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

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

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.

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.

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.

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: Folk music 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

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

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 Urdu

…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

Prior art - English Translation

Prior art English Translation

Prior art for Turmeric

Prior art for Turmeric

Revocation of Turmeric Patent

Revocation of Turmeric Patent

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

‘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 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 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

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 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.

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

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.