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SANJEEVANI BOOTI: PROTECTION, PROBLEM AND SOLUTION

(Summary: This post is about traditional knowledge, how it is being legally protected and the problems relating to its protection.
This talk was delivered by Justice Yatindra Singh, Judge Allahabad High Court, Allahabad on 4.5.2008 National Judicial Seminar on 'IPRs: Current developments and Key Issues for the District Judiciary' at National Judicial Academy Bhopal)



Sanjevani Booti! ... Am I supposed to talk about traditional knowledge or Sanjevani Booti?

Hanumaan and Sanjevani Booti: Photograph courtesy Ramanand Sagar's TV serial Ramayan

Who does not know the Laxman-Meghnath episode in Ramayan. Lakshman was wounded by Meghnath and Hanumaan was send to Himalayas to fetch Sanjevani Booti, a plant having medicinal properties. In botanical terms the plant is known as Selaginella bryopteris and this episode is nothing but traditional knowledge.



Traditional knowledge (TK), is also known as indigenous knowledge (IK), or local knowledge. It generally refers to the long-standing traditions and practices of regional, indigenous, and local communities and includes their wisdom, knowledge, and teachings. It often takes form of stories, legends, folklore, rituals, songs, and even customary laws and may be passed orally, from one generation to another.

Traditional knowledge is often connected with medicinal properties of the plants and depends on the biodiversity of the place. It is rich in the communities with ancient culture and civilisation.

With passage of time and rise of new culture, it became imperative to safeguard the rights and habitats of the local people. United Nations established a Working Group on Indigenous Populations in 1982 as a part of United Nations Commission on Human Rights. This was done,
  • To give attention to the evolution of international standards concerning indigenous rights.
  • Address rights of the indigenous (local) communities.
World Commission on Environment and Development in its report, 'Our Common Future' in 1987 gave concrete shape to the concept of sustainable development (Endnote-1) and recommended a change in development policy to allow for direct community participation and respect their rights and aspirations. This commission was chaired by the then Prime Minister of Norway Ms. GH Brundtland (Endnote-2) and this report is known as 'Brundtland Report'. This led to the Earth Summit – the United Nations' conference on Environment and Development (UNCED) in Rio de Janeiro in 1992.

CONVENTION ON BIOLOGICAL DIVERSITY
It was at the Earth summit in 1992 at Rio that the Convention on Biological Diversity (the CBD), also known as the Biodiversity Convention, was adopted. It is the first international environmental convention that talks about traditional knowledge—its protection, development, fair and equitable sharing of benefits arising from its use—in connection with sustainable development and conservation of biodiversity. It has been ratified by many countries including India however the notable exception is the United States of America (US). The three main objectives of the CBT are:
  1. Conservation of biological diversity (or biodiversity);
  2. Sustainable use of its components; and
  3. Fair and equitable sharing of benefits arising from genetic resources and from traditional knowledge.

The CBD recognises the close and traditional dependence of many indigenous and local communities embodying traditional lifestyles on biological resources and the desirability of sharing equitably benefits arising from the use of traditional knowledge, innovations and practices relevant to the conservation of biological diversity and the sustainable use of its components. (For relevant part of the CBT see Appendix-1)

Article 8(1) of the CBD is titled 'In-Situ Conservation' and obliges the parties (subject to their laws) to respect, preserve and maintain knowledge, innovation, and practices of indigenous and local communities embodying tradition life style and promote their wider application. However this is to be done with approval and involvement of the holder of such knowledge. The parties also have to encourage the equitable sharing of the benefits arising from the utilisation of such knowledge, innovation and practises.

Article 10 of the CBD is titled as 'Sustainable use of Components of Biological Diversity'. It's sub clause (c) requires the parties to protect and encourage customary use of biological resources in accordance with traditional cultural practices that are compatible with sustainable development.

Article 18(4) of the CBD is titled as 'Technical and Scientific Cooperation”. It requires the parties to encourage and develop methods of cooperation for the development and use of technologies including indigenous and tradition technologies.

THE BIOLOGICAL DIVERSITY ACT
We have enacted the Biological Diversity Act, 2002 (the BD Act) to fulfil our obligation to the CBD.

Restrictions
The BD Act establishes National Biodiversity Authority (NBA) (Section 8) and State Biodiversity Board (SBB) (Section 22) and mandates constitution of Biodiversity Management Committee by every local authority (BMC) (Section 41).

Chapter-II of the BD Act is titled as 'Regulation of Access to Biological Diversity'. Section 3 mandates that some persons are not entitled to obtain biological resource occurring in India or knowledge associated thereto for research or for commercial utilisation or for bio-survey and bio-utilisation without prior approval of the NBA. These persons are-
  1. A person who is not a citizen of India;
  2. Who are not resident of India as defined in clause (3) of section 2 of the Income-Tax Act.
  3. A corporation, association or organisation not incorporated or registered in India.
  4. Corporation, association or organisation incorporated or registered in India which has non-Indian participation in share capital or management.

Section 4 of the BD Act prohibits any person to transfer the results of any research relating to any biological resources occurring in, or obtained from India without prior approval of NBA to the persons who are required to take prior approval under section 3 of the BD Act. However section 5 provides that section 3 and 4 may not apply to certain research projects as mentioned in that section.

Section 6 of the BD Act prohibits any person from applying for any intellectual property rights (IPRs) in or out side India for any invention based on research or information on a biological resource obtained from India. This can only be done after obtaining prior approval of the NBA. In the case of patents, the permission may be obtained after acceptance of the patent but before sealing of the same. The NBA while granting approval may impose condition including one regarding sharing of benefits or royalty or both; it may also include sharing of financial benefits arising out of the commercial utilisation.

Section 7 of the BD Act requires citizen of India, corporation, association or organisation registered in India to give prior information to the SBB for commercial utilisation or bio-survey and bio-utilisation.

Section 24 of the BD Act empowers the SBB to prohibit or restrict any activity which in its opinion is detrimental or contrary to its objectives of conservation and sustainable use of biodiversity or equitable sharing of benefits arising out of such activity.

Functions
The basic function of the NBA and SBB are to issue guidelines and advise the government on matters relating to,
  • Conservation biodiversity;
  • Sustainable use of its components; and
  • Equitable sharing of benefit arising out of the utilisation of biological resources.

Chapter V of the BD Act is titled as 'Functions and Powers of the National Biodiversity Authority'. It provides conditions that can be imposed while granting approval under the BD Act. Section 21 of this chapter is titled as ' Determination of equitable benefit sharing by National Biodiversity Authority'. It empowers the NBA to impose terms and conditions,
While granting approval under the BD Act,
To secure fair and equitable benefit sharing to the person entitled.

The function of the BMC is to promote conservation, sustainable use, and documentation of the biological diversity including preservation of habitats conservation of land races, folk varieties and cultivars, domesticated stocks and breeds of animals and micro organisms and chronicling of knowledge relating to biological diversity. It can collect fee from any person for accessing or collecting any biological resource. The NBA and SBB are required to consult BMC before taking any decision.

Offences and Penalties
Section 55(1) of the BD Act provides Penalties for contravention or attempts to contravene or abets the contravention of the provisions of section 3, 4 and 6 which may extent to five years or fine which may extend to Rs. Ten lakhs.

Section 55(2) of the BD Act provides imprisonment which may extend to three years, or with fine which may extend to give lakh rupees in case of contravention of section 7 or section 24(2) of the BD Act.

Section 56 of of the BD Act provides penalty for contravention of directions or orders of Central Government, State Government, NBA and SBB. It provides that in case they are not otherwise punishable, they will be punished with a fine which may extend to one lakh rupees and in case of subsequent offence with a fine which may extend to two lakh rupees and in case of continuous contravention with additional fine which may extend to two lakh rupees everyday during which default continues.

Section 57 of the BD Act provides offence by companies. It provides that in case offence by a company, then the person responsible for conducting the business of the company shall be liable to be proceeded and punished. For the purpose of this section,
The company includes body corporate, association; and
The director in relation to a firm mean a partner in the firm.

The offences under the BD Act are cognizable and non-bailable (section 58) However the court cannot take cognizance unless a complaint is made by the Central Government or any authority or officers authorised by the government or by the person who is entitled to claim a benefit under the Act and has given a prior notice of thirty days of his intention to make such complaint (Section 61).

In order to understand the problems, a reference to Patents Act and the TRIPS is necessary.

THE PATENT ACT
Patents have defined in the the Patents Act. This Act has been amended in 2002 and 2005. The preamble to the 2002 Amendment states that it has been enacted, ‘to make the law not only TRIPS compliant but also to provide therein necessary and adequate safeguards for protection of public interest, national security, bio-diversity, traditional knowledge, etc.'

Section 3 of the Patent Act defines what are not inventions i.e. what can not be patented. We have added sub-section (p) to it by the 2002 amendment. Section 3(p) {read with section 2(1)(l)} provides for exclusion of inventions that are in effect traditional knowledge or are aggregation or duplication of known properties of traditionally known components. This is kind of elaboration as otherwise also it can not be patented: they can not be said to be novel.

Many patents have been granted that are based on traditional knowledge. Some of them like on Neem, and Haldi have been cancelled (See appendix-2). However there are many other (See Appendix-3) that continue to exist. It is essential that in future no such patent be granted. This is possible if traditional knowledge is documented. This will establish a prior art and will negate the claim for patents.

Documentation and Prior Art
In order to fulfill the aforementioned requirement, National Institute of Science Communication and Information Resources, CSIR have started 'The Indian Journal of Traditional Knowledge'. It carries original research papers, review articles, short communications, etc. concerned with the observation and experimental investigation of the biological activities of the materials from plants, animals and minerals, used in the traditional health-care systems such as Ayurveda, Siddha, Yoga, Unani, Naturopathy, Homoeopathy, Folk-remedies, etc. As validation of indigenous claims it also covers Ethno-biology, Ethno-medicine, Ethno-pharmacology, Ethno-pharmacognosy & Clinical Studies on efficacy.

The journal also welcomes interdisciplinary papers on traditional uses (non-medicinal) of Indian raw materials of plant, animal and mineral origin and development of appropriate technologies for community benefit with specific interest to the rural areas.

TRIPS
The eight round of General Agreement on Tariff and Trade (GATT) started in 1986, with a meeting in Uruguay. This led to the creation of the World Trade Organisation (WTO).

The eight round continued for seven and half years and it often appeared that an agreement would not be reached. But ultimately a draft for creation of WTO was prepared under Secretary-General Arthur Dunkel that came to be known as the Dunkel draft. It was debated and most of it was approved of in December 1993. It was formally signed on April 15, 1994 by 125 countries at a meeting held in Marrakech (Morocco) inter alia, it meant,
  • Establishment of the WTO from January 1, 1995,
  • The Trade Policy Review Body, and the Dispute Settlement Body; and
  • Accepting the agreements forming the basis for international trade.

All the WTO agreements (except for some including the plurilateral agreements) apply to all WTO members i.e. a member has to accept all of them; he cannot choose. These agreements provides certain minimum standards to be observed by members and keep trade policies of the members within agreed limits. Among the other agreements is, the Agreement on the Trade related aspect of intellectual property rights (TRIPS).

TRIPS mandates minimum protection to be given to the IPRs by the member countries. This is the reason as to why we have amended our IPRs laws. It talks about the following kinds of Intellectual Property Rights:
  1. Copyright and Related Rights;
  2. Trademarks;
  3. Geographical Indications;
  4. Industrial designs;
  5. Patents;
  6. Layout - designs (Topographies) of Integrated Circuits;
  7. Protection of Undisclosed Information (Trade Secret).

Patents
Article 27 of the TRIPS (See Appendix-4) is titled as 'Patentable Subject Matter'. Article 27(1) explains under what can be patented; broadly they are to be granted in all fields of technology that involve inventive steps and capable of industrial applications. Article 27(2) and 27(3) explain what may be excluded from being patented.

Article 29 (see Appendix-4) is titled Condition on Patent applicants. It explains what conditions may imposed by the member countries on the applicant for obtaining patents.

TRIPS does not take into account protection of traditional knowledge except to the extent that what is in the realm of traditional knowledge can not be patented as it can not be novel―even this is not expressly mentioned but can be inferred. However an innovation arising out traditional knowledge may be patented (see Appendix-3) without providing any benefit to the person who have given basis for the same.

Reviews and Proposed Amendment
Article 27(3)(b) provides for review after four years regarding the matters that may be excluded from being patented. Article 71 of the TRIPS is titled as 'Review and Amendment'. It requires the TRIPS Council to review the implementation of the TRIPS after every two years in light of the experience and relevant new developments. It is in pursuance of this that 2001 Doha declaration was made.

The 2001 Doha Declaration states that the TRIPS Council should also look at the relationship between the TRIPS Agreement and the CBD; it also requires to consider the protection of traditional knowledge and folklore.

In light of Doha Declaration, either Article 27(3)(b) or Article 29 or both may be modified. Brazil, India, (including Bolivia, Colombia, Cuba, Dominican Republic Ecuador, Peru, Thailand) and supported by some other developing countries have proposed the amendments to Article 29 of the TRIPS (See Appendix-5). This amendment broadly obliges the members to have regard to the CBD for establishing a mutually supportive relationship between TRIPS and the CBD. It requires that:
(a) In case the patent is based on traditional knowledge then the patent application should disclose the country of origin of traditional knowledge,.
(b) The applicants should provide information (evidence) that they have complied with the legal provisions of the country of origin relating to,
  • Obtaining prior informed consent for access; and
  • Fair and equitable benefit-sharing arising from the commercial or other utilisation of such resources.
(c) The administrative and/ or judicial authorities to have the authority to prevent the further processing of the patent application or to revoke the patent in case the applicant has failed to comply with the above mentioned obligations.

CONCLUSION
The parties to the CBD has set 2010 as target to negotiate an Internationally law abiding regime on access and benefit sharing. Will this be done? It is for the future to disclose.

Endnote-1: The word 'sustainable development has been explained by the Supreme court in Vellore Citizen Welfare Forum Vs. Union of India AIR 1996 SC 2715. This case was filed against the pollution caused by discharge of untreated effluents by the tanneries and other industries in Tamil Nadu. It means that the development should meet the needs of the present without compromising the ability of the future to meet their own needs.

Endnote-2: MS Brudtland is a medical doctor and was Prime Minister of Norway for 10 years. She stepped down as a Prime Minister to become Director General of World Health Organisation.

Appendix-1
(The part of the Convention on Biological Diversity dealing with traditional knowledge is as follows)
Preamble
The Contracting Parties,
...
Recognizing the close and traditional dependence of many indigenous and local communities embodying traditional lifestyles on biological resources, and the desirability of sharing equitably benefits arising from the use of traditional knowledge, innovations and practices relevant to the conservation of biological diversity and the sustainable use of its components,
...

Article 8. In-situ Conservation:
Each Contracting Party shall, as far as possible and as appropriate:
...
(j) Subject to its national legislation, respect, preserve and maintain knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity and promote their wider application with the approval and involvement of the holders of such knowledge, innovations and practices and encourage the equitable sharing of the benefits arising from the utilization of such knowledge, innovations and practices;
...

Article 10. Sustainable Use of Components of Biological Diversity
Each Contracting Party shall, as far as possible and as appropriate:
...
(c) Protect and encourage customary use of biological resources in accordance with traditional cultural practices that are compatible with conservation or sustainable use requirements
...

Article 18. Technical and Scientific Cooperation
...
4. The Contracting Parties shall, in accordance with national legislation and policies, encourage and develop methods of cooperation for the development and use of technologies, including indigenous and traditional technologies, in pursuance of the objectives of this Convention. For this purpose, the Contracting Parties shall also promote cooperation in the training of personnel and exchange of experts.
...

Appendix-2
Neem: Azadirachta Indica
Neem (Azadirachta Indica) is Sarva Rog Nirvarini – curer of all illness. Numerous patents have been granted on products using Neem or utilising its properties. Some of them are to Indian companies also. Only one such patent has been cancelled. This patent was granted to WR Grace and US department of Agriculture for extending shelf life of Neem oil (azadirachtin). Shell life of Neem oil is extended by crushing the seeds in an aprotic solvent. Broadly aprotic solvents are those that do not exchange hydrogen ion (protons) with the substances dissolved in them; they do not participate in hydrogen bonding (for example ethers, ketones, benzene). Protic solvents have hydrogen attached to electronegative atoms such as oxygen and nitrogen and participate in hydrogen bonding (for example water and alcohols).

A coalition of Environmental groups challenged the patent. This challenge was upheld and European Patent Office cancelled the patent granted on 10.5.199 on the ground that the invention was not novel and was in public use in India.

Haldi: Turmeric
Many patents using turmeric have been granted for treating degenerative musculoskeletal diseases such as rheumatoid and osteoarthritis. One patent was granted in March 1995, two expatriate Indians at the University of Mississippi Medical Centre, Jackson, US for use of turmeric to heal wounds. We filed an objection with the USPTO challenging the patent on the grounds of ‘prior art’. This objection was upheld and the patent was cancelled.

Wheat
Monsanto had obtained a patent on 21.5.2003 from the Munich office of Europen Patent Office (EPO) on genetically modified wheat strain. This variety, called Galatea, was bred by Unilever. Mosanto acquired Galate, when it brought Unilever. It is said that it possess genetic characteristic derived from a common variety in our country known as Nap Hal which is used to make Chapati. Nap Hal has less gluten than other wheat varieties, which gives it lower viscoelasticity, meaning it expands less during baking. This makes it perfect for crisp breads such as Chapati.

A PIL (Research Foundation for science, Technology and Ecology vs. Union of India WP (Civil) No. 67 of 2004) was filed in the Supreme Court for not taking any action on the grant of wheat patent. Notices were issued in this petition. Greenpeace with support of NGOs had filed legal opposition to the patent in the EPO. This patent was ultimately cancelled by the EPO on 23.9.2004.

Appendix-3
The biological diversity is a natural asset of our country. Ayurved contains tradition knowledge of our fore fathers. Many patents for different uses Isabgol: Psyllium Husk, Saunf: FENNEL, Dhania: CORIANDER, Jeera: CUMIN, Surajmukhi: SUNFLOWER, Moongphali: PEANUT, Arandi, Reri: CASTOR, Karela (Bitter gourd), Jamun and Brijnal, Jar Amla: Phyllanthus Niruri, of have been granted world over and might have used our traditional knowledge. This might not have happened if amendment to article 29bis as has been suggest was in force.

Appendix-4
(Article 27, 29, and 71 of the TRIPS are as follows)
Article 27
Patentable Subject Matter
1. Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.3 Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.
2. Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law.
3. Members may also exclude from patentability:
(a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals;
(b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement.

Article 29
Conditions on Patent Applicants
1. Members shall require that an applicant for a patent shall disclose the invention in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art and may require the applicant to indicate the best mode for carrying out the invention known to the inventor at the filing date or, where priority is claimed, at the priority date of the application.
2. Members may require an applicant for a patent to provide information concerning the applicant’s corresponding foreign applications and grants.

Article 71
Review and Amendment
1. The Council for TRIPS shall review the implementation of this Agreement after the expiration of the transitional period referred to in paragraph 2 of Article 65. The Council shall, having regard to the experience gained in its implementation, review it two years after that date, and at identical intervals thereafter. The Council may also undertake reviews in the light of any relevant new developments which might warrant modification or amendment of this Agreement.
2. Amendments merely serving the purpose of adjusting to higher levels of protection of intellectual property rights achieved, and in force, in other multilateral agreements and accepted under those agreements by all Members of the WTO may be referred to the Ministerial Conference for action in accordance with paragraph 6 of Article X of the WTO Agreement on the basis of a consensus proposal from the Council for TRIPS.

Appendix-5
{The amendment to Article 29 of the TRIPS proposed by Brazil, India, (including Bolivia, Colombia, Cuba, Dominican Republic Ecuador, Peru, Thailand and supported by African ground and some other developing countries.}

Article 29bis: Disclosure of Origin of Biological Resources and/or Associated Traditional Knowledge
1. For the purposes of establishing a mutually supportive relationship between this Agreement and the Convention on Biological Diversity, in implementing their obligations, Members shall have regard to the objectives and principles of this Agreement and the objectives of the Convention on Biological Diversity.
2. Where the subject matter of a patent application concerns, is derived from or developed with biological resources and/or associated traditional knowledge, Members shall require applicants to disclose the country providing the resources and/or associated traditional knowledge, from whom in the providing country they were obtained, and, as known after reasonable inquiry, the country of origin. Members shall also require that applicants provide information including evidence of compliance with the applicable legal requirements in the providing country for prior informed consent for access and fair and equitable benefit-sharing arising from the commercial or other utilization of such resources and/or associated traditional knowledge.
3. Members shall require applicants or patentees to supplement and to correct the information including evidence provided under paragraph 2 of this Article in light of new information of which they become aware.
4. Members shall publish the information disclosed in accordance with paragraphs 2 and 3 of this Article jointly with the application or grant, whichever is made first. Where an applicant or patentee provides further information required under paragraph 3 after publication, the additional information shall also be published without undue delay.
5. Members shall put in place effective enforcement procedures so as to ensure compliance with the obligations set out in paragraphs 2 and 3 of this Article. In particular, Members shall ensure that administrative and/or judicial authorities have the authority to prevent the further processing of an application or the grant of a patent and to revoke, subject to the provisions of Article 32 of this Agreement, or render unenforceable a patent when the applicant has, knowingly or with reasonable grounds to know, failed to comply with the obligations in paragraphs 2 and 3 of this Article or provided false or fraudulent information.

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