Unit 4 Herbal Drug Technology As per PCI syllabus B. Pharm Sem VI

1. Patenting and Regulatory Requirements
of Natural Products:
Presented by :
Mrs. Poonam N. Chougule
HOD Pharmacognosy &
Assistant Professor AMCP

2. Topic contains-
• a) Definition of the terms: Patent,
IPR, Farmers right, Breeder’s right,
Bioprospecting and Biopiracy
• b) Patenting aspects of Traditional
Knowledge and Natural Products.
Case study of Curcuma & Neem.

3. Patent
• Patent is a legal document that gives to patent holder
exclusive right to implement described invention
commercially.
• The word Patent is Latin term PATERE, which means open
letter.
• The person who has granted patent called as Patentee.
• A Patent is exclusive monopoly granted by a govt. to an
inventor over his invention for limited period of time and
the purpose of this system is to encourage inventions by
promoting their protection and contribute to develop
industry.

4. IPR- Intellectual Property Rights.
• IPR is defined as the exclusive rights of inventor for
protection of his intellectual 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 products.
• IPR are the rights given to person who over the
creation of their mind.
• It also having certain period of time.

5. IPR includes
1) Patent- For processes, product and apparatus
having industrial applications.
2) Copy Right- any design, Book, Charts, Films and
Advertisements.
3) Trade Secrets- Literary works, Artistic works,
Software and Photography.
4) Trade marks- Any Words, Symbols and signs.

6. Farmers right
• This is a Right given to farmers for improvement,
conversation and making available of any plant
genetic recourses (PGR) so that farmers need not go
to the breeder every time.
• The protection of plant variety and farmers right act
2001, this act of Parliament of India was provided for
effective system for protection of verities of plants.

7. Breeder’s right
• It is also known as Plant Variety Right (PVR)
• This right granted to breeders of a new variety of
plant that give the breeder exclusive control over
propagating materials which includes seeds, cutting,
divisions, tissue culture and harvesting material such
as flowers, fruits and any new variety for no. of
years.
• It is granted by International Union for protection of
new variety of plant.

8. Bioprospecting
• It is also known as Biodiversity.
• Bioprospecting is a systemic search for biochemical
and genetic information in nature, to develop
commercially valuable products for pharmaceutical,
agriculture, cosmetic and other preparations.
• It includes search for plant and animal species from
which medicinal drugs and other compounds can be
obtained.

9. Biopiracy
• The Biopiracy word coined by “Patmooney” to describe a
practice in which indigenous knowledge of nature,
originating with indigenous people is used by others for any
benefits and profit without authorization.
• Under US patent law Biopiracy is any person who invents
any new and useful process, machine, manufacture or any
new useful improvement is eligible to obtain a patent.
• In general four requirements to be satisfy to qualify for
Biopiracy patent-
1. The subject matter must be Patentable.
2. The invention must be Novel.
3. The invention must have usefulness.
4. The invention must not be fake.

10. b) Patenting aspects of Traditional Knowledge
and Natural Products.
• List of Patentable Natural Products:-
1. Novel isolation process of natural products from its
surrounding. Ex.- Indian patent for process of
Azadirachtin from seeds of neem plant.
2. Characterization of new product either by its structure
or by other physical parameter.
3. A new application of isolation product provided unless
such knowledge or invention do not exist anywhere.
Ex.- A Japanese patent for the use of turmeric as a
stabilizer for antifungal agent.
4. Invention and novelties. Ex.- Products like biopesticides.
5. Patenting in relation to biotechnology.

11. 6. Patenting for biological matter. Ex.- Microorganisms like E.
coli in which human genes are introduced for the production
of human insulin, human growth hormone, human tissue,
etc.
7. Transgenic plants: plants can be altered genetically to obtain
transgenic plants of desired characters. Ex.- Herbicide
resistant cotton plants, insecticidal resistant tobacco plants.
8. Patenting of secondary metabolites by cell culture which
includes sophisticated and specific methods can be
patented. Ex.- Production of taxol by cell culturing of taxus
species.
Non Patentable natural Products:-
1. Plants growth in wild.
2. Plants adopted for cultivation.
3. Hybrids or cultural varieties which have been tried particular
use.
b) Patenting aspects of Traditional Knowledge and Natural
Products.

12. Thank you…

13. Case study of Curcuma -
• Turmeric is a tropical herb grown in east India. Turmeric
powder is deep distinct color and bitter in taste.
• It is used as dye, cooking ingredient, litmus in chemical tests
and for medicinal purpose.
• A United states Patent on turmeric was awarded to the
University of Mississipi Medical centre in May 1995,
specifically for 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 from
thousands of years for healing wounds and rashes, therefore
Patent on its medicinal use was not a Novel invention.

14. • The CSIR claimed that 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, USPTO upheld the CSIR objection and
cancelled the patent due to lack of novelty.

15. Case study of Neem-
• The Neem tree Azadirachta Indica is a tropical evergreen tree native to
India and is also found South East countries the seeds, bark and leaves
contains compounds with an antiseptic, antiviral, antipyretic, anti-
inflammatory, antiulcer and antifungal properties.
• In 1971, US Timber importer ‘Robert Harson’ observed that trees
usefulness in India and began importing Neem seeds to his company
headquarters, he conducted safety and performance test of neem.
• Three years later, he sold his invention to the US department of
agriculture and multinational chemical Corporation WR Grace and co.
• In 1992, The WR Grace and co secured it's right to the formula that used
the emulsion from the Neem trees, seeds to make powerful fungicidal.
• In applying for the patent, the company had argued that it had used and
extract of trees seed to make a new fungicide but the Indians claims that
its patent was not sufficiently novel, as Indian farmers have used this
fungicide for decades.

16. • The Indians and Members of Green party in European
Union opposed the patent because they believed that
the rights of poor farmers in developing countries will be
harmed.
• The name patent become a first to challenge European
and US patents on grounds of biopiracy.
• The Indian scientist argued that Indians have known a
medicinal properties of Neem long back ago.
• The European patent office accepted the arguments
offered by Indian scientist and rejected the order of US
patent office to our the patent to WR Grace and co.
• The victory is the result of 4 year long efforts by
Research Foundation for science, technology and
environment.

17. Thank you….