PATENTING AND REGULATORY REQUIREMENTS OF NATURAL PRODUCTS PROTECTION OF PLANT VARIETIES AND FARMERS' RIGHTS ACT, 2001 BIOPROSPECTING AND BIOPIRACY PATENTING ASPECTS OF TRADITIONAL KNOWLEDGE AND NATURAL PRODUCTS. CASE STUDY OF CURCUMA & NEEM

1. PATENTING AND REGULATORY REQUIREMENTS OF
NATURAL PRODUCTS
PROTECTION OF PLANT VARIETIES AND FARMERS'
RIGHTS ACT, 2001
BIOPROSPECTING AND BIOPIRACY
PATENTING ASPECTS OF TRADITIONAL KNOWLEDGE
AND NATURAL PRODUCTS. CASE STUDY OF
CURCUMA & NEEM
K SUDHEER KUMAR
Assoc.Professor
MAK COLLEGE OF PHARMACY , HYDERABAD
Sudheer.y2k8@gmail.com

2. Regulation in India
Herbal drugs are regulated under the Drug and Cosmetic Act (D and C) 1940
and Rules 1945 in India, where regulatory provisions for Ayurveda, Unani,
Siddha medicine are clearly laid down.
Department of AYUSH is the regulatory authority and mandate that any
manufacture or marketing of herbal drugs have to be done after obtaining
manufacturing license, as applicable.
The D and C Act extends the control over licensing, formulation composition,
manufacture, labelling, packing, quality, and export.
Schedule “T” of the act lays down the good manufacturing practice (GMP)
requirements to be followed for the manufacture of herbal medicines.

3. Intellectual property rights (IPRs) are rights to make, use, and sell a new product
or technology that are granted, usually for a period of 17- 20 years, solely to the
inventor or the corporation which files a claim on the inventor's behalf.
IPRs are meant to reward innovators, inventors and researchers. It is a driving
force behind rapid industrial growth and progress.
Under intellectual property law, owners are granted certain exclusive rights to a
variety of intangible assets, such as musical, literary, and artistic works, discoveries
and inventions, words, phrases, symbols, and designs.
Common types of intellectual property include copyrights, trademarks, patents,
industrial design rights and trade secrets in some jurisdictions.
Among various kinds of IPRs patents and trademarks are more important to
pharmaceutical industries. IPR does not provide protection for inventions that are
based on prior existing knowledge.

4. Common types of IPR include:
Copyright – this protects written or published works such as books, songs, films,
web content and artistic works;
Patents – this protects commercial inventions, for example, a new business
product or process; Designs – this protects designs, such as drawings or
computer models;
Trade marks – this protects signs, symbols, logos, words or sounds that
distinguish your products and services from those of your competitors.
Plants- Plant Variety farmers Right, trees
Geographical Goods – Certain Goods, Basmati Rice , Banaras silk

5. A patent is a set of exclusive rights granted by a state (national government) to an
inventor or their assignee for a limited period of time in exchange for a public
disclosure of an invention.The association of patents and thievery has a long history.
When Columbus sailed out to "discover" a world that was new to him, he was
carrying letters patent from the King and Queen of Spain.
The procedure for granting patents, the requirements placed on the patentee,
and the extent of the exclusive rights vary widely between countries according to
national laws and international agreements.
Typically, however, a patent application must include one or more claims
defining the invention which must be new, inventive, and useful or applicable. In
most countries, both natural persons and corporate entities may apply for a
patent.
The grant and enforcement of patents are governed by national laws, and also
by international treaties.

6. Pharmaceutical companies have been making use of traditional knowledge of
tribal people to identify plants and their ingredients for developing new
medicines.
Researchers, screening plants for useful substances can cut down time taken,
by getting information from tribal healers on variety of plants used for treating
ailments.
Many pharmaceutical corporations are misusing traditional knowledge and
making huge profits in form of what is known as biopiracy.
Trade secret is an IPR which provides simplified protection. It does not require
registration with government and is not bound by time. It is useful in countries
like India in managing heavy cost of IP protection

7. The patent system has been introduced and known in India since 19th century. The first patent act
came into effect in the year 1856.It was based on British patent law of 1852.This act granted exclusive
rights to inventors for period of 14 years. Later the patent law was amended from time to time.
Year Act
1856 The act vi of 1856
1859 The act modified as act xv.
1872 The Patents & Designs Protection Act.
1883 The Protection of Inventions Act.
1888 Consolidated as the Inventions & Designs Act.
1911 The Indian Patents & Designs Act.
1972 The Patents Act (act 39 of 1970)
1999 Patents (amendment) Act, (1999) came into force from 01-01-1995.
2002 The Patents (Amendment) Act 2002 came into force from 2oth May 2003
2005 The Patents (Amendment) Act 2005 effective from 1st January 2005
2016
The Patents (Amendment) Rules 2016.On May 16, 2016, India Brought In Various Changes to
the Patent Rules, 2003. This Includes Changes Like Mandatory e-submission and Vedeo-
Conferencing for faster examination.

8. A patent can be granted for an invention which may be related to any process or product.
The word “Invention “ has been defined under the Patents Act 1970 as amended from
time to time.
“An invention means a new product or process involving an inventive step and capable of
industrial application.”
According to The Patent Second Amendment Act, 2002, process patents are allowed on
microbiological, biochemical and biotechnological processes.
Thus, methods of genetic engineering, processes in the pharmaceutical industry using
microorganisms and related processes are patentable. The non-patentable aspects of the
invention are specified in Patent Second Amendment Act, 2002 This includes plants,
animals in whole or any part thereof, including seed varieties and essentially biological
processes for the production or propagation of plants and animals. Microorganisms can
be claimed for a patent provided; they are not mere discovery of organisms existing in
nature. Methods for rendering plants free of diseases or to increase their economic value
will be patentable.

9. The Act of 2002 makes it mandatory to deposit the biological material mentioned in
the specification with a depository notified in the Gazette of India.
It is also required that the source and geographical origin of the biological material
is disclosed in the specification.
In U.S there are three types of patents. These consist of utility patents, design
patents, and plant patents. Utility patents are the most common of the three and
cover the invention of any new and useful process, composition of matter, machine,
or article of manufacture.
 The plant patents are those covering new plant varieties.
But there are some stipulations or conditions with plant patents. Plants that have
been bred are acceptable, while plants growing naturally in the wild are not
patentable. Plants that are sexually reproduced also do not fulfil the requirement.
Only those that are asexually reproduced (i.e., they are reproduced by making a
cutting, layering, grafting or inarching) qualify for a patent.

10. Section 5 Subject to Section 9, a patent may be granted only for an invention in respect of
which the following conditions are satisfied:
(1) the invention is new;
(2) involves an inventive step; and
(3) is capable of industrial application
Section 9(1) The following inventions are not protected under this Act:
(1) naturally occurring microorganisms and their components, animals, plants or extracts
from animals or plants;
(2) scientific or mathematical rules or theories;
(3) computer programs;
(4) methods of diagnosis, treatment or cure of human and animal diseases;
(5) inventions contrary to public order, morality, health or welfare.
India has established patenting of GMO (Genetically Modified Organisms) including genes
of animals and plants. Example: Biotechnology Company Agracetus was granted patent in
1994 that covered all transgenic Soybeans

11. TRIPS allows member countries to exclude certain subject matters provided under
article 27.3 from patentability which includes essentially biological processes, however
member countries can decide on their patentability.
Plant patents in US are granted to any persons who invents or discovers and asexually
reproduces any distinct and new variety of plants including mutants, hybrids and newly
found seedlings other than a tuber, propagated plant or plant found in uncultivated
state.
Trade secret encourages investment in non-patentable inventions and non-
copyrightable works. It provides requisite protection for complex research intensive
patent. Trade secrets can protect ethno biological medicinal knowledge also.
In case of patent to protect such knowledge requires contributors to reveal a part of
knowledge. In case of trade secret need not be revealed.

12. Advantages and Disadvantages of Patents
Patents are exclusive legal rights given to an inventor that prevent other individuals or
businesses from profiting from the inventor's creation(s).
Having a patent means that only the inventor can decide how their creation is used.
They can license the invention for use by third parties or manufacture and sell it
themselves.
While this is generally positive, there are advantages and disadvantages to patents.
A patent holder can typically charge a premium for an invention because of the
restricted competition. No one else is making a similar product.
A patent holder can exclude the competition from recreating their product or service.
This allows them to sell the product or service at a higher profit margin.
An inventor can profit from selling licenses or selling the patent outright. Though
royalties are often only 5 percent or less, they can be a better option for many inventors
who may be unable to foot the expense of bringing the idea to market themselves.

13. Disadvantages of Patents
While there are many advantages to filing for a patent, there are some disadvantages
as well.
Details of the invention are publicly disclosed. To file for a patent application, the
inventor is required to make public the technical information about the invention.
Depending on the invention, some inventors choose to not disclose this information and
keep the details of their product or service a trade secret.
The application process can be lengthy and time-consuming. It can take three to four
years for a patent application to be completed and granted. There is also the risk that the
market could change significantly over time or that technology could advance.
A patent can be an expensive process even if it unsuccessful. With patent fees,
attorney fees, and the cost of creating drawings, a patent can run anywhere from $2,000
to $5,000, depending on its complexity.

14. Protection of Plant Varieties and
Farmers' Rights Act, 2001

15. In order to provide for the establishment of an effective system for the
protection of plant varieties, the rights of farmers and plant breeders and to
encourage the development of new varieties of plants it has been considered
necessary to recognize and to protect the rights of the farmers in respect of
their contributions made at any time in conserving, improving and making
available plant genetic resources for the development of new plant varieties.
The Govt. of India enacted “The Protection of Plant Varieties and Farmers'
Rights (PPV&FR) Act, 2001”

16. Objectives of the PPV & FR Act, 2001
To establish an effective system for the protection of plant varieties, the rights of
farmers and plant breeders and to encourage the development of new varieties of
plants.
To recognize and protect the rights of farmers in respect of their contributions made
at any time in conserving, improving and making available plant genetic resources for
the development of new plant varieties.
To accelerate agricultural development in the country, protect plant breeders’ rights;
stimulate investment for research and development both in public & private sector for
the development new of plant varieties.
Facilitate the growth of seed industry in the country which will ensure the availability
of high quality seeds and planting material to the farmers.

17. Rights under the Act
Breeders’ Rights : Breeders will have exclusive rights to produce, sell, market,
distribute, import or export the protected variety. Breeder can appoint agent/
licensee and may exercise for civil remedy in case of infringement of rights.
Researchers’ Rights : Researcher can use any of the registered variety under
the Act for conducting experiment or research. This includes the use of a
variety as an initial source of variety for the purpose of developing another
variety but repeated use needs prior permission of the registered breeder.

18. Farmers' Rights
A farmer who has evolved or developed a new variety is entitled for registration
and protection in like manner as a breeder of a variety;
Farmers variety can also be registered as an extant variety;
A farmer can save, use, sow, re-sow, exchange, share or sell his farm produce
including seed of a variety protected under the PPV&FR Act, 2001 in the same
manner as he was entitled before the coming into force of this Act provided farmer
shall not be entitled to sell branded seed of a variety protected under the PPV&FR
Act, 2001;
Farmers are eligible for recognition and rewards for the conservation of Plant
Genetic Resources of land races and wild relatives of economic plants;
There is also a provision for compensation to the farmers for non-performance of
variety under Section 39 (2) of the Act, 2001 and
Farmer shall not be liable to pay any fee in any proceeding before the Authority or
Registrar or the Tribunal or the High Court under the Act.

19. General Functions of the Authority
Registration of new plant varieties, essentially derived varieties (EDV), extant
varieties;
Developing DUS (Distinctiveness, Uniformity and Stability) test guidelines for new
plant species;
Developing characterization and documentation of varieties registered;
Compulsory cataloging facilities for all variety of plants;
Documentation, indexing and cataloguing of farmers' varieties;
Recognizing and rewarding farmers, community of farmers, particularly tribal and
rural community engaged in conservation and improvement;
Preservation of plant genetic resources of economic plants and their wild relatives;
Maintenance of the National Register of Plant Varieties and
Maintenance of National Gene Bank.

20. Bioprospecting and Biopiracy

21. Bioprospecting is the process of discovery and commercialization of new products based
on biological resources.
These resources or compounds can be important for and useful in many fields, including
pharmaceuticals, agriculture, bioremediation, and nanotechnology, among others.
Between 1981-2010, one third of all small molecule new chemical entities approved by
the U.S. Food and Drug Administration (FDA) were either natural products or compounds
derived from natural products.
Despite indigenous knowledge being intuitively helpful, bioprospecting has only recently
begun to incorporate such knowledge in focusing screening efforts for bioactive
compounds
Bioprospecting may involve biopiracy, the exploitative appropriation of indigenous forms
of knowledge by commercial actors, and can include the patenting of already widely
used natural resources, such as plant varieties, by commercial entities

22. The term biopiracy was coined by Pat Mooney to describe a practice in which indigenous
knowledge of nature, originating with indigenous peoples, is used by others for profit,
without authorization or compensation to the indigenous people themselves.
For example, when bioprospectors draw on indigenous knowledge of medicinal plants
which is later patented by medical companies without recognizing the fact that the
knowledge is not new or invented by the patenter, this deprives the indigenous community
of their potential rights to the commercial product derived from the technology that they
themselves had developed.
Critics of this practice, such as Greenpeace claim these practices contribute to inequality
between developing countries rich in biodiversity, and developed countries hosting biotech
firms.
In the 1990s many large pharmaceutical and drug discovery companies responded to
charges of biopiracy by ceasing work on natural products, turning to combinatorial
chemistry to develop novel compounds.

23. Patenting aspects of Traditional Knowledge and Natural
Products. Case study of Curcuma & Neem

24. Traditional Knowledge (TK) is a living body of knowledge that is developed, sustained
and passed on from generation to generation within a community, often forming part of
its cultural or spiritual identity. Traditional Knowledge per se that is the knowledge that
has ancient roots and is often informal and oral, is not protected by conventional
intellectual property protection systems.
This scenario has prompted many developing countries to develop their own specific
and special systems for protecting traditional knowledge. India has played a very
significant role in the documentation of traditional knowledge thereby bringing the
protection of traditional knowledge at the centre stage of the International Intellectual
Property System.
Provision of Traditional Knowledge Digital Library (TKDL) Access (Non-Disclosure)
Agreements with several international patent office's including USPTO, EPO, JPO etc. by
Indian Government has led to many patent applications concerning India's traditional
knowledge have either been cancelled or withdrawn or claims have been amended in
several international patent offices2

25. Traditional Knowledge (TK), variously referred to as traditional knowledge‘, traditional
ecological knowledge‘, local knowledge‘, folk knowledge‘ is knowledge developed by
local and indigenous communities over time in response to the needs of their specific
local environment. The World Intellectual Property Organization (WIPO) defines
traditional knowledge as indigenous cultural and intellectual property, indigenous
heritage,‖ and customary heritage rights

26. Traditional Knowledge Digital Library
TKDL is a pioneer initiative of the Indian Government, and came to the fore due to the
India's efforts on revocation of patent on wound healing properties of turmeric at the
USPTO and the patent granted by the European Patent Office(EPO) on the antifungal
properties of neem. India's traditional medicinal knowledge exists in local languages
such as Sanskrit, Hindi, Arabic, Urdu, Tamil etc. is neither accessible nor comprehensible
for patent examiners at the international patent offices.
It was identified by the TKDL expert group in 2005 that annually around 2000 patents
were granted around the world erroneously concerning Indian system of medicine by
patent offices around the world. TKDL provides contents of the ancient texts on Indian
Systems of Medicines i.e. Ayurveda, Siddha, Unani and Yoga, into five international
languages, namely, English, Japanese, French, German and Spanish, with the help of
information technology tools and an innovative classification system - Traditional
Knowledge Resource Classification (TKRC) Bio-piracy and Misappropriation of TK.

27. Turmeric Patent
Turmeric is a tropical herb grown in east India. Turmeric powder is widely used in India as a
medicine, a food ingredient and a dye to name a few of its uses. For instance, it is used as a blood
purifier, in treating the common cold, and as an anti-parasitic for many skin infections. It is also
used as an essential ingredient in cooking many Indian dishes. In 1995, the United States awarded
patent on turmeric to University of Mississippi medical center for wound healing property. The
claimed subject matter was the use of "turmeric powder and its administration", both oral as well
as topical, for wound healing. An exclusive right has been granted to sell and distribute. The Indian
Council for Scientific and Industrial Research (CSIR) had objected to the patent granted and
provided documented evidences of the prior art to USPTO. Though it was a well known fact that the
use of turmeric was known in every household since ages in India, it was a herculean task to find
published information on the use of turmeric powder through oral as well as topical route for
wound healing. Due to extensive researches, 32 references were located in different languages
namely Sanskrit, Urdu and Hindi. Therefore, the
USPTO revoked the patent, stating that the claims made in the patent were obvious and
anticipated, and agreeing that the use of turmeric was an old art of healing wounds. Therefore, the
TK that belonged to India was safeguarded in Turmeric case.

28. Neem Patent
The patent for Neem was first filed by W.R. Grace and the Department of Agriculture, USA
in European Patent Office. The said patent is a method of controlling fungi on plants
comprising of contacting the fungi with a Neem oil formulation. A legal opposition has
been filed by India against the grant of the patent.
The legal opposition to this patent was lodged by the New Delhi-based Research
Foundation for Science, Technology and Ecology (RFSTE), in co-operation with the
International Federation of Organic Agriculture Movements (IFOAM) and Magda Aelvoet,
former green Member of the European Parliament (MEP). A tree legendary to India, from
its roots to its spreading crown, the Neem tree contains a number of potent compounds,
notably a chemical found in its seeds named azadirachtin.
It is used as an astringent in so many fields. The barks, leaves, flowers, seeds of neem tree
are used to treat a variety of diseases ranging from leprosy to diabetes, skin disorders and
ulcers.
Neem twigs are used as antiseptic tooth brushes since time immemorial. The opponents'
submitted evidence of ancient Indian ayurvedic texts that have described the
hydrophobic extracts of neem seeds were known and used for centuries in India, both in
curing dermatological diseases in humans and in protecting agricultural plants form
fungal infections.
The EPO identified the lack of novelty, inventive step and possibly form a relevant prior
art and revoked the patent. Apart from this, several US patents were recently taken out
Neem-based emulsions and solutions.

29. Basmati Rice In 1997, the US patent office granted a patent in September 1997 to Rice
Tec‘ for a strain of Basmati rice, an aromatic rice grown in India and Pakistan for
centuries.
This case has not yet been resolved, but the Indian Government is actively pursuing the
case, stating that it violates both TRIPS and the CBD. According the „South Asia
Commission on Economic and Social Policy, Rice Tec‟s patent also violated the CBD in not
recognizing the sovereign rights of India and Pakistan over Basmati rice. In basmati case
demonstrates the problem as illustrated in TRIPS that patents are granted to
biotechnological processes.
Thus, even though basmati rice has been in South Asia for centuries, Rice Tec just altered
it slightly through crossing with a Western strain of grain, and successfully claimed it was
its own.