1. IP Guidelines and Agreements for Access and Use of Genetic and Natural Resources

2. content Patents Act 1970 Convention on Biological diversity
Biodiversity Act 2002
TK related to biodiversity rules 2009 (draft)
Draft guidelines for accounts benefit sharing
Case studies

3. Indian Patents Act, Section 10(4)(d)(ii)(D)
if the applicant mentions a biological material in
the specification………………………………… such
material is not available to the public, the application
shall be completed by depositing the material to an international depository authority under the Budapest Treaty and by fulfilling the following conditions, ………………. disclose the source and geographical origin of the biological material in the specification, when used in an invention.

4. Section 3: Inventions not patentable
p. Invention which is traditional knowledge which is an aggregation or duplication of known properties of traditionally known component or components.

5. FORM 1
Point 9(iii) of form 1 has a declaration from the applicant which reads as;
The invention as disclosed in the specification uses the biological material from India and the necessary permission from the competent authority shall be submitted by me/us before the grant of patent to me/us.

6. Pre/Post Grant Opposition
Sections 25 (1) and (2).
a……
b…..
j. that the complete specification does not disclose or wrongly mentions the source and geographical origin of the biological material used for the invention

7. Revocation Section 64(1)(p). a…… b…..
p. that the complete specification does not disclose or wrongly mentions the source and geographical origin of the biological material used for the invention

8. Convention on Biological Diversity (1993)
The CBD has three primary objectives:
The conservation of biological diversity
The sustainable use of its components; and
The equitable sharing of benefits arising from the use of genetic resources.
The CBD provides that States have sovereign rights over their natural biological resources including genetic resources. Genetic resources are no longer considered ‘the common heritage of mankind’.
Key Principles
Prior Informed Consent
Mutually Agreed Terms

9. Negotiations under the CBD to establish an international regime on access and benefit-sharing 2010.
Form of the treaty not agreed but could include:
Standards for national legislation
Standard material transfer agreements
Model clauses for benefit-sharing agreements
Monitoring and enforcement capability
Impacts regulates genetic resources as such, trade in genetic resources and development of products derived from them

10. Biodiversity Act 2002
6. No person shall apply for any intellectual property right, by whatever name called, in or outside India for any invention based on any research or information on a biological resource obtained from India without obtaining the previous approval of the National Biodiversity Authority before making such application.
Provided that if a person applies for a patent, permission of the National Biodiversity Authority may be obtained after the acceptance of the patent but before the sealing of the patent by the patent authority concerned:
Provided further that the National Biodiversity Authority shall dispose of the application for permission made to it within a period of ninety days from the date of receipt thereof.

11. Biodiversity Act 2002
Permission from NBA needed before making IP application for an invention
Atleast before sealing/grant of the patent
Request disposed within 90 days
NBA may impose such terms and conditions/benefit sharing fee/ royalty or both
Not applicable to Protection of plant varieties but intimation of such grant to NBA

12. Procedure for obtaining the permission
Filing Form III with prescribed fees of (Rs.500)
Approval will be in the form of a written agreement executed by both the parties.
If rejection- an opportunity of being heard to the applicant.

13. Where permission needed?
when the results of any research which has made use of the country's biodiversity is sought to be commercialized
when the results of research are shared with a foreigner or foreign institution.
when a foreign institution/individual wants access to the country's biodiversity for undertaking research.

14. Agreement
If the biological material is of Indian origin then an agreement has to be executed by the applicant with the NBA
Annexure
Details of the Biological Resources
Details of the Invention
Details of the territories where intellectual property rights over the Invention is sought to be taken.

15. PENALTIES Violation of S.6
Imprisonment may extend to 5 yrs, or fine up to Rs.10 lakhs or damages with fine

16. TRADITIONAL KNOWLEDGE RELATING TO BIOLOGICAL DIVERSITY RULES, 2009 (DRAFT)

17. Definition of Traditional Knowledge (TK)
No agreed definition
Working definition:
“The knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles” as well as “indigenous and local technologies”
(CBD, Articles 8(j) and 18.4)

18. TK-definition
The collective knowledge of a traditional community including of a group of families, on a particular subject or a skill and passed down from generation to generation, either orally or in a written form, relating to properties, uses and characteristics of a plant and animal genetic resources; agricultural and healthcare practices, food preservation and processing techniques and devices developed from traditional materials; cultural expressions, products and practices such as weaving patterns, colors, dyes, pottery, painting, poetry, folklore, dance, and music; and all other products or processes discovered through a community process including by a member of the community individually but for the common use of the community

19. Biodiversity Act
S.36(5) and S.62 empowers the Central Government to make rules

20. TK Traditional medicines Folklore Songs Dances Rituals Designs
Handicraft … ….

21. Characteristics of Traditional Knowledge (TK)
TK is usually
held collectively
transmitted orally or otherwise from generation to generation
dynamic, evolving over time
Access and use of TK in communities is generally governed by a wide variety of unwritten customary laws

22. Role of TK Pharmaceuticals and botanical medicines
Personal care and cosmetics
Agricultural and horticultural products-like insecticides
Biotechnologies in fields other than healthcare and agriculture

23. Issues
More than 6000 patents in USA are obtained based on plant traditional knowledge
Should each patent be monitored?
Solution?
Should ex-cheq be spent on challenging patents?
How can TK be preserved ?

24. TK Problems: not documented origin difficult to trace
knowledge source: often “a person”
difficult to particularise
Does not easily fit into known forms of IP
Awareness low

25. TK Traditional medicines: Folk music It has been used: no novelty
not documented
who is the inventor?
Folk music
author?
Various versions? How many copyrights?

26. Objectives of protecting TK
Preserve TK
Increase awareness of its value
Commercialize it, where appropriate, with equitable benefit sharing
Prevent its unauthorized use
Conserve biodiversity

27. Systems for protecting TK
Special regime: International Understanding
Documentation
Access and benefit-sharing mechanisms
Sui generis systems to protect TK

28. Documentation & registries
Important tool to preserve TK
Can help to establish the existence of prior art
Registries: Access to registries : improper use ?????

29. Criteria for Benefit sharing
The Authorities will notify in the official gazette, guidelines for the formula for benefit sharing, which includes applying for patent and IPRs.
Authority shall ensure conservation and sustainable use of biodiversity
The benefit sharing is based on case to case basis to the third parties

30. Criteria for Benefit sharing-2 contd
The monitory benefits will be deposited in the National biodiversity fund

31. Access & benefit sharing (ABS)
Prior Informed Consent
Contractual arrangements
standard modus operandi of many companies
bargaining power disparity problem
ABS legislation
Over fifty countries are currently in the process of writing ABS legislation
In many cases such legislation refers explicitly to the protection of TK

32. DRAFT GUIDELINES ON ABS
Point of concern
“Knowledge associated thereto” not defined
Unreasonable benefit sharing principles:
1. Participation of atleast one researcher from research institute designated by NBA
2. Sharing of IP rights with the designated institute

33. POINTS OF CONCERN (Contd)
Complicated procedure to obtain access to TK
1. Involvement of a chain of offices
2. No prescribed time limit
Too much of discretion in hands of NBA
Treatment of confidential information
No proper adjudication mechanism
Appeal to Supreme court not justified

34. Kani tribe
Tropical Botanical Garden and Research Institute (TBGRI) in Kerala on an expedition
Tribe did not get tired
“aarogya pacha” (Trichopus zeylanicus) -
Analysed-prepared-“Jeevani” a TK based restoractive, bio/immno-enhancing, anti-stress/fatigue agent.
Jeevani manufactured by Arya Vaidya Sala
benefit shared with Kani tribe with the help of a trust fund.

35. MISUSE OF TK

36. Turmeric Patent U.S. Patent No. 5,401,504 was granted to Das et al.
Related to wound healing property of turmeric
Is commonly known in India : grant of patent outraged Indians
This patent was challenged by way of re-examination at USPTO by CSIR
All claims eventually cancelled

37. Prior art for turmeric in Urdu

38. …Revocation of “turmeric” patent...
K & S Patent Experience
…Revocation of “turmeric” patent...
32 prior art citations finally cited
Patent and all its claims revoked by USPTO

39. Prior art - English Translation

40. Prior art English Translation

41. Prior art for Turmeric

42. Prior art for Turmeric

43. Revocation of Turmeric Patent

44. Revocation of Turmeric Patent

45. ENOLA BEAN PATENT (Mexican Bean Bio-Piracy)
Yellow bean
commonly grown by Mexican farmers
US Company Pod-Ners patented it in 1999 Patent No:584079
Filed cases against Mexican farmers selling yellow bean in US
Patent challenged at USPTO
29 April 2008 board of patent appeals (BPA) affirms rejection of the case
Federal court affirms ( October 2009) affirms BPA’s rejection

46. KILTA case

47. ‘A device for manually hauling agricultural products’
Dhanpath Seth & Others Vs M/S Nil Kamal Plastic Crates Ltd OSA No.8 of 2006
‘A device for manually hauling agricultural products’
Patent No granted on

48. Court Held Patentee went for DB.
DB intern held that the “device developed by the plaintiff is in fact the result of the traditional knowledge and aggregation/duplication of known products such as polymers and, therefore, cannot be said to be an invention”.
Therefore the plaintiff’s are not entitled for injunction

49. BASMATI CASE

50. TITLE: BASMATI RICE LINES AND GRAINS
Filed : Jul. 8, 1994
Appl.No.: 272,353
Patent Number : 5,663,484
Date of Grant : Sep. 2, 1997
Inventors : Eugenio S. Sarreal, John A. Mann, James Edward Stroike, Robin D. Andrews
Assignee : Rice Tec, Inc.

51. Basmati Patent

52. Ricetec’s Patent ABOUT THE PATENT...
Novel rice lines- cross of Basmati rice of Pakistani origin and semi-dwarf variety of American origin;
Claims to replicate self-defined “traditional Basmati” characteristics when grown in the Territory
Claims to overcome inherent deficiencies of “traditional Basmati” including
photoperiod sensitive - long maturity period
low-yielding
disease - susceptible
tall plant prone to lodging

53. Basmati Patent

54. Basmati Claims

55. Basmati claims -contd.

56. Ricetec’s Patent CRUX OF THE INVENTION
“Invention” of a rice plant which can grow in North, South, Central America and Caribbean Islands (The Territory) and produces grains with ‘Basmati’ characteristics

57. Request for Re-examination filed on April 28, 2000
May 22, 2000: Examiner finds new question of patentability is raised by the Request; orders re-examination of all the claims
RiceTec surrendered claims 1-7, 12 to 20

58. NEEM CASE

59. EP 90250319 Claim 1 as originally filed (1990)
An insecticide and foliar fungicide comprising neem oil
which is substantially free of azadirachtin and salannin,
said neem oil prepared by:
a) extracting dried, coarsely ground neem seeds with a
non-polar, hydrophobic solvent to obtain a neem oil
extract,
b) removing the solvent to obtain the neem oil product

60. Objections by Examining Division
Claim 1 to be construed as directed to neem oil as such
Neem seed extracts with hexane known, as well as their insecticidal properties
Antifungal effects of neem seed also known
However:
Antifungal effects of azadirachtin-free extract of neem seed neither known nor suggested from any document retrieved during search

61. Neem Case – Claim 1 as granted (1994)
A method of controlling fungi on plants comprising contacting the fungi with a neem oil formulation containing 0.1 to 10 % of a hydrophobic extracted neem oil which is substantially free of azadirachtin, to 5.0% of emulsifying surfactant and 0 to 99% water.

62. Neem Case – Grounds for opposition
Exceptions to Patentability
Art. 53(a) EPC: exploitation of invention contrary to morality:
Neem tree has been used in India for millenia,
patent would threaten livelyhood of gatherers of neem tree
Art. 53(b) EPC: Patent claims plant variety:
By using seed from one plant variety, the patent indirectly claims the variety as such

63. Neem Case – Grounds for Opposition Novelty and Prior Use
Art. 54 EPC: Novelty
Antifungal effects of neem oil and neem leaves known for centuries
Affidavit Mr. Phadke (India):
Public field trials took place in 1985/1986 involving treatment of plants with hexane extracts of neem seed,antifungal effect observed

64. Neem Case – Oral Proceedings (2000) Morality – Plant variety
Decisions by Opposition Division:
Morality:
No direct link between endangering of livelihood of people in India and claimed method of controlling fungi,
European Patent gives no rights in India
Traditional uses known for centuries are related to novelty/prior use issues and have to be documented
Plant variety:
Azadirachta Indica is not a variety, but species, a higher taxonomic unit
Claim to method of controlling fungi cannot be construed as relating to the plant as such

65. Neem Case – Oral Proceedings Novelty criteria Art. 54 EPC
(1) An invention shall be considered to be new if it does not form part of the state of the art.
(2) The state of the art shall be held to comprise everything made available to the public by means of
a written or oral description,
by use,
or in any other way,
before the date of filing of the European patent application.

66. Neem Case – Oral Proceedings Novelty – Witness Hearing- Decision
Oral testimony of Mr. Phadke credible to Opposition Division
Established that hexane neem seed extract containing a surfactant used in public to treat plants against fungi
Decision
Main request lacks novelty and (restricted) auxiliary request inventive step
Patent revoked

67. Neem Case – Appeal (2005) T 416/01
The Technical Board of Appeal dismissed
the appeal of the Patent Proprietor against the decision of the Opposition Division.

68. Wapishana tribes
A tribe in amazon jungles divided between Brazil and Guyana
Betrayal of British Scientist-Prof. Conrad Gorinsky.
Cunani (Clibadium Sylvestre)
US pat titled Polyactylenes for reversible heart blocking agent / neuro - muscular active or for use as a mycobactericide
Tipir, the nut of greenheart tree
US pat titled Biologically active Rupunines”
*Source: Journal of Intellectual property rights. Vol 15, March 2010,PP

69. Medicine from Kadambh tree
Kadambh tree (Mitragyna parvifolia)
A composition- cadambine and dihydroconchonine – granted patent in India
Cure for Type II diabetes
Kadambh is considered as a sacred tree
“ The tree is widespread and there would not be any dearth of the raw materials for the medicine”
Filed a petition in Rajasthan high court against cutting of kadambh trees

70. Thoughts to share
Should not be a barrier for research, development of products and trade
To avoid conflict between established IPs and the non conventional rights.
Regulated by International treaty.
Change of mind sets
Trust and confidence should be built between the stake holders.