JAMIA MILLIA ISLAMIA

Faculty of law

Project

Intellectual Property in Patent Rights

Development of TRIPS in India

Submitted to: Prof. Dr. Aakriti Mathur

Submitted by: Zene Qamar

BA.LLB (Self-finance) 8th Semester

Roll no. 58

Batch: 2017 - 2022

Introduction

Protection of intellectual property plays a very important role in India. In the past two or
three decades, a number of changes have been made to IP policy and regulation in India to
increase the protection of intellectual property i.e. patent, trademark, copyright, design and
geographical indication. India signed the TRIPS agreement in the year 1994 which came into
effect from 1st January, 1995. In India, pharmaceutical patents were not granted prior to 1995,
which changed after the TRIPS agreement came into effect and brought about the amendment
of 1995 in the Patent Act, 1970. Section-5 of the Patent Act, 1970 which stated that patent is
granted only for methods or processes and not for products was repealed after the amendment
of 2005 and hence, today, patent is not only granted for methods or processes but also for
pharmaceutical products which has had a very huge impact on the growth of the economy.
A patent is one of the most effective of the intellectual properties for achieving economic
development1.
The number of Indian patent applications filed in recent days has increased as compared to
previous years and as a result, has led to the growth in the economy. At present the well-
established multinational companies in India have clearly proven the effect of intellectual
property for the growth of the economy in the world.
The scope of the patent system is to implement backing to research and methodology; which
eventually prefers the innovative brain. It wanted to support the creation of inventors by
providing them with a monopoly from any sort of commercial exploitation; maintaining the
flow of inventions. This system will increase the potential of such countries with the potential
to provide utility products through qualitative and quantitative methods through the
production of new methods for goods and services. It will improve the model of living and
encourage systematic sturdiness. The purpose following the procedure remains to execute the
privilege of creators by trading or practising their inventiveness. The primary postulate of
Patent is that the commodity is required to be innovative and serviceable.
The negotiation of Trade-Related Aspects of Intellectual Property Rights (TRIPS)
acknowledged being a complete treaty came into force on 1st January 1995 2. The domain of
the covenant covered by this agreement is copyrights and related rights, undisclosed

1https://www.mondaq.com/india/patent/827016/impact-of-patent-law-on-economic-growth-of-india-an-analysis
(last visited 17-05-21).
2 https://blog.ipleaders.in/trips-compliance-india-stand/ (last visited 17-05-21)
information, design for industries, protection of multiple plants and patents. The feature of
this agreement distinguished in the following manner:

1. Standard
2. Enforcement
3. Settlement of Disputes amongst nations

This agreement tries to cover the major areas for intellectual property rights, the obligation
shall be upon nations to provide protection. They define the protection i.e. subject-matter, the
minimum duration for protection and exception to Rights provided to nations. The relevant
provisions to this agreement are present. The agreement is related to the Convention of Paris
and Berne; the obligations are more on situations where pre-existing agreements were silent3.

We find the relevant provisions of this agreement under Article 2.1 and 9.1 of this treaty;
sometimes referred to as the Berne-Paris Convention. Primary customs as a common
approval on the International country and nations are granted in Article 3, 4 and 5; these are
obvious upon sections implemented in the Agreement for Intellectual Property Rights.
Introducing the TRIPS Agreement confers the purposes of Uruguay Round Negotiation and
customary laws discussed in it.

The treaty of TRIPS states in Article 9.2 to the strength of Copyright will spread exceeding
character will not bind to concepts, assurance, or methods of operations and others which is
necessary4.

A number of changes were introduced by the 2005 amendment, few of the important
definitions bought by this amendment are:

“inventive step” means a feature of an invention that involves technical advance as compared
to the existing knowledge or having economic significance or both and that makes the
invention not obvious to a person skilled in the art[1]

“new invention” means any invention or technology which has not been anticipated by
publication in any document or used in the country or elsewhere in the world before the date

3 ibid.
4 https://blog.ipleaders.in/trips-compliance-india-stand/#TRIPS_in_the_Indian_Patent_Act (last visited 18-05-
21)
of filing of patent application with complete specification, i.e. the subject matter has not
fallen in public domain or that it does not form part of the state of the art[2]

“capable of industrial application”, in relation to an invention, means that the invention

“invention” means a new product or process involving an inventive step and capable of
industrial application5[3]

“pharmaceutical substance” means any new entity involving one or more inventive steps[4]

Section 3(d) has been amended to read:

“the mere discovery of a new form of a known substance which does not result in the
enhancement of the known efficacy of that substance or the mere discovery of any new
property or new use for a known substance or the mere use of a known process, machine or
apparatus unless such known process results in a new product or employs at least employs
one new reactant”.

The use of the phrase “mere discovery of a new form of a known substance which does not
result in the enhancement of the known efficacy” has been brought into the statute book to
prevent what is known as ‘evergreening’.

Allowance of ongoing generic production:

The amendment permits generic manufacturers to continue producing generic versions of

new drugs which are in the mailbox. However, this only applies where the generic producer
has made a significant investment provided they were producing and marketing the generic
version prior to 1 January 2005.

But the generic companies are required to pay the patent holder a reasonable royalty.6

Public Health Protection

In the developing world there were deaths of up to 90 per cent of total deaths in the world and
these deaths occurred in South America, Asia and Africa which were related to HIV/AIDS,
Respiratory infections and Tuberculosis (TB). There are millions of people; who are suffering
from HIV but don’t have access to medicines to treat them. The reason behind the lack of

5 https://indiankanoon.org/doc/367586/ (last visited 17-05-21)

6 https://www.wto.org/english/tratop_e/trips_e/trips_e.htm (last visited 18-05-21).
facilities increased to a manifold, the barriers for treatment is the higher prices on drugs
imposed by companies. The stronger intellectual property increased the prices for prohibitive
drug prices and attempts by developing countries to reduce the amount got pressure from
industrialized countries and multinational companies. The minimum standard for protection
of Intellectual property including patents imposed on pharmaceuticals received criticism as
the treaty of TRIPs caused an increase in prices of drugs in the market. There are safeguards
which are available in the agreement to remove the negative effects upon the level of
protection upon drug prices. It is not clear from the agreement which countries can use the
safeguard because of the barriers to get access in medicine.

In 2001 in Doha, Qatar adopted a declaration titled TRIPs and Public Health under the
Ministerial Conference of WTO. The resolution specified that the Government of different
nations have the power to protect public health as they have self-determination. There were
many public health advocates; who embraced the resolution taken by ministers in Conference
because it prelates public health over private intellectual property. One of the important cases
under Public Health Protection was Big Pharma vs. Nelson Mandela; the dispute for trading
in the nation of South Africa. A suit was brought against the Government of South Africa by
Multinational Pharmaceutical Companies, which were 39 in number along with the South
African Pharmaceutical Manufacturers Association (SAPMA). The allegation made by
Pharmaceutical Companies concerned the Act of Medicines and Related Substances (MRS)
which as per them violates the basic principles of TRIPs and the Constitution of South Africa.
The amendment of the Act comprised a framework which provides affordable medicines
within the territory of South Africa. The provision of this amended Act was to substitute
generic with off-patent medicines, imposing prices on medicine transparently along with the
import of patent medicines.

The United States of America came to support Pharmaceutical companies to impose pressure
upon the Government of South Africa against the Act; received the support of the European
Union to restrict the benefits which it received through trading and warned them to face
severe sanctions. The Presidential Candidate for Democratic Party; Al Gore got confronted
with activists of AIDS, who highlighted the profound positive part of the amendment in the
Act which embarrassed him. Later, he received crowds during his election campaign which
made an allegation of his involvement in the dispute with South Africa and killings of kids in
the African continent. The policies against South Africa changed in 1999; the case reached
court in 2000. The multinational companies did not receive the support from their country
and the case was eventually dropped in April 2000 as they realized their weak position and
strong International outrage.

Last, we learned two issues after this case and they were a flexible interpretation of the
Treaty of TRIPs; during the public health use by developing with no challenge. Second, there
was an involvement of industrialized countries in developing countries to defend the interest
of multinational companies7.

TRIPS in the Indian Patent Act

The legislation of patent was brought by imperialist Britishers as they ruled over India over a
century. The influence of Great Britain started from the early 1600s with receiving
permission from Queen Elizabeth I under “Governor and Company of Merchants of London
trading into the East Indies”. Further, the responsibility of the company was taken over by
the Queen after the battle of 1857; considered as the first battle for Independence. We can
trace the enforcement for the rule of patent law from 1856 onwards; it gave the privilege to
inventors up to 14 years. There was a new law enacted in 1859 which gave privilege to
inventors to use and sell the invention in India and it aimed to secure control over the then
undesignated or undefined territory of India.

There were two legislations which were enacted; the Patents and Design Protection Act &
Protection of Invention Act which was passed in 1872 and 1883, respectively, consolidated as
Inventions and Designs Act 1888. Before the Independence of India, the Britishers brought
legislation in the category of goods protection, known as the Indian Patents and Designs Act
1911. This law brought an administration for a patent in India; its functions performed under
the supervision of the Controller of Patents. The terms which were allowed for filing date
were for 16 years and it was extended for an additional seven years. This legislation was
removed after Independence in the year 1970 after enactment of the Patents Act by the
Parliament of India8.

7 http://www.rajdeepandjoyeeta.com/#_ftn3 (last visited 19-05-21)

8 https://shodhganga.inflibnet.ac.in/bitstream (last visited 18-05-21)
The transmutation concerning India’s protection legislation under some multi-phased style
that resembled three alterations upon this Patents Act, 1970. This permitted claimants to
register pharmaceutical output license entreaties. Claimants moved to give exclusive
marketing rights (“EMRs”), ruled upon specified contingencies and warehouse these
outcomes to a term up to five ages of this time from the award.

The following addendum on this 1970 act remained enacted inside 2002. Aforementioned
alteration produced this within conformism among TRIPS approaching various matters, since
this fitted toward a twenty-year copyright duration, a repudiation from this freight regarding
evidence concerning method protection transgression, including alterations over obligatory
licensing necessities.

Exemptions from implementing pharmaceutical products for a patent until the year 2005.
Initially, India tried to implement the facility of mailboxes and EMRs which should have
been granted as per the order of the President; this rule didn’t pass in the Parliament of India.
This led to the USA using the dispute resolution mechanism of WTO against India as they
could not bring mailboxes and EMR. The failure of India discussed in WTO’s Appellate
Body in 1997 as they didn’t comply with the Treaty of TRIPs as Article 70.8(a) ignored as it
establishes a line “a means” which preserves novelty and priority to the pharmaceutical
product application for protection. They passed the amendment in 1999 of March, the
framework brought the composition of mailbox complied with the requirements of TRIPs; it
ended in December 20049. The amendment of 2002 brought various changes; as per the rules
provided in the treaty of TRIPs as definitions like invention and inventive step, algorithms
and traditional knowledge. The amendment brought three grounds provided to seek a
compulsory patent license and abolished the concept about the license of Right.

A petition filed by Novartis in 2006 in the High Court of Madras against the rejection of their
application for the license for the drug of a beta crystalline form of imatinib mesylate under
Section 3 (d) of the Patents Act by Patent Controller. The argument which was brought by the
Company was that the rejection violated Article 14 of the Constitution of India as the Act
provides discretionary powers to controllers which led to discriminatory results. The issues

9 https://mckinneylaw.iu.edu/iiclr/pdf/vol8p69.pdf (last visited 19-05-21)

were divided by the Bench of the High Court of Madras and Intellectual Property Appellate
Board (IPAB); The judgment was heard by the appellate body which decided against them.

The bench examined three issues:

(i) Whether the Indian court has a jurisdiction to decide upon International treaties?

(ii) Whether Section 3(d) of the Patents Act is consistent with Article 27 of TRIPs?

(iii) Whether Section 3(d) violated Article 14 of the Constitution of India?

The court decided they do not have jurisdiction on the issue raised by the Company because
the treaty is based on an International Convention. The third issue brought that Section 3(d)
doesn’t violate the principle of Article 1410 of the Constitution of India. They ended by saying
that the Government of India will have the duty to provide good health to its citizens by
providing easy access to life-saving drugs.

The recommendation addressed through these developed nations concentrated superimposed

the strength concerning Intellectual Property Rights. The Council of the European
Communities installed a European Agency for the Evaluation of Medicinal Products (EMEA)
that furthermore established forward methods concerning that Commission of the European
Union; midway empowered retailing consent concerning some social including veterinary
remedial commodities following an affirmative experimental evaluation through the EMEA.
The exceptional brand condition exists strenuously resisted through the pharmaceutical
industry. Areas for adversary imply the provision remains inimical over these directives
concerning this EMEA, does hostile over European Union sanctioned constitution, against so
holdings regarding this Court of Justice of the European Communities, antithetical toward
that Identity tag statutes, is inimical to Council Directives is profoundly unrealistic.

Section 3(d) of the Patents Act specifies that an insignificant development of a distinct matter
which continues to the known will not result in the augmentation of observed productiveness

10 https://www.who.int/healthsystems/topics/health-law/chapter10.pdf (last visited 19-05-21)

of that matter. The simple use of a recognised material; learning shall not hold as originality
to get the permission of the copyright. The new Act for a Patent is upon the principle of ”
exhaustion of Patent Rights” which says that once an investor sells their invention will lose
the right to control the sale of the invention. The aim of this principle contains an interest to
provide medicines at lower-rate, although this principle isn’t in developed countries.
Moreover, Article 6 of TRIPs agreements doesn’t mention much about the exhaustion as it
says the issue concerns the exhaustion of intellectual property rights. The principle of
inherent anticipation used by the USA & United Kingdom to deal with trivial modifications
in pharmaceutical patents.

Recommendations

1. The confession regarding specific beginning and realm regarding this source of the

organic supply.
2. An improvement regarding this TRIPs Agreement to counter systemic struggles;

including the CBD stemming of that implementation concerning TRIPs.

3. An antecedent notified acquiescence by permission regarding jurisdictions under

these appropriate governmental administrations.

4. The just and impartial benefit-sharing following each applicable governmental

administration.
5. Conventional producers are entitled to store including trade grains that people

must have accumulated.

6. The Indian Patent Act obliged to amend in addressing impairment of Intellectual

Property Rights an area toward abolishing this protection.

Conclusion

India has a distinct demand for consumerism along with holding a store towards professional,
managerial and entrepreneurial abilities. The nation can convert as a haven for projects in
analysis and improvement onward with assurance proffered to copyrights. The administration
of Government expects to have a reflection towards globalisation; moderately than isolation.
The standard and norms to provide a license to goods or inventions are required as per the
treaty of TRIPs and outlined to defend the heterogeneity of the ecosystem11.

Indian Patent Law was amended in compliance with the TRIPS agreement after India became
a signatory to the TRIPS agreement. As a result, many Multinational Companies started
investing in India. MNCs also started their Research & Development process in India which
has indirectly increased the economic growth of India and has provided employment to the
people of India. At present India needs to invite more Multinational Companies for investing
and starting their Research & Development process in India. This way, the economy of India
will increase. The Pharmaceutical Industry of India has grown from 6 billion US Dollar to 30
billion US dollar over the last ten years, this is because many Pharmaceutical Multinational
Companies have invested and started their research and development process in India after
the year 200512.

11 id.
12 https://rajdeepandjoyeeta.com/trips-and-india/ (19-05-21)