Patenting and regulatory
requirements of natural products
What is patent
⚫ It refers to the right approved to anyone who invents something
new, useful and non-obvious.
⚫ It is a grant of security for an invention. It is a form of intellectual
property that gives possessor the legal right to prohibit others
from making, using, selling, and importing an invention for a
limited period of years in exchange for detailed public disclosure
of patented invention.
⚫ In order to get a patent, technical information about the invention
must be disclosed to the public in a patent application.
IPR (Intellectual Property
Rights):
⚫ These are legal rights that protects creations or inventions
resulting from intellectual activity in the industrial, scientific,
literary or artistic fields. The most common IPRs include patents,
copyrights, and trademarks.
⚫ These rights allow their possessor to completely benefits from
his/her products which was initially an idea developed and
crystallized.
⚫ They also permit him/her to prevents others from using, dealing
or tempering with his/her product without prior permission from
him/her. He/she can in fact take legal action against them and
force to stop and compensate for any damages.
Farmers right
⚫ The protection of Plant Variety and Farmers Right Act, 2001
(PPVFR Act) is an act of the Parliament of India that was enacted
to provide for the establishment of an effective system for
protection of plant varieties, the rights of farmers and plant
breeders, and to encourage the development and cultivation
of new varieties of plants.
⚫ It provides several rights to the farmers entitling them for
reasonable share of benefits arising from new varieties in
future.
These rights include:
farmer’s right to register traditional varieties developed by a
farmer.
farmer’s right for reward and recognition if he is engaged in the
conservation of genetic resources of landraces and wild relatives of
economically important plants.
farmer’s right on seed i.e. have rights to save, use, sow, re-sow,
exchange and share or sell his farm produce including seed of a
variety.
farmer’s right for benefit sharing of new varieties developed by
farmers which may lead to huge profit to Plant Breeder’s Right
(PBR) holder.
farmer’s right to get compensation for the losses caused by the
registered variety.
farmer’s right to receive compensation for the undisclosed use of
traditional varieties.
farmer’s right for seeds of registered varieties.
farmer’s right for receiving free services like registration fee, test
fee, fee for renewal or registration, fees for opposition and
benefit claim. Etc.
Breeder’s right
⚫ Plant breeders' rights (PBR), also known as plant variety
rights (PVR) is a form of intellectual property which is specially
designed to protect new plant varieties.
⚫ It is a special right over the commercial production and marketing
of the reproductive or vegetative propagating material of the
protected variety.
⚫ These rights are assigned to the breeder of a new variety of plant
which gives him exclusive control over the propagating material i.e.
seed, cuttings, divisions, tissue culture and harvested material like
cut flowers, fruit, foliage etc.
⚫ According to this right anyone who creates a novel plant variety
can obtain exclusive rights to it. With the help of these rights, the
breeder can become an exclusive marketer of the variety, or can
license the variety to others.
Bioprospecting and biopiracy
⚫ Bioprospecting:
⚫ is the process of discovery and commercialization of new products
based on biological resources.
⚫ it is defined as the orderly search for and development of new
sources of chemical compounds, genes, micro-organisms, and
other valuable products from the nature.
⚫ It encourages the search for economically valuable genetic and
biochemical resources from nature. It aims at looking for ways to
have maximum benefit from the natural resources.
Advantages:
a) Generate income for developing countries
b) Provide incentives for the conservation of biological resources
and biodiversity.
c) Lead to the development of new products like new medicines.
Disadvantages:
a) Create a number of problems, including environmental
problems like unauthorized overexploitation.
b) Social and economic problems like unfair sharing of benefits or
total absence of benefit sharing.
Biopiracy:
⚫ It is defined as the unethical commercial exploitation of biological
materials like medicinal plant extracts that are indigenous to a
particular country without providing fair financial compensation to
the people or government of that country or territory.
⚫ Biopiracy occurs when research organizations take biologicals
resources without official sanction from poor countries or trivial
people.
⚫ Developed countries are exploiting developing countries genetic
resources and indigenous communities traditional knowledge in
the name of patents on the inventions derived from those genetic
resources. Major effect of biopiracy is that it causes depletion of
biodiversity.
⚫ The act of Piracy is an unauthorized reproduction of another
person’s work or material. When someone indulges in piracy, the
accused is using someone else’s work illegally or without taking any
permission.
Example of biopiracy
⚫ Patenting of Neem: The USDA and an American MNC W.R Grace in
the early 90s wanted a patent (no. 0426257 B) from the European
Patent Office (EPO) on the “method for controlling on plants by aid
of hydrophobic extracted neem oil.” The patenting of the
fungicidal properties of Neem was an example of Biopiracy.
⚫ Patenting of Basmati: Basmati is a long-grained, aromatic variety
of rice native to the Indian subcontinent. In 1997 the US Patent
and Trademark Office (USPTO) approved a patent (No. 5663484) to
a Texas based American company Rice Tec Inc for “ Basmati rice
line and grains” but in March 2001 the USPTO has rejected all
grains.
⚫ Rice Biopiracy: A biotech company Syngenta tried to grasp the
valuable collections of 22,972 varieties of paddy, India’s rice
diversity, from India’s rice bowl, Chattisgarh in India.
⚫ Syngenta has signed a MoU with the Indira Gandhi Agricultural
University (IGAU) for contact to Dr. Richharia’s priceless
collection of rice diversity. Dr. Richharia is the ex-director of
Central Rice Research Institute (CRRI), Cuttack and is known as
the rice sage of India who has done revolutionary work in this
field.
Patenting Aspects of Traditional
Knowledge and Natural Products
⚫ The innovations which are based on the traditional knowledge may
be benefited by the trade mark, the patent or it is being protected
as confidential information or even as a trade secret.
⚫ The Indian patent Act protects the rights of local people in the
form of known traditional knowledge. After the endorsement of
new legislations in India regarding the traditional knowledge and
protection of other indigenous products there are certain issues in
documentation of indigenous products and the traditional
knowledge of Indian products are being patented in other
countries and this at last leads to biopiracy of Indian traditional
knowledge.
⚫ Traditional knowledge is the knowledge which has been gathered
by a population through years of experience, tried and tested over
long period of time, well adapted to local culture and environment.
⚫ The main stress of it is to minimize risks for the society rather than
to maximize profits. This knowledge system is essential for their
well being and for continuous development.
⚫ Traditional knowledge refers to the knowledge, innovations and
practices of original and local populations around the world.
⚫ The way in which intellectual property rights have been designed
in modern context, it is not possible to protect traditional
knowledge. For e.g., traditional knowledge cannot be patented
because such knowledge lacks original character due to inbuilt lack
of novelty.
⚫ Several traditional plants and related knowledge in India, have
also been supposedly falsely patented by the US patent office,
including: Neem, Haldi, Pepper, Mustard, Basmati rice, Ginger,
Castor, Karela, Jamun.
⚫ Many countries have a definite legislation which protects this kind
of knowledge but, India does not have a definite legislations which
protects such TK but is still in the process of developing such
legislation.
⚫ TK is a combined knowledge of the whole society and a single
human being cannot claim over it. World population mainly
depends on traditional medicine for its primary health care and is
essential for its survival.
⚫ The use of “neem” and “turmeric” in first-aid, curing rashes,
cosmetics is the examples of traditional knowledge. At first it was
the patent on wound-healing properties of turmeric; now patents
have been obtained in other countries on hypoglycaemic
properties of bitter gourd.
⚫ For example case study of Turmeric and Neem are explained as
below-
Turmeric patent
⚫ Turmeric powder is widely used in India as a medicine, a food
ingredient and as a dye. For example, it is used as a blood purifier,
in treatment of common cold, and as an anti-parasitic for many
skin infections.
⚫ In 1995, the United States awarded patent on turmeric to
University of Mississippi Medical Centre for wound healing
property.
⚫ The claim subject was the use of “turmeric powder and its
administration”, both orally as well as topically, for wound healing.
A special 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 use of turmeric to USPTO.
⚫ It was a well known fact that the use of turmeric was familiar in
every household since ages in India; it was an exceptional task to
find published information on the use of turmeric powder through
oral as well as topical route for wound healing.
⚫ Due to wide researches, references can be found in different
languages like Sanskrit, Urdu and Hindi.
⚫ As a result, USPTO revoked the patent, stating that the claims made
in the patent were obvious and expected, and agreed that the use
of turmeric was an old art of healing wounds.
⚫ Therefore, the traditional knowledge that belonged to India was
protected in Turmeric case. This explains how easy it was to untruly
Patent centuries-old traditional knowledge.
Neem patent
⚫ The Neem tree is an indigenous evergreen species India. Neem is
also called as “the village pharmacy” in India for its healing property
in Ayurveda from its very beginning.
⚫ It had been in use for a period of more than 4000 years ago. The
neem is also called as “Arista” which is a Sanskrit word and means
complete.
⚫ Along with the Neem leaves the tree itself is used in medicine. It is
used as anti-inflammatory, anti-pyretic, antiseptic, anti-fungal,
anti-viral medicines.
⚫ The main chemical constituent present in neem is “ Azadirachtin”.
⚫ The patent for Neem was first filed by W.R. Grace, Department of
Agriculture, USA in European Patent Office (EPO).
⚫ The said patent was a method of controlling fungi on plants
comprising of contacting the fungi with 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 Agricultural Movements (IFOAM) and Magda Aelvoet,
former green member of the European Parliament (MEP).
⚫ According to India’s claim, it was stated that Neem is an indigenous
product and still in practice as a form of traditional knowledge in
India.
⚫ It was also said that Neem if granted patent it would affect the
poor farmers and by this the Indian economy will also be harmed.
⚫ A group of individuals and several NGO’s initiated the Neem
campaign and this was done to mobilize the worldwide people for
Support and to protect the traditional knowledge system and also to
protect Indian traditional products from biopiracy.
⚫ The Neem case was the first initiative to challenges US and
European patents with regards to Biopiracy. The European Patent
Office recognized the lack of originality, innovative step and hence
revoked the patent.
