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OVERVIEW ON LEGAL PROVISIONS ON COPYRIGHTS AND PATENTS OF MEDICINAL PLANTS IN INDIA

Dhruv Tripthi*

Introduction

All medicinal preparations were derived from plants, whether in the simple form of

plant parts or in the more complex form of crude extracts, mixtures, etc. Today, a large number

of drugs are made from plants. The majority of these involve the isolation of the active

ingredient (chemical compound) found in a particular medicinal plant and its subsequent

modification. A semi-synthetic analogue of such a compound could typically be a useful

pharmaceutical product.

A large proportion of such drugs have been discovered with the aid of ethno- botanical

knowledge of the traditional uses of the plant. The pharmaceutical company that makes such a

drug applies for some form of intellectual property protection; the most favoured being the

patent. If granted, the patent gives the company the right to prevent anyone else from

manufacturing or selling the product. The company gets, in effect, a commercial monopoly. In

addition, the source of the ethno-botanical knowledge is generally not mentioned. Thus both

the credit for the product and the financial reward generally go to the company. The country

from which the knowledge is obtained is simply treated as a source of raw material, whether of

knowledge or of a biological resource. This has led some activists to coin the term “bio-piracy”

to refer to a commercially useful product that is derived from traditional knowledge without

any return to the knowledge holder. Bio-piracy is a major issue in developing countries today.

The rich knowledge base of countries like India in medicinal plants and health care has

led to a keen interest by pharmaceutical companies to use this knowledge as a resource for

research

_______________________________________________*Student of B.A, LL.B IX Semester, law college Dehradun

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and development programs in the hope of discovering and producing new drugs. In such a situation, the country is faced with a dilemma. On one hand, there is often a wish to share biological resources and knowledge, especially in relation to medicinal plants, although different communities may have different conditions for imparting such knowledge. On the other hand, there is a natural wish for some return. This includes not only a wish for some benefit, whether financial or non-financial, but also for credit or acknowledgment for contributing to the final product.

The intellectual property laws do not protect traditional knowledge adequately, so as to ensure benefit sharing with and credit to the concerned community. India is presently considering certain legislative and other measures to safeguard these rights. The main legislative measures are the Biological Diversity Bill, 2000, the Patents (Second Amendment) Bill, 1999 and the Protection of Plant Varieties and Farmers' Rights Act, 2001.

Meaning of Patents

The word patent originates from the Latin patere, which means "to lay open" (i.e., to make

available for public inspection). More directly, it is a shortened version of the term letters

patent, which was a royal decree granting exclusive rights to a person, predating the modern

patent system. Similar grants included land patents, which were land grants by early state

governments in the USA, and printing patents, a precursor of modern copyright.

In modern usage, the term patent usually refers to the right granted to anyone who invents any

new, useful, and non-obvious process, machine, article of manufacture, or composition of

matter. Some other types of intellectual property rights are also called patents in some

jurisdictions: industrial design rights are called design patents in the US, plant breeders' rights

are sometimes called plant patents, and utility models and Gebrauchsmuster are sometimes

called petty patents or innovation patents.

The additional qualification utility patent is sometimes used (primarily in the US) to distinguish

the primary meaning from these other types of patents. Particular species of patents for

inventions include biological patents, business method patents, chemical patents and software

patents.

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Meaning of Copyrights

Copyright is a legal concept, enacted by most governments, giving the creator of an

original work exclusive rights to it, usually for a limited time. Generally, it is "the right to copy",

but also gives the copyright holder the right to be credited for the work, to determine who may

adapt the work to other forms, who may perform the work, who may financially benefit from it,

and other related rights. It is a form of intellectual property (like the patent, the trademark, and

the trade secret) applicable to any expressible form of an idea or information that is substantive

and discrete.

Copyright initially was conceived as a way for government to restrict printing; the

contemporary intent of copyright is to promote the creation of new works by giving authors

control of and profit from them. Copyrights are said to be territorial, which means that they do

not extend beyond the territory of a specific state unless that state is a party to an international

agreement. Today, however, this is less relevant since most countries are parties to at least one

such agreement. While many aspects of national copyright laws have been standardized

through international copyright agreements, copyright laws of most countries have some

unique features. Typically, the duration of copyright is the whole life of the creator plus fifty to

a hundred years from the creator's death, or a finite period for anonymous or corporate

creations. Some jurisdictions have required formalities to establishing copyright, but most

recognize copyright in any completed work, without formal registration. Generally, copyright is

enforced as a civil matter, though some jurisdictions do apply criminal sanctions.

Most jurisdictions recognize copyright limitations, allowing "fair" exceptions to the creator's

exclusivity of copyright, and giving users certain rights. The development of digital media and

computer network technologies have prompted reinterpretation of these exceptions,

introduced new difficulties in enforcing copyright, and inspired additional challenges to

copyright law's philosophic basis. Simultaneously, businesses with great economic dependence

upon copyright have advocated the extension and expansion of their intellectual property

rights, and sought additional legal and technological enforcement

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Copyright and the Internet

As the Internet has became more prevalent, the need for copyright protection there has

also become a necessity. Today, copyright law has been adapted to protect Internet items, just

as it has been adapted through the years to protect various other new mediums. It protects

original work or work that is fixed in a tangible medium, meaning it is written typed, or

recorded. But because it was not designed specifically for the internet, in some areas copyright

law on the Internet can be as clear as mud.

Copyright and the Internet: The International Framework

Recently, International Copyright law rested on the Berne Convention for the Protection

of Literary and Artistic work and the Agreement on Trade-Related Aspects of Intellectual

Property Rights (TRIPS) of 1995. Issues relating to sound recordings and performances were

addressed in Rome Convention for the protection of Performers, Producers of Phonograms and

Broadcasting Organizations (1961). Since 1974, the international Copyright Instruments have

been managed by a special United Nations Agency- the worlds. Since 1974, the international

Copyright Instruments have been managed by a special United Nations Agency- the world

Intellectual Property Organisation (WIPO).

Knowledge relating to medicinal plants

Mere knowledge is difficult to protect legally, as it is intangible. One kind of protection is

by means of asserting an intellectual property right, such as a patent, copyright, or trade secret.

In the case of medicinal plants, traditional knowledge relating to these plants does not fall

within any of these established categories. On the other hand, the use of technology, including

biotechnology, to develop a useful product using this traditional knowledge is generally

protected. The issue of bio-piracy in relation to such useful and financially productive

knowledge has come into Knowledge relating to medicinal plants prominence as a result of the

cases challenging the patent granted on neem and on turmeric.

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In the turmeric case, the US Patent and Trademark Office granted a patent on the “use of

turmeric in wound healing”. India successfully challenged this patent by showing that this use

of turmeric was well known and that nothing new had been invented. The documents relating

to this traditional knowledge of India were unknown to the US Patent and Trademark Office.

When they were brought to the attention of the Office they were considered to be “prior art”

and the patent was revoked

In the case of neem, the patent challenged referred to improving the storage stability of an

insecticide containing neem seed extracts. This patent could not be revoked as the patent

holder (W.R.Grace & Co.) had improved on existing knowledge. While neem based insecticides

were well known, they did not have the storage-stability claimed in the patent. The patented

composition could thus be distinguished from the traditional knowledge.

The cases of turmeric and neem are illustrative of the dilemma facing India in relation to the

traditional knowledge of medicinal plants. On the one hand, traditional knowledge is not

documented in an easily accessible form so as to be considered “prior art”. On the other hand,

where traditional knowledge is available as to the property of a particular plant, it can be

modified so as to be distinguishable from the original traditional knowledge for legal purposes.

The end result is that a particular company may get the sole right to manufacture and sell the

active chemical compound derived from a plant, although communities may have used the

plant for the same or similar purpose over a long period of time.

The Patents (Second Amendment) Bill, 1999 has a limited form of protection for traditional

knowledge. It states that an Indian patent may be opposed or revoked if the invention was

anticipated having regard to the knowledge, oral or otherwise, available within any local or

indigenous community in any country. This would need to be reciprocated by other countries

for Indian traditional knowledge to be adequately protected. India has adopted a combination

of methods for the protection of medicinal plants. Wherever a pluralistic legislative framework

is adopted, the efficacy of the system depends to a large extent on the amount of friction

between the parts. As each legislative proposal has been promoted by a different

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Governmental Department, it could be difficult for the national interest to be promoted

without close co-operation between the different Authorities involved.

Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPs)

In the fast developing world of today, when multilateral trade between different countries is

the order of the day, the agreement on TRIPs, which was signed by 138 Countries (as on July,

2000), was by far the most important legislation to have been drawn up in order to provide

protection to the IPR holders against the differences in legal provisions on IPRs in various

countries.

TRIPS is an important international agreement, which:-

Obliges new standard for various types of IPRs.

Includes the multilateral trading system in which trade law and jurisprudence are taken

in consonance with Intellectual Property Law and provides for effective dispute

settlement process by WTO.

Includes detailed standards for domestic enforcement of IPRs, both within as well as

across the borders of a country.

Obliges protection on IPRs related to food, medicine and drugs in developing countries.

Provides for higher level of protection for geographical indications and reversal of

burden of proof for process patentees.

All WTO members were given one year i.e. up to January, 1996 to phase in these changes into

their IPR or other laws and regulations. Developing and other countries were given an

additional four years time i.e. up to January, 2000 and the least developed countries ten years

i.e. up to January, 2006. A further period of five years i.e. up to January, 2005 was given to

developing countries for introducing the product patents in the field of technology excluded

thus far from their patent laws. Therefore, developing countries effectively have time up to

January, 2005 to promulgate regulations on product patents on food, medicines and drugs (9).

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Convention on Biological Diversity (CBD)

The prime objective in Article 1 of CBD is to conserve biological diversity on one hand and to

provide appropriate access to this resource for utilization. Moreover, the signatories of CBD are

required to "respect, preserve and maintain knowledge" of indigenous communities. The use of

the term "traditional" along with the term "knowledge, innovation and practices" implies all

notions of time bound and historical. As a result the traditional knowledge systems of

indigenous communities fall within the purview of this article. This usage of terms also bestows

ownership of knowledge, innovation and practices upon indigenous local communities.

Moreover, this article also encourages equitable sharing of benefits, thereby making the

indigenous communities as stakeholders in benefits arising out of the utilization of knowledge,

innovation and practices.

The article 8j also emphasizes upon in situ conservation of knowledge, innovation and practices

of indigenous and local communities. Conservation of indigenous knowledge would therefore,

include conservation of bio-resources being used.

Article 15 emphasizes the access to genetic resources and reaffirms the sovereignty rights of

States over their natural resources as an established principle of international law. Therefore, it

indirectly implies that natural resources are under the ownership of States and cannot be

patented by individuals. Only the use of these bio-resources can be patented and in, that too,

the traditional knowledge holders will have a stake.

Article 16 makes a direct reference to IPRs by emphasizing on the access to and transfer of

technology. It outlines that the access to and transfer of technology to the developing world

shall be facilitated under fair and favorable terms. In case of technology subject to patents and

other IPRs, such access and transfer of technology shall be provided on terms, which recognize

and are consistent with effective protection of IPRs on mutually agreed terms.

Article 17 and 18, stress upon the exchange of the information, which is to be facilitated by

contracting parties by all publicly available sources including indigenous and traditional

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knowledge. Most indigenous and traditional knowledge is based on the utilization of bio-

resources becomes important.

TRIPs and Biotechnology

At the time of the TRIPs negotiations in the Uruguay Round, the US and the EU differed in their

approaches to the patenting of biotechnological inventions. While the US believed that

`anything under the sun made by man', except human beings, was patentable, the EU was

grappling with strong internal resistance to patents on living organisms. Since the debate had

not yet been settled in committing to revisit this provision within four years from the entry into

force of TRIPs i.e. by 1999. Article 27.3(b) of TRIPs incorporates this minimal agreement.

Article 27 of TRIPs requires that patents be made available, for both processes and products, in

all fields of technology. Under Article 27.3(b), plants and animals, and essentially biological

processes for their production may be excluded from patentability. However, microorganisms

and microbiological or non-biological processes must be protected. While there is uncertainty

as what is "biological', clearly, microorganisms and microbiological processes are not excluded

from patent protection despite resistance from some developing countries during the TRIPs

negotiations.

Controversies Related to IPRs

Although, CBD provides for access and sharing of biological resources on one hand and TRIPS

provides for exclusion of plant and animal material from patenting, yet, there has been a spurt

in the arena of IPRs, which periodically give rise to controversies. Some such controversies are

as given below:-

The patenting of ancient herbal remedies, for instance, the US Patent (No. 5,401,504)

given to the healing properties of turmeric, known for centuries to Indians.

The US Plant Patent (No. 5751) on the "Ayahuasca Plant", which is considered sacred

and used for medicinal purposes by Amazon's indigenous people.

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The patenting of crop varieties whose name is similar to those grown for centuries in

certain geographical areas, for instance, the term Basmati used by US Firm Rice-Tec

Corporation (Patent No. 5,663,484). The term Basmati is used for certain varieties of rice

grown in Northern India.

The patenting of human genetic material, for instance, on the human cell line of Hagahai

tribesmen from Papua New Guinea (US Patent No. 5,397,696).

Conclusion:

The potential for integration is great in India. Traditional medicine is widely understood

and greatly respected. Walk down an Indian street and you will see stalls set up as mini

traditional hospitals where many poor people consult Ayurvedic doctors. At the same time,

modern drugs are also widely used, particularly in urban areas

Not only are we great practitioners of modern and traditional medicine, we also host a rich

source of raw materials for both. Medicinal plants abound in the subcontinent, particularly in

the Himalayan regions in Kashmir, the Western Ghats and Pakistan's North-West Frontier. We

have huge reserves of herbal plants and remedies, many of which remain unknown to modern

science.There are already efforts to try and tap these reserves — many pharmaceutical

companies in India are screening wild herbs for medicinal uses and are making medicines with

both modern and traditional components. Such research and development efforts would

benefit from involving tribal people, who are often experts in local herbal remedies.

The potential for integrating traditional medicine is great, so too are the challenges. The lack of

awareness about medicinal plants and widespread deforestation of areas rich in biodiversity

poses an enormous threat. Human activity has put much pressure on the subcontinent's wild

flora and many plants have become rare, and precious information lost.

In particular, many medicinal plants now stand on the brink of extinction because of

development in tribal areas that have historically provided most of these precious resources.

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Wild tuberous plants in Rajasthan, for example, are under severe threat from environmental

pollution.

Protecting these resources and integrating them into modern medical practice would bring

enormous benefits. Not only could we develop new drugs but we would also provide much

needed job opportunities — from researchers and medical professionals to field workers and

farmers — in a country suffering an unemployment crisis.

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