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-diusion
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 diusion 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
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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 diusion 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 oer 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-eectiveness.
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 oer a simple tool for protection of novel designs and this instrument should be
explored for eective 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
Oce to study a variety of issues surrounding trademark protection for the ocial 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 ocial insignia of Native American
tribes, or of prohibiting any new use of the ocial insignia of Native American tribes, aect Native American tribes?
· How would such changes aect trademark owners?
· How would such changes aect the US Patent and
Trademark Oce?
· How would such changes aect 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 ocial insignia of Native
American tribes aect any/all of the above-mentioned
entities?
· What eect 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 eorts 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 eectively 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 suering 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 eective 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 oce Docket no. 981214305-8305-01. http://
www.uspto.gov/web/oces/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 eorts 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 dierent.
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 eectively 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 dierentiate 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 dierentiate 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 dierentiated, 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 oces
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, eective 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
oces 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 oces around the world.
The title of the patent granted by the US patent Oce
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/oces/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 Eect 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 oce practices or a
rigorous follow-up is necessary to meet statutory
deadlines for ®ling of oppositions, submission of documents to the statutory oces, 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 oces 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 oering 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 eectiveness 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 diusion 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.
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