For B.Pharm, 6th Sem

1. Patenting aspects of
Traditional Knowledge and
Natural Products.
Case study of Curcuma &
Neem

2. INTRODUCTION
• Traditional Knowledge: It may be considered as
knowledge, know how, skills, innovations or
practices; that are passed through generations
within your communities, and thereby form part
and parcel of your community.
• For examples, your knowledge
About traditional medicines
Traditional hunting or fishing techniques
Animal migration patterns
Water management, etc.
These are precious assets, which are required to
be protected.

3. Why it is important to protect?
Traditional knowledge is integral to the
identity of most local communities.
It plays an important role in your health care,
food security, culture, religious identity,
environment, trade and development.
If somebody tries to exploit your traditional
knowledge for industrial or commercial
benefits, it can affect your interests.

4. Intellectual Property Right (IPR)
• Defined as the Legitimate
rights of the inventor for
protection of his intellectual
property thus excluding
others from making, copying,
using or selling his
proprietary subject matter.
• IPR provides such protection.
• The Head Office of the Patent
office is at Kolkata and its
Branch offices are located at
Chennai, New Delhi and
Mumbai.

5. Types of IPR

6. PATENT
• Patent is
• A grant of exclusive right/type of IPR
• For an invention
• By the Government
• To the inventor
• For limited period (20 years)
• In exchange for full disclosure of invention
• To prevent others from selling, making or using the invention.
• A patent is an exclusive right granted for an invention, which is a
product or a process that provides, in general, a new way of doing
something, or offers a new technical solution to a problem.
• To get a patent, technical information about the invention must be disclosed
to the public in a patent application.

8. OBJECTIVES OF PATENT
1.Giving a legal monopoly to the patentee
to reap the economic benefits from his
invention.
2.Facilitating the improvements or
providing the alternative approaches to
develop the new ideas or and products.
3. Invention of new drugs.

9. THE PATENT ACT 1970
According to the act:
1. A new invention
2. It should be new and non-obvious with respect
to prior art
3. It must useful (Utility)
4. Not previously in use
• Invention, as per the act may be defined as any
new and useful.

10. PATENTABLE: (From pharmacy)
New process of manufacture
NCE (New chemical entities, after
2005)
New formulation processes
New composition of matter

11. NON-PATENTABLE
1. Well established natural laws
2.Methods of detection, diagnosis or treatment of diseases
3. Analytical methods
4.Methods of agriculture/cultivation
5. The products made by Chemical synthesis
6.Animal,plant and biological methods for growing and
rearing them.
7. Scientific methods
8. Mathematical/business methods
9. Literacy, drama, Music,.
10. Arrangement and re-arrangement/duplication

12. PROCEDURE FOR PATENTING: STEPS
 Step 1 – Check if your invention is patentable
 Step 2 – Draft the patent application
 Step 3 – Filing the patent application:
 Form 1 – Application for patent grant
 Form 2 – Patent specification form (provisional or complete)
 Form 3 – Undertaking and statement with regards to foreign applications under section 8 (mandatory only
in case a corresponding application for patent is filed in a foreign country)
 Form 5 – Declaration of invention to be filed with complete application
 Form 26 – Form authorizing patent agent (applicable only if you opt for an agent to help file the patent)
 Form 28 – Mandatory only if applicant is claiming small entity or start-up status
 Priority Documents – You need to provide priority documents only if priority is being claimed from a foreign
patent claim or application.
 Step 4 – Publishing the patent application
 Step 5 – Examining the patent application
• The patent examiner is obligated to follow a few steps of his/her own while examining your application. They
are as under
• When the application lands on the examiner’s desk, it is scrutinized according to the Patent Act and
underlying rules.
• The patent examiner searches for similar technologies to ensure the invention satisfies patentability criteria.
• After reviewing the application, a first examination report (FER) is submitted in which, grounds for
objections, if any, are also stated.
• The examiner lists his objections in detail. This can further extend the application process by another 6- 9
months. Note that examiner objections are quite common in case of patents.
• If the inventor needs to make changes to his/her objection, he/she can file a request for time extension by
submitting Form 4.

13. Step 6 – Decision to grant patent
• Once the examiner finds no objections in the
patent application, he grants the patent. The
patent is then published in the official patent
gazette. https://ipindia.gov.in/
Step 7 – Renewing the Patent
• The patent holder also needs to renew his
patent by paying an annual renewal fee.
• In India, it is possible to renew your patent for
a period of 20 years at maximum, from the
date the patent was first filed.

14. FILLING AN APPLICATION
A. Name, address and nationality of the
applicant
B. Title, Name, address and nationality of the
inventor, if he is not the applicant or co-
applicant
C. Specifications (provisional and complete)
giving the details of the invention
D. Claims, definition and scope of the invention

15. EXAMINATION OF THE APPLICATION
• A. Prior approved patents or
applications filed
• B. Novelty
• C. Usefulness
• D. Nature of claims

16. Opposition:
• A three month time period is given for any
opposition.
• Contrary claims can be filed and contested
Granting & sealing of patent :
• In case of no opposition or clearing
satisfactorily all the objections by the
applicant, patent is granted and sealed by the
patent office by publishing in the official
gazette. https://ipindia.gov.in/

17. Revocation :
• The validity of the patent can be challenged in
High court under specified grounds. The
patent will be revoked if the court upholds the
challenge.
Validity of a patent:
• Patent for food and medicines and drugs
produced by chemical processes 5 Years
period from the date of Granting the patent
OR 7 Years period from the date of filing
application OR whichever is earlier.
• The term of every patent granted is 20 years
from the date of filing of application.

18. PATENTABLE NATURAL PRODUCTS
I. Formulation of new composition or improved
formulation is patented:
Eg: Patented herbal anti-allergic composition which
comprises a synergistic mixture of extracts from the
fruits of Terminalia chebula, bark of Albizia lebbeck,
Terminalia bellerica and Embblica officinalis and
process of preparation of such composition.
• The present invention also contains the fruits of Piper
longum, piper nigraum and rhizomes of Zinger
officinalae and thoroughly mixed to get the final
composition which has potent anti-allergic activity.
• The preparation is useful for the treatment of allergic
conditions.

19. II. Patent for new use of the herbal
constituents
• Eg: The weight loss properties of Forskohlin
(obtained from the roots of Coleus forskohlli )
were discovered by the firm (Sabinsa
corporation), in humans, which is not a
traditional use of the Coleus active. For this,
the company was grantentd a patent for its use
and composition in promotion of lean body
mass, reduction of adipose tissue (fat) and
weight loss.

20. III. Modification or Synthesis of the natural compounds:
• Eg: The novel steroidal glycosides compounds which
are extracted and isolated from the extracts of plant of
the genus Trichocaulon or Hoodia containing an
appetite suppressant agent and the derivatives of such
compounds are synthesized with the aim of increasing
the activity of the active ingredient. Also, this
invention provides novel intermediates for the
synthesis of active compound.
• The active ingredient in the Hoodia gordonil plant is
called P57 and is responsible for its appetite
suppressant qualities. Phytopharm, a British
pharmaceutical company, has the exclusive patent on
P57.

21. IV. A Novel isolation process:
• Eg; For the process of isolation of Azadirachtin
(fungicidal activity) from the seeds of neem and
also its storage. N.C.L, Pune, Indian patent
V. A new application of an isolated compound:
• Eg; For the use of turmeric as a stabilising agent
for menadione, an antifungal agent. Japanesh
patent.
VI. The inventions with novelties:
• Eg; Bio-pesticides
VII. Biotechnology related products
VIII. Purification of the natural products

22. 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.
• 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.

25. 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 Larson" 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.

26. • 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.
• 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.

30. References
1.V.D.Rangari. Pharmacognosy &Phytochemistry.
2.Pharmacopoeal standards for Ayurvedic
Formulation (Council of Research in Indian
Medicine & Homeopathy).