ASSIGNMENT – 1

Name – ABINASH DAS

Institution – P. G. Department of law, Utkal University

(Q.1) Explain the role of artificial intelligence, evergreening of patent

and compulsory license in the field of IPR?

I. ROLE OF ARTIFICIAL INTELLIGENCE IN THE FIELD OF IPR

“A world deployed on Artificial Intelligence is a destiny chosen by humans and it will be

preferable to be appropriately prepared for this age of science where it is not mere fiction”.1

AI in simple terms can be defined as the ability of a machine to mimic intelligent behaviour.
Nowadays there are machines that create highly creative works that would definitely be
eligible for copyright protection if they were created by humans. This calls for a re-
examination of copyright standards for AI systems all over the world. In the near future, the
works of Artificial Intelligence systems cannot be denied IP protection solely on the basis of
the argument that they are not humans or legal persons. To deny them the rights enforceable
by any citizen of any country will amount to an infringement of their rights. Inclusive growth
in the future will mean the inclusion of every form of scientific advancements. This means
that even Artificial Intelligence systems or machines should be part of this growth. It is time
for a new world renaissance.

PATENTS ACT, 1970 AND ARTIFICIAL INTELLIGENCE

Section 2 (p) of the Patents Act, 1970 defines the term “patentee”. “Patentee” means a person
for the time being entered on the register as the grantee of proprietor of the patent. Section 2
(t) defines “person interested”. “Person interested” includes a person engaged in, or in
promoting, research in the same field as that to which the invention relates. Section 6
prescribes the list of persons who can apply for a patent. (a) Any person claiming to be the
1
Recently, Sophia became the first robot to receive citizenship of any country. Sophia became the citizen of
Saudi Arabia. This marked the beginning of an era of robot citizens. The society and the legislations governing
it should be well equipped to accommodate such revolutionary changes.
true and first inventor of the invention. Section 2 (y) of the act defines the term “true and first
inventor”. It does not include either the first importer of an invention into India, or a person
to whom an invention is first communicated from outside India. Section 2 (y) does not
specifically state that the “true and first inventor” should be a human and therefore it can be
considered to be providing a scope for the inclusion of works by AI systems. But since the
definitions for terms like “patentee”, “person interested” etc. states that it should be a person
(a legal person), intention of the legislature for the general purpose of the act can be
understood to be favouring humans and other legal persons. Thus, it is important that these
enactments should be amended in order to suit the requirements of the evolving society and
scientific systems

COPYRIGHT ACT, 1957 AND ARTIFICIAL INTELLIGENCE

The sine qua non of copyright is originality. Originality is a pre-condition to copyright

protection. A work is granted protection only when it is original i.e. it is not copied from any
other work. It is not even necessary that the work should involve novel expression of a
thought. All that is required for originality of expression is that the expression should not be
copied from another work. Thus the work should be composed by the author independently.
There are two doctrines related to the test of originality of a work. They are:

i) Sweat of the Brow Doctrine.

ii) Modicum of Creativity.

According to the Sweat of the Brow Doctrine, an author can get a copyright on his work by
employing simple diligence. There is no requirement of substantial creativity or originality.
He is entitled to a copyright only on account of efforts and expense put in by him in the
creation of such a work. According to Modicum of Creativity, originality subsists in a work
where a sufficient amount of intellectual creativity and judgment has gone into the creation
of that work. The degree of creativity need not necessarily be high but a minimum level of
creativity should be ensured for copyright protection. The Indian Courts have adopted the
modicum of creativity test in the case of “Eastern Book Company vs. D.B. Modak.” After a
thorough reading of this doctrine emphasized in the aforementioned judgement, it cannot be
said that AI systems cannot achieve modicum of creativity. Thus, the works of these
machines can pass the test of originality. A provision under the Copyright Act, 1957 which
poses a challenge to copyright protection to works of AI systems is Section 2 (d) of the act.
This section defines the term ‘author’. For ownership of any copyrighted work, the person
should fall under the ambit of an “author”. This is a complex situation for AI because they
are generally not regarded as a legal person. According to Section 2 (d) “author” means,- (vi)
in relation to any literary, dramatic, musical or artistic work which is computer generated, the
person who causes the work to be created. The problem under this definition is the phrase
‘the person who causes the work to be created’. For a person to cause a work to be created
proximity of the person with the work is important and for the purpose of this act person here
means a human or a legal person. Thus, the current Copyright Act is not inclusive of AI
systems. Thus, when it comes to works that are created by AI, their authorship would be
ambivalent under Indian Copyright Laws.

II. ROLE OF COMPULSORY LICENSE IN THE FIELD OF IPR

“Compulsory licence is an involuntary contract between a willing buyer and an unwilling

seller imposed or enforced by the law.”

Compulsory license is an authorization given by the national government or its agency to a

person without or against the consent of the title-holder, for the exploitation of a subject
matter protected by a patent or other intellectual property rights. 2 The compulsory license in a
sense is seen as a threat to greedy patent holders to work their productions at reasonable
prices. The Compulsory license thus provides a safeguard against lack of use of a patent or
misuse of the patent holder’s monopoly rights in order to protect the public interest. The
provisions with respect to compulsory licensing endeavour to secure that the articles
manufactured under the patent shall be available to public at the lowest possible prices
consistent with the patentees deriving a reasonable advantage from patent. The TRIPS
Agreement undertakes to tackle with the issue of high prices of patented drugs by allowing
for their compulsory licensing, under Article 31, which covers “Other Use without
Authorization of the Right Holder”. Under the provisions of TRIPS, a member country can
force patent holders to issue compulsory license under certain circumstances, including
“national emergency.” Hence, the compulsory license allows the generic version of the
patented drug to be manufactured and sold by the third parties or governments, in
competition with the patented versions. The interested user must first make efforts to obtain a
voluntary license from the patentee on “reasonable terms and conditions.” But in case of

2
A “compulsory license” is termed as “Other use without the authorization of the right holder” under TRIPS
Agreement, Article 31.
“national emergency or under circumstances of extreme emergency or in case of public non-
commercial use”, the aforementioned condition can be parted with after informing the
circumstances to the patentee. TRIPS provisions affect access to affordable medicines, a
crucial part of the right to health.3

DOHA DECLARATION - A HEALTH PERSPECTIVE

Doha Declaration emphasizes the right of every member to grant compulsory license and
freedom to determine the grounds upon which such licenses are granted. This provision in a
sense implies that none of the limitations on compulsory license, as enumerated under Article
31 of TRIPS shall apply. But the Declaration did not intend so, and also clarified “national
emergency” condition.4

INDIAN LAW ON COMPULSORY LICENSING

The provisions with respect to compulsory license are incorporated in Chapter XVI of the
Patents Act 1970, consequent to the 1999, 2002 and 2005 amendments following Ayyangar
Committee Report, in order to comply with the requirements of TRIPS agreement. 5 The effort
of the Government of India to provide a National IPR Policy in 2016 has provided an
impetus in enabling “strong and effective IPR laws, which balance the interests of rights
owners with larger public interest”. Further, amendment of 2017 enlarges the scope of
compulsory licence as, if any developing country needs to turn to the option of compulsory
licensing to produce needed affordable pharmaceuticals, producers overseas can step up and
supply that need, even if a compulsory licence is needed in that country. It is therefore a
compulsory licence especially for production in one country, for export, to meet the public
health needs of one or more other countries. The rational justifying the idea of compulsory
licence is that, patent so granted should not impede protection of public health and should act
as an instrument to promote public interest in the sectors of vital importance for socio-
economic and technological development of the nation. Patents are granted to make the
benefit of the patented product at a reasonable price that is affordable to a large section of
public. To access the benefits of patent compulsory licence can be granted. As per Section 84,
3
World Health Organization, Programme- Meadicines, Access To Essential Medicines As Part Of The Right To
Health.
4
Regarding clarification of “national emergency”, the Doha Declaration stated that each member had the right
to determine what will constitute national emergency or other circumstances of urgency in that nation. It being
understood that public health crises, like HIV/AIDS, T.B, malaria, etc can be circumstances of national
emergency/ extreme urgency.
5
The Patents (Amendment) Act 2002 (India) came into force on 20 May 2003 and has effected consequential
amendments to the Patents Act 1970.
any person, regardless of whether he is the holder of the license of that Patent, can make a
request to the Controller for grant of compulsory license on expiry of three years, when any
of the following conditions is fulfilled –

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.

The Indian Judiciary espouses the proposition of sparing grant of compulsory licenses to the
generic manufacturers. This is done to uphold equilibrium of the conflicting interest of the
parties involved. India's first ever compulsory license was granted by the Patent Office on
March 9, 2012, to Natco Pharma for the generic production of Bayer Corporation's Nexavar,
a life saving medicine used for treating Liver and Kidney Cancer. Bayers sold this drug at
exorbitant rates, with one month's worth of dosage costing around Rs 2.8 Lakh. Natco
Pharma offered to sell it around for Rs 9000, making it affordable for people belonging to
every stratum. The provision relating to compulsory licensing upon a notification by the
central government (section 92) and it comes into play only after the patent has been granted.
This can be significant for access to diagnostic kits, vaccines (like Bharat Biotech’s Covaxin)
and drugs undergoing trials (like Remdesivir), which are covered by existing patents. Idea of
a better world is one in which medical discoveries would be free from patent and there will
be no profiteering from life and death.

III. ROLE OF PATENT ACT – A CHECK ON EVERGREENING OF PATENT

“Section 3(d)” was enacted primarily to prevent “evergreening” as it specifically rejects the
patents for the mere discovery of a new form of known substance unless such product
manifests significant enhanced “therapeutic efficiency” over the original and known
substance. Section 3(d) does not allow patent protection for the mere discovery of any new
form of known substance unless it enhances the efficacy of the original substance. It also acts
as a bar on the new use patents by stipulating that mere discovery of any new property or new
use of a known substance would not be patentable. The term “evergreening” has not been
defined in Patents Act, 1970 but this patent strategy consists of securing patents on minor,
more often trivial, modifications of existing pharmaceuticals products or process in order to
indirectly extend the period of patents protection over previously patented compounds. It is
an improper extension of life of patent beyond 20 years without actually being benefiting the
pharmaceutical sectors. It is argued that, Novartis has attempted to do so by applying patent
for beta form of the compound.

The 2013 judgment of Novartis AG v. Union of India6 has a major implication in shaping the
Indian legislation regarding patent protection. The Novartis pronouncement was made after
considering many socio-economic factors. The Supreme Court upheld the intent of the
legislature behind Section 3(d) of Patents Act by providing strict and narrow interpretation of
test mentioned therein. As mentioned by the Supreme Court that Section 3(d) was introduced
to prevent evergreening, to provide access to the lifesaving drugs and to discharge their
constitutional obligation of providing good healthcare to its citizens. This shows that external
economic and social factors are a priority for India. But this pharmaceutical based specific
test of “therapeutic efficacy” has brought various uncertainties. It is pertinent to note that,
more uniform standard also provides a more predictable system for multinational
pharmaceutical companies and allows them to invest in research and development aimed at
addressing the health needs in developing countries. In 2003, WHO reported that more than
50% of the population in Asia and Africa did not have access to essential drugs. Many factors
contribute to this problem of limited access. One of the prime reasons could be the inadequate
production and inadaptability to the specific local conditions that can be addressed if
multinational corporations have the right incentives, such as patent protection for incremental
pharmaceutical innovations in the developing country. The concern of high price of drug is
also one of the facets but can be tackled by alterative measures like compulsory licensing.

(Q.2) Are there legal solutions to the pandemic and how can they be put
into application? Are there solutions to it in environmental law?
Discuss in detail.

I. OVERVIEW OF THE EPIDEMIC DISEASES ACT, 1897: FALLOUT OF

EXISTING LAWS

“Extraordinary situations warrant extra ordinary remedy”

6
(2013) 6 SCC 1.
The Epidemic Diseases Act, 1897 is one hundred and twenty-three years old legislation. It
was incorporated by the Britishers to fight the bubonic plague epidemic in 1896 in the
Bombay Presidency. This underlines a vital fact which cannot be ignored, i.e. the Act was a
mechanism for handling epidemics when the technology was not present, medical
advancement had not occurred, and India was not independent. This law was helpful in the
aforesaid conditions. This colonial-era law was meant to ‘to provide for the better prevention
of the spread of dangerous epidemic diseases’. At the outset, this Act7 merely talks about
giving powers to the government when they are ‘satisfied’ that the ordinary laws are
insufficient. The Act has a mere four sections which are supposed to help us through large-
scale epidemics. Out of those four sections, one is about the title and extent of applicability of
this Act.8 Sections 2 and 2A of the Act empowers the State Government to take temporary
measures for preventing a threatening epidemic if the existing laws are insufficient to curtail
it.9 It also has the power to determine the method and manner of covering the expenses
undertaken. However, the state government has to inform the people of such measures
through public notice. Another section prescribed the penal provisions, which said that any
disobedience of the Act would lead to an offence punishable under Section 188 of the Indian
Penal Code (IPC).10 The fourth section deals with legal protection to implementing officers
acting under the Act, i.e. it is a defence provision which exempts anyone doing an act in good
faith under the Act. This Act places too much emphasis on isolation or quarantine measures,
but is silent on the other scientific methods of outbreak prevention and control, such as
vaccination, surveillance and organised public health response.11

The existing state laws do not have a wide sweep and ambit. They generally do not cover
harassment at home and workplace and are focused more on physical violence only. Merely
shifting the burden on to the government to take necessary steps or to address quarantine
measures is not just the solution. This is a power which will be difficult to challenge because
the threshold set is very subjective and vague. Secondly, the Act refers to Section 188 of the
IPC for punishment which can give a maximum punishment of six months imprisonment or a
thousand rupees.12 Breaking of such laws can be fatal and might increase the spreading of the
7
The Epidemic Diseases Act, 1897
8
Section 1, The Epidemic Diseases Act, (1897)
9
Section 2, The Epidemic Diseases Act, (1897)
10
Section 3 prescribes the penalty for disobeying any regulation or order made under the Act in accordance with
Section 188 of the Indian Penal Code, which is an offence of disobeying directions of a public servant.
11
Owing to the current health needs of the nation, the first and the basic flaw that can be seen in the Epidemic
Act 1897 is that it is silent on the definition of “dangerous epidemic disease”.
12
Section 188 of Indian Penal Code: Disobedience to order duly promulgated by public servant will warrant
simple imprisonment for a term which may extend to one month or with fine which may extend to two hundred
diseases as we have seen in the COVID-19 case. Henceforth, in such demanding
circumstances, the maximum punishment is at such a low standard that it might not act as a
deterrent. Additionally, the need for amendment of the Act is there despite the existence of
other provisions like Section 269 and 270 of the Indian Penal Code, 1860. Primarily, these
provisions which talk about spreading fatal diseases have a maximum punishment of six
months and two years respectively. Moreover, both of these offences are bailable. This shows
the level of stringency of these provisions, which should be more, considering the situation
during the COVID-19 outbreak. Section 269 of the Indian Penal Code covers any unlawful
and negligent act and Section 270 covers a malignant act. These provisions do not cover an
act that was done legally, carefully and was a harmless or non-malignant act. During the
COVID-19 outbreak, there were instances all over the world where the virus was transferred
by doing legal and careful actions that were harmless, like handshaking, touching a common
surface, etc. The Act works hand-in-hand with the IPC, but in case of a conflict between the
both, the Act will override IPC since a special law overrides a general law. So, the Act needs
to cover various aspects that are not covered in the general laws.13

II. NEED FOR A NATIONAL LEVEL LEGISLATION TO PROTECT THE

CRITICAL SERVICE PROVIDERS

India, for all its glaring inefficiencies has done remarkably well so far. Credit is due for all
the health workers and the frontline staff for averting the crisis. Now the State under the
doctrine of ‘parens patriae’ is under a Constitutional obligation to protect the rights and
liberties of the health workers as envisaged under the Constitution of India. 14 A life-
threatening epidemic like COVID-19 is an eye-opener for us. It tells us that in tough
situations, time-worn laws cannot help us. Instances of violence against the health care
professionals acted as an impediment to the smooth functioning of medical facilities.
Members of healthcare services are targeted and attacked by miscreants, thereby obstructing
them from doing their duties. They have become the most vulnerable victims as they have
been perceived by some as carriers of the virus. Such a situation tends to hamper the medical
community from performing their duties to their optimum best and maintaining their morale,
which is a critical need in this hour of national health crisis. This has led to cases of their
stigmatization and ostracization and sometimes worse, acts of unwarranted violence and

rupees, or both.
13
The recent ordinance to amend the ‘Epidemic Disease Act, 1897’ traces its origin from the directions issued
by the Supreme Court in the case of ‘Dr. Jerryl Banait vs. Union of India.
14
Article 21 of the Constitution of India, 1950.
harassment.15 Currently, doctors are the ones who are most prone to viral infection. They are
being spat at and assaulted for entering their own homes because of their exposure to the
virus. Landlords are evicting them from their rented premises due to the risk of infection,
police officers are assaulting the female doctors and the relatives of the deceased are
attacking the doctors for negligence. All these instances demand protection for healthcare
workers.

There should be incorporation of stringent laws which deter the mischief mongering, like
implementation of Section 353 of Indian Penal Code 1860.16 It provides that “whoever
assaults or uses criminal force to any person being a public servant in the execution of his
duty with the intention to prevent or deter that person from discharging his duty” will be
punished with imprisonment of either description for a term which may extend to five years
or fine. With the increasing amount of pressure on health care personnel, their protection
takes precedence over other issues. The 2020 ordinance brings a sigh of relief to such
professionals but the true test of legislation lies in its effective implementation.

It is often said that the government machinery is slow, inept and ponderous. But having a
billion-plus people confined to homes for well over a month is no mean task. The ulterior
object of the government passing this ordinance is that the number of people getting cured is
increasing day by day. So the protection of health workers in averting this crisis is
quintessential. This can be done in following two-fold measures:

1. If the Central government is of the view that it is not feasible to enact special
legislation for the protection of doctors, relevant amendments can be made to the
Indian Penal Code to include a specific provision stating violence against them as an
offence.
2. Article 249 of the Indian Constitution gives power to the Parliament to make laws on
any subject matter enumerated in the state list in the national interest. Considering the
present scenario of COVID-19 and increasing violence against the doctors and other
medical staff, there is a dire need for a central law ensuring protection to be enacted in
the national interest. The Indian Judiciary should play a more active role in taking up
cases of violence against the healthcare professionals and assuring justice to them.17

15
Promulgation of an Ordinance to amend the Epidemic Diseases Act, 1897 in the light of the pandemic
situation of COVID-19; Press Information Bureau.
16
It should not be a mere dead letter and can act as a stonewall for the protection of health workers who are
dispensing public duty.
In this regard, the parliament should take necessary steps in furthering the ban of poaching or
illegal trade of endangered species, so that the world will not witness any such disaster like
that of COVID 19.

17
The right to health has been recognized by the Hon’ble Supreme Court time and again as an integral part of
the right to life and personal liberty. Article 21 of the Constitution of India, 1950.