TITLE OF THE PAPER: PROTECTION OF TRADITIONAL KNOWLEDGE

PERTAINING TO VARIOUS MEDICINAL PLANTS VARITIES

KIIT SCHOOL OF LAW

KIIT UNIVERSITY
BY:

SHRADDHA SUMAN CHANDEL

BALLB

ROLL NO. : 1283087

SEM: 10th (IPR Hons.)

TITLE : PROTECTION OF TRADITIONAL KNOWLEDGE PERTAINING TO
VARIOUS MEDICINAL PLANTS VARITIES

ABSTRACT

Traditional knowledge is an important element of the intellectual and cultural heritage of

indigenous peoples. It reflects their social and historical identity and significantly contributes
to the future well-being and sustainable development. India is sitting on a goldmine of well
recorded and traditionally well practised knowledge of herbal medicine. The country perhaps
is the largest producer of medicinal herbs and is rightly called the botanical garden of the
world. Therefore it is prone to bio piracy and hence need to be protected. The paper analysis
about the Protection of Traditional knowledge. Part 1 is the introduction to the topic . Part 2
states about the protection to traditional medicinal knowledge. Part 3 is the utilisation of
biodiversity. Part 4 talks about bio piracy .Part 5 deals Protection for indigenous medicinal
knowledge. Part 6 studies about Sui Generis Regime. Part 7 discusses about the Traditional
knowledge Digital Library. Part 8 deals with Gene Campaign. Part 9 studies about the access
and benefit sharing . Part 10 and Part 11 talks about the cases and the conclusion.

keywords : Bio piracy, Sui generis, Traditional knowledge digital library, Gene campaign ,
Access and benefit sharing , Nagoya protocol
 CONTENTS

1.INTRODUCTION .................................................................................................................................... 4
2. PROTECTION OF TRADITIONAL MEDICINAL KNOWLEDGE .............................................................. 5
3.UTILISATION OF BIODIVERSITY ............................................................................................................ 6
4. WHAT IS BIO PIRACY ?......................................................................................................................... 6
5. PROTECTION FOR INDEGENOUS MEDICINAL KNOWLEDGE ............................................................... 8
6.SUI GENERIS ......................................................................................................................................... 9
7.TRADITIONAL KNOWLEDGE DIGITAL LIBRARY ................................................................................... 10
8.GENE CAMPAIGN ............................................................................................................................... 11
9.ACCESS AND BENIFIT SHARING .......................................................................................................... 11
Nagoya Protocol................................................................................................................................ 12
10.ISSUES IN INDIA................................................................................................................................ 13
Neem case......................................................................................................................................... 13
Turmeric case ................................................................................................................................ 14
Phillanthus Niruri ...................................................................................................................... 14
Other cases ........................................................................................................................... 14
11.CONCLUSION.................................................................................................................................... 15
 1.INTRODUCTION

Traditional knowledge generally refers to the matured longstanding tradition and practises of
certain regional , indigenous or local communities developed from experience gained over
the centuries and adapted to the local culture and environment .traditional knowledge also
encompasses the wisdom , knowledge and teaching of the countries which come to us
through generations.1

the treasure of thousands year of old knowledge of ancient India is a matter of pride for its
citizen. Indian are fortunate to have been the holder of such a huge knowledge based on
diverse fields of arts, philosophy, language, literature , science, technology so on and so
forth; These have become integral part of rich cultural heritage of this country . This ancient
knowledge has huge potentiality to transfer the whole of India's economy if explored and
utilised properly. One such area is its traditional knowledge associated with medical
properties of the plants, at every corner of this country the traditional knowledge with a
strong scientific base is unique in the world that is Ayurveda , Sidha, Unani, etc.. The plants,
more specifically its genetic resources not only can do wonders of curing small or serious
types of illness, but also can guarantee as precautionary measures to prevent diseases. Over
the centuries India has successfully preserved the methods and means to ensure healthy lives
in a unique way.

In India, in most of the cases, the traditional knowledge is not identified with small particular
community- indigenous or tribal that is Neem, Turmeric, Aloevera, Karela, Tulsi, Brahmi, etc
the basic medicinal values of these plants are the knowledge of the whole society. Hence it
would be appropriate if traditional knowledge is accepted as a century old knowledge of
indigenous communities and societies in general.

World Intellectual property organisation , a specialised agency of UNO has given a very
broad definition of traditional knowledge with a sharp focus on nature of tradition which is as
follows:

What makes knowledge " traditional" is not its antiquity : TK is not ancient or inert , but is a
vital , dynamic part of the contemporary lives of many communities today . It is a form of
knowledge which has a traditional link with a certain community: it is a knowledge which is

1
Bhatt Seema, Why does India need a medicinal Plant Policy,
available at http://www.devalt.org/newsletter/jan98/of_2.htm (last visited on Feb 20 ,2017)
developed , sustained and passed on within a traditional community, and is passed between
generations sometimes through specific customary systems of knowledge transmission. A
community might see TK as part of their cultural spiritual identity so it is the relationship
with the community that makes it "traditional". TK is being created every day, and evolves as
individuals and communities respond to the challenges post by their social environment. This
contemporary aspect is further justification for legal protection.2

2. PROTECTION OF TRADITIONAL MEDICINAL KNOWLEDGE

Protection of Traditional Medicinal Knowledge means :

(a) Preservation,

(b) Promotion of its dissemination and use,

(c) Control of its use (avoiding misuse),

(d) Ensure benefit sharing with originators,

Need for protection :

Realising the advantages in this area, the pharmaceutical companies are behind acquiring the
traditional medicinal knowledge in a very cheapest and easiest manner. Traditional medicinal
knowledge is treated as a knowledge in public domain for free exploitation without showing
any respect or concern for the efforts made by the communities to preserve and promote the
same. So, it is high time we should think of protecting the valuable traditional knowledge
associated with medicine.3

Intellectual Property Rights offers two forms of protection of Traditional Knowledge :

A positive protection by granting exclusive rights over use to the member of the local
communities.

2
Gangotri Chakraborty and Partha Pratim Paul, "New type of Biopiracy and missappropriation of traditional
knowledge associated with Medicinal Plants in India",KJLS 9 (2014)
3
Hasain Danish , "Protection of Traditional Medicinal Knowledge",
available at: http://www.legalservicesindia.com/article/print.php?art_id=1681 (visited on Feb15,2017)
 A defensive protection by excluding others from the use of Traditional Knowledge

held by a particular community4

3.UTILISATION OF BIODIVERSITY

As per the estimates, biodiversity of India approximately amounts to 12.53% of the global

biodiversity. There are approximately 7,500 species which are used for the medical purposes

mainly for the extraction of drugs. As per the data's there are about )36 million Ayurveda

practitioners,11.6 thousands Siddha practitioners , 29.7 thousand Unani specialists in India.

As per estimates of the International market of herbal medicine there is an increase from

$16.5 million in 1997 to $ 22 million in 2000. International market is dominated by Europe

with $7.2 billion sales in 1997 followed by Asia with $5.5billion which includes markets of

Japan of $2.5 Billion . USA is the fastest going country for botanical medicine in 1997 with

retail sales of $ 3.7 Billion and $3.87 million in 1998. Annual mass growth is more than

100%.5

4. WHAT IS BIO PIRACY ?

Bio-piracy refers to the use of Intellectual Property systems to legitimize the exclusive
ownership and control over biological resources and biological products and processes that
have been used over centuries in non industrialized culture.

4
Swamy Narayan Raju, "Protection of traditional knowledge in the present IPR regime: a mirage or a reality",
IIPA 16 (2014)
available at http://www.iipa.org.in/New%20Folder/Dr.%20Raju%20Narayana%20Swamy.pdf ( Visited on
Feb20,2017)
5
Biswal Meeta and Biswal Debidutta, Issues relating to traditional knowledge systems and Intellectual Property
Rights (iprs)
available at http://www.fao.org/docrep/article/wfc/xii/0911-a3.htm (Visited on Feb17,2017)
Allopathy has huge side effects because of which traditional knowledge is gaining global
attention. Because of this traditional knowledge has become popular but it has also made the
indigenous system prone to bio-piracy and patenting in the country of origin as well as
outside. Patent has been granted in the products of Neem and Philanthus Niruri, which is a
part of traditional medicinal health system since time immemorial. WR Grace company
bagged the patent of the products Neem and Philanthus Niruri and justifies it to be noble but
it has been derived from the indigenous knowledge. It also claims that advanced
technological methods of extraction processes constitutes genuine innovation. This not only
implies the wrongful ownership of rightful property of someone else but also exploits the
rightful owner without recognising or protecting Traditional Knowledge.6
A serious problem is that there has been hundreds and thousands of instances of bio-piracy in
the form patents over the medicinal properties associating with India's traditional knowledge.
The patentees all over the world claimed that they themselves have invented the medical
properties of the herbs or plants by way of excessive research which are noble and non
obvious in nature and there is no such existing knowledge or prior art in this area.
Ginger is patented to treat obesity. However it is found that in a Siddha preparation extracts
of ginger root are used in a treatment of obesity. Citrus peel extracts is patented to treat skin
disorders and injuries. It is recorded on Ayurvedic texts as a key ingredient to treat skin
disease. Phyllanthus- amarus is patented for the inhibition of the replication of the
nucleocidic inibitor resistant retrovirus and / or a non nucleocide inhibitor - resistant
retorovirus, wherein said retrovirus is an HIV. Indian Traditional texts show the drug is used
for immuno - supressive emaciating diseases. Brassica-rapa is patented to normalise bowel
function or for the prevention of colonic cancer. Unani has prescribed it for the purpose of
stomach ailments. Researchers found that in Europe one company had patented an Indian
creeping plant - Brahmi - Bacopa- Monnieri for memory enhancement. Another patent was
awarded for Aleovera for its use as a mouth ulcer treatment.
These are not the ends . There are patents on Kumari - (Aleo Barbadenis), Amaltas- ( Cassia
Fistula), Kala Jeera- (Cuminum Cyminum), Harad- (Terminalia Chubula), Aswagandha-
(Withania Somnifera), Kali Marich- (Piper Nigrum), Erand - (Ricinus Communis), Amla -

6
Hiwwade Mangla and Hirwade Anil ," Traditional Knowledge Protection : An Indian Perspective"

DESIDOC 32 (2012)

http://publications.drdo.gov.in/ojs/index.php/djlit/article/view/2381(Visited on Feb17, 2017)

(Philunthus Emblica), Jar Amla - (Philanthus Amarus), Anar - (Punica Granatum), Dudhi-
(Euphoria Hirta), Karela - (Momordica Charantia), Rangun - Ki - Bel, Shallaki- ( Boswellia
Serrato), Jangli Erand- (Jatropha Curcus), Bhu Amla - (Hillanthus Niruri), Rangoon Creeper-
(Quisqualis Indica), Arjun- (Terminalia Arjuna), Guruchi - (Tinospora Cordifolia),
Chhotagokhuru- (Tribulus Terrestris), Ber - (Zizyphus Jujuba), Adrakha- (Zinziber
Officinale), Latjira- (Achyranthes Aspera), Dhaya (Woodfordia Floribunda), Neem -(
Azadiraachta Indica)etc.
The scientist in Delhi noticed an alarming trend - the bio-prospecting natural remedies by
companies abroad after trawling through the records of the global trademark offices, officials
found 5,000 patents had been issued at a cost of at least 150 million Dollars for 'medical
plants and traditional systems'. More than 2000 of these belong to the Indian system of
Medicine. It shows that there are open end clandestine attacks on traditional knowledge of
India on different corners of the world. Commercialisation of these patents yields huge profits
to the foreign multinational companies and others and traditional knowledge holders do not
get their due share of the profit.7

5. PROTECTION FOR INDEGENOUS MEDICINAL KNOWLEDGE

As there is no patent for indigenous medicine the pharmaceutical companies utilise the
traditional knowledge and indigenous medicinal methods in the development of new
patentable medicine. For this inequity proposals have been made for reformation and
providing patents to the indigenous people as a mark of empowerment and recognition of
their intellectual contribution . However, traditional knowledge has been excluded from
patenting in the western patent system. In addition to that traditional beliefs of indigenous
people are not reconcilable with IPR.
There are basically two international legal framework :
1.Convention of Biological Diversity (CBD)
2.World Trade Organisation's Trade related Aspects of Intellectual Property System
Member states are to treat their indigenous communities and to develop relations among each
other as per the CBD articles.8

7
Gangotri Chakraborty and Partha Pratim Paul, Supranote 2
8
Chatterjee Alimpan ," Traditional Knowledge Herbal Medicine and Intellectual Property : A Debate over
Rights",SYMBO 12
TRIPS agreement not only promotes but it also regulates the harmonization of intellectual
property all over the world and cover only Intellectual Property which includes Geographical
Indications, Trade Secret , Trademark and Patents. The provision of the TRIPS does not
make any reference for the promotion and regulation of traditional knowledge. It neither
acknowledges nor distinguishes between industry and the indigenous community based
knowledge.
TRIPS don't have to comply with UPOV standards, but with the provision 'for protection of
plant varieties either by the patents by effective Sui Generis system or by any combination
thereof (Article 23 (3) (b)).
Several countries believes that the UPOV Sui Generis system have developed as per the
requirements of the nation state or region. They are exclusively related to that country and
the region. 9

6.SUI GENERIS

Sui Generis means " of its own kind" and it consists of domestic laws and methods to
extend plant variety protection other than through patents. TRIPS does not define what is a
Sui Generis System or what should be a Sui Generis System. One of the main purpose of the
Sui Generis protection is to grant exclusive monopoly by the state and it should be able to
provide the owner of the traditional knowledge get adequately compensated for their
contribution .
Sui Generis in TRIPS
Although TRIPS does not mention UPOV but several countries believe that the UPOV
convention meets the requirements need for the Sui Generis system. However Countries need
not have to join UPOV to implement Sui generous system to comply with TRIPS.10

Available at http://www.smpborissa.org.in/KIIT%20Papers_PDF/Alimpan%20Chatterjee.pdf (Visited on 18

Feb 2017)
9
Ibid
10
Dua Pradeep, "Intellectual Property Rights:Need for Sui Generis Regime for Non Codified Traditional
Medicine in India"
available at
https://www.academia.edu/6065139/Intellectual_Property_Rights_Need_for_a_Sui_Generis_Regime_for_Non-
codified_Traditional_Medicine_in_India?auto=download (Visited on 18 Feb 2017)
 7.TRADITIONAL KNOWLEDGE DIGITAL LIBRARY

TKDL is a collaborative project between ministry of science and technology and department
of AYUSHI, Council of Scientific and research (CSIR), ministry of health and family welfare
and is being implemented CSIR.
In the creation of TKDC for Indian system of medicine, an interdisciplinary team of
traditional medicine ( Ayurveda, Unani, Siddha, and Yoga) experts, patent examiners, I T
experts, scientist and technical officers are involved.
TKDL project includes documentation of traditional knowledge in public domain in the form
of existing literature related Ayurveda, Unani, Siddha and yoga. And it is in digital format in
five different languages that is English , German, French, Japanese and Spanish. Re-
examination case was filed by CSIR India with USPTO raising objection against the patent
grounds of existing prior art for turmeric. CSIR challenged and argued that turmeric is being
used for more than 1000 years for healing rashes and wounds . Hence the use of turmeric is
not a novel invention. USPTO upheld the CSIR objection and challenged the patent . To
access TKDL database, India is signing agreements with other patent officers to prevent that
bio-piracy of India's Traditional Knowledge. Agreements have been signed by the
International patent officers, number of agreements have been signed by TKDL with other
several international patent office's like European Patent Office(EPO), US patent and
trademark office i. e USPTO on November 2009, Canadian IP office (CIPO) on September
2010, etc.

The critics of Traditional Medicinal Knowledge have argued that TKDL may be playing
into the hands of foreign companies by providing easy access to Indias TMK. They also
complain that the companies also use the information to develop new products, such drugs,
will be under no obligation to share any profits with local communities.138 Devender
Sharma, president of New Delhi based Forum for Biotechnology and Food Security, argues
that the countrys Indigenous Knowledge, which so far have been protected by language and
cultural barriers, is now being handed over officially to drug companies on a really accessible
digital platter.11

M.D. Nair a Chennai-based consultant on patent issues also doubt that whether the library
will succeed in protecting Indias Traditional Medicinal Knowledge because, at present, there

11
Kushal Nidhi , "Traditional Knowledge in Manacles of Intellectual Property Protection",TSPACE (2012)
Available at https://tspace.library.utoronto.ca/bitstream/1807/33263/1/Kaushal_Nidhi_201211_LLM_thesis.pdf
(Visited on Feb 24, 2017)
is no way to prevent patents on inventions derived from such knowledge. He further argues
that the TKDL can benefit India only if companies agree to share profits form a product that
could not have been invented without access to the library. This is already happening in some
areas of biotechnology, he says, where private and public agencies that have been placed
genetic sequences in the public domain for research purposes require the users to pay
royalties if they develop a product. Furthermore Nair argues that the TKDL cannot prevent
Utility patents being taken on new uses that are not mentioned in the TKDL. It will not stop
bio piracy unless the sovereignty granted for bio-resources under CBD is extended to
products which are derived from such resources. In practice it means, there should more
utilization of prior informed consent and benefit sharing schemes.12

Patrick Roy Mooney, executive director of the ETC Group, a Canadian non profit that is a
global leader in the biodiversity movement and which sponsors the annual Captain Hook
awards for bio piracy, says that while TDKLs approach is helpful, its absurd to believe that
it resolves the problem: I think there is no way this problem can be solved so easily as there
are so many ways and routes, so many channels around these things these days. Its just not
realistic. In the absence of a global agreement, there is no way this is going to be resolved by
a single country.13

8.GENE CAMPAIGN

Gene Campaign is another project which was initiated in India in 1993 to impede the
consideration of knowledge as "new " and therefore patentable in some jurisdiction . This
organisation played important role in revoking the patent of Turmeric . The Gene Campaign
has also worked on documentation of biodiversity knowledge about it in possession of tribal
population like Mundas and Oraons of the Jharkhand , Bhils and Bhilalas of Madhya Pradesh
and etc . As a part of this endeavours educated tribal youth are recruited to help document
medicinal plants and related knowledge.14

9.ACCESS AND BENIFIT SHARING

originally benefit sharing was seen as a way to bring justice and equity to the holder of
traditional beneficial knowledge. Benefit sharing became one of the main pillar of CBD

12
Ibid
13
Mehra Achal, "Bio piracy Killer App",(2010)
Available at http://www.littleindia.com/life/6173-biopiracy-killer-app.html (Visited on Feb19 , 2017)
14
Kushan Nidhi ,Supra note 11
which states for fair and equitable sharing of benefits generated from the utilisation of genetic
resources. but now it is moving in the reverse direction. Corporate lawyers negotiate benefit
sharing agreements with local communities sitting on the sidelines.

One example for benefit sharing programme in India is between Kani Tribe and the Tropical
Gardens Botanical Research Institute (TGBRI) . However the Traditional Knowledge of the
plant resides with the local community i.e. the Kani Tribe in the Western Ghats

Firstly Kani Tribe negotiated with the state Government for the transfer of fund
Secondly , the Kerala Government seeking share of royalties,
Thirdly, the kani Tribe does not hold little of the customary land and the forest department
has been reported to be preventing from harvesting Jeevni,
Fourthly, high return of Jeevni plant has resulted in overharvesting by immigrants worker to
the source of income
There was a establishment of term of partnership between the traditional knowledge and
herbal pharmaceutical industry in the process of Jeevni patenting. Apart from the community
based initiative to protect local traditional knowledge with respect to indigenous medicine
there are , there are two new and important database initiatives ,designed to establish prior art
as a pre-emptive measure against patenting of indigenous medical products and application of
plants one of these , in India operates international for the defence of national Traditional
Knowledge and the other established by the science and Human Rights program of the
American Association for the advancement of Science (AAAS), operates internationally for
the defence of Traditional Knowledge globally.15

Nagoya Protocol
Nagoya Protocol was adopted on 29th October2010 in Nagoya, Japan. It was adopted to
access the genetic resources and for the fair and equitable sharing of benefit arising from the
utilisation to the CBD. The purpose of the protocol was to prevent misappropriation of
genetic resources and fair and equitable benefit sharing with the holder of the resources . The
protocol has been signed by the 92 countries and 52 countries have ratified so far.16

15
Mangla Hirwade and Anil Hirwade, Supra Note 6

16
Saez Catherine, "Nagoya Protocol Enters Into Force, Will Be Tested In Months To Come" ( 2014)
According to the CBD , several issues need to be discussed :

an access and benefit-sharing clearing-house; voluntary codes of conduct; awareness raising;

the need for and modalities of a global multilateral benefit-sharing mechanism; monitoring
and reporting; cooperative procedures and institutional mechanisms to promote compliance
and to address cases of non-compliance; guidance on resource mobilization for the
implementation of the Nagoya Protocol; and guidance to the financial mechanism
The benefit of the Nagoya protocol is it creates a legally binding framework that helps
researchers to access genetic resources for biotechnology research, development and other
activities. In return of fair share of benefits from their use this also provides the R&D sector
with the certainty they need to invest in the biodiversity based research. Indigenous and local
communities might get benefits from a legal framework that respects the value of traditional
knowledge associated with genetic resources.17

10.ISSUES IN INDIA

Neem case
As per the Sanskrit text Neem tree is a curer of all disease. Neem tree is a multipurpose tree
which is used for medicinal agricultural , contraceptive, pesticide, cosmetic and dental
application. Neem products are very cheap and easily available. The leaves and the bark of
the tree have been used to cure illness such as ulcers, diabetes , leprosy and skin disorders .
It has also been used to prepare pesticide and spermicides.
In the year 1995, representatives of Indian farmers and a group of International NGO filed
legal opposition against the patent of Neem and they submitted the evidence of the fungicidal
effects of extracts of Neem seed had been known and used for centuries to protect India
culture to protect crop and therefore was un patentable. The patent granted on Neem was
revoked in May 2000.18

Available at http://www.ip-watch.org/2014/10/09/nagoya-protocol-enters-into-force-will-be-tested-in-months-
to-come/m(Visited on 17 Feb, 2017)

17
The Nagoya Protocol - Convention of biological Diversity
Available at http://www.environment.gov.au/topics/science-and-research/australias-biological-
resources/nagoya-protocol-convention-biological (Visited on Febl 25, 2017)
18
Biopiracy: A threat to the traditional Medicine
Available at http://shodhganga.inflibnet.ac.in/bitstream/10603/12824/11/11_chapter%205.pdf (Visited on 24Feb
,2017)
Turmeric case
The re -examination case was filed by the CSIR India with the USPTO for challenging the
patent granted of existing prior art. CSIR argued that turmeric has been used for more than
1000 years for healing of wounds and rashes. Hence its use is not an novel invention. Their
claim was supported by the documents on the traditional knowledge which includes Sanskrit
texts and paper published on 1953 in the journal of the Indian Medical Association . The
USPTO upheld the CSIR objection and cancel the patent.19

Phillanthus Niruri
Phillanthus niruri is a traditional treatment for various forms of hepatitis and other liver
disorder in India for centuries . Its use is common knowledge and well documented. Even
though the use of Phillanthus niruri for treatment of jaundice has been ancient and well
recorded innovation in the Indian System of medicine . The Fox Chase Centre in
Philadelphia, US applied for patent for its use curing hepatitis. The patent claim is for the
manufacture of a medicine for treating hepatitis B and the patent is allowed.20

Other cases
Because of the growing demand of the Ayurvedic herbs in the western countries it has led to
the controversies in the battle with the western pharmaceutical companies who are trying
these herbs such as Aswagandha, Tulsi, Amlakai, Shatvani, and Brahmi and the preparation
of Triphala and Trikatu which are known to have significant medical values without side
effects. several western pharmaceutical company and academic institution have come into
conflict with Indian academic institution and traditional Ayurvedic practitioners over IPR's of
herbal product researched by the western agencies. The Ayurvedic practitioners have known
about the potentiality of Ayurvedic products over centuries and hence they contend that they
carry precedence with regard to patent rights on Ayurvedic products.

19
Pradeep Dua,Supranote10
20
Supranote 16
 11.CONCLUSION

Traditional knowledge is not new and innovative to the Indian society. It has been used since
ages . The growth of the herbal sector and the increasing demand on traditional medicinal
products is very much new in the field of Traditional Medicinal Knowledge and Intellectual
Property . This trend will increase and it will grow and it should become the prime focus of
the IPR development. India has been experiencing various initiatives regarding the protection
of traditional knowledge under IPR including TKDL and sui generis protection which is a
welcoming step to curb bio-piracy. To provide new models for development information
needs to be gather and current practise.