Patenting and regulatory requirements of natural products

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2. Patent
A patent refers to an exclusive right which is granted to an inventor. The
person who has been granted patent is called "Patentee”
Patent is a legal document that gives patent holder exclusive right to
implement described invention commercially. The word patent is a Latin
term "PATERE" which means to lay open or open letter.
A patent is a form of intellectual property, it gives its owner the right to
exclude others from making, using, selling and importing an invention for
a limited period of time usually 20 years. If an invention is patented, it
implies that no other person can commercially benefit from making,
using, selling or distributing it.

3. 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 its ossessor 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.

4. INTELLECTUAL PROPERTY RIGHTS (IPR)
IPR is defined as the exclusive rights of the inventor for the protection of his
or her actual property, thus excluding others from making, copying, using or
selling his proprietary subject matter.
It is a legal characterization and treatment of trade related biotechnological
processes and product.
Intellectual property right are the rights given to persons who over the
creations of their mind. They usually give the creator an exclusive right over
the use of his or her creation for a certain period of time.

5. INTELLECTUAL PROPERTY RIGHTS (IPR)
IPR includes the following things.
• Processes, product and apparatus having
industrial applications.
Patent
• Design, book, charts, films, advertisement.
Copy right
• Literary works, artistic work, software,
photography,
Trade secrets
• Words, signs.
Trade marks

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Purpose of the patent
To motivate the inventor
It gives legal monopoly
to the patentee
ensures that ultimately
better products and
processes are found to
prove the quality of
human life.

7. FARMERS RIGHT
This is the right given to farmers for the improvement, conservation
and making available of plant genetic resources (PGR) so that farmers
need not go to the breeder every time.
The protection of plant variety and farmers right act 2001 (PPV& FR
act) is an act of the parliament of India that was enacted to provide for
the establishment of an effect system for protection of plant varieties.
The rights of the farmers and plant breeders are to encourage the
development and cultivation of new varieties of plants. The PPV & FR
act 2001 was enacted to grant intellectual property rights to plant
breeders researchers and farmers who have developed any new or
extinct plant variety.

8. These rights include:
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• Farmers' Right to register traditional varieties developed by a farmer
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• Farmers' Right for reward and recognition if he is engaged in the conservation
of genetic resources of land races and wild relatives of economically important
plants
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• Farmers' 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
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• Farmers' Right for benefit sharing of new varieties developed by farmers
which may lead to huge profit to Plant Breeders' Right (PBR) holder
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• Farmers' Right to get compensation for the losses caused by the registered
variety

9. Breeder's Right
It is also known as plant breeder's right (PBR) and 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 Le. seed, cuttings, divisions,
tissue culture and harvested material like cut flowers, fruit foliage etc.

10. 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.
In order to meet the criteria for these exclusive rights, a variety must be
new, distinct, uniform and stable in nature.
Breeder's Right

11. Bioprospecting
It is defined as the orderly search for and development of new sources of
chemical compounds, genes, micro-organisms, macro-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.

12. It also includes exploration and research on native knowledge related to
the utilization and management of biological resources.
It helps in conservation and sustainable use of biological resources and
the rights of local and indigenous communities.
Majority of the medicinal plants were discovered by the process of
bioprospecting.
Bioprospecting

13. Biopiracy
The term Biopiracy was coined by "Patmooney" to describe a practice in which
indigenous wledge of nature, originating with indigenous people is used by
others for profit without authorization or compensation to the indigenous
people themselves.
For example, when indigenous knowledge of medicinal plant which is later
patented by medicinal companies without recognizing the fact that the
knowledge is not new or invented by petentee and depriving the indigenous
community to the rights to commercial exploitation of the technology that they
themselves had developed.

14. It is defined as the unethical commercial exploitation of biological materials like
medicinal plant extracts that are indigenous to a particular country without
providing fait financial compensation to the people or government of that country
or territory, Biopiracy occurs when research organizations take biological
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 patent on invention
derived from those genetic resources.
Biopiracy

15. 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.
Biopiracy is the appropriation of another's knowledge of use of biological
resources.
Of late, the major issue involving biopiracy is the exploitation of patent
biological resources or knowledge of farmers and traditional
communities and indigenous tribes by many organizations and
multinational companies.
The innovations and discovery of the pharmaceutical and agricultural
researches are not new as to qualify as invention as they are based on
centuries of knowledge of the traditional societies.

16. Example of Biopiracy
Patenting of Neem
(Azadirachta
indica)
Patenting of
Basmati
Rice Biopiracy

17. Patenting Aspects Of Traditional Knowledge And
Natural Products
The Traditional knowledge is the knowledge of practice and the skills
which have been developed, sustained and passed from generation to
generation within a population which forms a part of its cultural or
spiritual identity.
The innovations which are based on the traditional knowledge may be
benefited by the trade mark, the patent or it is being protected rights of
local people in the form of known traditional knowledge.

18. 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 (TKO) 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 load culture and environment

19. Patenting Aspects Of Natural
Products
Patentable natural products
The following are the list of natural products which can be patentable.
1.Novel isolation process of natural products from its surroundings. Example an
Indian
patent for process of isolation of azadirachtin from the seeds of neem plant.
2.Characterization of new product either by its structure or by other physical
parameters.
3.A new application of isolated product provided unless such knowledge or
invention do not exist anywhere. Example a Japanese patent for the use of
turmeric as a stabilizer for an antifungal agent.

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4.Invention and novelties. For example products like biopesticides.
5.Patenting in relation to biotechnology.
6.Patenting for biological matter. For example microorganisms like E
coli in which human genes are introduced for the production human
insulin, human growth hormone, human tissue, plaminogen
activators are patented.

21. Methods for producing new organisms.
Reducing pathogenicity,
Increasing biological activity.
Invention of new organisms and their composition.
8.Transgenic plants can be altered genetically to obtain transgenic plants
of desired characters Example herbicide resistant cotton plant,
insecticidal resistant tobacco plant Such techniques are patentable.
9.Patenting of secondary metabolites by cell culture which includes
sophisticated and specific methods can be patented. Example production
of taxol by cell culturing of taxus species
7.Patentable microbial inventions include the following.

22. Non patentable natural products
Plants grown in wild.
Plants adopted for cultivations
Hybrids or other cultural
varieties which have been tried
for particular use.

23. Procedure For Obtaining Patent
1.FILLING AN
PPLICATION
2.EXAMINATION
OF APPLICATION
3.OPPOSITION/C
LAIM FOR
PATENT
4.GRANTING &
PATENT SEALING

24. Case Study Of Curcuma
Turmeric is a tropical herb grown in east India. Turmeric powder has a deep
distinct colour and bitter taste. It is used as dye, cooking ingredient, litmus in
chemical tests and for medicinal purposes.
A United States patent on turmeric was awarded to the university of
Mississippi Medical centre in May 1995, specifically for the use of turmeric in
wound healing. Two years later, a complaint was filed by India’s council of
scientific and industrial Research (CSIR).
CSIR argued that turmeric has been used in India for thousands of years for
healing wounds and rashes and therefore the patent on its medicinal use was
not a novel invention.

25. The CSIR claim was supported by documentary evidence of traditional
knowledge including ancient Sanskrit text and paper published in 1953 in the
journals of Indian medical association.
United States patent and trade mark office (USPTO) investigated the validity
of the patent.
In 1997 despite an appeal made by the patent holders, the USPTO upheld the
CSIR objection and cancelled the patent due to lack of novelty.
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Case Study Of Neem
The Neem tree Azadirachta indica is a tropical evergreen tree native to India and
is also found n other south east countries.
The seeds, bark and leaves contain compounds with proven antiseptic, antiviral,
antipyretic, anti-inflammatory, anti ulcer and antifungal properties.
In 1971, US timber importer "Robert Harson" observed that the trees usefulness
in India and began importing neem seeds to his company head quarters.
He conducted safety and performance test of neem. Three years later he sold his
invention to the US Department of agricultural and multinational chemical
corporation WR Grace and co.

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In 1992 the WR Grace and co secured its right to the formula that used the emulsion
from the neem trees, seeds to make a powerful fungicide.
In applying for the patent, the company had argued that it had used an extract of
the trees, seed to make a new fungicide but the Indians claim that its patent was not
sufficiently novel as Indian farmers have used this fungicide for decades.
The Indians and members of the green party in the European union opposed the
patent because they believed that the rights of the poor farmers in developing
countries will be harmed.
The Neem patent became the first to challenge European and US patents on
grounds of biopiracy.

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The Indian scientists argued that the Indians have known the medicinal
properties of neem long back.
The European patent office (EPO) accepted the arguments offered by
Indian scientist and rejected the order of the US patent office to award the
patent to WR Grace and The victory is a result of four yearlong effort by the
research foundation for science, technology and environment.