PATENTING & REGULATORY

REQUIREMENTS OF NATURAL
PRODUCT
 SUB:- HERBAL DRUG TECHNOLOGY
 SUB. TEACHER:- DR. SIDDHI UPADHYAY
ENROLLMENT NAME CONTENT NO.
NO.
182610290070 Rathva Harshil 1. Patent
2. IPR
182610290023 Maisuriya Aakash 3.Farmers Right
4.PBR
182610290061 Prajapati Rushil 5.Bioprospecting
6.Biopiracy
182610290056 Patel Meet 7.Patent aspects of natural
products
8.Procedure for obtain
patent
182610290084 Vaghela Kuldeep 9. Case study of Curcuma
10. Case study of Neem
 1.PATENT
•A patent refers to an exclusive right which is granted to an inventor.
The person who has been granted patent is call “Patentee”.
•Patent is a legal document that gives patent holder exclusive right to
implement describe invention commercially. The word patent is a latin
term “PATERE” which mean to lay open or open letter.
•A patent is a form of intellectual property, it gives its owner right to
exclude other from making, using, selling & importing invention for a
limited period of time usually 20 years. If invention is patented, it
implies that no other person can commercially benefit from making,
using, selling or distributing it.
•Patent is exclusive monopoly granted by a government to inventor
over his invention for limited period of time. Purpose of this system is
to encourage inventions by promoting their protection & invention so
as to contribute to develop industries which in turn provide better
utility to society.
2. INTELLECTUAL PROPERTY RIGHTS
 IPR is define as exclusive rights of inventor for protection of his or
her intellectual property, thus excluding others from making,
copying, using or selling his proprietary subject matter.
 It is a legal characterisation & treatment of trade related
biotechnological processes& product. Intellectual property right are
right given to persons who over creations of their mind. They
usually give creator exclusive right over use of his or her creation
for a certain period of time.
 IPR includes the following things
 Patent: Processes, product & apparatus having industrial
applications.
 Copy right: Design, book, charts, films, advertisement.
 Trade secrets: Literaryworks, artisticwork, software, photography.
 Trademarks: words, signs.
Purpose of patent:
 Patents are granted in order to motivate inventors to
continue their efforts to develop innovations.
 This ensures that ultimately better products & processes
are found to improve quality of human life.
 Patent gives a legal monopoly to patentee so that he can
derive monetary benefits from his inventions.
 3.FARMERS RIGHT
 This is right given to farmers for the improvement,
conservation & making available of plant genetic resources
(PGR) so that farmers need not go to breeder every time.
 Protection of plant variety & farmers right act 2001(PPV&
FR act) is act of parliament of India that was enacted to
provide for establishment of an effective system for
protection of plant varieties.
 Right of farmers & plant breeders are to encourage
development & cultivation of new varieties of plants.
 PPV &FR act 2001 was enacted to grant intellectual property
right to plant breeders, researchers & farmers who have
developed any new or extinct plant variety.
4.PLANT BREEDERS RIGHT(PBR)
• It is also known as plant variety right (PVR).they are
rights granted to breeders of a ne variety of plant that give
breeder exclusive control over propagating material which
includes seeds, cutting, divisions, tissue culture &
harvested material such as cut flowers, fruit, foliage of a
new variety fir a number of years.
• With these rights of breeder is required to use that
particular variety. The PBR is granted by International
union for protection of new varieties of plants(UPOV)
 5. BIOPROSPECTING
 Bioprospecting or biodiversity prospecting is systemic search
for biochemical & genetic information in nature, in order to
develop commercially valuable products for pharmaceutical,
agriculture, cosmetic & other applications.
 Bioprospecting is process of discovery & commercialization of
new product based on biological resources. Search for plant &
animal species from which medicinal drugs & other
commercially valuable compounds can be obtained.
Investigation of living things to see how they can be
commercially useful to human beings.
 Bioprospecting is utilizing knowledge of natural resources
such that it benefits society as well as individuals.
6.BIOPIRACY
 The term biopiracy was coined by “Patmooney”to
describe a practice in which indigenous knowledge of
nature, originating with indigenous people is used by
others for profit without authorization or compensation to
indigenous people themselves.
 For example, when bioprospector draws indigenous
knowledge of medicinal plant which is later patented by
medical companies without recognizing fact that
knowledge isn’t new or invented by patentee & depriving
indigenous community to rights to commercial
exploitation of technology that they themselves had
developed.
 Under US patent law, any person who invents or discovers
any new & useful process, machine, manufacture or
composition of matter or any new & useful improvement
is eligible to obtain a patent. In general four requirements
have to be satisfied to qualify for a patent which are as
follows.
1. The subject matter must be patentable.
2. The invention must be novel.
3. the invention must have same utility or usefulness.
4. The invention must not be devious.
7.PATENTING ASPECTS OF NATURAL
PRODUCT
Patentable natural products:
The following are list of natural product which can be patentable.
1.Novel isolation process of natural products from its surroundings. Ex.
Indian patent for process of isolation of azadirachtin from 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 don’t exist anywhere. Ex. Japanese patent for use of turmeric as a
stabiliser for an antifungal agent.
4.Invention & novelties. For ex. 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 production
human insulin, human growth hormone, human tissue,
plaminogen activators are patented.
Patentable microbial inventions include the following:
 Processed products.
 Methods for producing new organisms.
 Reducing pathogenicity.
 Increasing biological activity.
 Invention of new organisms & their composition.
7.Transgenic plants: Plant can be altered genetically to obtain
transgenic plants of desired characters. Ex. herbicide resistant
cotton plant, insecticidal resistant tobacco plant such techniques
are patentable.
8. Patenting of secondary metabolites by cell culture which
includes sophisticated & specific methods can be patented.
Ex. Production of taxol by cell culturing of taxus species.
Non patentable natural products:
i. Plants grown in wild.
ii. Plants adopted for cultivations.
iii. Hybrids or other cultural varieties which have been
tried for particular use.
 8.PROCEDURE FOR OBTAINING PATENT
It involves the following steps:

FILLING AN APPLICATION

EXAMINATIN OF APPLICATION

OPPOSITION/CLAIM FOR PATENT

GRANTING & PATENT SEALING

a) Filing an application for patent:
A patent application can be made on prescribed application
form. This can be obtained from patent office, applicant have to
furnish following information:
 Title, name, address & nationality of inventor.
 Specification: Giving the details of invention.
 Claims: Definition & scope of invention.
b) Examination of application:
Patent office examines patent applications with respect to
usefulness, nature of claim & weather patent has been filed
earlier.
c) Opposition of any claim of patent:
A three month time is given for any application before granting
& sealing of patent.
d) Granting & sealing of patent:
• In case of no opposition or clearly satisfaction of all objection
by applicant, patent is granted by patent office & published in
official gazette.
• A patent can be kept alive by paying an annual fee within date
which increases age of patent.
• It can be renewed after its expiry.
Advantages of patenting:
A patent gives right to stop others from copying, manufacturing,
selling or importing invention without permission of inventor.
A protection is provided for a predetermined period keeping
competitors at bay.
Inventor has authority to license his invention to others to use or
sell it.
9.CASE STUDY OF CURCUMA
 Turmeric is a tropical herb grown in east India. Turmeric
powder has a deep distinct colour & bitter taste.
 It is used as dye, cooking ingredient, litmus in chemical
tests & for medical purposes.
 A US patent on turmeric was awarded to university of
Mississippi medical centre in may 1995, specifically for use
of turmeric in wound healing.
 Two year later, a complaint was filed by India council of
scientific & industrial research (CSIR).
 CSIR argue that turmeric has been used in India for
thousands of years for healing wounds & rashes & therefore
patent on its medicinal use was not a novel invention.
 CSIR claim was supported by documentary evidence of
traditional knowledge including ancient Sanskrit text & paper
published in 1953 in journals of Indian medical association.
 US patent & trade ,ark office (USPTO) investigated validity
of patent.
 In 1997 despite an appeal made by patent holders, USPTO
upheld CSIR objection & cancelled patent due to lake of
novelty.
10.CASE STUDY OF NEEM
 The Neem tree Azadirachta indica is a tropical evergreen tree
native to India& it’s also found in other southeast countries.
 Seeds, bark & leaves contain compounds with proven
antiseptic, antiviral, antipyretic, anti-inflammatory, anti ulcer
& anti fungal properties.
 In 1971, US timber importer “Robert Harson” observed that
trees usefulness in India& began importing neem seeds to his
company head quarters.
 He conducted safety & perfomance test of neem.
 3 years later he sold his invention to US Department of
agricultural & multinational chemical corporation WR Grace
& co.
 In 1992 WR Grace & co. secured its right to formula that
used emulsion from neem trees, seeds to make a powerful
fungicide.
 In applying for patent, company had argued that it had used
extract of trees, seed to make a new fungicide but Indians
claim that its patent was not sufficiently novel as Indian
farmers have used this fungicide for decades.
 Indians & members of green party in European union
opposed patent because they believed that rights of poor
farmers in developing countries will be harmed.
 Neem patent became 1st to challenge European & US
patents on grounds of biopiracy.
 Indian scientists argued that the Indian have known
medicinal properties of neem long back.
 European patent office (EPO) accepted arguments offered
by Indian scientist & rejected the order of US patent office
to award the patent to WR Grace & Co.
 The victory is a result of four yearlong effort by research
foundation for science technology & environment.
THANK YOU