IP Guidelines and Agreements for Access and Use of Genetic and Natural Resources A presentation By D.CALAB GABRIEL of K&S Partners 06 th April 2010.

IP Guidelines and Agreements for Access and Use of Genetic

and Natural Resources

A presentation

By

D.CALAB GABRIEL

of K&S Partners

06th April 2010

SYNOPSIS

• 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

Indian Patents Act,

Section 10(4)(d)(ii)(D) if the applicant mentions a biological material inthe specification………………………………… suchmaterial is not available to the public, the applicationshall 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.

p. Invention which is traditional knowledge which is an aggregation or duplication of known properties of traditionally known component or components.

Section 3: Inventions not patentable

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.

FORM 1

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

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

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

• 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

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.

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

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.

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.

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.

PENALTIES

• Violation of S.6

• Imprisonment may extend to 5 yrs, or fine up to Rs.10 lakhs or damages with fine

TRADITIONAL KNOWLEDGE RELATING TO BIOLOGICAL DIVERSITY RULES, 2009

(DRAFT)

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)

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

Biodiversity Act

• S.36(5) and S.62 empowers the Central Government to make rules

TK

• Traditional medicines

• Folklore

• Songs

• Dances

• Rituals

• Designs

• Handicraft … ….

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

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

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 ?

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

TK

• Traditional medicines:

– It has been used: no novelty

– not documented

– who is the inventor?

• Folk music

– author?

– Various versions? How many copyrights?

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

Systems for protecting TK

• Special regime: International

Understanding

• Documentation

• Access and benefit-sharing mechanisms

• Sui generis systems to protect TK

Documentation & registries

• Important tool to preserve TK

• Can help to establish the existence of prior art

• Registries: Access to registries : improper use ?????

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

Criteria for Benefit sharing-2 contd

The monitory benefits will be deposited in

the National biodiversity fund

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

Point of concern

“Knowledge associated thereto” not defined

Unreasonable benefit sharing principles:1. Participation of atleast one researcher from research institute designated by NBA2. Sharing of IP rights with the designated institute

DRAFT GUIDELINES ON ABS

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

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.

MISUSE OF TK

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

Prior art for turmeric in Prior art for turmeric in UrduUrdu

K & S Patent Experience…Revocation of “turmeric” patent...

• 32 prior art citations finally cited

• Patent and all its claims revoked by USPTO

Prior art - English Prior art - English TranslationTranslation

Prior art English Prior art English TranslationTranslation

Prior art for TurmericPrior art for Turmeric

Prior art for TurmericPrior art for Turmeric

Revocation of Turmeric Revocation of Turmeric PatentPatent

Revocation of Turmeric Revocation of Turmeric PatentPatent

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

KILTA case

Dhanpath Seth & OthersVs

M/S Nil Kamal Plastic Crates LtdOSA No.8 of 2006

‘A device for manually hauling agricultural

products’

Patent No 195917 granted on 11.07.2005

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

BASMATI CASE

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.

Basmati Patent

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

Basmati Patent

Basmati Claims

Basmati claims -contd.

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

• 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

NEEM CASE

EP 90250319Claim 1 as originally filed (1990)

An insecticide and foliar fungicide comprising neem oilwhich is substantially free of azadirachtin and salannin,said neem oil prepared by:a) extracting dried, coarsely ground neem seeds with anon-polar, hydrophobic solvent to obtain a neem oilextract,b) removing the solvent to obtain the neem oil product

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

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, 0.005 to 5.0% of emulsifying surfactant and 0 to 99% water.

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

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

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

Neem Case – Oral ProceedingsNovelty 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.

Neem Case – Oral ProceedingsNovelty – 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

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.

Wapishana tribes

• A tribe in amazon jungles divided between Brazil and Guyana

• Betrayal of British Scientist-Prof. Conrad Gorinsky.• Cunani (Clibadium Sylvestre)

– US pat 5786385 titled Polyactylenes for reversible heart blocking agent / neuro - muscular active or for use as a mycobactericide

• Tipir, the nut of greenheart tree– US pat 6048867 titled Biologically active Rupunines”

*Source: Journal of Intellectual property rights. Vol 15, March 2010,PP146-150

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

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.