World Patent Information 22 (2000) 43±52 www.elsevier.com/locate/worpatin Intellectual property rights: mothering innovations to markets q Prabuddha Ganguli 1 Hindustan Lever Ltd., Corporate Planning, 165-166 Backbay Reclamation, Near Churchgate, Mumbai 400020, India Abstract This paper examines innovation and knowledge generation processes and the supporting role of intellectual property rights (IPR) both for systematized investigative science and traditional community led activities. Options for protection of traditional knowledge and life materials and processes are suggested. It is suggested that the systematic and logical merging of ideas from conventions like TRIPs, convention of biodiversity (CBD), and union pour la protection des obtentitous vegetales (UPOV) can lead to the creation of harmonized provisions that could satisfy basic and minimum standards of IPR and societal ethics. The need for the unambiguous de®nition of discovery and invention in the granting of patents for biotechnological investigations is explored, as well as the issues of the establishment of prior art from unstructured traditional knowledge, identifying legal owners of traditional knowledge and evaluating prior art in this domain. The imperative task of creating a structured knowledge database of traditional practices and linking them through global networks is highlighted. The author also points to the fact that rigorous examination and search of patents in biotechnology is demanding ever greater levels of technical expertise and ultrahigh speed computing. Four case studies are presented to illustrate issues related to: · · · · the erroneous granting of a patent and the role of documented community prior art in its revocation, equitable sharing of bene®ts with indigenous tribes, sharing of bene®ts with the community and integrating indigenous knowledge, modern science and reciprocity into novel drug discovery. Ó 2000 Elsevier Science Ltd. All rights reserved. Keywords: Traditional knowledge; Biotechnology; Integrated IPR and business; Societal ethics; TRIPs; UPOV; Turmeric patent 1. Introduction Cumulative learning integrated with creative exploitation of intelligence is a trait organic to any living entity. The human race however has a unique ability to anticipate the future, proactively innovate and create an array of options for survival in a changing environment. The continual demand for food, shelter and the coupled urge to reproduce nucleated communities with residential ties to particular localities. Geographic mobility, cooperation and competition catalyzed cross-di€usion of diverse communities to form interdependent cultures. After slow beginnings human ability to invent grew exponentially and it is well accepted that all modern q Presentation at the First Commonwealth Science Forum ``Access, Bio-prospecting, IPR and bene®t sharing and the Commonwealth'', 23±25 September 1999, Goa, India. 1 Views expressed in this paper are of the author and not of the organization. E-mail address: ramu.p.ganguli@unilever.com (P. Ganguli). technology has developed in less than 1/2500th of the total time it has taken culture to reach its present state. Throughout the course of human history, trade served as a strong binding force and distinctive competitive economic performance resulted in inter/intra strati®cation of societies. What evolved were norms and sanctions for societal governance. The knowledge and skill base in ethnocentric societies were vertically transmitted and con®ned within families. Cross-cultural di€usion of knowledge was poor and transfer of knowledge within the communities was mostly executed through ``training on the job''. Subsequent generations introduced fresh innovations based on emerging needs or discovery of new raw material sources. Protection of community knowledge as understood in todayÕs concepts of ``intellectual property rights'' was not considered a necessity. The main driver of innovation was better utilization of natural resources and community survival. However the insular nature of community knowledge also set in the undesired ``inbreeding characteristics'' resulting in the slow genera- 0172-2190/00/$ - see front matter Ó 2000 Elsevier Science Ltd. All rights reserved. PII: S 0 1 7 2 - 2 1 9 0 ( 0 0 ) 0 0 0 2 9 - 6 44 P. Ganguli / World Patent Information 22 (2000) 43±52 tion and propagation of innovations across various cultures. Documentation of accumulated and transferred knowledge is scanty. In contrast modern management of science and technology established formal processes for innovations, value creation, sharing of knowledge within communities for its rapid realization in the market place. Enhanced di€usion of knowledge aided the rate of growth of new ideas and applications. Formal frameworks were set up for recognition to the innovator by protection of the innovation via instruments of intellectual property rights, rules for rewards to the inventor, conditions for legal use of the protected innovation and deterrents/measures to discourage copying (Fig. 1). It was expected to o€er a conducive and transparent legal system for fair sharing of bene®ts and also protect the interests of the consumer and society at large. Intellectual property rights (IPR) have been in transition trying to keep up with the pace of change in technology and social demand [1]. The dominating role of technology in every ®eld of human activity is now an accepted reality. However the phase lag between progress in science and technology vis- a-vis legal frameworks in IPR continue to widen. Today competitiveness is determined by ones ability to integrate IPR into project management by protecting innovations from the moment of conception of an idea, through birth and further to realization of its full potential value in the market place [2]. The pace of converting ideas into innovations with appropriate IPR protection and further ensuring value creation will decide future winners from losers. The blurring of boundaries between disciplines, formalized frameworks for ownership of the developed knowledge and bene®t sharing between partners to create niche domains are issues that society will have to cope with. The emerging scene in future will need to seek positive linkages between enhancing competition in society on the one hand and establishing legal ownership Fig. 1. IPR tools. of innovations (with enforcement of acquired rights) on the other. Societal, moral and ethical issues are getting intertwined into technology management, ownership of innovations and business processes. The nurturing and formal mothering of innovations especially in ®elds touching human health, food, and shelter raise contentious issue in IPR. The future lies in enhanced understanding of diverse national IPR laws, global/national licensing issues and utilization of all possible resources with speed and cost-e€ectiveness. The challenge is to arrive at meaningful, internationally acceptable and enforceable IPR laws that are compatible with technology options and encourage innovations to meet societal needs, ethics and commitments. This paper examines the innovation process, its interface with IPR and the emerging issues especially with respect to activities involving biotechnology and life processes. 2. Innovation processes and IPR [3] Over the years, research processes have undergone considerable metamorphosis. Starting from typically compartmentalized up-stream (basic) and down-stream (applied) management of research it has now evolved into a complex set of operations involving optimized use of global knowledge base comprising intra-enterprise and extra-enterprise resources. This includes formally documented sources, as well as traditional community beliefs, practices and knowledge. As soon as ideas are conceived, the process of IPR sets in even at the incubation stage. A detailed knowledge search is normally initiated to establish what the public already knows at large in the form of reasonably authentic documentation. Research strategies are constructed and merged with business planning. As the project progresses and innovations are made, IPRs are acquired at speci®c critical stages before the ®ndings of the project are made public. Licensing options are worked out fairly early and return on the investments is realized in a planned manner at times even before the project reaches completion. Effective research is no longer a loners paradise. It needs symphony-like teamwork and harmonized networking with diverse groups and organizations. Fig. 2 illustrates the processes involved in mothering in the innovation value chain. As one travels from concepts to products on the ``innovation highway'', one is intercepted by several ``knowledge check posts'' (KCPs) that are well protected by tight patent claims and other forms of intellectual property rights. The key to progress along the highway depends on oneÕs ability to manage meaningful interactions with these KCPs through mutually bene®cial P. Ganguli / World Patent Information 22 (2000) 43±52 Fig. 2. The processes involved in mothering in the innovation value chain. licensing agreements, bartering knowledge, expertise and patents or evolving creative by-passes mediated by technological breakthroughs without infringing existing patents and others' intellectual property. Weaving oneÕs way through the maze of protected technologies demand organizational (or communityÕs) ability to manage intellectual property and make it an integral part of the business processes (and community way of life). It is against such a dynamic backdrop that one has to take a non-emotive and objective view of issues linked to knowledge protection, conservation of bio-diversity, bio-prospecting, farmers/plant breeders rights, bene®ts sharing provisions, technological and human progress. It should be recognized that an innovation can and should only be benchmarked against the level of inventiveness and value addition to existing authentic public knowledge. 3. Protecting traditional knowledge and life materials and processes. What are the options? It would be useful to investigate legal frameworks in which traditional knowledge can be protected that would mother and nurture innovations from communities for competitive exploitation in the marketplace. If the Patents are used as a means of protecting community innovations then they must naturally satisfy the rigid criteria of novelty, non-obviousness and utility. This would demand explicit and systematic disclosure of community innovations. Design registration does o€er a simple tool for protection of novel designs and this instrument should be explored for e€ective protection of community knowledge. Petty patents could be a reasonable way of protecting community innovations that do not strictly satisfy all the conditions of ``patentability'' especially with respect 45 to novelty benchmarks and can be granted based on usefulness. Such protection would be local in character, as there is little internationalization or harmonization of petty patents. Several organizations have proposed this instrument as a workable means to protect traditional community knowledge. Options in trademark law and copyright laws can be exploited to protect symbols, marks, words or their combinations and explicit expression of ideas that are generated from community knowledge. On 30 October 1998, President Clinton signed Public Law 105-330 requiring the US Patent and Trademark Oce to study a variety of issues surrounding trademark protection for the ocial insignia of federally and/ or State recognized Native American Tribes. Hearings on this issue at the USPTO are still in progress and are due for submission of a report including ®ndings and completion to the Committee on the Judiciary of the Senate and the Committee on the Judiciary of the House of Representatives. The questions in these hearings being discussed are: 2 · How would any change in law or policy with respect to prohibiting the Federal registration of trademarks identical to the ocial insignia of Native American tribes, or of prohibiting any new use of the ocial insignia of Native American tribes, a€ect Native American tribes? · How would such changes a€ect trademark owners? · How would such changes a€ect the US Patent and Trademark Oce? · How would such changes a€ect any other interested party? · What impact would any such changes have on the international legal obligations of the US? · How would prohibiting Federal registration of trademarks identical to the ocial insignia of Native American tribes a€ect any/all of the above-mentioned entities? · What e€ect would such prohibitions have on the intentional legal obligations of the US? · What defenses, including fair use, might be raised against any claims of infringement? Many such issues will become topics for global debates in the future. Could one consider trade secrets as a legal instrument for protection of traditional and community knowledge that is most often vertically transmitted within the communities/families and ``kept secret'' via informal and non-documentary mechanisms? Obviously there are is- 2 The website of GRAIN. Eight Chapters by various authors in ``Signposts to Sui Generis Rights'' http://www.grain.org/publications/ signposts. 46 P. Ganguli / World Patent Information 22 (2000) 43±52 sues related to con®dentiality and contracts between parties concerned keeping in mind the ways of community working. Therefore enforcement of such rights would require very special e€orts and legal structures in many cases. Geographical indications can be constructed to act as a very powerful instrument. They provide protection for agricultural produce, which has special and distinctive characteristics because of its area of origin, either because of speci®c geographical conditions and/or human inputs, which are particular to that area or simply as a result of reputation of that ``produce''. The implication of this instrument is that it gives rights to the people who produce these products to stop others from using the geographical name in marketing produce which does not originate from that de®ned area. Examples of such products are wines, champagne, cognac, port, sherry, etc. This has been e€ectively exploited in Europe but is yet to be put into practice in developing nations where traditional goods (agricultural and non-agricultural) have been in existence for centuries. It is yet to be explored by governments in most developing countries. The search for options is ridden with contentious issues on questions related to protection of life processes or biological materials. 3 There are several inter-related international agreements that have implications on IPR linked to living species and materials of relevance to propagation of living species. They are: · TRIPs has two avenues namely patents and protection of new plant varieties. · ``Convention of biodiversity (CBD)''. · Sui generis system for protection of ``plant genetic resources (PGR)''. · Union pour la protection des obtentitous vegetales (UPOV) or better known as ``international union for the protection of new varieties of plants'' which includes ``plant breeders rights (PBR)''. · The concept of ``farmers rights (FR)'' ¯oated by the Food and Agricultural Organisation of the United Nations (FAO) to recognize and reward farming families in the conservation of PGR. Mutual compatibility between these conventions continues to be a subject of intense international debates. The essential features of four international conventions are summarized in Fig. 3. The biotechnology patenting directive of the European Union endorsed on 6 July 1998, harmonizes patent laws in the European Union for biotechnology inventions, in- cluding plants, animals and genes. Biological material means any material containing genetic information and is capable of reproducing itself or can be reproduced in a biological system. Patents are available for products consisting of or containing biological materials. This adds a new dimension to the on-going debate [4]. Unlike in the USA and Australia no patents will be granted for methods of medical treatment (includes surgery, therapy or diagnostic, gene therapeutic methods) on humans and animals. Materials, tools in biotechnology are patentable (e.g., RNA constructs or vectors). No patents will be granted for mere gene sequences without indication of a function (e.g., expressed sequence tags must show industrial applicability). The human body at various development stages and simple discovery of one of its elements, such as a gene sequence is not patentable. But an element isolated from the human body or otherwise produced by means of a technical process may constitute a patentable invention even if the structure of that element is identical to that of the natural element. The process of cloning human beings, the use of human embryos are not patentable as they are considered to be contrary to ``ordre public'' and morality (as of today, benchmarks could change with time). Similarly industrial or commercial processes for modifying the genetic identity of animals which are likely to cause them su€ering without substantial medical bene®t to man or animal and also animals resulting from such processes are not patentable. The European biotechnology directive however has not been e€ective with respect to formalizing material transfer agreements/prior informed consent/reporting of the geographical place of origin of the source biological material etc. as these provisions are only recitals and are not in the operable part of the directive. This makes it vulnerable to issues associated with and bordering on ``bio-prospecting (bio-partnering)'' and ``biopiracy''. The pros and cons of these approaches continue to be subjects for extensive debates. The outcomes of these discussions need to be analyzed with extreme caution, as they will signi®cantly impact formulation of rational policies and their implementation. There have been suggestions in a few debates that genetic sequences may be considered as ``biological algorithms'' and like computer software (algorithms) should qualify for protection under copyright. Fundamentally there does not appear to be any major contradiction or con¯ict between various international conventions described above. The key issues could be resolved by a systematic and logical merging of ideas from each of these conventions in a self-consistent manner to create a harmonized set that would satisfy basic and minimum standards of IPR and societal ethics. Options for consideration are: 3 Patent and Trademark oce Docket no. 981214305-8305-01. http:// www.uspto.gov/web/oces/com/sol/notices/fr981229.html, http://www. uspto.gov/web/menu/current.html#transcripts. · TRIPs outlines conditions for patentability of inventions. UPOV is designed to promote inventions in P. Ganguli / World Patent Information 22 (2000) 43±52 47 Fig. 3. Summary of four international conventions with implications for IPR linked to living species and materials of relevance to propagation of living species. plant breeding. CBD outlines measures for conservation of bio-diversity. FR seeks recognition to farmers for their continued e€orts in developing and maintaining genetic diversity. The question is, should ``protection of inventiveness through patents'' or otherwise be linked and confused with ``conservation aspects'' so long as benchmarks for inventiveness and discoveries can be arrived at? Possibly the frames of reference for inventions resulting from ``formal science/technology'' and ``community evolved science/technology'' should be di€erent. Maybe a system of patents and petty patents could be a solution. Unambiguous de®nition of discovery and invention within the traditional meaning of patents is essential. Inventions have been considered for patents whereas discoveries have not. However in the USA an isolated and puri®ed form of a natural product is patentable if it is found in nature in a non-puri®ed form. Similarly in the European patent convention a patent can be granted when a substance found in nature can be characterized 48 P. Ganguli / World Patent Information 22 (2000) 43±52 by its structure or by other criteria, if it is new in the sense that it was not available to public in that form. Such interpretations have used to patent gene sequences and isolates of DNA. Such borderline cases of inventions and discoveries have been the subject of intense debates leading to claims that mere isolation and characterization of such naturally occurring entities do not satisfy criteria of ``novelty'' and ``inventiveness''. There is nothing in the TRIPs agreement or in any other international conventions that obliges the member states to follow such an expansive approach towards patenting of substances already existing in nature. One may argue that if microorganisms or naturally occurring substances in plants and animals can be considered for patenting what about extension of this logic to the whole range of complex ores, marine reserves, etc. Conservation aspects could be statutorily controlled by the State through environmental legislation on lines similar to that controlling safety, national security etc. · TRIPs allows members to evolve their own appropriate sui generis system for protection of plant varieties. Therefore the member states are allowed to build into their National Laws appropriate measures to introduce ``reasonable operative clauses in the interest of the public''. · CBD requires the convention countries to grant access to their genetic resources on ``mutually agreed terms'' to include ``prior informed consent (PIC)'', appropriate ``material transfer agreements (MTA)'' and ``information transfer agreements (ITA)'' between the parties. These will force the concerned parties to de®ne the subject matter under consideration and also resolve ``ownership'' issues that are basic to any patenting process. Such practices are becoming fairly standard in memoranda of understanding (MOUs) signed between organizations for collaborative research and licensing agreements. When patenting inventions resulting from such situations ``inventorship/authorship'' would be clearer than it is today. This will pave the way for productive use of the existing knowledge base and modern technology, thereby fostering cooperative working and faster innovation. The issue is ``who'' or ``which recognized body'' will legally represent a community for purpose of ownership of traditional knowledge and innovation? · TRIPs does provide other instruments such as ``anti competitive practices in contractual licenses'' and within patents and copyrights the options for compulsory licensing. These instruments can be used by the member states within the meaning of the agreement to e€ectively control any monopolistic practices. · De®ning what constitutes prior art and establishing the state of knowledge at any point in time especially within the community (public domain) would be a major challenge. To incorporate community knowledge within the meaning of prior art, one will have to include any disclosure by oral, written or other means such as public use or sale in any part of the world. These issues will continue to be debated. 4. Traditional knowledge and prior art: implications A series of questions can be raised: · What is the existing identi®able knowledge base in a speci®c area? · Who can the knowledge base be associated with? · To what extent can the innovation be associated with or be related to speci®c parts of the knowledge base? · Is the knowledge base in the public domain? Is the public domain knowledge part of ``traditional knowledge'' or ``community knowledge''? · Is the knowledge documented and authenticated in any form? · Which part of the existing knowledge base is proprietary? Who is the legal owner? · How does one di€erentiate individual ownership of PGR from community ownership? One needs to analyze questions on traditional knowledge from diverse angles. The state of knowledge in any ®elds especially those evolved in communities over considerable length of time may have wide gaps and defy quanti®cation and exactness. Innovations based on such empirical knowledge often require extensive work with remote or variable chance of success. The modern inventor exploiting quantitative or semiquantitative methods in science successfully completes the last mile in the innovation highway. Thus it is not just a question of borrowing knowledge but also substantially adding value to transform it to meaningful applications or marketable products. One will have to objectively di€erentiate between appropriation of traditional knowledge (e.g., exploiting existing genetic resources and gaining control on them through wrongfully granted patents) from those patentable inventions resulting in value added knowledge goods using the existing community knowledge base. Most often these two categories are not di€erentiated, causing confusion and wrong branding of legitimate inventions as bio-piracy. Mere use of a genetic resource as permitted by the convention of bio-diversity through rightful material transfer agreements is better de®ned as bio-prospecting and should not be termed as bio-piracy. P. Ganguli / World Patent Information 22 (2000) 43±52 Under the circumstances where the lead was obtained form traditional empirical knowledge what would be a fair scale for bene®ts sharing between the inventor completing the crucial last mile and the source of the initial lead? The ®rst step would then be to create constructs and document the present state of community and traditional knowledge in targeted areas of relevance. International initiatives such as the WIPO net are set to achieve this in the next few years and serve as a powerful tool to aid examiners in patent and trademark oces across the world to assess the state of current traditional knowledge while conducting their examinations. The concept of community registers for community innovation and knowledge has been progressed by several non government organisations (NGOs) [5,6]. The content and the structure of these ``databases'' and community registers are therefore most critical for them to be useful, e€ective and enforceable. Examples of such databases [7] are: · NAPRELET which is a database drawn from over 100 000 technical papers, referencing more than 43 000 species of plants and animals and documents over 100 000 chemical compounds. · A database of ethno-pharmacology of Indian medicinal plants is being constructed in a collaborative programme between The Royal Danish School of Pharmacy and the Tropical Botanical Garden and Research Institute (TBGRI), Trivandrum. · CSIRÕs volumes on Wealth of India with details on IndiaÕs plant and mineral wealth. · CSIRÕs CDROM on medicinal and aromatic plants abstracts. The issue of accessing and extracting information to establish prior art in work related to gene sequences has been the subject of major ongoing debates, even in the USA. Recent hearings in the USA on the use of computers for assisting in searches on gene sequences have shown an enormous growth in the demand for such information. To quote from the transcript 4 of one of the hearings ``For example in Fiscal Year 1991, the Scienti®c and Technical Information Center of the PTO searched about 4000 sequences. In Fiscal Year 95, they searched about 22 000 sequences. In 1996 they had over 200 000 sequences claimed in at least 70 patent applications awaiting search and examination. The USTPO estimated that the search of 100 sequences requires about 15 h of computing time but the evaluation of the search results for those 100 sequences requires about 65 h of examiner time. The PTO currently has two massive parallel processor computers and could run the searches in about two years, with the computers running 24 h a day, seven days a week. To examine this relatively small number of patent applications only with respect to the prior art, however, would require over 90 seniorlevel sta€ years. Thus, in order to process these applications, the entire sta€ of the Biotechnology Patent Examining Group 1800 would have to work for more than nine months exclusively on these applications. Such is the enormity of the task in terms of expertise, facilities and cost for examining patent applications in the ®eld of gene sequences, even in the USTPO with their advanced high speed computing systems. Developing countries will have to take note of these issues before embarking on examination of patents in genetic engineering. Global networking between various patent oces will have to be established especially in the ®eld of biotechnology to ensure that patents are speedily and correctly issued. The commonwealth knowledge network (CKN) could play a signi®cant role. 5. Case studies Four case studies are discussed to illustrate: · Erroneous granting of a patent and role of documented community prior art in revocation of the patent (5.1). · Equitable sharing of bene®ts with indigenous tribes (5.2). · Sharing of bene®ts with community (5.3). · Integrating indigenous knowledge, modern science and reciprocity into novel drug discovery approach (5.4). 5.1. Case study 1 5.1.1. Erroneous granting of patent 5 Revocation of turmeric patent [8]. The case of the revocation of the turmeric patent [US Patent 5401504] in a proceeding initiated by the Council of Scienti®c and Industrial Research (CSIR, India) at the USPTO illustrates the signi®cance of proper documentation of traditional knowledge. Non-availability of an authentic database of traditional knowledge and practices can often lead to erroneous granting of patents in such areas by patent oces around the world. The title of the patent granted by the US patent Oce was ``Use of Turmeric in Wound Healing'' assigned to University of Mississippi Medical Centre, Jackson, Mississippi, USA. The chronology of events for US 5 4 http://www.uspto.gov/web/oces/com/sol/notices/seq-hear.txt. 49 This case was more extensively analysed by R.K. Gupta and L. Balasubrahmanyam in an earlier issue of this journal [20 (1998) 185±91]. 50 P. Ganguli / World Patent Information 22 (2000) 43±52 Lessons learnt. The turmeric opposition has exposed several issues vis-a-vis traditional knowledge systems and IPR such as: Fig. 4. The chronology of events for US 5401504. Fig. 5. Claims of US 5401504. 5401504 is shown in Fig. 4 and the patent claims are shown in Fig. 5. There was no comprehensive database in which to search to directly identify the relevant prior art. Thirtytwo references were cited in the revocation proceedings by CSIR at the USPTO. A few typical ones are given below: · The E€ect of Indigenous Remedies on Wounds, J. Ind. Med. Asso (1953). · Ayurvedic Healing (1989). · The Wealth of India (1950). · Indian Materia Medica (1976). · Economic and Medical Plant Research (1990). · Home Remedies (1958). · The Ayurvedic Pharmacopea of India (1986). · Selected Medicinal Plants of India (1992). · Bustanul Mufredat (1867). · Khazanatul Adviy Vol-3 (1920). · Chakhambha Orientalia (1979). · Kyaa Khya aur Kyoon? by G.N. Chauhan. Based on these references the USPTO took a decision in favour of the opposition and revoked the granted patent. The basis was that the invention claimed in the patent lacked novelty with respect to the prior art. · The strength of the US patent system which is transparent to enable fair proceedings. · Signi®cance of following patent information especially linked to gazette noti®cation of the patents ®led, issued etc. Familiarity with patent oce practices or a rigorous follow-up is necessary to meet statutory deadlines for ®ling of oppositions, submission of documents to the statutory oces, etc. · Problems of establishing relevant prior-art due to non-existence of any comprehensive, reliable and authenticated database on information related to traditional and ethno-medicinal practices. In the present case a nationwide hunt to identify relevant literature had to be made. In several cases one will have to conduct a global search. A global programme is necessary to construct a good database. While constructing a database one will have to structure the information so that it is easily indexed for user-friendly retrieval. Several ®elds will have to address the topic, such as approximate date of creation of that knowledge, geographical area of its origin, the community involved in the activity, the details of the process or product, the applications ± with data if possible, broad indications etc. · Appreciation of the techno-legal issues involved while tackling soft information. · Training of Science and Technology (S&T) personnel to critically read and interpret patent claims to assist in any techno-legal proceedings. · These proceedings will alert patent oces to look for appropriate prior art before granting patent in ®elds related to claimed inventions derived from traditional practices. 5.2. Case study 2 5.2.1. Equitable sharing of bene®ts with indigenous tribes 6 · The TBGRI, Thiruvananthapuram, Kerala State, India developed an innovative procedure for the equitable sharing of bene®ts with the tribal families who discovered the anti-fatigue properties of the plant Trichopus Zeylanicus. 6 A conceptual Framework for promoting bene®ts sharing in the area of conservation and use of plant genetic resources. A report prepared by the M.S. Swaminathan Research Foundation Chennai for UNEP (December 1998) and [9]. P. Ganguli / World Patent Information 22 (2000) 43±52 · Members of the Kani tribe living in the Western Ghats Region of the State of Kerala drew the attention of the All India Coordinated Research Project on Ethnobiology team (AICRPE) to the energy and strength giving properties of the fruits of this plant. · Scientists from the Regional Research Laboratory Jammu (India), and TBGRI veri®ed the tribal claims by chemically analysing the fruits and developing an anti-fatigue drug named Jeevani. · The invention has been patented by TBGRI and licensed for manufacture to an ayurvedic pharmaceutical company. · The agreement between TBGRI and the company contains the following bene®t sharing provisions.  50% of the licence fee, and  2% royalty at ex-factory sales price to be paid to Kani tribal families · Additionally TBGRI arranged for the cultivation of the plant by 50 tribal families on the basis of a buyback arrangement with the company and receive a steady annual income by domesticating the plant for commercial use. 5.3. Case study 3 5.3.1. Sharing of bene®ts with community [9] Xa21 gene work. · The ``Xa21'' gene was cloned in 1995 by Pamela Roland (University of California at Davis). The genetic material was taken from plants native to West Africa. This gene is known to confer resistance to bacterial blight in rice. · The University of California took the patent for this gene. · The genetically engineered blight resistant rice plants help to reduce the quantity of chemical pesticides used in traditional rice cultivation. · Signi®cant amount of the breeding work linked to location of the Xa21 gene was conducted at the International Rice Research Institute in the Philippines. · The University of California at Davis subsequently established a ``Genetic Resources Recognition Fund'' to be used to ®nance graduate fellowships for students from the countries that originally provided the plants carrying the gene. · It should be noted that in this case it was possible to identify the communities that contributed to locating the gene. 5.4. Case study 4 5.4.1. Shaman Pharmaceuticals [10] Integrating indigenous knowledge, modern science and reciprocity into novel drug discovery approach. 51 · It is a company located in San Francisco (USA) that focuses on isolating bio active compounds from tropical plants that have a history of medicinal use. · Its ®eld research teams consist of ethno-botanists, western trained medical doctors, local botanical collaborators, indigenous healers and herbalists. · These teams assist in focused selection and collection of plant candidates for screening and development from various locations for further work in Shaman. · Starting in 1990, and using this approach, they brought two products within 24 months to the clinical trail stage. · They ®led patents on anti-diabetic agents based on their ®ndings. · Their community reciprocity strategy for sharing of bene®ts is driven by the expressed needs of the people from the communities from which they derive their collaborators. · This includes short, medium and long term reciprocity arrangements. · Short-term compensation included building an airstrip extension in the Ecuadorian Amazon, organizing public health workshops and forest conservation workshops and o€ering direct medical care to their partner communities, providing clean drinking water systems to communities in Ecuador and Indonesia. · Medium term approaches have been to provide scholarships and fellowships to scientists working in traditional medicine and also to enhance infrastructural features for research in science and technology for the community. · As a part of their long-term strategy, the company has formed a Healing Forest Conservancy as a nonpro®t organization dedicated to conserve cultural and biological diversity and sustain the development and management of natural and bio-cultural resources that are part of the heritage of native populations. The results of these pilots have to be evaluated for their e€ectiveness in due course. 6. Conclusion Demands on natural resources are continually on the rise. Productivity of traditional agricultural practices and food, development of new medicines is plateauing. Using the traditional knowledge of communities to ®nd useful leads and to exploit advances in biotechnology for discontinuous increases in productivity are imperatives for the future. Establishing inventiveness and non-obviousness in patenting of inventions in genetic engineering will continue to challenge legal frameworks. Ownership of knowledge and its legal use in cooperative development activities, making rapid innovations with quick di€usion to the market place and fair sharing of 52 P. Ganguli / World Patent Information 22 (2000) 43±52 bene®ts will be the key means to success. This will require a ``motherÕs'' committed touch from governments, NGOs, corporates and the communities to create operative frameworks for intellectual property rights, to engender respect for community/traditional knowledge, and to nurture all forms of innovations for the bene®t of mankind. References [1] Ganguli P. Intellectual property rights in transition. World Patent Information 1999;20(3±4):171. [2] Ganguli P. Gearing up for Patents ± The Indian Scenario. Hyderabad: Universities Press (India), 1998. [3] Ganguli P. Intellectual property rights ± an imperative for sustained growth in pharmaceutical industry. Chemical Industry News 1999;XLV(9):749. [4] Stau€er TP. Intellectual property rights bulletin. TIFAC 1999;5(1):3. [5] Gadgil M. Personal communication. [6] Gupta AK. The Honey Bee Network: Linking knowledge rich grassroots innovations, Publication by Society for Research and Initiatives for sustainable Technologies and Institutions (SRISTI) and the Gujrat Grassroots Innovation Network (GIAN). [7] Arunachalam S. In: West R, editor. Science on the Periphery Enriches Mainstream Science But at What Cost? 20th Century Science: Beyond the Metropolis, vol. 6. Sciences in the South. Current Issues, Paris, 1996. [8] Mashelkar RA. Personal communication. [9] Pushpagandhan P. In: Swaminathan MS, editors. Agrobiodiversity and FarmersÕ Rights. Konark Publishers, 1996. [10] Bierer DE, Carlson TJ, King SR. http://www.netsci.org/Science/ Special/feature11.html.