A CRITICAL STUDY ON PATENTABILITY OF TRADITIONAL

KNOWLEDGE

A DISSERTATION

Submitted by
MANEESHA SUNILKUMAR
Reg.no. 2357224

Under the Guidance of

Dr. RAM RAO
Professor

In Partial Fulfilment of the Requirements for the Award of the Degree of

MASTERS OF LAW IN
INTELLECTUAL PROPERTY AND TRADE LAW

School of Law
CHRIST (Deemed to be University)
BENGALURU, INDIA

1
 MARCH, 2023

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 ABSTRACT

During the era of spreading deceases throughout the world,

pharmaceutical and biotech companies are still striving for new and better
ways to healing diseases. The bulk of these firms have understood that
useful ingredients for these goals may be found in the natural resources of
indigenous and local communities. Despite widespread recognition of the
importance of these biological resources to global health and economic
survival, the legal ownership and management of traditional knowledge is
still a difficult topic. The goal of this paper is to compare how traditional
knowledge is protected in different communities. In addition, there is
international patent law and conventional knowledge rules to
consider.Some of the important questions to be considered are what is
traditional knowledge? And what role have national patent laws had in the
preservation of plant species and genetic resources in different countries?
What are the current international patent regulations, and how do they
influence conventional knowledge protection? Finally, what more
safeguards are on the prospect.This research looks at patent rules and
clarifies terms like conventional knowledge and other important ideas.
After that, the article will discuss why traditional knowledge should be
maintained. The paper will discuss the current international legal
framework for the patent system, as well as the challenges of using a
patent to conserve traditional knowledge and some case studies in this
field. It also assesses some of the ideas and methods that have been
offered.

WIPO is currently working on a draft international law aimed at

safeguarding traditional knowledge. The research's focal point is which
examines whether existing intellectual property laws are adequate for
safeguarding traditional knowledge.Furthermore, the research highlights
various instances where indigenous communities have harnessed

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intellectual property laws such as patents, copyrights, trademarks, and
geographical indications to shield their traditional knowledge. In
conclusion, the research asserts that while intellectual property laws offer
a degree of protection to traditional knowledge, they do not provide
comprehensive safeguards.

Statement of problem

The existing legislation and the authorities thereunder are unable to curb
the subject matter of traditional knowledge as TK include a wide range of
topics . And it can be inferred that there is no protection of traditional
knowledge in India ,there are several unresolved problems like the
ownership and modes of enforcement of rights. A strict patent protection
is needed for the protection of medicines as TK which belong to
indigenous communities. Furthermore, Indian patent Acts legal provisions
are insufficient to preserve traditional medical knowledge. And the need of
title holders whether individuals or communities ,modes of acquisition,
including registration , duration and means of achieving rights of
Traditional knowledge by nature belongs to indigenous community who
lacks awareness about the existing legislation to protect their respective
traditional knowledge which results in the misuse or infringement of their
intellectual property rights

Research question

1.What is the impact of India's legal framework, specifically the Indian

Patent Act, on the protection and conservation of traditional knowledge
belonging to indeginous community ?

2. How can the Intellectual Property system, particularly patent law, be

utilized to protect and preserve traditional medicinal knowledge and
biodiversity in India?

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3. What are the challenges and limitations faced by existing legislations
and authorities in curbing the subject matter of traditional knowledge and
protecting indigenous communities' rights?

Research Objectives

1. To analyse the impact of national patent laws in the conservation of

plant species and genetic reserves in various countries

2. To find the most recent developments in international patent laws

3. To evaluate whether the present mechanisms are adequate to meet the

problems involved in protecting the traditional knowledge

4.To analyse the weaknesses and inadequacies existing in the regulatory

measures and to find what all improvements can be introduced for the
protection of traditional knowledge

Research Methodology

In contrast to a research approach centred largely on gathering relevant

data from a wide group of instances, a case study concentrates on a
particular case such as a person, an institution, an event, or a country. A
case study focuses on a deep case study of a small number of incidents or
situations, as well as their connections. In this paper, research will rely on
the findings, conclusions, and suggestions of qualitative research
methods, as well as studies undertaken in the field of Intellectual Property
regime.Furthermore, the research is limited to secondary data. Secondary
data is information that has previously been acquired by someone else
and has gone through to the statistical process. These data are collected
from a multiple of sources, comprising earlier publications on the subject,
newspapers, and Internet websites. The researcher completed extensive
study in order to comprehend and develop the difficulties around the
current dilemma.

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 CHAPTER- 1

LITERATURE REVIEW

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 Literature Review

1.WILLFUL PATENT FILING; A CRIMINAL PROCEDURE PROTECTING THE

TRADITIONAL KNOWLEDGE” – By Vincent M. Smolczynski (ARTICLE)

This section discusses the issues that exist in traditional knowledge

balancing normative and economic/public considerations when
determining the appropriate level of protection for objects. The right of
recognition and protection of the group is responsible for the
development, testing and validation of traditional knowledge. While their
contribution is undeniably important, an outright ban on all intellectual
property rights that would appear to use traditional knowledge would go
against any regime on Intellectual property rights. The author has

7
explained in detail how TK holders need to be able to play an active role in
this process without having to bear the burden of fighting patent seekers.
Furthermore, the document emphasizes that by protecting traditional
knowledge from foreign intellectual property rights, the misuse of
traditional knowledge will be reduced and the gap between developing
and developed countries will be reduced.The extracted parts of the article
discuss the protection of traditional knowledge under current intellectual
property schemes. It highlights the challenges faced in protecting
traditional knowledge and the potential consequences for local
ecosystems and indigenous communities. The content emphasizes the
importance of balancing normative and economic considerations when
determining the level of protection for traditional knowledge. The
document also mentions the ability of traditional knowledge holders to
initiate criminal prosecution and the different manners in which traditional
knowledge can be protected, such as through positive protection or
defensive protection schemes. Additionally, there is debate over the
proper venue for protecting traditional knowledge, including national laws,
international directives, or a cohesive body of patent law.

2 .“PATENTS IN INDIA”- By Ved P. Mithal (ARTICLE)

Thorough analysis of the Indian patent landscape. Starting with the

historical perspective, it would delve into the colonial-era origins of patent
law in India and the subsequent reforms that took place post-
independence. The evolution of patent regulations and their alignment
with international treaties and agreements, such as TRIPS (Trade-Related
Aspects of Intellectual Property Rights), would be examined in
detail.Within the legal framework, the review would highlight key
provisions of the Patents Act, 1970, and its subsequent amendments,
shedding light on what is considered patentable subject matter and the
criteria for patent examination. The delicate balance between protecting
innovators’ rights and ensuring public access to knowledge and essential
goods would be explored, emphasizing the broader context of intellectual
property rights within India.Moreover, the review would assess the

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practical implications of the Indian patent system on innovation and
technological advancement within the country. It might include case
studies or statistical data demonstrating the impact of patents on various
industries, particularly in areas like pharmaceuticals, where issues of
evergreening and access to affordable medicines have been
contentious.Comparisons with patent systems in other nations,
particularly those in similar economic development stages, would be a
valuable aspect of the review. Analyzing how India’s approach aligns or
diverges from global norms can provide insights into its competitiveness
and innovation ecosystem.Incorporating recent developments in Indian
patent law and policy changes would ensure the review’s relevance to the
current landscape. This could encompass amendments, court rulings, or
shifts in patent examination practices and their potential ramifications.

In conclusion,holistic understanding of the Indian patent system, ranging

from its historical roots to its contemporary challenges and opportunities.
It would serve as a valuable resource for scholars, policymakers, and
practitioners interested in India’s intellectual property landscape and its
implications for innovation and access to technology.

3.“INDIA’S CONTROVERSIAL NEW PATENT REGIME: THE END OF

AFFORDABLE GENERICS?” – By Sierra Dean (ARTICLE)

This article likely delves into India's evolving patent regime and its
potential consequences for the production and accessibility of affordable
generic medicines. It would likely explore recent changes in India's patent
laws and their alignment with international agreements, such as TRIPS,
and how these changes impact the pharmaceutical industry. The article
may scrutinize the implications for both the Indian pharmaceutical sector,
including its capacity to manufacture low-cost generics and compete
globally, and the broader global healthcare landscape, especially in terms
of access to essential medications. It might also touch on the legal
disputes and controversies that have arisen due to these changes and the
ongoing debate surrounding the balance between safeguarding
intellectual property rights and ensuring affordable healthcare. Overall,

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the article would provide a critical examination of the shifts in India's
patent regime and their potential effects on the availability of affordable
generics.

.4.“INTELLECTUAL PROPERTY; PATENTS, COPYRIGHT, TRADE MARKS AND

ALLIED RIGHTS”- 7TH Edition, By W. Cornish, D.Llewelyn and T. Aplin

This comprehensive book offers a thorough examination of intellectual

property law, providing in-depth insights into the realms of patents,
copyrights, trademarks, and related rights. It begins by establishing the
fundamental principles and historical context of intellectual property,
tracing its evolution from its origins to the modern legal framework. The
book then delves into the specific areas of intellectual property protection,
starting with patents. It covers the requirements for patentability, the
patent application process, and the enforcement of patent rights. Moving
on to copyright law, the book explores the protection of creative works,
including literary, artistic, and musical creations. It addresses issues like
the duration of copyright, fair use, and the challenges posed by the digital
age. In the section on trademarks, the authors discuss the significance of
branding and how trademarks are registered, protected, and enforced to
safeguard a company's identity and reputation.Throughout the book,
readers can expect to find detailed analyses of pivotal legal cases,
statutes, and international treaties that have shaped intellectual property
law globally. The authors also consider emerging trends and contemporary
challenges, such as the impact of digital technologies on intellectual
property rights, and the balance between innovation and access to
knowledge.Furthermore, this book provides valuable insights for
practitioners, scholars, and policymakers by offering practical guidance on
navigating the complexities of intellectual property law. It serves as a
comprehensive reference that helps readers understand the intricate
interplay between innovation, creativity, and commerce within the context
of intellectual property rights.

5.INTELLECTUAL PROPERTY PROTECTION AND TRADITIONAL KNOWLEDGE

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An Exploration in International Policy Discourse

Dr. John Mugabe

Executive Director, African Center for Technology Studies Nairobi, Kenya

The paper discusses the issue of intellectual property protection and

traditional knowledge. It argues that conventional intellectual property
laws are not sufficient to cover or protect the knowledge and innovations
of indigenous and local peoples. The paper suggests that non-patent
forms of intellectual property protection, such as trade secrets and
trademarks, could be used to protect traditional knowledge and
innovations. It also highlights the lack of strong institutional arrangements
for indigenous and local peoples to safeguard their property and enforce
trade secrets and trademarks in the modern economic space. The paper
proposes that countries invest in the establishment of sui generis regimes
that specifically cover traditional knowledge and rights. Overall, the paper
emphasizes the need for better protection of traditional knowledge and
innovations and suggests alternative approaches to achieve this.The
paper discusses the issue of intellectual property protection and
traditional knowledge. It argues that conventional intellectual property
laws are not sufficient to cover or protect the knowledge and innovations
of indigenous and local peoples. The paper suggests that non-patent
forms of intellectual property protection, such as trade secrets and
trademarks, could be used to protect traditional knowledge and
innovations. It also highlights the lack of strong institutional arrangements
for indigenous and local peoples to safeguard their property and enforce
trade secrets and trademarks in the modern economic space. The paper
proposes that countries invest in the establishment of sui generis regimes
that specifically cover traditional knowledge and rights. Overall, the paper
emphasizes the need for better protection of traditional knowledge and
innovations and suggests alternative approaches to achieve this.

6.TRADITIONAL KNOWLEDGE PROTECTION AND DOCUMENTING:CRITICAL

STUDY ON TRADITIONAL KNOWLEDGE DATABASE AND REGISTRY

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By; basil b. mathew, research scholar, school of international relations and
politics mahatma gandhi university

In this article the author takes a comprehensive and objective approach to

the topic. The author provides a detailed analysis of the foundations of
conflict of laws and the internet, exploring various aspects such as
jurisdiction, regulation, enforcement, limitations, and technological
influences. The inclusion of references to various sources and the
discussion of different perspectives indicates that the author aims to
present a well-rounded view of the subject matter.The article discusses
the foundations of conflict of laws and the internet, with a focus on
international jurisdiction. It highlights the lack of binding international
standards in this area, leading to significant variations in rules across
different countries. The role of governments in regulating internet
activities and transactions is also explored, along with the influence of
technology in enforcing the law and implementing restrictions. The
content further touches upon limitations, coexistence, and fragmentation
in this field. The article includes references to various sources such as the
European Commission's study on residual jurisdiction, national reports
edited by Basedow, Rühl, Ferrari, and De Miguel Asensio, and publications
by Friedmann, Riis, Benkler, De Filippi, and Wright The article also
discusses the challenges posed by the ubiquitous nature of the internet
and the global reach of online content. It mentions that controlling certain
online activities and enforcing traditional law enforcement mechanisms
becomes difficult due to the accessibility of online content regardless of
physical location. Additionally, the article mentions that parallel
compliance with multiple laws from different jurisdictions can be
burdensome for internet service and content providers, potentially leading
to fragmentation of certain services. However, the article also highlights
the availability of mechanisms to monitor online activities and implement
territorially limited responses. Technological developments such as peer-
to-peer networks, social sharing and exchange models, cloud services,
and blockchain technology are also mentioned as posing continuous
challenges to governments in controlling network activities. The article

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notes that the temporary adoption of practices of outright illegality by
internet users is not uncommon in these contexts. Overall, the article
provides a comprehensive review of the foundations of conflict of laws and
the internet, exploring various aspects such as jurisdiction, regulation,
enforcement, limitations, and technological influences.

7.PROTECTION OF TRADITIONAL KNOWLEDGE: THE WORK AND THE ROLE

OF

INTERNATIONAL ORGANISATIONS AND CONFERENCES

By; Asiia Sharifullovna Gazizova Junior Researcher of Research and

Educational Center for Human Rights, International Law and Problems of
Integration, Faculty of Law, Kazan Federal University, Russia

The article "Protection of Traditional Knowledge: The Work and the Role of
International Organisations and Conferences" explores the topic of
protecting traditional knowledge and discusses the work and role of
various international organizations and conferences also mentions the
involvement of international organizations such as the World Intellectual
Property Organization (WIPO), the United Nations Educational, Scientific
and Cultural Organization (UNESCO), the World Health Organization
(WHO), the World Trade Organization (WTO), and the Food and Agriculture
Organization of the United Nations (FAO). These organizations are actively
involved in the development of policies and rules to ensure the protection
of traditional knowledge.The article also highlights the importance of
international conferences in addressing the issue of protecting traditional
knowledge. Specifically, it mentions the Conference of the Parties to the
Convention on Biological Diversity and the United Nations Conference on
Trade and Development (UNCTAD). These conferences provide a platform
for discussions and negotiations on the protection of traditional
knowledge.The article discusses the challenges and difficulties faced in
the process of developing policies for the protection of traditional
knowledge. One of the challenges is the lack of clarity regarding the
nature of the document being drafted. Developing countries prefer a
legally binding document, while other states, such as the US, EU, and

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Russia, prefer a flexible international document that is not binding.
Another unresolved issue is whether there should be one document
combining the protection of genetic resources, traditional knowledge, and
traditional cultural expressions, or three separate independent
documents.The article also mentions the role of the Globally Important
Agricultural Heritage Systems (GIAHS) in the preservation of traditional
knowledge and practices. Currently, there are 57 recognized sites in 21
states, with the largest number in China and Japan. These sites
demonstrate the importance of traditional knowledge in agricultural
practices.In addition to international organizations and conferences, the
article highlights the involvement of other international organizations such
as the World Trade Organization (WTO), the World Health Organization
(WHO), and the Food and Agriculture Organization of the United Nations
(FAO) in addressing issues related to the protection of traditional
knowledge.Overall, the article provides a comprehensive overview of the
work and role of international organizations and conferences in the
protection of traditional knowledge. It discusses the challenges and
ongoing discussions in developing policies for the protection of traditional
knowledge and highlights the importance of preserving traditional
knowledge and practices in various fields.

8. CONSERVATION OF TRADITIONAL KNOWLEDGE IN INDIA AND NEED OF

KNOWLEDGE NETWORK

By; Dr prabhat ranjan,Labrarian Jagat taran girls collage.

The article titled "Conservation of Traditional knowledge in India and Need

of Knowledge Networks" discusses the importance of preserving and
developing traditional knowledge in India. It emphasizes that traditional
knowledge plays a crucial role in the development of Indian society and is
closely connected to the natural environment. also provides detailed
information about various aspects of Indian traditional knowledge, such as
different art forms, agriculture, metal technology, folk materials, and
rainwater harvesting. Additionally, the chatbot highlights the significance
of traditional knowledge and presents it as an alternative to modern

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science and technology. The article also mentions the authors, Dr. Prabhat
Ranjan and Dr. Bhupendra Kumar Singh, along with their affiliations and
contact details. It was published in February 2020 as part of the First
International Conference on Bridging Traditional Knowledge to Modern
Science. The chatbot also mentions the abstract of the article, which
states that traditional knowledge encompasses not only technology but
also ethics, culture, language, and lifestyle. The article suggests the
development of knowledge and social networks to involve more people in
the preservation and advancement of traditional knowledge. It concludes
by emphasizing the importance of traditional knowledge in human society
and the need to establish networks among traditional knowledge
practitioners.

9. WHOSE KNOWLEDGE COUNTS? THE STRUGGLE TO REVITALISE

INDIGENOUS KNOWLEDGES IN GUATEMALA

The article focuses on the importance of including different perspectives,

including traditional forms of knowledge such as indigenous knowledge, in
environmental governance and management. The struggle for the
revitalization of indigenous knowledge involves issues of racism,
discrimination, poverty, extractive industries, deforestation, and
urbanization. The article emphasizes the need to address climate change,
which accelerates the loss of indigenous traditional knowledge due to the
loss of biodiversity. The study includes interviews with leaders and
representatives who work to reduce climate change and strengthen
resilience in their communities. The article also discusses the challenges
and importance of including indigenous knowledge in the education
system. Overall, the article highlights the significance of incorporating
diverse perspectives and knowledge in environmental management and
public understanding of science.The article also addresses the need for
Western universities to promote a less hierarchical approach to knowledge
production and transmission. This is crucial for the global struggle for
social justice and cognitive justice, as well as the transformation towards
more sustainable systems. The document highlights the challenges faced

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in revitalizing indigenous and traditional knowledge, such as racism,
discrimination, poverty, extractive industries, deforestation, and
urbanization. It emphasizes how climate change further accelerates the
loss of indigenous knowledge due to the loss of biodiversity. The results of
the study demonstrate the resistance against epistemic violence and the
importance of protecting and transmitting these knowledge systems. The
article also mentions the efforts to revitalize indigenous knowledge
through the education system and the training of indigenous teachers. In
summary, the content emphasizes the significance of including diverse
perspectives and knowledge in environmental management and public
understanding of science.

10.OPEN SOURCE SEEDS AND THE REVITALIZATION OF LOCAL

KNOWLEDGE

By; Martin Fredriksson,Department for Culture and Society, Linkoping

University

The article provides a research on the open source seed movement and its
relation to the information commons. It mentions that the overview of the
open source seed movement presented in Chapter 3.4 relies on a
narrative literature review, as there is limited scholarly literature on the
topic. The article draws on a synthesis of existing research fields that
address the question of the information commons. It also mentions the
limited number of studies analyzing the legal implications and
social/political significance of the open source seed movement. Overall,
the article provides a comprehensive overview of the open source seed
movement and its context within the information commons.The article
also discusses the enclosure of the information commons and its
implications. It mentions that proponents of strong property rights argue
that expanding and protecting private property leads to more efficient use
and commercialization of resources. However, opponents argue that
expanding intellectual property rights restricts various uses that serve
social and cultural purposes for different communities. The article
highlights the mobilization of the information commons movement,

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involving organizations like the Pirate Party, Electronic Frontier
Foundation, and Anonymous, who aim to promote and protect the free
sharing of information against expansive intellectual property regimes. It
emphasizes the belief that digital technologies have the potential to
create new ways of sharing culture, knowledge, and information for the
benefit of public education and democratic participation. Additionally, the
article mentions the depletion of seed diversity and the loss of traditional
and local seed varieties due to mass-produced commercial varieties. It
discusses the struggle to preserve landraces and maintain traditional
knowledge as acts of revitalization. The article also addresses the
imbalance between proprietary rights and the rights of users in
intellectual property rights legislation, with a focus on enforcing ownership
rights rather than user rights. It highlights the rapid expansion of
intellectual property rights in the 1990s to support content-based
industries and the commodification of information. The article
acknowledges the limited research on the open source seed movement
and its legal implications, with only a few studies examining the impact of
open source strategies on the freedom to use certain breeds. It mentions
that the legal implications of open source "bag-tag licenses" and the
legitimacy of the Open Source Seed Initiative (OSSI) pledge are still
unclear and untested. The article also notes the European initiative to
reinvent legal open source seed licenses but states that existing studies
do not provide a clear response to whether these licenses could effectively
address the enclosure of the information commons.

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 CHAPTER - 2

A WALK THROUGH PATENT REFORMS

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 INTRODUCTION

For a limited time, a patent is granted to an individual who has developed

a fresh and valuable object, an enhancement of a prevailing thing, or a
new method of producing a thing. According to studies, the domain of folk
medicine is the most important site of intersection among patents and
traditional knowledge1. Indigenous people's therapeutic traditions aren't
the exclusive source of folk medicines. Traditional therapies, the healing
abilities of herbs and plants, and other treatments formerly unknown to
the rest of the globe are among them. The tendency among multinational
firms and emerging nations has been to patent local communities'
traditional knowledge by turning it into medicines using new technology
and profiting from it. Developing countries are plainly at a disadvantage
as a result of this. There have been multiple documented cases of
traditional knowledge bearers being put at a disadvantage. Ayahuasca is
1
Srividhya Ragavan, “Protection of Traditional Knowledge”, 2 MINN. INTELL.PROP.REV.1,4 (2001).

19
an old treatment that has played a significant role in the existence of
individuals in the ancient Amazon. Loren Miller petitioned for a US patent
to be accepted as the "creator" through The International Plant Medicine
Corporation, and the patent was approved. In 1995, the US Patent System
issued a patent on turmeric, a spice used in Indian cookery and medicine.
The Indian Council for Scientific and Industrial Research (CSIR) objected to
the application, claiming that turmeric has been used in India for
thousands of years for its medicinal benefits. 2As a result, the patent was
eventually denied Most ancient medicines are not eligible for protection of
patent. In the United States, an object must be beneficial, innovative, and
non-obvious to be considered an invention. US patent law states that the
invention must not be apparent to an individual expert in the art. The TK
does not rate this test also The protection of IPRs has a substantial
influence on the economy's ability to innovate and invent. A patent is a
legal exclusivity awarded by a government to the proprietor of an
innovation for a certain era of phase. The mere possession of a patent
doesn't really entitle the owner to utilise or exploit the patented
innovation. Other laws, including such health and safety regulations, food
and drug regulations, or even other patents, may still influence that
privilege. The patent is a property right in the eyes of law, and it may be
given, inherited, sold, granted, or even abandoned. It can be withdrawn
by the state in specific circumstances, even after it has been granted or if
it has been sold or licenced in the meantime, because it is imposed by the
state. Patents encourage inventors to pursue new ideas and aid in the
marketing of new products. Patent rights must be available for wholly
inventions, whether properties or procedures, in all arenas of information
given, according to the TRIPS agreement. They are:

1. New (novelty);

2. Non-obvious with admiration to the preceding art (Inventiveness); and

3. Are proficient of industrial submission (Applicability).

2
Trade and Development Case Studies, available at: http://www.itd.org/issues/india6.htm

20
A patent is a document that describes an innovation and establishes a
legal position wherein the patent application can only be exploited
(produced, used, sold, or imported) with the owner's permission. In the
sphere of technology, "invention" refers to situation to a particular
problem. A procedure or a product can be the subject of an innovation.
The patent's protection has a temporal limit (WIPO, 2004).

Patents are legitimate rights granted by the administration to an

individual or group for innovative innovations based on scientific and
technical knowledge. A patent is a country's exclusive right to produce,
use, manufacture, and market an invention, provided innovation meets
specific legal requirements. Deprived of the consent of the patent holder,
no one else is permitted to produce, use, manufacture, or market the
innovation. For a short time, this permission is accessible. Regardless of
who owns the rights, the holder of the patent may not be capable of
utilizing or exploit them because of other regulations in the nation where
the patent was issued. These laws may pertain to heath, security,
agriculture, and safety, among other things. Existing patents in a related
field might potentially get in the way. In legal terms, a patent is a right
granted that can be given, inherited, transferred, sold, or licenced.
Because the right is granted by the authority, it can be cancelled by it in
exceptional circumstances, even though the patent has indeed been sold,
licenced, manufactured, or promoted in the interim.Patent rights are
territorial in nature, and they are specified by a country's patent
legislation. An Indian patent does not confer rights outside of India,
therefore inventors/assignees will be need to file additional patent
applications in the countries of their choice, together with the requisite
costs, in order to secure patents in other countries. Patented matters are
novel chemical method, drug molecule, electronic circuit, new surgical
device, or vaccination that meets all of the legal requirements. In a
patented invention, the innovation must be revealed in a precise format.

TERM OF THE PATENT

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The TRIPS agreement stipulates a minimum length of protection of 20
years from the day the claim is submitted. To keep the rights to a patent,
it must be renewed on a regular basis until the end of the period. If a
patent is not renewed as required by law, it becomes public property
which can be used by those without risk of infringement.

HISTORY OF INDIA'S PATENT POLICY

Patent policy in India has a prolonged history, stretching lower back to

1856; however it become handiest after independence that policymakers
started out to be aware of patents. In independent India, expert
committees had been shaped to analyse patents and offer guidelines at
the type of patent device that must be implemented. The Indian patent
device has failed in its important purpose, specifically to stimulate
innovations amongst Indians and to inspire the improvement and
exploitation of recent innovations for commercial functions within the USA
in an effort to stable the advantages thereof to the biggest segment of the
public, in line with the Patent Enquiry Committee (1948-50). The Ayyangar
Committee (1957-59) cited that global patentees had been acquiring
patent safety now no longer to gain the financial system of the USA
issuing the patent or to fabricate in USA, however to defend an export
marketplace from contest from rival manufacturers, especially the ones
from different components of the world.3

As a result of the patent protection provided in India, India is unable to

obtain items at lower rates from alternative suppliers in many
circumstances. According to the claims, foreigners controlled 80-90% of
rights in India and were taking advantage of the structure to gain
authoritarian mechanism of the marketplace. As a result, the boards
proposed that India benefit from a patent system that emphasized access
to the properties at cheaper rates. These committees' suggestions formed
the basis of the Patent Act of 1970, India's present patent legislation. In

3
Zambad, Sarika, and B.R. Londhe. "To Study The Scope & Importance of Amended Patent Act on Indian

Pharmaceutical Company with Respect to Innovation", Procedia Economics and Finance, 2014

22
India, the measure was supported by domestic businesses and political
parties.

SCOPE OF PATENTABILITY

Proceeding to the passage of the Patent Act, there were significant fears
that the introduction of invention patents in India could effect in a large
number of patents being issued on spurious grounds.4 Ever greening is the
practise of pharmaceutical firms renewing expiring patents by identifying
a new application for the same medicine, hence prolonging the patent
domination. The introduction of generic pharmaceuticals onto the market
is being held up by ever-greening. By limiting the scope of patents
awarded on spurious claims, the Convention addressed these problems.

An inventive step, according to the Ordinance, must be a technological

advancement over earlier innovations or that has economic relevance.
Any innovation or technique that takes not existed predicted by publishing
in any document or employed in the nation or elsewhere in the globe prior
to the filing of a patent application with comprehensive specification is
considered a new invention. 5A pharmacological compound has to be a
"new organization comprising one or more creative steps," as defined by
the FDA. The use of such a word "mere" in stating that a simple new
application of an existing chemical or any new attribute of a known
material was not patentable was the sole genuinely contentious
component of the Ordinance. The usage of the term "mere" was criticised
by critics because the clause was confusing regarding what sort of new
usage is patentable. It may be possible for an applicant to get a patent
just by introducing a new chemical reactant rather than generating whole
new medications. Because the term is open to multiple meanings, it might
potentially lead to unending litigation.The Patent Act resolves this worry

4
Srividhya Ragavan, “Protection of Traditional Knowledge”, 2001, V2- Issue 2,

https://scholarship.law.umn.edu/cgi/viewcontent.cgi?article=1371&context=mjlst

5
Ikechi Mgbeoji- University of British Columbia, Vancouver , “Patents and Traditional Knowledge of the Uses

of Plants: Is a Communal P Communal Patent Regime Patent Regime Part of the Solution t t of the Solution to

the Scour o the Scourge of Bio Piracy”, V9-Issue 1, 2001, Indiana Journal of Global Legal Studies,

https://www.repository.law.indiana.edu/cgi/viewcontent.cgi?article=1232&context=ijgls

23
by strengthening the clause by removing the phrase "mere." By limiting
the exclusions to innovations, this removes any ambiguity about the
scope of patentability. The Ordinance does not affect any of the other
patentability provisions. As a result, new uses of a known chemical are not
patentable under the Patent Act, and novel dosage forms are only
patentable if an unexpected outcome is discovered. Combinations of
existing compounds can only be copyrighted if they show improved
therapeutic efficacy, and pharmaceutical substances can only be patented
if the components have a synergistic effect.

COMPULSORY LICENSING

Compulsory licences allow patented material to be produced without the

permission of the patent owners. If a government uses compulsory
licencing, it can permit patents to be violated if cheaper generic
pharmaceuticals are needed in an emergency. Compulsory licencing
obligations were increased under the Patent Act. The rule was changed to
allow nations with limited or no manufacturing capability to import
patented medications from India under obligatory licencing as long as
they notify or otherwise permit importation. In addition, a country's
capacity to get compulsory licencing is important.

Furthermore, previous to the Patent Act, there was considerable fear that
the granting of compulsory licences might take very long if a Patent
Controller had enough time to consider issuing compulsory licences after
patent holders had refused them. The Patent Act solves this by requiring
the Patent Administrator to consider issuing a compulsory licence within a
reasonable timeframe of up to 6 months.

INDIA’S PATENT POLICY

Although India has a lengthy history of patent regulation, it was only after
independence that

policymakers began to pay attention to patents. India's attitude to patents

varies from that of

24
developed countries in that it views patents as a tool for government
policy making.6 The

desire for IPR reform to comply with TRIPS is putting a strain on India's
policies. Over the

last decade, the Indian patent law has undergone several changes,
partially as a result of

differing viewpoints and shifting goals among the government, domestic

industry, public

health NGOs, and other stakeholders. India's patent policy aims to strike a
balance between

development issues and the need to promote inventions. 7 Patents were

significant tool for

economic progress in India, and the scope and length of patents were
limited.

THE INDIAN PATENT ACT 1970

The Indian Patents Act has been lauded as a model piece of law for
developing nations. It

aims to strike a balance between the need to reward innovators while also
assuring that

India's developmental requirements are met.

The following essential features of the Act reveal the basic patents policy
of India:

1) General Principle of Patent Grant

2) Principle of National Treatment — No limits or borders on foreigners in

relating for or
6
Vedaraman, no.2, pp.43-54.

7
Riya,”PROTECTION OF TRADITIONAL KNOWLEDGE UNDER INTELLECTUAL PROPERTYRIGHTS REGIME”, Vol. 1 (01), Dec 2020, pp. 149-164 2, E- Journal of
Academic Innovation and Research in Intellectual Property Assets (E-JAIRIPA), http://www.cnlu.ac.in/2021/CIRF/10%20Riya.pdf

25
procurement patents in India.

3) Inventions Not Patentable

4) Search for Novelty — compulsory search is obligatory spreading to prior

publications not

only in India but also in any other part of the world.

5) Patentability of Inventions in the Area of Chemicals, Food and Drugs —

In the case of

innovations involving compounds that are intended for use as food,

pharmaceuticals, or

medications, or substances created through chemical processes.

Patentability will be

restricted to claims for manufacturing techniques or processes

exclusively.

6) Term of Patent — the patent is valid for 14 years from the date of filing
the entire

specification, which is the date of patenting. The duration will be 7 years

from the date of

filing or 5 years from the date of sealing, whatever is shorter, for

inventions in the fields of

food, medicines, and medicine.

7) Licensing Provisions — two types of licenses: compulsory licenses and

license of rights.

Compulsory licences allowing another party to work on the invention can

be sought for at

any time after the patent has been sealed for three years. After three
years from the date of

26
patent issuance, they must be endorsed with the term "License of Right"
in the field of food,

medicines, medicine, or chemicals. As a result, any interested party has

the right to work on

such patents as a matter of right.

8) Royalties — The royalty allocated to the patentee under a licence in the

event of patents

linked to food, medications, or medicines should not exceed 4% of the net

example —

factory sale price in bulk of the patented object.

9) Use of Patented Inventions by the Government — to prevent scarcity of

a patented item

from resulting in high costs, the government is given the authority to

utilise or exercise any

protected innovation only for its own purposes.

10) Appeals — in all cases, appeals will be only with the High Court

Indian Patent Act 1970 vs. TRIPs

The Indian Patent Act of 1970 has a philosophy that is vastly different from
the TRIPS

framework. India considers various fields of knowledge and information to

be non-

patentable. The World Trade Organization's (WTO) creation of "Trade

Related Intellectual

Property Rights Agreements" (TRIPS) was the trigger for reforms in India's
patent policy.

TRIPS were created as a result of business activity in the United States.

Foreign companies

27
accused India of "piracy" in the 1980s, prompting criticism of India's
patent policies. In the

late 1980s and 1990s, the US began to put pressure on developing

countries to enhance patent

protection. One of the key focuses of US strategy was India. Intellectual

property rights were

legally included with Uruguay Round of Negotiations under the "General

Agreement on

Tariffs and Trade (GATT)" and became a component of "The World Trade
Organization."

India initially opposed the WTO's inclusion of IPRs, but eventually agreed
to it. India did so

because the WTO was a "take it or leave it" arrangement (either a

member accepts all of the

accords or none at all, leaving little room for partial agreement), and India
anticipated to get

advantages in cotton and farming in exchange for giving up on intellectual

property rights.8

In India, the impact of TRIPS in two industries, agriculture and medicines,

has sparked the

greatest debate. India was able to amend its patent legislation in 1998-99
to provide better

protection to patent holders as a result of the domestic policy shift.

8
Rajdeeplaw, “Compliance of Trips in Indian Patent Law”,

http://www.legalservicesindia.com/article/1103/Compliance-of-Trips-in-Indian-Patent-

Law.html#:~:text=This%20amendment%20seeks%20to%20implement,as%20TRIPS%20compliant%20as%20p

ossible.&text=The%20Patents%20Act%2C%201970%20was,again%20in%202002%20and%202005

28
Patent Amendment Act of 1999

In food, chemicals, and pharmaceuticals, the Patent Amendment of 1999

reframed a language

in the Patent Act of 1970 that said that only process patents, not product
patents, may be

issued. The amendment allows for product patent applications in the

agrochemical and pharmaceutical industries to be considered in 2004 and
awarded in 2005 (if the conditions are met), as well as (ii) exclusive
marketing rights for these items.The Patent Act 1970, as amended by the
Patents (Amendment) Act 1999, governs thegranting of patents in India.
The current law's concept is to stimulate inventions and ensurethat they
are commercialised in India as soon as possible.

The Patent (Amendment) Act 2002

The Patent Act of 1970 was revised in 2002 with the goal of bringing
India's intellectual

property rights system into accordance with the TRIPS Agreement. India is
a signatory to the

TRIPS Agreement of the Uruguay Round's Final Act of global trade talks. As
a result, from

January 1, 2005, it must grant product patents to medications and

pharmaceuticals,

agrochemicals, and processed foods. Meanwhile, India must award

Exclusive Marketing

Rights (EMR) to items that have received patents and marketing

authorization in any

convention country. Since 2005, India has had regulations in place to

receive applications for

29
product patents via a mailbox system. The Patents Amendment Bill aims
to meet a few more

of TRIPS' requirements. The key changes it seeks to make to the current

Patent Act include

raising the life of patents for 20 years, reducing the framework for
compulsory licencing, and

eliminating right-of-first-refusal licences. 9

The Act attempts to exploit TRIPS exclusions to exempt patents on living

organisms, but as

some experts have pointed out, the measure strengthens patent holders'
protections and

suggests that the balance of power between authors and the public at
large is shifting in

advantage of the former. The Patents (Amendment) Act 2002 has made
several substantialchanges to the Patents Act 1970. To begin with, these
revisions were meant to make the Indian Act TRIPS-compliant. These
changes, on the other hand, add some new functionality.

Non-patentable Subject Matters

The list of elements that are not patentable has been updated to provide
additional clarity. The

changes include additions, deletions, and alterations to certain existing

provisions. The

following are notable additions to the current list of things that aren't
considered

inventions:—10

9
The Patent (Amendment) Act 2002

10
Aayush Sharma, “India: Non Patentable Subject Matter - Laws Of Nature”, 19 November 2015,

https://www.mondaq.com/india/patent/444782/non-patentable-subject-matter--laws-of-

nature#:~:text=Thus%20inventions%20which%20are%20fully,are%20not%20patentable%20subject%20matter

30
i. Any living or non-living substance found in nature is discovered.

ii. An innovation whose use or commercialization would be in violation of

public order or

morals, or would have a significant negative impact on human, animal, or

plant life, health,

or the environment.

iii. Mathematical or business procedures, as well as computer programmes

and algorithms in

general.

iv. Animals and plants in whole or in part, excluding microorganisms, but

including seeds,

varieties, and species, as well as fundamentally biological processes for

plant and animal

production and propagation.

v. A method of presenting information.

vi. Integrated circuit topography.

vii. A simple plan, rule, or procedure for executing a mental function or for
playing games.

Testing techniques used in the manufacturing process to make a machine,

apparatus, or other

piece of equipment more efficient, or to enhance or restore an existing

machine, apparatus, or

other piece of equipment, or to manage or regulate the manufacturing

process were not

patentable. These are now patent-eligible topics. Other parts of the 1970
Act, it should be

emphasised, have not changed.

31
RECENT DEVELOPMENTS IN PATENT LAW

A study of previous patent law changes reveals that those in charge of its
current

administration confront similar challenges. The basic tension between a

free market and the

granting of tiny organisations limited monopolies with such an economic

has yet to be

resolved. Most recent patent law advances are based on recognition of

this basic issue.

It should be remembered that before to the ratification of the Constitution,

individual

colonists' experiences with "monopolies" practised either under royal or

colonial powers had

been less than gratifying. These "monopolies" had been exploited

successfully in the

Colonies to stifle economic growth. The majority of colonists had been

abused economically

as a result of these monopolies, which benefited just a few monopoly

holders. The colonists'

widespread consensus would be that all monopolies were "idius."

Many of the original patents were determined to be invalid when they

were tested in court

for all the same grounds that have recently been mentioned in rulings
rejecting current

patents. Indeed, one of the really notable trends in recent Supreme Court
patent law rulings is

the Court's "recurrence to principles" established in prior patent decisions.

The case either for

32
or against the patent regime were ably articulated by several authors, as
public opinion was

inflamed by the misuse occasionally ascribed to the patent laws. Both

governmental and private-sector organisations have conducted research
of the patent laws and the broader

patent system.

The current trend of judicial judgments demonstrates that the courts are
continuing to

examine the core notions of our patent system and are consciously
seeking to uphold the

preceding ideal patent system precepts. The economic-judicial-patent

philosophy represented

in the majority and dissenting opinions of the United States Supreme

Court Justices is the

greatest available guide for prosecution and appellate courts engaging

with patent disputes.

As a result, in order to draw some conclusions about new developments in

patent law, an

analysis of the most significant recent Supreme Court rulings has been
conducted. The

following key developments in the present evolution of patent law are

highlighted in this

overview.

JUDICIAL INVOLVEMENT IN PATENT PROTECTION IN INDIA

Using patent law as an example, describe the structure of IPRs in India

and illustrate the

active court engagement in the enforcement of intellectual property

rights. Intellectual

33
property is adequately protected under India's legal system, as it is in
other modern countries

across the world. In India, intellectual property rights date from before
independence. The

Indian Patent and Des, which has since been changed several times, and
finally the Patents

Act, 1970, is an example of legislation safeguarding rights in India can be

traced back

1900s.11 Defence of intellectual property in India today finds room in both

the Constitution

and various statutory instruments.

Under Article 300 A of The Indian Constitution assures that no be rundown

of property,

protect by authority of rules.12 This clause, which might be expanded to

include intellectual

property, provides the foundation for guaranteeing that the

inventor/author retains ownership

of his idea or work. Patents, designs, trademarks, and service marks,

copyrights, plant

varieties and Plant Breeders' rights (under consideration by Parliament),

trade secrets

(together with data protection), and geographical indications are all

protected by the Indian

legal system through various legislative enactments. The above-

mentioned statutes

11
Narayan, Patent Law (2006)

12
A.K. Ganguli, Right to Property: Its Evolution and Constitutional Development in 48(4) J. Indian L. INST.

489 (2006).

34
acknowledge intellectual property owners' rights, and violations of these
rights result in civil

litigation and criminal prosecutions. As a result, in the event of

infringement, the holder of

intellectual property has the choice of filing a civil action or beginning

criminal proceedings

against the accused. Aliens and foreign businesses can utilise the
constitutional provisions

ensuring equality before the law to demand the same protection.

In India, the judiciary has been deeply involved in determining the scope
of patent protection.

The Patent Act of 1970 defines a patent as "the gift by the nation's
government of some

privilege, property, or power to one or more individuals or businesses." A

patent monopoly

can only be awarded for innovations that are fresh, non-obvious, and
valuable, which have an

industrial application, according to a fundamental premise of patent law. 13

The term

"innovation" refers to the determination of whether a device or technique

is novel, non-

obvious, and helpful. The necessity of an invention is an important

condition for the award of

a patent, which is defined as "a novel product or technique incorporating

an innovative

breakthrough and capable of industrial application" under Section 2(l)(j) of

the Patents Act,

13
section 2(1 )(j), Patents Act, 197022 section 2(1 )(j), Patents Act, 1970

35
1970. These issues are sometimes difficult to answer since they are
dependent on the status of

"prior art" with in field, which includes earlier publication and application
of the topic.

The lack of effective legal protection for intellectual property all around
the world prompted

international collaboration for a protection system, which culminated in

the Uruguay Round

of GATT Negotiations in 1983. The World Trade Organisation (WTO) was

established in 1994 as a result of these international discussions, and the
Trade Related Intellectual

Property Rights Agreement was introduced (TRIPS). The TRIPS Agreement

was perhaps the

most comprehensive international agreement on intellectual property

rights ever drafted. The

TRIPS Agreement gave the WTO particular authorities to protect

intellectual property rights

and required state parties to ensure that intellectual property rights were
properly enforced.

The Indian judiciary is facing additional hurdles when it comes to

determining patent issues

as a result of India's WTO responsibilities. New types of parties, such as

companies,

approach the courts, and they must make judgements based on unique
factors such as

jurisdiction, international intellectual property registrations, market data,

and so on. These

additional problems are exemplified in the following examples.

36
Two non-resident Indians affiliated with the University of Mississippi
Medical Centre in the

United States received a patent for the use of turmeric in wound healing
in 1995. The

Council of Scientific and Industrial Research (CSIR) contested the patent

because it lacked

innovation because turmeric is often used as a traditional wound healer in

India from time

immemorial. The CSIR was able to unearth references (some of which

were over a century

old and written in Sanskrit, Urdu, and Hindi) that demonstrated that this
discovery was well

recognized in India prior to the filing of this patent. The inventors argued
that the powdered

and paste forms of turmeric have different physical properties, and that a
person who is

normally competent in the use of turmeric would not anticipate the

powdered form to be

helpful for the same purposes as the form of powder with any reasonable
degree of

confidence. The creators also said that oral administration was only
possible with honey,

which was thought to have wound-healing capabilities. The examiner, on

the other hand,

dismissed all of the inventors' claims and backed CSIR's arguments. The
case of the turmeric patent is one of the earliest successful examples of
infringement of intellectual property

37
rights.14

In a separate lawsuit from 2006, Novartis, a Swiss pharmaceutical

company, sued the Indian

government over the 2005 Amendment to the Patents Act, 1970, arguing
that it needed

stronger patent protection for its goods than was provided under existing
law. The

controversy began in January 2006, when a Novartis patent case was

dismissed on the

grounds that the medicine intended to be patented was just a new version
of an old drug, and

hence not patentable under current Patents Act, 1970 rules. This rule
made obtaining patents

on modifications to medication combinations or even modestly better

formulations of current

pharmaceuticals more challenging for pharmaceutical corporations.

Novartis, on the other

hand, contended that this clause was not only in violation of WTO
standards, but also

unlawful. In 2005, the applicable regulations of the WTO TRIPS Agreement

required India to

begin evaluating pharmaceutical patents, and in required to conform with

these WTO

standards, India began issuing pharmaceutical patents. However, India's

rules include

protections to guarantee that patents are only issued for genuine

inventions, and that retail

14
Turmeric Patent Overturned in Legal Victory, 41 Herbal Gram 11 (1997)

38
companies a patent for alterations to an already-invented chemical in
order to prolong their

monopolies on current pharmaceuticals are unable to do so. 15

TRENDS IN INTERNATIONAL PATENT REFORM

Patent rules have been strengthened and harmonised globally during the
last half-century,

with the majority of this happening in the 1990s. Patent rights are
controlled by a complex

network of national laws as well as international treaties and conventions.

Until 1995, the

Paris Convention of 1883 was the most widely signed international treaty.
The Paris Treaty

guarantees non-discrimination and defines standards for assessing rights

priority. Who gets to file for a patent is determined by their priority. The
1947 General Agreement on Tariffs and

Trade (GATT), which subsequently became the World Trade Organization

(WTO), did not

address intellectual property rights expressly. The provisions were largely

aimed at

combating counterfeiting. In general, the GATT had no authority to resolve

issues arising

from the Paris Treaty. As global commerce and invention grew, the
demand for worldwide

patenting regulations and standards grew, leading to the establishment of

the World

15
24 J.M. Mueller, Taking TRIPS to India - Novartis , Patent Law, and Access to Medicines , 356(6) New ENG. J.

MED. 541 (2007 ).

39
Intellectual Property Organization (WIPO), a United Nations agency, in
1970. The Patent

Cooperation Treaty (PCT), which allows for, among other things, a single
submission of an

international patent application, is one of WIPO's most important treaties.

UPOV (Union for

the Protection of Plant Varieties), which oversees biotechnological

innovation, is another key

treaty.

CRITICISM

Thousands of drugs given patent protection in the other countries during

1995 and 2005,

along with medicines that will be granted patent protection after January
1, 2005, will be

evaluated for patent protection in India under the Patent Act. While the
Patent Act does not

cover generic pharmaceuticals manufactured before 1995, opponents

claim that generic

production of pre-1995 editions of medicines is insufficient to meet the

treatment

requirements of people in developing nations. They say that any new

pharmaceuticals needed

to replace existing, inefficient treatments will be copyrighted, making

them prohibitively

expensive.16

Challengers claimed that the prices to customers as a significance of the

Patent Act will be
16
Press Release, Health Gap Global Access Project, The Impact of India's Amended Patents Act on Access to Affordable HIV Treatment (Feb. 2005), available at
http://www.healthgap.org/press-releases/05/020105-HGAPFSINDIAIPR.pdf

40
unsustainable.They say that the new restrictions would discourage normal
generic competition for better, higher expensive AIDS treatments, and
that drug monopolies lasting

twenty years will push up treatment costs till the largest producer of
cheap HTV medicines

runs out. They believe that the 5.1 million Indians misery from HIV/AIDS
will be incapable

to have enough money, the possible 99% growth in the cost of these
medicines.17The

majority of African countries that now buy low-cost generic

pharmaceuticals from India

would be similarly impacted. According to analysts, costs for patented

breakthrough

pharmaceuticals in India might approach those in the United States, while

prices for more

common treatments would only rise significantly. The Indian government

has declared that it

will intervene if price hikes become exorbitant, although it is unclear how

this will be carried

out.

The Patent Act's compulsory licencing procedures, according to critics, are

too cumbersome

to give speedy relief in the event of an outbreak.They contend that robust

mandatory

licencing procedures are essential for maintaining inexpensive

pharmaceutical access. Unless

17
Ranjit Devraj, Global Poor to Suffer If Denied Indian Generic Drugs-Experts, INTER PRESS SERVICE

NEWS AGENCY (Feb. 22, 2005), http://www.ipsnews.net/africa/interna.asp?idnews=27563.

41
there are national emergencies, the Patent Act forces generic producers to
delay three years

after a patent is awarded before applying for a compulsory licence to

manufacture it, which

some feel is excessively long.

Other criticisms of the compulsory licencing rules include the lack of a cap
on compared to

the value to patent holders, the ability of pharma companies to object to

the granting of a

forced licence, and the lack of a deadline by which a compulsory licence

must be awarded to

an application. As a result, opponents contend, pharmaceutical

corporations can use gaps in

compulsory licencing procedures to postpone the issuance of forced

licences. They believe that as long as a patent is awarded, generic
producers should be permitted to file for

compulsory licencing.

Furthermore, critics claim that product patents would harm tiny generic
medication firms.

Mergers are to be expected, with larger pharmaceutical corporations

absorbing smaller ones

that can't afford to invest in R&D. Opponents believe that these tiny
businesses will be

pushed out of the medication market and will eventually go out of

business. Following the

introduction of drug patents in 1984, Italy changed from being a

significant drug

manufacturer and supplier to a major importer of medications.

42
Critics of the Patent Act often minimise the impact on Indian investment
and research. They

say that earnings earned in India will not be significant enough to

influence international

pharmaceutical corporations' research and development plans. They

further say that foreign

corporations would make up the large number of patent filers in India,

which has yet to

achieve a level of growth where patent monopolies will benefit it

CONCLUDING REMARK

Stronger patent rights have a range of consequences on inventive

activity, notably frequency

variation, depending on the details of the patent reform and the country's
economic progress.

In rich nations, there is an inverted-U relationship between patent

protection and international

patent filings, while no such link exists in poor countries.

We claimed that, given the scarcity of complementary resources required

for innovation in

underdeveloped nations, local inventive activity will not be able to adapt

exclusively or

predominantly too related to the legal environment, at certainly not

without a considerable

time lag. High worldwide patent protection rules may also be incompatible
with developing-

43
country innovation systems, which rely heavily on incremental, adaptable,
and imitative research. Not only for the rapid resolution of intellectual
property rights conflicts, but also for the

effective administration of justice, are procedural improvements a must.

Furthermore,

international judicial cooperation and collaboration may be a good means

of advancing the

rule of law and improving the quality of justice. However, the most
essential duty of the

judiciary in intellectual property law is to ensure that intellectual property

rights are

effectively enforced. The judiciary must take proactive steps to prohibit

improper use and

misuse of protected intellectual property.

Finally, we evaluated patent intensity and patent innovations as

exogenous variables in our

study, concentrating on their impact on inventive activity. Future research

might look at the

factors that influence patent strength. This might aid in determining which
nations are more

likely to pursue patent reforms or are competent of adhering to

international treaty

responsibilities.

44
45
 CHAPTER- 3

DEFINING TRADITIONAL KNOWLEDGE

INTRODUCTION

Traditional knowledge does not relate to any product that is qualified for
intellectual property

protection in and of itself. Various terminologies, on the other hand, have

been developed in

46
order to acknowledge the rights that may be obtained from traditional
knowledge.

"Traditional intellectual property rights" is a concept coined by well-known

writers, although

others prefer the terms "community intellectual property rights" or

"traditional group

knowledge and practice," while the OAU Model Law simply uses the word
"community

rights.18"

The lack of agreement on what constitutes traditional knowledge is a

perennial issue when it

comes to protecting it. To date, defining "traditional knowledge" has

proven to be a daunting

task for academics and scholars. Different sources have provided various
comprehensive

definitions, which we will discuss in the following paragraph. The phrase is

still a bit of an

enigma. Traditional knowledge may be defined as the body of information

that is passed

down through generations of men through the method of practices,

rituals, customs, and other

knowledge and skill bearers.

A feasible explanation has been providing by the Director General of

United Nations

18
Cattier and M. Panizzon, legal Perspectives on Traditional Knowledge: The Case for Intellectual Property

Protection, 7 Journal of International Economic Law, 2004, p. 371, at p. 387.

47
Educational, Scientific, and Social Group as follows: 19The world's
indigenous peoples have

a vast understanding of their environs, based on millennia of living in

close proximity to

nature. They have a specialized and often extensive grasp of the qualities
of plants and

animals, the functioning of ecosystems, and the ways for exploiting and
managing them since

they live in and from the diversity and richness of complex ecosystems.
Regionally existing

creatures are depended on for many—if not all—foods, medicines, fuel,

construction

materials, and other items in rural areas in poor nations. People

understand and impressions of the environment, as well as their
connections with it, are frequently crucial components of

cultural identity.

Traditional knowledge (TK) is defined by the WIPO Secretariat as ideas

developed by

traditional communities and indigenous peoples in a traditional and

informal manner as a

response to the needs imposed by their physical and cultural

environments, and these ideas

contrast with corresponding phrases, such as folk tales, poetry, and

riddles, folk songs and

instrumental music, dances, plays, and so on. 20

19
Frederick Mayer, Director General of UNESCO (1994)

20
Consolidated Survey of Intellectual Property Protection of Traditional Knowledge, Traditional Knowledgeand Folklore, delivered to the Intergovernmental
Committee on Intellectual Property and Genetic Resources,WIPO/GRTKF/IC/5/7.

48
WIPO defines traditional knowledge as "all other tradition-based
innovations and creations

resulting from intellectual activity in the industrial, scientific, literary, or

artistic fields;

performances; inventions; scientific discoveries; designs, marks, names,

and symbols;

undisclosed information; and all other tradition-based innovations and

creations resulting

from intellectual activity in the industrial, scientific, literary, or artistic

fields," according to a

report.21

As a result, "traditional knowledge" is a wide word that encompasses

indigenous and local

communities' economic and cultural endowments. Some individuals

describe the phrase as

simply indigenous people's wisdom. Furthermore, Traditional Knowledge is

described in the

context of local communities' traditions or practices, which invariably

gives it a distinct

flavour due to the many disparities in local communities' traditions and

practices.

Furthermore, recognizing small communities and defining "indigenous

people" is difficult

and ambiguous until established by the community's national statute.

That is also why

Traditional Knowledge cannot be accommodated under the present types

of Intellectual

21
Available at www.wipo.int/globalissues/tk/report/final/pdf/partI.pdf

49
Property Rights regimes.The utilization of existing legislation can be used
to provide defensive protection. Though positive protection may
necessitate the passage of new legislation, existing intellectual

property categories can be utilized to safeguard traditional knowledge. All

States, in

principle, agree on the reason for maintaining defensive protection. The

key question

becomes whether states are obligated to do more than simply prohibit

subject matter theft.

Human rights might have a role in the preservation of traditional

knowledge in this case.

THE NATURE OF TRADITIONAL KNOWLEDGE

Due to the difficulties of articulating its essence, the phrase traditional

knowledge often

misconstrued and utilized in perplexing ways. The nature of TK, on the

other hand, needs be

established if any legal structure addressing TK is to be successful. The

WIPO draft

instrument for the preservation of traditional knowledge defines TK by

describing the many

characteristics that make it up. Article 1 of the Draft is significant for two
reasons. By

explaining the nature of TK, it establishes suitable bounds for the extent of
the legally

protected subject matter. It outlines the characteristics that a TK must

possess in order to be

qualified for protection against infringement. The provision is also critical

in comprehending,

50
interpreting, and putting the instrument into practice.

The knowledge must be developed and preserved in a collective setting,

be intergenerational,

be specifically tied to indigenous peoples or local areas, be changing, and

existing in

codification or other forms, according to the criteria defined in these

clauses.22

The term 'collective context' is used in the draft clause to stress that TK
should be attributed

to organizations such as indigenous peoples and/or local communities. As

a result,

information that can be traced back to a single person will not be

recognized TK. Simply

because an idea is attributed to persons who've been members of a

specific culture does not constitute the knowledge TK. For varied
purposes, certain traditional information is retained

and kept private and confidential. In this instance, we must distinguish

between collective

knowledge and individual knowledge. Traditional knowledge that is kept

collectively is the

only type of TK that is protected.

Article 1 (c) of the Draft Articles stresses the intergenerational character

of TK. The fact that

TK is intergenerational means that information is handed along from a

generation to the next.

A community's success and common legacy is referred to as TK. It belongs

to future

22
Art 1 of the Draft instrument

51
generations as well as past and present generations.

CONTROVERSIAL PATENT CASES INVOLVING TRADITIONAL

KNOWLEDGE AND GENETIC RESOURCESL

1 Turmeric case23

Turmeric (Curcuma longa) is a ginger family plant that produces saffron-

coloured rhizomes

that are used as a spice in Indian cookery. It also possesses qualities that
create a good

component for medications, cosmetics, and colour dyes. It has long been
used to treat wounds

and rashes as a medication.

• In 1995, two Indian nationals at the University of Mississippi Medical

Centre were given a

US patent for the "use of turmeric in wound healing," which was issued
under the number

5,401,504.

• The Indian Council of Scientific and Industrial Research (CSIR) have

requested that the

patent be re-examined by the US Patent and Trademark Office (USPTO).

Turmeric is being used for centuries to cure wounds and rashes, according
to the CSIR, and

hence its therapeutic application is not new.

• Documentary proof of traditional knowledge, such as an old Sanskrit

manuscript and a

23
Nasser Alasous , “Patents and Traditional Knowledge”, APRIL 2016,https://www.researchgate.net/publication/317106328_Patent_Traditional_Knowledge

52
study published in the Journal of the Indian Medical Association in 1953,
backed up their

assertion.

• The USPTO sustained the CSIR objections and cancelled the patent,
notwithstanding the

patentees' protestations.24

Observations: The turmeric case was significant since it was the first time
a patent based on a

poor country's customary knowledge had been successfully challenged.

The legal fees

expended by India in this dispute have been estimated to be around

$10,000 by the Indian

government.

2. Neem case25

Neem (Azadirachta indica) is a South and Southeast Asian tree native to

India. Because of its

characteristics as a natural medicine, insecticide, and fertilizer, it is now

widely cultivated

across the tropics. Neem extracts are effective against a wide range of
pests and fungal

diseases that affect food crops; the oil produced from its seeds is used to
treat colds and flu;

and when combined with soap, it is thought to provide low-cost treatment

from malaria, skin

ailments, and even meningitis.In 1994, the EPO issued the US Corporation
W.R. Grace and USDA European Patent No.
24
Walter Lewis &Veena Ramani ‘Ethics And Practice In Ethnobiology: Analysis Of The International Cooperative Biodiversity Group Project In Peru’ [2007] Biodiversity and the Law:
Intellectual Property,Biotechnology and Traditional Knowledge

25
Nasser Alasous , “Patents and Traditional Knowledge”, APRIL 2016, https://www.researchgate.net/publication/317106328_Patent_Traditional_Knowledge

53
0436257 for a "method for controlling fungus on plants with the use of a
hydrophobic

extracted neem oil."

• In 1995, a collection of foreign NGOs and Indian farmer representatives

launched a legal

challenge to the patent.

• They provided proof that the fungicidal activity of neem seed extracts
had been recognized

and utilized in Indian agriculture for millennia to preserve crops, indicating

that the

innovation asserted in EP257 was not new.

• In 1999, the EPO found that "all characteristics of the current claim were
publicly disclosed

prior to the patent application, and [the invention] was not judged to
include an inventive

step" based on the evidence.

• In the year 2000, the European Patent Office (EPO) cancelled the patent.

3. Ayahuasca case26

Shamans of indigenous tribes in the Amazon Basin have been processing

the bark of

Banisteriopsis caapi for years to make a ceremonial drink known as

"ayahuasca." In religious

and healing ceremonies, shamans utilize ayahuasca (which means "vine

of the soul") to

26
Nasser Alasous , “Patents and Traditional Knowledge”, APRIL 2016, https://www.researchgate.net/publication/317106328_Patent_Traditional_Knowledge

54
diagnose and treat ailments, communicate with spirits, and divine the
future.

Loren Miller, an American, received US Plant Patent 5,751 in June 1986,

providing him

rights to a purported B. Caapi variation he termed "Da Vine." The "plant

was discovered

growing in a residential garden in the Amazon rain-forest of South

America," according to

the patent description. Because of the colour of the flowers, the patentee
claimed that Da

Vine was a unique and distinct variety of B. caapi. The patent was
discovered in 1994 by the Coordinating Body of Indigenous Organizations
of

the Amazon Basin (COICA), an umbrella organization that represents over

400 indigenous

groups. The Centre for International Environmental Law (CIEL) submitted a

request for re-

examination of the patent on their behalf. CIEL objected, claiming that a

survey of the

previous art revealed Da Vine to be neither innovative nor unique. They

further claimed that

issuing the patent were in violation of the Patent Act's public and morals
provisions due to

Banisteriopsis caapi's hallowed status across the Amazon area. CIEL

produced extensive new

prior art, and the USPTO invalidated the patent claim in November 1999,
saying that Da

55
Vine was not different from the prior art supplied by CIEL and that the
invention should

never have been awarded. However, the patentee's further arguments

convinced the USPTO

to change its ruling and declare the patent valid in early 2001.

Observation: The patent was not protected by the new inter parts re-
examination regulations

in the United States due to the general date of filing. As a result, CIEL was
unable to

comment on the patentee's arguments that resulted to the patent been

upheld.

NEED OF PROTECTION OF TRADITIONAL KNOWLEDGE

Folksongs, rituals, legends, and traditional medical knowledge are among

the most well-

known types of traditional knowledge, with the latter in particular in need

of preservation.

For ages, people have understood the value of plant extracts and
biological modification. For

thousands of years, the Chinese have relied on herbal remedies to cure a

range of health

issues. Plant-based remedies, particularly 'Ayurveda,' 'Siddha,' and

'Unani,' have risen to

prominence in India as a popular and effective alternative to the prevailing

Western medical

system and principles. Traditional medicines (especially Ayurveda

mixtures based on

56
documented information available through ancient texts) have gotten a lot
of attention in the last decade, as pharmaceutical companies have seen
them as a source of patentable and

protected drugs, both for evolving medicinal applications and for profit. 27

The patenting of neem (Azadirachta indica) and turmeric (Curcuma longa)

are two notable

examples of Indian biota bio-piracy. Two Indian nationals working at the

University of

Mississippi Medical Centre were given a US patent in 1995 for their

"application of turmeric

in wound healing." The Indian Council of Scientific and Industrial Research

(CSIR)

challenged the US patent, claiming that turmeric has been used in India
for thousands of

years to heal wounds and rashes, and was successful in having the patent
revoked, thwarting

an attempt to profit from India's traditional knowledge. Similarly, the

European Patent Office

issued a European Patent to W.R. Grace and USDA in 1994 for a "method
for controlling

fungus on plants using hydrophobic extracted neem oil." In 2000, the

patent was withdrawn

due to the fact that neem has been utilized in India for millennia. 28

Other patents on Indian biota include Phyllanthus amarus, an Ayurvedic

cure for jaundice

27
Gerard Bodeker, “Traditional Medical Knowledge, Intellectual Property Rights & Benefit Sharing”,Cardozo J. Int'l & Comp. L. 785 (2003).

28
Vera Shrivastav, “Protection of Traditional Knowledge within the existing framework of Intellectual Property Rights: Defensive and Positive approach”, SSRN-
id2463017.pdf

57
that has a U.S. patent for use with Hepatitis B, and Piper Nigrum, an
Ayurvedic treatment for

vitiligo (a skin pigmentation condition) that has a British paten 29t.

THE EXISTING STATE OF INTERNATIONAL LAWS AND

TRADITIONAL KNOWLEDGE

There are several international agreements that deal with traditional

knowledge holders'

rights, but three stands out as being particularly relevant to the patent
regime: the Convention

on Biological Diversity (CBD), the Agreement on Trade Related Aspects of

Intellectual Property Rights (TRIPS), and the Patent Cooperation Treaty
(PCT). This section will give an

outline of the potential and constraints that such international

mechanisms present to

indigenous peoples.

The Convention on Biological Diversity

The CBD is a non-governmental organization that was established in 1993

and presently has

over 180 nations as signatories. Article 1 of the CBD states that its goal is
to establish a fair

and equal distribution of benefits, which is the central problem of patent

protection and

traditional knowledge. The CBD aims to identify and codify the value of
traditional

knowledge, as well as ensure that holders of such resources are fairly

compensated.
29
Gerard Bodeker, “Traditional Medical Knowledge, Intellectual Property Rights & Benefit Sharing”,Cardozo J. Int'l & Comp. L. 785 (2003).

58
 The CBD is the only international agreement dedicated to traditional
knowledge, inventions,

and biodiversity protection measures. Traditional knowledge bearers have

rights to their

knowledge, ideas, and practices, according to Article 8(j), even though

such rights cannot be

protected through intellectual property rights.

Because many developing nations rely on biological resources, they

support the CBD's goal

of preventing unauthorized individuals from exploiting traditional

knowledge and ensuring

benefit sharing rather than instituting laws for positive protection.

Traditional knowledge in the TRIPS agreement

Traditional knowledge's ability to give birth to intellectual property rights

was not even

debated among academics during the discussions for the Agreement on

Trade-Related

Aspects of Intellectual Property Rights (the TRIPS Agreement). In this

regard, the recent shift toward the development of a new intellectual
property category is all the more

significant. Depending on whether the subject matter is "trade-related,"

the TRIPS Agreement recognizes some types of intellectual property while
ignoring others. It's also worth noting that moral rights are expressly
excluded from the TRIPS Agreement's scope. However, there has recently
been a lot of anger in the Council for TRIPS over the lack of
acknowledgement of traditional knowledge, which is seen as legitimizing
the theft of traditional information. for example, has advocated that TRIPS
Article 29's collection of procedural criteria be expanded so that
traditional knowledge might be controlled.

59
The EC concludes that the first two alternative procedural requirements
are appropriately

addressed within patent offices, but that the third procedural condition is
too complicated for

patent offices to handle. In terms of origin disclosure, the EC believes that

the "sufficiently

explicit and full wording of TRIPS Article 29.1 might include a geographical
indicator, but

that this is only an obligation if it is “essential to make the invention into

effect.”30

Struggling to incorporate traditional knowledge in some way under the

TRIPS Agreement, on

the other hand, would technically only cover the trade-related

components of this knowledge,

not the moral dimensions. Of course, one might argue that the reduced
danger of theft

associated with formal acknowledgement of traditional knowledge has

moral implications,

but traditional knowledge is currently regarded prior art and hence not
susceptible to patents or other kinds of intellectual property protection.
Moral rights, on the other hand, are thought

to be particularly important in conserving traditional knowledge.

It is important to note that the TRIPS Agreement does not prohibit the
creation of new

intellectual property categories as long as this does not interfere with the
duties that States

30
European Communities and their Member States, Review of Article 27.3(b) of the TRIPS Agreement, and the Relationships between the TRIPS Agreement and
the Convention on Biological Diversity (CEO) and the Protection of Traditional Knowledge and Folklore, WTO Doc. IP/C/W/383, para 54

60
already have under the Agreement, meaning that the TRIPS provisions are
not implemented.

For example, as part of their CBD implementation, four states have

acknowledged traditional

knowledge in their law, with Portugal being one of them. Portugal's

legislation expressly

addresses the registration and identification of plants which were not

qualified for plant

variety protection. Despite the fact that negotiations for the establishment
of an international

system for the registration and recognition of farm owner plant varieties
appear to be off the

table for the time being, the validation of native plants as giving rise to
intellectual property

protection on a national level must be recognized as a step in the right

direction.

Traditional knowledge is stated to constitute a "problem" for the TRIPS

Agreement, despite

the fact that the TRIPS Agreement is legally mute on the subject. Some
contend, however,

that some kinds of intellectual property recognised by the TRIPS

Agreement may be relevant

to indigenous peoples and local communities in order to safeguard their

knowledge and

plants, as will be described more below.

The Patent Cooperation Treaty

In 1970, the Patent Cooperation Treaty (PCT) was developed, and it went
into effect in 1978.

61
The World Intellectual Property Organization (WIPO) is in charge of it. The
PCT's mission is

to provide a unified system for registering patent applications at the

worldwide level.31 The

PCT was created with the intention of filing a single 'international'

application rather than filing individual applications in each state that
wishes to preserve its conventional

knowledge.

The PCT technique is divided into two stages. First, there is the
international phase, which

comprises the agreement's norms as well as any extra rules that regulate
the prosecution and

procedure of applications. Second, there is a national phase, in which

international

applications are changed to a collection of national applications, with

domestic legislation

and practice predominating.

The PCT, on the other hand, has two reservations about traditional
knowledge protection. The

first question is at what level governments are permitted to enact

restrictions, particularly

those relating to the disclosure of traditional knowledge's origins, which

have a demonstrable

impact on the international stage.The second point of contention is the

extent to which non-

binding prior art examination is required during the international phase, as

well as whether or
31
Riya,”PROTECTION OF TRADITIONAL KNOWLEDGE UNDER INTELLECTUAL PROPERTYRIGHTS REGIME”, Vol. 1 (01), Dec 2020, pp. 149-164 2, E- Journal of
Academic Innovation and Research in Intellectual Property Assets (E-JAIRIPA), http://www.cnlu.ac.in/2021/CIRF/10%20Riya.pdf

62
not it is anticipated to recognize and seek innovations based on
conventional knowledge.

Traditional Knowledge Digital Library Unit (TKDL)

The Traditional Knowledge Digital Library (TKDL) is a groundbreaking

initiative in India, a collaborative effort between the Council of Scientific
and Industrial Research (CSIR) and the Ministry of Ayurveda, Yoga &
Naturopathy, Unani, Siddha, Sowa Rigpa, and Homoeopathy (AYUSH). Its
primary goal is to safeguard Indian traditional knowledge globally by
preventing exploitation at Patent Offices. Traditional Knowledge (TK),
crucial to indigenous communities, faces exploitation risks, particularly in
healthcare where over 70% of India's population relies on traditional
medicine.A key incident involved a US patent granted for turmeric's
wound healing properties, underscoring the need for proactive protection.
The complexity of India's traditional medicinal knowledge, documented in
languages like Sanskrit and regional dialects, poses challenges for global
patent examiners.TKDL addresses these challenges by systematically
translating ancient texts, primarily focusing on Ayurveda, Siddha, Unani,
Sowa Rigpa, and Yoga, into international languages like English, Japanese,
French, German, and Spanish. With over 4.54 lakh formulations/practices
in its database, TKDL employs the Traditional Knowledge Resource
Classification (TKRC) to classify Indian TK, enhancing search quality and
examination of prior art in patent applications. 32

TKDL sets global standards, adopted by the World Intellectual Property

Organization (WIPO), providing specifications for TK databases. It
integrates diverse disciplines, languages, and traditional knowledge with
modern science, serving as a bridge for patent examiners between
ancient texts and modern medicine.Access to TKDL is granted to sixteen
Patent Offices under a non-disclosure agreement, allowing examiners to
32

63
use it for search and examination, safeguarding India's interests. The
unique Access Agreement ensures non-disclosure to third parties.TKDL's
impact is evident, with 324 patent applications set
aside/withdrawn/amended based on prior art evidence. It has proven
effective against bio-piracy, setting a global benchmark for proactive TK
protection. The focus is on deterrence, preventing erroneous patent grants
by providing access to TK-related prior art for examiners without
restricting traditional knowledge use.

GOALS OF The TKDL

 seeks to prevent the granting of patents for products developed

utilizing TK where there has been little, if any, inventive step
 intends to act as a bridge between information recorded in ancient
Sanskrit and patent examiners (with its database containing
information in a language and format understandable to patent
examiners)
 facilitates access to information not easily available to patent
examiners, thereby minimizing the possibility that patents could be
granted for “inventions” involving only minor or insignificant
modifications

OBJECTIVES OF TKDL

- Preventing the issuance of patents for innovations with minimal, if any,

genuine breakthroughs rooted in traditional knowledge.
- Acting as a conduit between ancient Sanskrit texts and patent
examiners, presenting information in a format and language easily
understood by them.
- Enhancing accessibility to information not readily available to patent
examiners, thereby minimizing the chances of patents being granted for
innovations with only minor or inconsequential modifications.

TRADITIONAL KNOWLEDGE AND THE PROBLEMS

64
ASSOCIATED WITH ITS PATENTING

The phrase "traditional knowledge" refers to a variety of topic areas that

all have one thing in

common: they are all made up of information that is shared among

members of indigenous

groups. Traditional knowledge, despite its colonial language, is not static;

it grows and

develops with time and encompasses a vast spectrum of biological and

cultural knowledge.33

The phrase "bio-piracy" refers to the acquisition of intellectual property

rights over traditional

biological knowledge traditionally held by indigenous peoples in

biologically varied parts of

the world by industrially developed enterprises, often in the form of

patents.34 Hagen

Abyssinia, Ayahuasca, basmati rice, and turmeric are examples of

biological knowledge for

which patent protection has been sought. Bio-piracy is considered to be

contributing to the

growing gap between rich and poor countries, with the material and
monetary benefits gained

from misappropriating this information. Beyond the monetary divide,

indigenous peoples

may see the patentee's exploitation of their understanding as violating

non-commercial and

33
Arewa, TRIPS and Traditional Knowledge: Local Communities, Local Knowledge, and Global Intellectual Property Frameworks, REV. 155, 175 (2006); Press
Release, http://www.etcgroup.org/en/materials/publications.html?pubid=683

34
Graham Dutfield, What is Biopiracy? International Expert Workshop on Access to Genetic Resources and Benefit Sharing, at I
http://www.canmexworkshop.com/documents/papers/1.3.pdf

65
spiritual health, demonstrating the patentee's disregard for such interests
and values.

The word "bio-piracy" has a negative connotation due to the lack of

remuneration given to

indigenous peoples who develop traditional knowledge. Bio-piracy has

expanded to

encompass a wide range of activities, including the collecting and

utilization of traditional

knowledge, as well as unfair free-riding on such information through the

patent system.

Patentees who actively sought to patent a tradition of purification the

medicinal purpose

product, the component itself, or a process while using the product reduce
the costs of

research and development of new products by utilizing species that

indigenous people have

originally defined to be effective and useful, and then pursue to patent a

tradition of cleansing

the medicinally-effective product, the component itself, or a procedure for

using the product.

Biological variety is the product of human involvement with local

ecosystems; in order to not

only conserve, but also increase future diversity, circumstances must be

maintained that allow

those who have nurtured the environment to do so again. If intellectual

property rights

destabilize the previously stable equilibrium, the effects might be harmful

to both the

66
ecosystem and the indigenous peoples that rely on it. Beyond the
immediate influence that a

patent may have on local indigenous groups, there are the possible long-
term consequences of overconsumption and the modification of varied
ecosystems. Biodiversity isn't a static

concept. Biodiversity is maintained via involving interplay within an

ecosystem, such as plant

competition, animal eating, natural disasters, and human contact, which

allow the

environment to adapt.35

When one element in an ecosystem is depleted, the competitive power

balance in relation to

the remaining resources is altered. Because it is hard to predict what

biodiversity we will

require in the future, preserving the processes by which we produce

biologically varied

resources must be a top priority. In the near term, genetically modifying

food crops, for

example, may enhance agricultural productivity. Because of the enhanced

production and

fortitude of the crops, indigenous groups are under pressure to embrace

genetically modified

seeds with higher production capacities.

Biological variety and "preservation of the strongest" evolvement can only

thrive as long as

the weak can be weeded out using traditional farming techniques.

Changing the fine line of
35
Rosemary J. Coombe, The Recognition of Indigenous Peoples' and Community Traditional Knowledge in International Law, 14 ST. THOMAS L. REV. 275, 278
(2001).

67
human interactions within a particular ecosystem can have far-reaching
consequences when

nearly 1.4 billion rural people rely on traditional biological knowledge

merely to eat.

PRESERVING TRADITIONAL KNOWLEDGE: INITIATIVES IN

INDIA

Traditional knowledge is a great asset for every country since it aids in the
advancement and

transformation of the nation's society. The importance of traditional

knowledge is discussed

in this study. The Traditional Knowledge Digital Library's function in

conserving traditional

medical knowledge in India is described in this publication. The role of

intellectual property systems in relation to traditional knowledge, its
preservation, protection, and use, has recently received increased
attention in a number of international forums on topics as diverse as food
and agriculture, the environment (particularly biological diversity
conservation), health (including traditional medicine), human rights and
indigenous issues, and aspects of trade and economic development. 36
While the policy issues surrounding TK are numerous and varied, the IP
issues can be divided into two categories: positive

protection (giving TK holders the right to take action or seek remedies in

the event of certain

forms of TK misuse) and defensive protection (providing TK holders with

the ability to take

action or seek remedies in the event of certain forms of TK misuse).

Indigenous and local groups had contended in national and international

law-making

36
Plant Interactions. (2010) Traditional medicine. Retrieved July 1, 2010, from http://www.plantinteractions.co.uk/ethnobiology/traditional-medicine/

68
authorities that their knowledge systems must not be exploited without
their agreement, and

that fair sharing of the benefits should be established. Various

intergovernmental

organisations, such as the Convention on Biological Diversity, have

studied the role of

intellectual property and traditional knowledge (CBD) , the World

Intellectual Property

Organisation (WIPO),37 the Food and Agriculture Organisation of the United

Nations

(FAO),38 the World Trade Organisation (WTO) and the United Nations
Conference on Trade

and Development (UNCTAD)39 are working in this course. WIPO has taken
the lead by

taking into account the needs of representatives from TK-holding

communities across the

world. WIPO and UNESCO approved model legislation on folklore in 1981.

The FAO

adopted the notion of Farmers' Rights into its International Undertaking on

Plant Genetic Resources in 1989, and the CBD emphasized the need of
promoting and preserving

traditional knowledge in 1992. In 2001, the World Intellectual Property

Organization (WIPO)

established the Intergovernmental Committee on Intellectual Property,

Genetic Resources,

37
World Intellectual Property Organisation, from http://www.wipo.int/portal/index.html.en

38
Food and Agriculture Organization of the United Nations, http://www.fao.org/

39
United Nations Conference on Trade and Development. (UNCTAD), Retrieved December 20, 2009, from http://www.unctad.org

69
Traditional Knowledge, and Folklore (IGC) as an international policy
forum.Over the

previous 100 years, several multilateral treaties have been enacted, with
country states

implementing the broad concepts inherent in such accords into their own
domestic

legislation. For example, India has enacted unique legislation to conserve

at least some

components of traditional knowledge.Amla (Phyllanthus emblica), black

pepper (Piper nigrum), basil (Ocimum basilicum), and

other therapeutic plants and spices have long been used by Indians. Amla
(Indian

Gooseberry) is the most effective natural source of vitamin C, a great

antioxidant that has the

same amount of vitamin C as two oranges. It aids in the maintenance of a

stronger, healthier

digestive system, increased general immunity, detoxification, blood

purification, cholesterol

reduction, eyesight enhancement, and the strengthening of the lungs,

respiratory system, and

central nervous system. Expectorant, carminative, antipyretic,

anthelmintic, and appetizer,

Kali Mirch (black pepper) It has been used in India to treat toothaches,
asthma, chronic

indigestion, colon toxins, obesity, nasal congestion, fever, colic pain,

cholera, and stomach

illnesses, among other conditions. Methi (fenugreek), another Indian spice,

treats indigestion,

70
constipation, mouth ulcers, avoids kidney stones, and regulates blood
sugar levels. Tulsi,

India's most sacred herb is used as a nerve tonic, to improve memory, and
to treat fevers,

common colds, and respiratory illnesses such as bronchitis, asthma, and

influenza, among

other things. It can also help with influenza, kidney stones, and heart
problems by lowering

blood cholesterol. Sweating, vomiting, dizziness, nausea, arthritic pain,

ulcerative colitis,

headaches, fevers from flu and colds, sore throats, and chemotherapy are
all relieved by ginger, possibly the most popular spice in most Indian
dishes. This ancient knowledge of

herbal usage, known as 'dadi maa ke nuskhe' (Grandma's remedy) among

Indians, has been

passed down from generation to generation and is an essential element of

Indian culture.

A lot of pharmaceutical companies make use of such traditional expertise.

The Kani tribes'

medical expertise led to the invention of Jeevani, an anti-stress and anti-

fatigue agent based

on the natural herbal plant arogyapaacha in South India.

Patents have been issued in the past to innovations that were previously
known traditional

knowledge because patent examiners were unable to look for relevant

traditional knowledge

as prior art due to the non-availability of such material in the classified

non-patent literature.

71
The US Patent Office issued a claim on the wound-healing capabilities of
turmeric (Curcuma

longa) in 1995, however the patent was successfully challenged and

cancelled. Another

example is the European Patent Office's cancellation of the patent issued

to W.R. Grace

Company and the United States Department of Agriculture on the Neem

plant on the same

grounds that its usage had already been recognized in India. According to
a research done in

2000, the US Patent Office had issued 4,896 patents on medical plants,
with 80% of them

being on species from India.40

India's response to TRIPS article 27(3) is the Protection of Plant Varieties

and Farmers'

Rights Act, 2001. The Act aims to strike a compromise between

commercial breeders' rights

and those of small-scale and subsistence farmers. The Central

Government establishes the

National Gene Fund, which is credited with benefit-sharing payments,

yearly fees paid to the

authorities, money acquired through compensation claims, and donations

from national and international organizations and other sources.
Furthermore, rather than being freely discussed

between the parties, the benefit sharing is determined by the Authority

under the Act.

40
65 Sen, N. (2002) TKDL– A safeguard for Indian traditional knowledge. Current Science, 82(9), 1070– 1071. http://www.ias.ac.in/currsci/may102002/1070.pdf

72
India's response to the 1992 Convention on Biological Diversity is the
Biological Diversity

Act of 2002. The Act asserts states' sovereign rights over biological
resources and allows for

conservation, long-term use, and equitable distribution of benefits

resulting from genetic

resource use. The Biological Diversity Rules, 2004, complement the Act by
dealing with

access, information transfer, and intellectual property rights.

In the area of specification of non-patentable inventions, the Patent

(Amendment) Act of

2005 added that "an invention which is merely a new use for a known
substance" and "an

invention which is, in effect, traditional knowledge or which is an

aggregation or duplication

of defined properties of traditionally known substances" will not be

considered inventions.41

Section 25 of the Act, which governs post-grant objection, has been

revised to allow anybody

to file an opposition based on a lack of novelty and anticipation of the

invention based on

information, oral or otherwise, existing within any local or indigenous

community. Positive

protection has been advocated by way of sui generis legislations above

and above this

modification, and this Act of 2005 offers a type of defensive protection

under Indian patent

41
6 6 Ss. 3(d) and 3(p) of Patent (Amendment) Act, 2005.

73
law.

Various initiatives have been made in India, a nation rich in traditional

knowledge and

biodiversity, to control access to traditional groups and promote equitable

benefit sharing. In

January 2009, a group of like-minded individuals with the goal of

conserving traditional

knowledge gathered in Bangalore to discuss the best practical means to

do so in what was

formally dubbed "The First National Consultation on TK and IPR." The

Delhi-based Forum for Biotechnology and Food Security, Thanal, a Kerela-
based NGO, and the National Law

School of India University, Bangalore, all took part in this gathering. 42

There was a hurry to build a new legal and legislative framework to

safeguard traditional

knowledge in the mid-1990s. Two propositions drew a lot of attention. Mr.

Pravin Anand

recommended granting everlasting but restricted rights to traditional

knowledge in order to

conserve it. Licenses to use this information may be issued in exchange

for a minimal charge

paid to a universal rights management organisation, which would oversee

the right to

procreate the information and prevent its distortion and harmful use.

However, the Indian strategy resulted in the creation of traditional

knowledge databases that

Sunita K. Sreedharan, “Bridging the Time and Tide- Traditional Knowledge in the 21st
42

Century”, Volume 15 JIPR, March 2010

74
may be utilized as prior art in assessing patent applications and TK
misuse. There have been

various projects in India to chronicle traditional knowledge, the most

notable of which is the

TKDL, which is backed by the Ministry of Science and Technology and the
Ministry of

Indian Systems of Medicine. Other noteworthy projects include the Honey

Bee Network's

National Innovation Foundation database and the Farmers Rights

Information System.

Finally, it is important to remember Kerala's 2008 Intellectual Property

Rights Policy. This

strategy attempted to control traditional knowledge in Kerala by

establishing a "property

right" around it. For conventional knowledge, the policy proposed the
concepts of

"knowledge commons" and "commons license." Despite the constitutional

challenges and

debates surrounding it, this policy has been viewed as a bold move
forward by the State of

Kerala to conserve traditional knowledge. In order to give safety to TK

even in the lack of

any meaningful comprehensive framework, this paper has discussed

Indian governmental

measures as well as individual legislations.

CONCLUDING REMARKS

Traditional knowledge and its acknowledgment as a type of Intellectual

Property have a

75
unique aspect in that intellectual property arose around the western idea
of individualized

property holding, but traditional knowledge is something that is owned by

the entire society.

This is a key area of disagreement in terms of conventional knowledge

consensus. As this

article shows, the current categories have attempted to preserve TK. The
present categories,

according to this chapter, are ineffective for the protection of TK. It has
identified

shortcomings in each category and emphasized that the traditional

intellectual property

system cannot fully safeguard all TK.

Traditional knowledge and its acknowledgment as a type of Intellectual

Property have a

unique aspect in that intellectual property arose around the western idea
of individualized

property holding, but traditional knowledge is something that is owned by

the entire society.

This is a key area of disagreement in terms of conventional knowledge

consensus. As Part I

of this article shows, the current categories have attempted to defend TK.
The present

categories, according to the report, are ineffective in protecting TK. It has

identified

shortcomings in each category and emphasized that the traditional

intellectual property

76
system cannot fully safeguard all TK.The relevance of safeguarding
indigenous people's traditional knowledge to their economic prosperity
and livelihood has been recognized in this study. The articles looked at the
international legal frameworks for patent systems and determined that
while such instruments allow nations to construct their own protection,
this strategy has limitations. Following that, the article describes the
challenges that indigenous people face if they pursue patents, including
identifying the particular creator and the date of the invention. Cases like
Turmeric or the Neem tree show that even though a patent was issued to
its owners, it did not prevent others from claiming the right to such plants.

CHAPTER - 4

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