The document discusses various aspects of patenting and regulating natural products. It defines what a patent is and explains intellectual property rights. It provides examples of patents on natural products for new formulations, new uses of constituents, and modified natural compounds. It also discusses biopiracy and provides case studies on patents granted on turmeric and neem in other countries. Finally, it outlines WHO guidelines and recommendations for regulating herbal medicines in South East Asia.

1. PATENTING AND REGULATORY
REQUIREMENTS OF NATURAL
PRODUCTS
Dr.U.Srinivasa,
Professor and Head,,
Srinivas College of Pharmacy, Mangalore
Email.Id usreenivas1966@rediffmail.com

2. WHAT IS PATENT -
It is a grant by a state to an inventor or to his
assignee , giving exclusive rights to make,
use, exercise and vend the inventions for a
limited period, in exchange for disclosure in a
patent specification.(contract b/n a nation and
inventor)
Patentee - A claimer of the patent

3. IPR- Intellectual property rights
An investor , having spent huge money
and efforts , requires a sort of protection for
his intellectual property. Such protection
allows him to gain the deserved incentive
for his innovation/invention. IPR provides
such protection.

4. 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

5. OBJECTIVESOF PATENT/ADVANTAGES
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

6. Farmers' Rights
Farmers' Rights consist of the customary
rights of farmers to save, use, exchange
and sell farm-saved seed and propagating
material, their rights to be recognized,
rewarded and supported for their
contribution to the global pool of genetic
resources as well as to the development of
commercial varieties of plants.

7. Plant breeders' rights
Plant breeders' rights Plant breeders'
rights (PBR), also known as plant variety
rights (PVR), are rights granted to the
breeder of a new variety of plant that
give the breeder exclusive control over
the propagating material (including seed,
cuttings, divisions, tissue culture) and
harvested material (cut flowers, fruit,
foliage) of a new variety for a number of
years.

8. Bioprospecting
Bioprospecting is the process of discovery
and commercialization of new products
based on biological resources. Despite
indigenous knowledge being intuitively
helpful, bioprospecting has only recently
begun to incorporate such knowledge in
focusing screening efforts for bioactive
compounds.

9. Biopiracy
Biopiracy is the practice of patenting and
marketing the use of traditional knowledge
and genetic resources of indigenous
peoples without authorization from source
countries.

10. Biopiracy
The commercial development of naturally
occurring biological materials, such as plant
substances or genetic cell lines, by a
technologically advanced country or
organization without fair compensation to
the peoples or nations in whose territory the
materials were originally discovered.

11. Examples
NEEM
In 1993 ,P.J.Margo Private Ltd . Obtained a
patent of neem bio-pesticides . But Indians
had been using neem products in the
same fashion for centuries, the European
patent office revoked the patent in Europe,
but the U.S.patent remains valid. (Because
in US, use of invention outside the US
does not destroy novelty)

12. 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
4. Not previously in use in India
Invention , as per the act may be defined as
any new and useful

13. 1.Art , process, method or manner of
manufacture
2. Machine, apparatus or other article
3.Substances produced by manufacture,
including any new and useful
improvements of any of them

14. PATENTABLE: ( From pharmacy)
1. New process of manufacture
2.NCE ( New chemical entities, after 2005)
3.New formulation processes
4. New composition of matter

15. • NON-PATENTABLE: (In INDIA)
• 1.Discoveries
• 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

16. PROCEDURE FOR
PATENTING :
Steps
Filling an application
Examination of the application by the patents
office
Opposition , if any to the claims of patent
Granting and sealing of the patent
Revocation of the granted patent

17. 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

18. Examination of the application
A. Prior approved patents or applications filed
B. Novelity
C. Usefulness
D. Nature of claims

19. Opposition:
A three month time period is given for
any opposition. Contrary claims can be
filed and contested

20. 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.

21. 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

22. 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

23. Who can apply for patents
1. By any person claiming to be the true and first
inventor of the invention
2.By any person being the assignee of the person
claiming to be the true and first inventor in respect of
the right to make such application
3.By legal representative of any diseased person who
immediately before his death was entitled to make
such an application

24. PATENTABLE NATURAL PRODUCTS
I. Formulation of new composition or improved
formulation is patented
Eg: Patented herbal antiallergic composition
which comprises a synergistic mixture of
extracts from the fruits of Terminalia chebula ,
bark of Albizia lebbeck, Terminalia bellerica and
Emblica officinalis and process of preparation of
such composition.

25. 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 antiallergic
activity. The preparation is useful for the
treatment of allergic conditions.

26. 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 gratentd
a patent for its use and composition in promotion
of lean body mass, reduction of adipose tissue
(fat) and weight loss.

27. 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 .

28. 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

29. 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.

30. VI. The inventions with novelties:
Eg; Bio-pesticides
VII. Biotechnology related products
VIII. Purification of the natural products

31. Traditional Knowledge (TK)
 Traditional Knowledge (TK) is a living body of
knowledge that is developed, sustained and passed
on from generation to generation within a community,
often forming part of its cultural or spiritual identity.
 Traditional knowledge that has ancient and is often
informal and oral, is not protected by conventional
intellectual property protection systems.

32. This scenario has prompted many developing
countries to develop their own specific and
special systems for protecting traditional
knowledge.
 India has played a very significant role in the
documentation of traditional knowledge
thereby bringing the protection of traditional
knowledge at the centre stage of the
International Intellectual Property System

33. Case study of Turmeric Patent
Turmeric is a tropical herb grown in east
India.
Turmeric powder is widely used in India as
a medicine, a food ingredient and a dye to
name a few of its uses.
For instance, it is used as a blood purifier,
in treating the common cold, and as an anti-
parasitic for many skin infections.
It is also used as an essential ingredient in
cooking many Indian dishes.

34. In 1995, the United States awarded patent on
turmeric to University of Mississippi medical
centre for wound healing property.
The claimed subject matter was the use of
"turmeric powder and its administration", both
oral as well as topical, for wound healing.
An exclusive right has been granted to sell and
distribute.

35. The Indian Council for Scientific and Industrial
Research (CSIR) had objected to the patent
granted and provided documented evidences of
the prior art to USPTO.
Though it was a well-known fact that the use of
turmeric was known in every household since
ages in India, it was a herculean task to find
published information on the use of turmeric
powder through oral as well as topical route for
wound healing.

36. Due to extensive researches, 32 references
were located in different languages namely
Sanskrit, Urdu and Hindi.
Therefore, the USPTO revoked the patent,
stating that the claims made in the patent
were obvious and anticipated, and agreeing
that the use of turmeric was an old art of
healing wounds.
Therefore, the TK that belonged to India was

37. Case study of Neem Patent
The patent for Neem was first filed by W.R.
Grace and the Department of Agriculture, USA in
European Patent Office.
The said patent is a method of controlling fungi
on plants comprising of contacting the fungi
with a Neem oil formulation.
A legal opposition has been filed by India against
the grant of the patent.

38. The legal opposition to this patent was
lodged by the New Delhi-based Research
Foundation for Science, Technology and
Ecology (RFSTE), in co-operation with the
International Federation of Organic
Agriculture Movements (IFOAM) and Magda
Aelvoet, former green Member of the
European Parliament (MEP)

39. A tree legendary to India, from its roots to its
spreading crown, the Neem tree contains a number
of potent compounds, notably a chemical found in its
seeds named azadirachtin.
It is used as an astringent in so many fields. The barks,
leaves, flowers, seeds of neem tree are used to treat
a variety of diseases ranging from leprosy to diabetes,
skin disorders and ulcers. Neem twigs are used as
antiseptic tooth brushes since time immemorial

40. The opponents' submitted evidence of
ancient Indian ayurvedic texts that have
described the hydrophobic extracts of neem
seeds were known and used for centuries in
India, both in curing dermatological diseases
in humans and in protecting agricultural
plants form fungal infections

41. The EPO identified the lack of novelty,
inventive step and possibly form a relevant
prior art and revoked the patent.
Apart from this, several US patents were
recently taken out Neem-based emulsions
and solutions

42. REGULATIONS & GUIDELINES OF COMPLEMENTARY /
ALTERNATIVE MEDICINE IN SOUTH EAST ASIA (SEAR)
 In many parts of South East Asia, countries such
as India, Indonesia, Nepal and Sri Lanka, a large
population use traditional medicines to meet their
primary health care needs.
 Given the role of TM along with its rich history,
Traditional Medicine and its practitioners have
been recognized by the governments and are
regulated by national policies which are
implemented under WHO (World Health
Organization) South-East Asia Region (SEAR).

43.  Due to large base of Traditional Medicine, many
countries in SEAR need expertise and guidance
to develop national regulations and safety
monitoring systems.
 According to the WHO global survey on the
national policy and regulation of Traditional
Medicine, there are three common difficulties
and challenges:
 Lack of information sharing; lack of safety
monitoring for herbal medicines; and lack of
methods to evaluate their safety and efficacy.

44. Some major highlights of these guidelines
are:
1) They classify herbal medicines
2) It states minimum requirements for
assessment of safety of herbal medicines
3)It proposes minimum requirements for
assessment of efficacy of herbal medicines
4) Quality Assurance of Herbal Medicine is
discussed
5) There is a section on Pharmacovigilance, and
6) Control over advertisement of Herbal
Medicines

45. Few Recommendations to Member States by
WHO SEAR are as follows:
 Member states should develop national
regulations on herbal medicines based on the
WHO guidelines;
 Member states should establish a national
advisory committee for herbal medicines;
 Member states should adopt requirements for
the registration of herbal medicines as
proposed during this workshop;
 Member states should establish an ADR
monitoring center and system for conventional
medicines and herbal medicines, and develop
necessary linkages with other ADR monitoring
center in the Region and with WHO

46.  Member states should work to strengthen the
regional network in all possible aspects of herbal
medicines, particularly with regard to their safety,
efficacy and ADR;
 Member states should develop and strengthen
herbal medicine education and training, practice
and research;
 Members states should work at facilitating
harmonization among those countries that have
common systems of herbal medicines