1. PATENTING AND REGULATORY
REQUIREMENTS OF NATURAL
PRODUCTS
Presented by
Sonali Gadge
Assistant Professor
P R Patil Institute of Pharmacy, Talegaon (SP)

2. INTELLECTUAL PROPERTY RIGHTS
Intellectual property is the property possessed by virtue of one’s
intellectual creativity.
Intellectual property rights (IPR) are exclusive rights to make,
use and sell a new product or technology for a limited period.

3. There are different types of Intellectual properties which can be protected by
law:
Table: Types of IPR
Sr.
No.
Types of
IPR
Law Protection
given
Application/Example Duration in years
1. Patents Indian Patent Act,
1970
Discoveries
and Inventions
Drugs, Medicines,
Scientific discovery
20 years after filing,
can’t be renewed
2. Trademarks Trademarks Act, 1999 Phrases,
symbols, and
designs
Business, branding 10 years duration can
be renewed for again
10 years
3. Industrial
design
Copyright Act, 1957 Musical,
Literary, and
artistic works
Books, Drama, literature Lifetime of author or
artist and 60 years
after death
4. Industrial
design
Design Act, 2000 Design of
machined,
equipment, etc.
Manufacture of equipment,
industries
Initial 10 years can be
extended 5 more
years
5. Plants The Plant variety
Protection Act of 1970
Plant variety,
Farmers right,
Trees
Farmer 15 years from date of
registration
6. Geographical
indication
The Geographical
indications of Goods
(Registration and
Protection Act, 1999)
Certain goods Basmati rice, banarasi silk,
Madhubani painting
Initial 10 years can be
extended for another
10 years

4. PATENT
A Patent is a set of monopoly rights
given to patentee by government that
excludes others from making, using
selling or importing particular
invention for limited period of time.

5. A patent may be granted only for an invention in
respect of which the following conditions are
satisfied:
(a) The invention is new
(b) Involves an inventive step; and
(c) Is capable of industrial application or utility

6. Important points related to patent
• A Patent is a statutory right for an invention granted for a limited period of
time. Currently, patent granted is for 20 years from the date of filing of
application.
• Patentee has to fully disclose his invention for grant of patent.
• Patent is territorial right means there is no world patent. One has to apply in
respective country to receive patent for that country.
• Patent is sort of negative right. For a patentee, after grant of patent, use of that
invention is not mandatory. It excludes others making, using, selling, and
importing the patented product.
• India has four patent offices which are located at Kolkata, New Delhi,
Mumbai, and Chennai.

7. History of Indian Patent System
Year History
1856 The act VI of 1856.
The objective of this legislation was to encourage inventions of new and useful manufacturers and to induce
inventors to disclose secret of their inventions.
1859 The act modified as act XV
1872 The Patents and Designs Protection Act
1883 The Protection of Inventions Act
1888 Consolidated as the Inventions and Designs Act
1911 The Indian Patent and Designs Act. This act brought patent administration under the management of Controller
of Patents for the first time and replaced all previous acts.
1972 The Patents Act (Act 39 of 1970). This act replaces patent act of 1911.
1999 First amendment of 1970 act: Patents (amendment) Act, (1999) came into force from 01-01-1995
2002 Second amendment of 1970 act: The Patents (Amendment) Act 2002 came into force from 20th May 2003
2005 Third amendment of 1970 act: The Patents (Amendment) Act 2005 effective from 1st January 2005
2016 (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 video-conferencing for faster examination.

8. Patent document is divided in following
section:
Writing of patent is art as well as skill. Ideal patent writer can write
patent documents in such a way that even single word cannot be
deleted without changing meaning of main text.
1. Title: The title document demonstrates and gives idea of the
invention for the grant of patent.
2. Abstract: It gives the precise or detail description of the
invention. Abstract also contain the technical information in brief
covering all important points.
3. Description: It describes an invention with the help of words,
drawings, and diagrams. The ai is to provide enough detail that a
person with ordinary skill in the area of the invention would
understand and recreate the invention.
4. Claims: This is the backbone of patent document. It describes
the inventive concepts of an invention.

9. Advantages of Good Patent System:
1. saves time and energy by making available current literature and technology to
other inventors reducing the duplication.
2. Identification of technology, transfer, licensing, alternative or substitute of
existing technology and new research is possible because of good patent system.
3. Knowledge on the latest technologies in desired field of expensive is available.
4. One can place more effective and better technology after current patent search.
5. Sharing of ideas, knowledge, and innovation is possible to benefit country and
mankind.
6. Know about the commercial applicability for the invention in the field of
expertise.
7. Ease of doing business is achieved because of good patent system.
8. Inventor can benefit from money while possible infringement can be avoided.
9. One can legally object grant of patent, if it conflict with particular
invention/claim.
10. Expired patents are pool of knowledge which is open to all free of cost.

10. Patents and Natural Products
Several common ways to obtain patents for herbal medicines:
• Finding new uses or therapeutically completely different action for an
existing herb.
• Isolation of a new active ingredient not previously reported.
• Significant improvement in the method for extraction/separation of the
active ingredients.
• Claiming entirely new uses for old compounds.

11. The following inventions are not protected under
patent act
• Naturally occurring micro-organisms and their components, animals, plants, or
extracts from animals or plants.
• Scientific or mathematical rules or theories.
• Computer programs
• Methods of diagnosis, treatment or cure of human and animal diseases.
• inventions which are hazardous and contrary to public order, morality, health or
welfare.

12. According to Second Amendment of Patent Act, 2002
following things are not patentable:
• Plants, animals in whole or any part.
• Seed or varieties of plant
• Biological processes for the production of plants and animals.
• Microorganisms can be claimed for a patent provided if they are not only
discovery of organisms existing in nature.
• Methods for rendering plants free of diseases or to increase their economic
value will be patentable.

13. The Geographical Indications of Goods (Registration
and Protection) Act, 1999
 This act provides facility for registration and better
protection of geographical indications relating to
goods.
 Any agricultural, natural or manufactured goods or any
goods of handicrafts or of industry include food stuff,
can be considered as Good according to this act.
 Indication can be aby name, geographical or figurative
representation or any combination of them conveying
or suggesting the geographical origin of goods to
which it applies.
 Examples- Kolhapur jaggery, Paithani saree,
Hydrabadi Haleem, Nagpur orange, Coorg orange

15. Bioprospecting and Biopiracy
Bioprospecting
Bioprospecting is “the process of
discovery and development of new
molecules from different biological
resources”
Biopiracy
Biopiracy is an injustice relating to
patent or intellectual property related to
biological materials and traditional
knowledge without sufficient
authorization and/or compensation.

16. Role of CBD in Biopiracy
• Prior to TRIPS, The Convention for Biological Diversity (CBD) was
established in 1992 as an international IPR agreement to give some
protection to indigenous people.
• According to the CBD provisions, source nations should receive some
compensation or benefit for sharing knowledge and resources with
corporations or multinational companies wanting to use the biodiversity.
• According to the CBD every country or states have sovereign rights and
power to protect own resources and those resources are no longer freely
available to others.
• So efforts for conservation and sustainable use are of critical importance.
• Clearly, rich nations and multinational companies are not much interested
in giving benefits to poor countries or people having resources.

17. Some important focus areas of CBD are:
1. Genes, species and ecosystems all these three levels
are considered under the convention.
2. The convention aims to address the causes rather the
effects of threats to biodiversity.
3. Conservation and sustainable use of bioresources are
considered to be inseparable.
4. It does not set any standards for protection but
outlines the goals and policies to be pursued by the
countries through their own legislation. But only few
countries have realized the importance of natural
resources and traditional knowledge and enacted the
legislation.

18. Recent Information of Biopiracy of
Natural Products
Basmati Case
This was the one of the most important cases from Indian perspective. The united
States Patent Office has granted the patent to company called “RiceTec” on
September 2, 1997. according to this patent, this company can grow aromatic rice
in America and call that rice as Basmati. India objected to this patent. This patent
covered 20 claims covering not only novel rice plant but also various rice lines;
resulting plants and grains, seed deposit 2 claims, method for selecting rice plant
for breeding and propagation. In claim number 15-17 a rice grain having
characteristics similar to those from Indian Basmati Rice lines was claimed.
According to Geographic indication, only rice grown in particular part of India
can be called as Basmati. Basmati grown from centuries, traditionally. This was
violation of GI provisions coming under protection of intellectual property. After
opposition from India these claims were withdrawn.

19. Kava Kava
French multinational company has patented the use of Kava to reduce hair loss
and stimulate hair growth. Kava is one of the plants used traditionally in many
countries. More than 100 varieties of kava are grown in the pacific region,
especially in Fiji and Vanuatu, where it was first domesticated thousands of years
ago.
Shamans
For generations, Shamans (Traditional healers) of indigenous tribes throughout
the Amazon basin are using the bark of B cappi to produce a ceremonial drink
known as “Ayahuasca” which means “wine of the soul”. Ayahuasca is used in
traditional medicine and cultivated for that purpose for generations. The
Shamans use Ayahuasca in religious and healing ceremonies to diagnose and
treat illness, meet with spirits, and divine the future.

20. Patenting Aspects of Traditional Knowledge
and Natural products
• Traditional knowledge refers to ideas, knowledge, innovations and peculiar
practice developed from experience gained over centuries and adapted to the
local people, culture and environment.
• Traditional knowledge system acts holistic way by considering mind and body.
• Traditional knowledge includes experiences, philosophies, politics, and
technologies practiced by the indigenous people.
• Products under traditional systems are not permitted to be manufactured without
a license. The license for the same should be obtained from the State Drug
Control Authorities.

21. • The Traditional Medicines Congress (TMC) was formed in the year 2004. The
Traditional Medicines Congress (TMC) is processing federal regulation that will
affect everyone involved with herbs.
• There are two important international conventions that have bearing on
intellectual property rights in indigenous knowledge systems.
• These are the World Trade Organization’s Trade Related Aspects of Intellectual
Property Rights (TRIPS) and the convention on Biological Diversity (CBD).
• The CBD is the only major international convention that gives ownership of
biodiversity to indigenous communities and individuals. This ensures their
rights to protect this knowledge.

22. Case Study of Curcuma
• Turmeric is common household remedy known as Curcuma longa traditionally
used as a spice in Indian food. In India, rhizomes of turmeric used as spice
during cooking from many centuries. Wide ranges of biological activities
including antibacterial, anti-inflammatory, antioxidant, and anticancer are
shown by this plant. So there is logical basis for its tractional use in foodstuff.
It is commonly used as a blood purifier, in treating the common cold, and as an
anti-infective for many skin infections.
• In 1995, two Indian scientists named as Dr. Suman K Das and DR. Harihar P
Kohli working at the University of Mississipi Medical Centre was granted a US
patent (number 5, 401, 504) on use of turmeric in wound healing. In this patent,
they made six patent clams covering the oral and topical use of turmeric
powder for healing of surgical wounds and ulcers.
• Dr Mashelkar, from the Council of Scientific and Industrial Research (CSIR),
India filed objection to this patent. They filed re-examination case with the US
patent office challenging the patent on the grounds of existing of prior art and
traditional knowledge.

23. According to CSIR claim, turmeric has been used for thousands of years for
healing wounds, rashes. This case do not have novelty. The traditional knowledge
claim was supported by documentary evidence including ancient Sanskrit text and
the research paper in the journal on the Indian Medical Association published in
1953. Despite an appeal by the patent holders, the US Patent office accepted the
CSIR objections and cancelled the patent.
This was first case considered as a landmark judgement of patent based on the
traditional knowledge of a developing country. The US patent office revoked this
patent 1997, after ascertaining that there was no novelty; the findings by
innovators have been known in India for centuries. After this case, all traditional
knowledge is documented in the form of TKDL (Traditional Knowledge Digital
Library) to avoid such cases in future.

24. Case Study of Neem
• Neem (Azadirachta indica, family Meliaceae) is very common tree found
throughout India.
• Different parts of Neem including seeds, extracts are used in India from several
centuries against hundreds of pests and fungal diseases that attack food crops.
Neem parts have been widely used in traditional medicine as contraceptive and
cosmetics for variety of skin problems.
• In 1994, European Patent Office (EPO) granted a patent (EPO Paten No
436257) to the US Corporation WR Grace Company and US Department of
Agriculture . This patent claimed for a method for controlling fungi on plants
by the aid of hydrophobic extract of Neem oil.
• A group of International NGOs and representatives of Indian farmers filed legal
opposition against the patent the next year.

25. • The evidence was submitted for the fungicidal effect of extracts of Neem seeds
had been known and used for centuries in Indian agriculture to protect crops. So
there was lack of novelty as this is in use for centuries in India, both in curing
dermatological diseases in humans and in protecting agricultural plants form
fungal infections.
• The main chemical involved is Azadirachtin, which a natural compound found
in the seeds of the neem tree. Synthetic form of a naturally occurring compound
may be patentable, because the synthetic form in this case is possible to prepare.
Traditionally people in India, smash neem seeds, soak overnight and scoop
emulsion part for spraying on crops. So the claim made in this patent was
already known publically.
• In 1999, the EPO determined this case as prior art because of all the evidence.
Finally, this patent was found lack of an inventive steps. The patent ranted was
finally revoked by the authority in May 2000.
• In Marck 2006, EPO even rejected the challenge made in 2001 by the USFDA
and the chemicals multinational, W R Grace to the EPOs previous decision to
cancel their patent on the fungicidal properties of the seeds extracted from the
neem tree.