayer Corporation, (2012) 2 SCC 357.

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population, hence Natco Pharma was given the mandatory licence. The medicine was
assessed at $5,000 per month by Bayer while Natco Pharma offered a price of $170 per
month, representing a 97% reduction in the overall cost. For the Indian market, Bayer clung
to an irrational price. Because Nexavar was deemed too expensive, a compulsory licence was
obtained. This was against Section 84(b), which stipulates that the drug must be reasonably
priced and accessible to the general public. The discussion of what constitutes "reasonable
affordability" has been sparked by this case.
Bayer attempted to justify its price of Nexavar citing R&D’s incurred costs during
development. As generic companies incur no such R&D costs, generics are approximately
97% cheaper than branded drugs.
Bayer attempted to justify its price of Nexavar citing R&D’s incurred costs during
development. As generic companies incur no such R&D costs, generics are approximately
97% cheaper than branded drugs.Natco Pharma contended that the price of Nexavar in India
shouldn't be set based only on the premise that the Indian market will cover all of the drug's
R&D expenses. Natco Pharma reminded the court that because they offer Nexavar in
numerous countries, Bayer's logic was flawed and that Bayer had made an incorrect
assumption. Bayer's explanation of the need for R&D implied that either India was the sole
market from which it received profits or that each country where Nexavar was sold would be
responsible for covering the same R&D expenses. In order for Bayer to introduce other drugs,
the expense of Nexavar must be recovered, however Bayer is not entitled to profit for R&D
costs incurred many times from different nations.
The Patent Controller ultimately concurred with Natco Pharma that the "fairly cheap price"
referenced in section 84 should be viewed from the public's perspective rather than from the
perspective of a firm. The Nexavar case could have an impact on further appeals because
India's judiciary seems to rule more frequently in patients' favour. Bayer attempted to appeal
the Patent Controller's decision to the Indian Patent Appellate Board (IPAB). The board
supported the Controller's judgement after the appeal was denied. Because Nexavar could not
be purchased by the general public for a reasonable price, Bayer's appeal was rejected.
After this judgment, BDR pharmaceuticals pvt. Ltd. Applied for the grand of Compulsory
license of DASATINIB which is a suitable chemotherapeutic option for the treatment of
chronic myeloid leukemia. In the case of BDR pharmaceuticals pvt. Ltd. Vs Bristol Myers 17,
the controller stated that the time has not come to make a determination regarding whether
the merits-based grounds of Section 84 are applicable. The Controller further ruled that the
17
BDR pharmaceuticals pvt. Ltd. Vs Bristol Myers, C.L.A. No. 1 of 2013

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deliberate actions taken by the applicant to only invoke the provisions relating to compulsory
licenses without taking the necessary legal steps and to refrain from engaging in any kind of
dialogue with the patentee in order to secure the grant of a voluntary license cannot be
categorized as an "irregularity in procedure/timeline" that can be waived, excused, or
declared not to have occurred. The controller thus held that a prima facie case for issuing a
Compulsory license under Section 87 is not made out and rejected the application of
Compulsory license. Similarly in the case of Lee pharma vs Astrazeneca 18, the applicant
failed to demonstrate whether the reasonable requirements of the public were met or not as
they could not statistically ascertain the requirements of Saxagliptin in India. Mere
assumption of tentative requirement of the drug was considered insufficient and an applicant
ought to statistically define the amount of the medication actually prescribed by doctors, the
demand of the medicine in the country vis-à-vis the supply etc.
We have seen that the Indian legal regime on compulsory licensing is well defined under the
Indian Patent laws and case of Natco pharma further adds to its development.
As we discussed earlier in this research paper that Compulsory Licensing is used in India for
the betterment of public sphere but the question arises that how does the grant of compulsory
licensing pose a threat to the economics or the competitive regime of a country.
As we discussed earlier, The TRIPS agreement19, which deals with trade-related aspects of
intellectual property rights, lays out the minimum standards for how national governments
must manage particular categories of intellectual property (IP), which also apply to the
citizens of other WTO members. The World Trade Organization (WTO member)'s countries
are all obligated to abide by this international agreement. In October 2020, India, Kenya,
South Africa, and Eswatini suggested a temporary suspension of the TRIPS restrictions due to
the current COVID-19 dispute. Under the conditions of the proposal, which called for a
waiver from TRIPS Part II, Sections 1 (Copyright), 4 (Industrial Designs), 5 (Patents), and 7
(Protection of Undisclosed Information) would not be carried out, applied, or required by the
WTO.20 This exemption would only apply to measures taken to avoid, manage, and address
the COVID-19 crisis. The WTO reached a decision on the contentious waiver on June 2022,
following a ministerial conference that was originally scheduled to last 4 days but ended up
lasting.

18
Lee pharma vs Astrazeneca, (C. L. A. No. 1 of 2015).
19
Supra Note 1
20
India, Kenya, South Africa, and Eswatini. "Waiver from certain provisions of the TRIPS Agreement for the
prevention, containment and treatment of COVID-19." Council for Trade-Related Aspects of Intellectual
Property Rights. WTO IP/C/W/669, October 2, 2022

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The popular assumption that IP protection hampers vaccine production and that
pharmaceutical company monopolies are the principal impediment to obtaining a universally
immunized population led to the TRIPS waiver. 21 When, in fact, what is needed to
accomplish the same thing is the creation of an effective distribution system. Instead of aiding
in the increase of vaccine manufacturing, the waiver of intellectual property rights would
serve as fuel for future abuse of IP and significantly impede innovation. 22 The very factor that
led to the creation of the COVID-19 vaccines, i.e., incentives for innovation in the form of IP
protections is being undermined by the waiver.
COMPULSORY LICENSING AND COMPETITION LAW
IPRs and competition law have a highly complex and difficult relationship. The IPRs forbid
the imitation and copying of goods, product features, industrial designs, and other things, and
in a way, they also promote fair competition in the market. On the other hand, the exclusivity
granted by IPR may be limited by the competition law if it has been used unfairly to exclude
rivals from the market. Therefore, a protection level for IPRs and competition that is either
too high or too low could be detrimental to the market because it will unnecessarily lead to
trade distortions.
India is moving more and more toward a free-market economy, where prices are set by
sellers, as opposed to a regulated market economy where prices are set by the government.
Compulsory licensing for prices set by sellers under the guise of "consumer welfare" is not
only unfair, but it also undermines the idea of a free market.23
Nevertheless, licensing agreements may provide threats to the competition. The possibility of
cartelization is the most significant of these and can appear whenever an agreement is
reached between real or future rivals in a particular market. There is a chance of collusion in
the market.
both in the market for goods created utilizing the licensed technology as well as the market
for the licensed technology itself.24 The implementation of cartel agreements between
licensees in the market for goods made with the licensed technology can take the form of
ostensibly vertical distribution agreements, such as getting the licensor to impose resale price

21
Huna Onderkova, Compulsory Licensing in India and changes brought to it by the TRIPS Agreement, IP
helpdesk, 12/10/2021, Compulsory Licensing in India and changes brought to it by the TRIPS Agreement
(europa.eu)
22
Supra Note 1
23
Suelen Carls, Daria Kim, Matthias Lamping et al, Arguments against a Waiver of Intellectual Property Rights,
Oxford Business Law Blog, 29/05/2021, 10 Arguments against a Waiver of Intellectual Property Rights | Oxford
Law Blogs
24
Padilla, Ginsburg, and Wong Ervin, 2019, OECD 20-21, 1989

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maintenance and thus setting prices at the licensee level. By increasing the transparency and
stability of the licensors' retail prices, vertical price fixing may likewise improve the stability
of a cartel arrangement at the licensor level.
Even in the absence of extraordinary circumstances, the CCI has the authority to impose a
compulsory license in order to further its socialist objectives, which utterly upset the harmony
between the IP and competition laws that are meant to foster innovation. Due to India's
obvious lack of IPR protection, it promotes socialism and discourages foreign investment, let
alone competition and a free market.
Another line of argument
But another line of reasoning could be that the grant of compulsory licensing may foster the
healthy competitive practices. By prohibiting anticompetitive agreements, enhancing
economic effectiveness, and enhancing consumer welfare, a well-developed competition
regime can offer a remedy.
Therefore, competition law intervenes to prevent such a monopoly scenario from becoming
deeply entrenched in the market, and from this, in certain niche circumstances, the concept of
compulsory licensing is established.
It meddles with the free market in order to prevent the monopoly holder from abusing it
against the interests of the broader populace. Due to the requirement that the license applicant
pay a specific fee to the patent holder, compulsory licensing fosters healthy competition. This
is consistent with the economic theories on that the foundation of the Competition Act.
The compensation provided to the patent holder serves as additional income and aids in
recouping the expenditures associated with producing the product.
Additionally, it adds to the cost of manufacture for the license applicant who wants to sell the
same product on the market. It thus brings about a just equilibrium in the market where the
interests of all parties are balanced. Competition law and IPRs converge and clash as a result
of this limitation on the IPRs available to the patent holder and his rights thereto, even though
they operate in separate domains and attempt to pursue two different goals.
In India, the system of mandatory licensing has experienced several changes and is still
evolving. There are various issues because of the weak jurisprudence.
considering the inventor's rights to his invention and if the general public interest outweighs
them. The promotion of knowledge access is the main goal of intellectual property law. If a
person is given a patent, their private right will prevail above the public "Right to Health"
right.

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For impoverished nations like India where access to medications may be hindered, this poses
a dilemma. They must pay a fee to access these patented goods the public by obtaining a
license for these products.
Due to the product's monopoly, highly large license fees are frequently expected, and access
to patented ideas is frequently exceedingly restricted and hard to come by, particularly in the
field of medicine.25
One common misconception is that IPRs and competition legislation work best together to
encourage both competition and innovation over the long term.
Despite this conviction, there is a rising dissatisfaction among some jurists who believe that
IPRs and competition law are incompatible. Because of the industry-wide exclusionary
impact of IPRs, the number of people who believe in ideas is increasing.
CONCLUSION
Compulsory licensing is a crucial tool in ensuring affordable access to life-saving medicines
for the public. India has been at the forefront of implementing this mechanism to balance the
interests of patent holders and the public. The Natco Pharma case serves as a significant
milestone in India's journey towards developing a well-defined legal regime for compulsory
licensing. However, the grant of compulsory licensing also raises concerns regarding the
impact on the economics and competitive regime of a country. The recent debate on the
TRIPS waiver during the COVID-19 pandemic highlights the need for a balanced approach
towards intellectual property rights and public health. While compulsory licensing can serve
as a means to achieve affordable healthcare, it is essential to strike a balance that does not
undermine the incentives for innovation and the development of new drugs. The ongoing
debate on this issue necessitates further discussion and engagement among stakeholders to
arrive at a solution that benefits all.
the relationship between IPRs and competition law is intricate, and a balance must be struck
to promote fair competition and innovation while preventing the misuse of exclusive rights.
India's move towards a free-market economy is a step in the right direction, but compulsory
licensing should not be used to undermine IPRs and promote socialist objectives under the
guise of consumer welfare. Instead, a balanced approach that protects IPRs and promotes fair
competition will encourage innovation, foreign investment, and a thriving free market.

25
Ruchika Ghosh, Compulsory Licensing of Patents and its effect on competition, J Med Soc [serial online]
2020 [cited 2023 May 11];34:55-60: https://www.jmedsoc.org/text.asp?2020/34/2/55/307907

15
In some circumstances, compulsory licensing may be necessary to ensure healthy competition
and prevent abuse of the market by a monopoly holder. However, the Indian system of
mandatory licensing still faces various challenges due to weak jurisprudence. The balance
between private rights and the public interest is a crucial issue, particularly in impoverished
nations where access to essential medicines may be hindered. The promotion of knowledge
access is a primary goal of intellectual property law, but the high license fees associated with
patented goods can make access difficult. While there is a growing belief among some jurists
that IPRs and competition law are incompatible, it is important to continue exploring ways in
which these two domains can work together to promote both innovation and healthy
competition over the long term. Ultimately, the goal should be to strike a balance between
protecting the inventor's rights and promoting the broader interests of society.

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