Contenu connexe



Lecture 36 (TK and case studies of neem, turmeric and Basmati).pptx

  1. Case studies on Neem, Turmeric and Basmati (Traditional Knowledge)
  2. 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.
  3. 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.
  4. 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.
  5. 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
  6. 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
  7. 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
  8. • 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
  9. 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.
  10. 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
  11. 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.
  12. 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.
  13. 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.
  14. PENALTIES • Violation of S.6 • Imprisonment may extend to 5 yrs, or fine up to Rs.10 lakhs or damages with fine
  16. 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)
  17. 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
  18. Biodiversity Act • S.36(5) and S.62 empowers the Central Government to make rules
  19. TK • Traditional medicines • Folklore • Songs • Dances • Rituals • Designs • Handicraft … ….
  20. 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
  21. 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
  22. 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 ?
  23. 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
  24. TK • Traditional medicines: – It has been used: no novelty – not documented – who is the inventor? • Folk music – author? – Various versions? How many copyrights?
  25. 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
  26. Systems for protecting TK • Special regime: International Understanding • Documentation • Access and benefit-sharing mechanisms • Sui generis systems to protect TK
  27. Documentation & registries Important tool to preserve TK Can help to establish the existence of prior art Registries: Access to registries : improper use ?????
  28. 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
  29. Criteria for Benefit sharing-2 contd
  30. Access & benefit sharing (ABS) Prior Informed Consent • standard modus operandi of many companies • bargaining power disparity problem Contractual arrangements • Over fifty countries are currently in the process of writing ABS legislation • In many cases such legislation refers explicitly to the protection of TK ABS legislation
  31. 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
  32. 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
  33. 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. 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
  36. Patent on wound healing property of Turmeric Traditional Knowledge : • traditionally used for centuries to heal wounds and rashes. • effective ingredient in medicines, cosmetics and dyes. • used as a spice for flavoring Indian cooking. Patent case: In 1995, a US patent was granted on use of turmeric in wound healing.
  37. Challenge to turmeric patent • Prior Art - Ancient Sanskrit text and a paper published in 1953 in the Journal of the Indian Medical Association. • The Council of Scientific & Industrial Research (CSIR), India, filed a re-examination case with the USPTO. • The USPTO revoked this patent in 1997; no novelty; known in India for centuries. • A landmark judgment - a patent based on traditional knowledge was successfully challenged.
  38. Prior art for turmeric in Urdu
  39. K & S Patent Experience …Revocation of “turmeric” patent... • 32 prior art citations finally cited • Patent and all its claims revoked by USPTO
  40. Prior art - English Translation
  41. Prior art English Translation
  42. Prior art for Turmeric
  43. Prior art for Turmeric
  44. Revocation of Turmeric Patent
  45. Revocation of Turmeric Patent
  46. 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
  47. KILTA case
  48. 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
  49. 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
  51. 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.
  52. Basmati Patent
  53. 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
  54. Basmati Patent
  55. Basmati Claims
  56. Basmati claims -contd.
  57. 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
  58. • 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
  60. 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
  61. 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
  62. 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.
  63. 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
  64. 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
  65. 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
  66. 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.
  67. 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
  68. 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.
  69. 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
  70. 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
  71. 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.
  72. More examples of TK as subject of patent application • Kava (Piper methysticum Forster) TK in the Pacific, Fiji and Vanuatu, North America and Europe • Ayahuasca (Banisteriopsis caapi Mort.) TK of Shamans of indigenous tribes throughout the Amazon basin • Quinoa (Chenopodium quinoa Willd.) TK of millions in the Andes, especially Quechua and Aymara people • Hoodia (Hoodia gordonii (Masson) Sweet ex Decne) TK of African tribesmen
  73. Traditional Knowledge Digital Library (TKDL) • A digital documentation, created by the Government of India. • Covers Indian traditional knowledge related to Ayurveda, Unani, Siddha and Yoga. (0.29 million medicinal formulations) • Available in five international languages (English, German, French, Japanese and Spanish) • Created 200 sub-groups under A61K 36/00 in International Patent Classification • Searchable with Boolean operators using Keywords, IPC and disease names
  74. TKDL - access available • European Patent Office. • United States Patent & Trademark Office. • Japan Patent Office. • United Kingdom Patent Office. • Canadian Intellectual Property Office. • German Patent Office. • Intellectual Property Australia. • Indian Patent Office • Chile Patent Office.
  75. Proposal to include TKDL as part of the PCT Minimum Documentation • In the 22nd MIA held in 2015, the Indian Patent Office presented a proposal for inclusion of TKDL in the PCT Minimum Documentation. • A draft Access Agreement was also proposed.
  76. Concerns Some Authorities expressed concerns about certain provisions contained in the draft access agreement of TKDL, notably in relation to : • the confidentiality and non-disclosure requirements, • the necessity to monitor and report statistics on the use of citations from the TKDL • the implications for an ISA losing access to the full PCT minimum documentation if the access agreement to the TKDL was terminated under the termination provisions of the draft agreement. • the importance for Authorities to be able to load the data from the TKDL into its own IT systems. • if added to the PCT minimum documentation, the TKDL should have the same level of access as other collections in the PCT minimum documentation and should be equally available to the applicant.
  77. Progress during the 23rd session of MIA held in January 2016 The Indian Patent Office was invited to present a Revised Access Agreement along with a working document setting out its proposals with regard to the inclusion of the Indian TKDL in the PCT Minimum Documentation, taking into account the discussions in the MIA, the PCT Minimum Documentation Task Force and the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC of WIPO).
  78. Revised TKDL Access Agreement - Major changes “The User shall, whenever required, deliver only that information from TKDL contents which is relevant for the purposes of citation in patent grant procedure in all phases including opposition proceedings, to the patent applicant(s) or any other person who is party to such proceedings. The User may, whenever required, deliver only, such relevant information from TKDL contents to other patent offices under any agreement between the User and such offices to share the cited documents of a patent application. Except as mentioned above, the User undertakes to preserve confidentiality of the entire contents of TKDL” • Modified to clarify that TKDL citations could be communicated to opponents and other patent offices also apart from the applicant.
  79. Revised TKDL Access Agreement - Major changes The User shall on a quarterly basis send the number of times content of TKDL was cited by the User’s examiners during the search process relating to published patent applications. The need for submitting quarterly reports on citations taken from TKDL by the User has been eliminated as the Users stated that the necessity to monitor and report statistics on the use of citations from the TKDL is inconvenient.
  80. Revised TKDL Access Agreement - Major changes “This Agreement shall be renewed further automatically for periods of 5 years each, on completion of the Agreement period, provided the Agreement is not terminated under clause 11 of this agreement.” • Period of Agreement increased from 3-5 years with facility for auto-renewal
  81. Revised TKDL Access Agreement - Major changes • This Agreement can be terminated by either of the signatories by giving three months notice to the other signatory. This clause has been removed as it was a concern for other offices. (the implications for an International Searching Authority losing access to the full PCT minimum documentation if the access agreement to the TKDL was terminated under the termination provisions of the draft agreement)
  82. Revised TKDL Access Agreement - Major changes “Either party may terminate this Agreement if the other party materially breaches its obligations under this Agreement and fails to cure such material breach, provided that the non-breaching party shall give written notice of its intention to terminate and shall allow the breaching party 15 days after receipt of such notice to remedy the breach”
  83. Revised TKDL Access Agreement - Major changes “Failure of either party to discharge any obligation or perform as per the terms or conditions of this Agreement as a result of conditions beyond its control such as but not limited to, war, strikes, fires, floods, government restrictions, acts of terrorism, public health emergencies, power failure or damages to or destruction of any network facilities or servers, shall not be deemed a breach of the Agreement”
  84. The importance for Authorities to be able to load the data from the TKDL into its own IT systems. • The significance of the technical content was the main consideration • No such criterion was considered for inclusion of existing items of non-patent literature part of PCT Minimum Documentation. (The Indian Patent Office has experienced the difficulty of negotiating with different Publishers as there is no uniform format for data, subscription rates and conditions for transfer of raw data) • All International Authorities not desirous of loading the non-patent literature data on to their internal servers.
  85. TKDL is currently offered for subscription only to patent offices and that it should be equally available to the applicant to make an informed decision while applying for a patent. • The TKDL is offered for subscription only to Patent Offices for the purpose of defensive protection. This is to protect traditional medicinal knowledge from misappropriation, on which livelihood and healthcare needs of millions of people in India are dependent. • TKDL is based on published books of Indian Systems of Medicine, which are available in open domain and can be sourced by any individual/organization at national/international level. • Special nature of Traditional Knowledge database is accepted by MIA . • There needs to be different criteria for inclusion of TK databases. The Inter-Governmental Committee on Genetic Resources, Traditional Knowledge and Folklore (IGC) was set up by WIPO acknowledging the special protection required for Traditional Knowledge. Traditional knowledge periodicals were first added to the PCT Minimum Documentation, based on a suggestion by the IGC.
  86. Online prior art search • Online prior art search services on TKDL for applicants before filing a patent application. • The Indian Patent Office could offer such services directly to the applicants or to any other Authority • Other Authorities may also offer such services to their applicants