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WIPO/GRTKF/IC/6/8
page 10
WIPO

E
WIPO/GRTKF/IC/6/8
ORIGINAL: English
DATE: December 15, 2003
WORLD INTELLECTUAL PROPERTY ORGANIZATION
GENEVA
intergovernmental committee on
intellectual property and genetic resources,
traditional knowledge and folklore
Sixth Session
Geneva, March 15 to 19, 2004
Defensive Protection Measures Relating TO Intellectual Property,
Genetic Resources and Traditional Knowledge: AN UPDATE
Document prepared by the Secretariat
I. OVERVIEW
1 The Intergovernmental Committee on Intellectual Property and Genetic
Resources, Traditional Knowledge and Folklore (“the Committee”) has
developed and implemented a range of practical mechanisms for the
defensive protection of traditional knowledge (TK) and genetic
resources. It has also referred proposals to other WIPO bodies which
have taken up defensive protection measures relating to TK. At its
fifth session, the Committee considered a comprehensive overview of
defensive measures, document WIPO/GRTKF/IC/5/6, and noted some points
that required clarification. This document supplements and updates the
full report in document WIPO/GRTKF/IC/5/6. It gives an update on the
practical steps in the development of defensive protection measures.
It then clarifies some of the issues raised in the previous document,
and in other material and discussions within the Committee.
2 The term “defensive protection,” when applied to TK and genetic
resources, refers to measures aimed at preventing the acquisition of
intellectual property rights over TK or genetic resources by parties
other than the customary custodians of the knowledge or resources.1
The development of measures for defensive protection have formed a
significant component of the early outcomes of the Committee. An
overview of the outcomes produced by the Committee was contained in
Annex 1 of document WIPO/GRTKF/IC/5/6.
3 In the work of the Committee, it has frequently been stressed that
protection of TK should be undertaken in a comprehensive manner,
potentially using both positive and defensive forms of protection.
Defensive protection is no substitute for positive protection, and
should not be mistaken for the acquisition and active exercise of
rights in the protected material. Its impact is limited to preventing
other parties from gaining intellectual property (IP) rights, and does
not in itself prevent others from using this material. Often, the
active assertion of rights (positive protection) is necessary to
prevent the unauthorized or illegitimate use of TK. In some scenarios,
defensive protection may actually undermine the interests of TK
holders, particularly when this involves giving the public access to
TK which is otherwise undisclosed, secret or inaccessible. In the
absence of positive rights, public disclosure of TK may actually
facilitate the unauthorized use of TK which the community wishes to
protect.
4 Previous discussion has clarified that defensive protection
strategies focussed on the patent system have two aspects:
*
a legal aspect, ensuring that information is published or
documented in such a way as to meet the legal criteria to be
counted as prior art in the jurisdiction concerned (this may
include, for instance, ensuring that there is a clear date of
publication, and that the disclosure enables the reader to put the
technology into effect); and
*
a practical aspect, ensuring that in fact the information is
available to search authorities and patent examiners, and is
readily accessible (such as through being indexed or classified),
so that it is likely to be found in a search for relevant prior
art.
These two aspects were elaborated fully in the previous survey in
document WIPO/GRTKF/IC/5/6.
II. UPDATE ON DEFENSIVE PROTECTION MEASURES
International Patent Classification
5 Paragraphs 44 to 52 of document WIPO/GRTKF/IC/5/6 described the
current activities to update and expand the International Patent
Classification (IPC) to take better account of TK subject matter, and
in particular concerning medicinal products based on plant extracts.
It described how a WIPO Task Force on Classification of Traditional
Knowledge had developed a new main group for the IPC, designated A61K
36/00, with approximately 200 subgroups, in the field of medicinal
preparations containing plants. This should increase the likelihood
that patent examiners will locate already published TK that is
relevant to claimed inventions in patent applications, without
adversely affecting the legal status of TK from the point of view of
TK holders.
6 The IPC Revision Working Group, at its tenth session held in Geneva
from November 24 to December 5, 2003, approved the revision proposal
relating to traditional medicine classifications, with some
amendments.2 The results of this revision would be ready to submit to
the next session of the Committee of Experts for final adoption which
is scheduled to take place in February 2004 and would be integrated
into the new edition of the IPC that will be published in June 2004
and will enter into force on January 1, 2005.
7 The Committee of Experts of the IPC Union has agreed with the
suggestion of the Task Force that a more detailed revision could be
carried out at a later stage, in the course of the next IPC revision
period. This opens up the scope for future development of the IPC to
draw on further practical experience in various countries concerning
the interaction between TK systems and the patent system, as the IPC
system moves towards a more interactive mode of revision and
development, based on the separation of the IPC into a relatively
stable core level and a dynamic advanced level. The advanced level
will always be the current, continuously updated IPC ‘edition.’3
8 The Committee of Experts has instructed the Task Force to continue
its work on further development of classification tools for
traditional knowledge and to investigate possible patent
classification aspects relating to components of biodiversity and
folklore and requested the Task Force to consider how the future
revised IPC could be linked to TK resources classifications which may
be developed in various countries, and how to best organize access to
TK documentation which was in public domain, including hyperlinking
the IPC to TK databases.
9 A work progress report will be submitted by the Task Force to the
Committee at its next session which is scheduled to take place from
February 23 to 27, 2004.
Revision of the Minimum Documentation under the Patent Cooperation
Treaty
10 As document WIPO/GRTKF/IC/5/6 noted, the “Patent Cooperation Treaty
(PCT) is a WIPO-administered treaty for international cooperation in
the field of patents. One international patent application under the
PCT can have the legal effect of simultaneously filing applications in
a large number of countries throughout the world. Importantly, from
the point of view of the current document, the PCT provides for
international coordination with regard to the filing, searching and
examination of patent applications and the publication of technical
information contained therein. The PCT simplifies and reduces the cost
of obtaining patent protection and facilitates public access to a
wealth of technical information relating to inventions, including in
the field of TK and genetic resources. The international search and
examination processes also have significance for defensive protection
strategies.”
PCT Minimum Documentation
11 Article 15(4) of the PCT provides that in the context of
international searches “[t]he International Searching Authority …
shall endeavor to discover as much of the relevant prior art as its
facilities permit, and shall, in any case, consult the documentation
specified in the Regulations.” The “documentation specified in the
Regulations” is specified in Rule 34 of the Regulations Under the PCT
and is generally referred to as the PCT minimum documentation. Rule 34
provides that the minimum documentation shall include certain national
patent documents, as specified in the Regulations, the published
international applications, the published regional applications for
patents and inventors’ certificates, the published regional patents
and inventors’ certificates, and “such other published items of
non-patent literature as the International Searching Authorities shall
agree upon and which shall be published in a list by the International
Bureau when agreed upon for the first time and whenever changed.”4
12 Document WIPO/GRTKF/IC/5/6 (paragraphs 31 to 43) described the work
under way to integrate published TK into the PCT minimum
documentation, so as to ensure that TK is given greater recognition
during the crucial international search and examination processes.
This is aimed to increase the likelihood that, even before
international patent applications enter the national phase within
individual jurisdictions, pre-existing TK that is relevant to the
claimed invention can already be cited against the patent application
in the preliminary search and examination process, thus ensuring that
relevant TK is given full consideration when the application reaches
the national level. The process described in the earlier document has
now reached a mature stage, and it is expected that changes to the PCT
minimum documentation will be agreed in the near future.
13 Specifically, in July 2003, shortly after the fifth session of the
Committee, the ninth session of Meeting of International Authorities
under the PCT (the MIA) considered the process for enhancing the
minimum documentation based on document PCT/MIA/9/4. Circular C. PCT
911 issued on March 28, 2003, had invited members of the PCT Committee
for Technical Cooperation (PCT/CTC) to evaluate the Non-Exhaustive
Inventory of Traditional Knowledge-Related Periodicals and the
Non-Exhaustive Inventory of Traditional Knowledge-Related Databases,
attached to the Circular, and to suggest a selection of appropriate
periodicals and databases with a view to providing improved access to
traditional knowledge documentation for search purposes. On the basis
of replies received from 20 PCT/CTC members, the International Bureau
had compiled ranked lists of periodicals and databases which included
only those periodicals and databases that had been proposed by more
than one of the PCT/CTC members (see document PCT/MIA/9/4, Annexes I
and II).
14 According to the report of this session of the MIA (document
PCT/MIA/9/6):
“127. The Meeting reiterated the conclusion … that integration of
traditional knowledge documentation into searchable prior art could
significantly improve the quality of international searches in areas
where traditional knowledge documentation represented a rich source of
information (see document PCT/MIA/7/5, paragraph 10).
128. The Meeting agreed that the ranked lists prepared by the
International Bureau provided a good basis for selection of the most
appropriate periodicals and databases. Criteria for selection of
periodicals had been agreed upon by the Meeting at its seventh session
(see document PCT/MIA/7/5, paragraph 12). The Meeting noted
particularly that selected periodicals and databases would need to
contain descriptions of disclosed technical knowledge to a
sufficiently practical or technical level to be of relevance when
conducting prior art searches. …
129. Some Authorities expressed the view that providing examiners with
access to databases relating to traditional knowledge, for example
through the framework of an IPDL, would in general yield more
satisfactory results than consultation of periodicals, although the
mandatory use of such databases in the examination process was not
envisaged.
130. The Meeting concluded that periodicals and databases mentioned in
the lists prepared should be further studied in the light of their
accessibility, facilities for electronic searching, and technical and
geographical coverage. The Meeting requested the International Bureau
to prepare revised ranked lists, taking into account the comments and
further suggestions made during the session and making a comprehensive
check of their conformity with the established criteria. …”
15 On the basis of this process, a proposal for revision of the PCT
minimum documentation is under preparation, and depending on the
schedule of meetings, is expected to be considered for possible
adoption and implementation early in 2004. The Committee, at its sixth
session, will be updated on any further progress achieved by March
2004.
III. COOPERATION ON DEFENSIVE MEASURES
16 This section considers the potential avenues for further
cooperation, including between patent search and examination
authorities, to promote the development of defensive strategies. This
builds on the discussion in documents WIPO/GRTKF/IC/5/6,
WIPO/GRTKF/IC/4/14 “Technical Proposals on Databases and Registries of
Traditional Knowledge and Biological/Genetic Resources: Document
submitted by the Asian Group,” and WIPO/GRTKF/IC/5/13, “Patents
Referring to Lepidium Meyenii (Maca): Responses of Peru.” Other
activities within WIPO and in other fora are also relevant to the
international enhancement of defensive measures, and in this regard it
should be noted that the General Assembly, in establishing the revised
mandate for the Committee, noted that its particular consideration of
the international dimension should be “without prejudice to the work
pursued in other fora.”5 Certain organs of the Convention on
Biological Diversity and of the World Trade Organization, and the
Working Group on Reform of the PCT,6 are considering various proposals
relating to enhanced disclosure under the patent system of the source
or origin of genetic resources or TK used in a claimed invention (as
well as related matters such as the legal circumstances of access to
such genetic resources and TK), a matter also considered by the
Committee (see documents WIPO/GRTKF/IC/5/10 and the update in document
WIPO/GRTKF/IC/6/9).
17 A further legal means of enhancing defensive strategies especially
relevant to TK is the recognition of orally disclosed information.
Much TK is customarily transmitted orally, and is not normally reduced
to a written or fixed form. This has led to concerns that, to the
extent that any patent law system specifically recognizes documented
or written knowledge when determining the validity of patent claims,
there is the possibility of claimed inventions being deemed valid,
even when they may involve the appropriation of orally disclosed TK.
The concern is that this would prejudice the interests of those
communities with a stronger oral tradition. From the legal
perspective, it is possible to recognize orally disclosed material as
being relevant prior art, and this recognition may be universal, in
the sense that knowledge disclosed by any means, in any geographical
location, may be considered as prior art relevant to the novelty of a
claimed invention.7 Recognizing its legal status as relevant to the
determination of validity of patent claims would clearly increase the
legal basis for defensive protection, without necessarily requiring TK
holders to disclose or publish their TK in violation of the principle
of prior informed consent. In practice, taking account of orally
disclosed TK, including that which is disclosed in foreign
jurisdictions, would create some evidentiary issues, precisely because
of the lack of documentation.8 On the other hand, there is concern
that documentation of oral TK, including for the sake of patent
procedures, can accelerate or facilitate its misappropriation,
including its commercial use by third parties without the prior
informed consent of the holders of TK.9 The need to respect the
wishes, interests and concerns of TK holders suggests that legal
recognition of orally disclosed TK as relevant prior art would enhance
the impact of defensive strategies, while leaving clearly open the
choice to TK holders in practice as to whether, how, and under what
conditions they choose to disclose, publish or otherwise make
available their TK. The prospects for TK holders to identify and
promote their interests in a practical context should be enhanced by
capacity‑building programs along the lines requested by TK holders
during the WIPO Fact‑finding Missions,10 such as the such as the
toolkit to identify and protect TK holders’ interests during any
documentation process.
18 Apart from these proposals, a number of other suggestions have been
put forward that may be relevant to increased international
cooperation on defensive strategies. The documents submitted to the
Committee by the Delegation of Peru and by the Asian Group discuss in
detail a range of measures relating to improved documentation of
genetic resources and TK, and increased application of such
information in patent procedures. This raises the kind of technical
matters addressed by the Data Standards adopted by the Committee at
its fifth session, but also raises a range of technical‑legal
questions about how the patent examination process can pay greater
heed not merely to the technical content of disclosed TK, but also the
background of the TK in a more holistic manner. For instance,
*
The Asian Group has proposed that: “The Intergovernmental
Committee should explore practical means of integrating into
substantive patent examination procedures the teaching of TK
systems in such a way that “the person with ordinary skill in
the art” who is referenced in the determination of inventive
step includes a person with ordinary skill in the relevant TK
systems.”11
*
The Delegation of Peru has noted that there is a “need to
evaluate how it would be possible to organize and systematize
much of this information [on genetic resources and TK] and the
role that could be played by a national database in that regard.
In summary, how is it possible to articulate this database and
information with the search procedures and examinations of the
main patent offices throughout the world in order to avoid
patents being granted on the basis of partial and limited
examinations of novelty and inventive step?”
*
The Group of Countries of Latin America and the Caribbean
(GRULAC) commented that “the Committee could look into ways of
devising a means of settling this problem at the international
level in such a way as to include within the state of the art
also that which has become known through use, traditional
marketing, oral disclosure or any other means whereby a product
or process has been made known to the public.”12
19 Such proposals raise legal-technical questions of how greater
understanding of the technological background of and information about
innovations within TK systems may be brought to bear during the patent
search and examination process. To some extent, this is a legal
question. The standard of inventiveness typically hinges on what would
appear obvious to the ‘person skilled in the art.’ If a claimed
invention is to some extent a hybrid, drawing in part on a TK system
and in part on a separate scientific and technological discipline,
should the test for non-obviousness consider the person skilled in the
relevant background of TK.
20 A similar issue arises in relation to novelty, and the requirement
that an invention not be publicly disclosed before the priority date
of a patent. The legal dilemma was set out in a leading decision on
patent law, by using an example directly relevant to the traditional
knowledge debate:
“The Amazonian Indians have known for centuries that cinchona bark can
be used to treat malarial and other fevers. They used it in the form
of powdered bark. In 1820, French scientists discovered that the
active ingredient, an alkaloid called quinine, could be extracted and
used more effectively in the form of sulphate of quinine. In 1944, the
structure of the alkaloid molecule (C sub20 H sub24 N sub2 O sub2 )
was discovered. This meant that the substance could be synthesised.”
“Imagine a scientist telling an Amazonian Indian about the discoveries
of 1820 and 1944. He says: ‘We have found that the reason why the bark
is good for fevers is that it contains an alkaloid with a rather
complicated chemical structure which reacts with the red corpuscles in
the bloodstream. It is called quinine’ The Indian replies: ‘That is
very interesting. In my tribe, we call it the magic spirit of the
bark.’ Does the Indian know about quinine? My Lords, under the
description of a quality of the bark which makes it useful for
treating fevers, he obviously does. I do not think it matters that he
chooses to label it in animistic rather than chemical terms. He knows
that the bark has a quality which makes it good for fever and that is
one description of quinine.”
“On the other hand, in a different context, the Amazonian Indian would
not know about quinine. If shown pills of quinine sulphate, he would
not associate them with the cinchona bark. He does not know quinine
under the description of a substance in the form of pills. and he
certainly would not know about the artificially synthesised alkaloid…”
“The quinine example shows that there are descriptions under which
something may in a relevant sense be known without anyone being aware
of its chemical composition or even that it has an identifiable
molecular structure. This proposition is unaffected by whether the
substance is natural or artificial. So far I have been considering
what it means to know about something in ordinary everyday life. Do
the same principles apply in the law of patents? Or does patent law
have a specialised epistemology of its own?”13
21 Because they entail distinct judgments on the patentability of
individual patent claims, such legal questions are ultimately resolved
case by case within the framework of national and regional patent
systems. Nonetheless, given the interest expressed in promoting
international cooperation on such questions, there may be avenues for
more focussed work on the questions that have been put to the
Committee. For example, there has been considerable practical work
undertaken in Latin America,14 South Asia,15 China16 and Africa,17 as
well as other regions, concerning the interaction between various TK
systems and the patent system.
22 There is in particular an increasing amount of practical experience
in certain patent offices in considering the patentability of TK-based
inventions from the specific point of view of the TK systems in which
they have been developed. For instance, it is reported that the State
Intellectual Property Office (SIPO) of China received 20,864 patent
applications in the field of traditional Chinese medicine (TCM) up to
2002, and that SIPO has a team of specialist patent examiners with
expertise in the field of TCM.18 In general, those countries with rich
backgrounds in traditional knowledge are likely to develop a strong
basis of practical understanding in making judgements about whether
claimed inventions are truly novel or inventive, having regard to the
standards and conceptual framework of the TK holders and traditional
communities themselves. This experience would illustrate how the
conceptions of novelty, inventive step, and person skilled in the
relevant art, may be adapted and applied most appropriately to
innovations based on TK, so as to deal with concerns such as those
noted above (in paragraph 18). This could in time lead to the
recognition of certain regional or national patent offices in
countries which are the source of certain TK systems as having
specific expertise in providing at least an initial judgement on the
validity of patent claims directed to material using such TK systems.
Possible future directions
23 As discussed in document WIPO/GRTKF/IC/5/6, at the practical level,
planning and implementation of defensive protection strategies would
be assisted by the compilation of information about the criteria that
apply to the determination of relevant prior art in various
jurisdictions, so that where defensive publication is made for patent
purposes, it would achieve the intended objectives. This information
could be compiled on the basis of a questionnaire concerning key
aspects of prior art (such as the nature of disclosure, including
enablement, the nature of public access required, criteria concerning
the medium, location, written or oral character, and documentation of
the date of disclosure); such a compilation would be a practical tool
for defensive protection activities.
24 Another possibility would be to prepare recommendations or
guidelines for national patent offices concerning searches in the area
of inventions linked to TK (within specific technical fields) or
genetic resources, with the goal of ensuring that patent authorities
with little background in traditional knowledge systems are better
equipped to base decisions on a clearer understanding of the manner in
which TK is maintained and developed within the traditional context.
This could put into practical effect the developments outlined above
concerning the IPC and PCT minimum documentation. Recommendations
could call for search and examination to take into account disclosed
genetic resources and TK as prior art, and could set out suggested
approaches to ensuring that disclosed genetic resources and TK are
given full weight in practice as prior art. This could draw on studies
and practical examples such as document WIPO/GRTKF/IC/5/15, and draw
on the practical experience of those offices with specific expertise
in certain traditional knowledge systems linked to their own region,
to illustrate for the benefit of patent examiners with little exposure
to traditional knowledge systems how questions of patentability can be
assessed in a manner that reflects the original context of TK. Such
guidelines would recognize and give broader influence to the expertise
and perspectives of those patent offices, generally in developing
countries, which are more familiar with customary TK systems.
IV. Conclusion
==============
25 The practical activities adopted by the Committee focussed on
enhanced defensive protection measures have all either been delivered
or are currently in the final stages of completion, including through
other relevant WIPO bodies for further implementation, such as the
PCT/MIA and the PCT/CTC. The Committee’s initial work program on
defensive protection can be seen as successfully carried out. There
remain, however, some possibilities for future work to improve the
defensive protection of TK and genetic resources. In particular, there
is scope for broader application of the practical lessons learned from
ensuring defensive protection of TK and genetic resources. The
expertise and experience of those countries which are rich in TK
backgrounds and in genetic diversity could provide insight and
guidance to those in other regions, so as to strengthen the
understanding of how TK systems can be weighed appropriately within
the overall framework of patent law.
26 Any work on defensive approaches should, however, be undertaken
within the context of a comprehensive approach to the protection of
TK, which takes account of the needs, widely expressed, for more
effective positive protection and for any holders or custodians of TK
to be fully informed of the consequences of making any disclosure of
their TK, especially when disclosure leads to publication of the TK or
its more ready access by members of the public.
27 The Committee is invited: (i) to call for further responses to be
submitted on the Questionnaire on Databases and Registries Related to
TK and Genetic Resources (WIPO/GRTKF/IC/Q.4); (ii) to consider
practical steps to promote further use and development of the
technical proposals contained in document WIPO/GRTKF/IC/4/14 and
adopted at its fifth session; and (iii) to consider future work
including a questionnaire on prior art criteria and development of
draft recommendations to authorities responsible for patent search and
examination to take greater account of traditional knowledge systems.
[End of document]
1See the overview of forms of legal protection provided in document
WIPO/GRTKF/IC/5/12, from paragraph 17, and the discussion of defensive
protection from paragraph 28.
2 See the report of this Working Group in document IPC/WG/10/3 Prov.
3 See ‘What are the goals of IPC reform?’ at
http://www.wipo.int/classifications/en/ipc/faq/ipcfaq-ver01.htm#P348_22246
4Rule 34.1(b)(iii) of the Regulations Under the PCT.
5 Document WO/GA/30/8, paragraph 93.
6 Documents PCT/R/WG/5/11 Rev. and PCT/R/WG/4/13, the latter also
considered by the Committee itself at its fifth session.
7 See, for example, the proposal under consideration by the Standing
Committee on the Law of Patents, document SCP/9/2, p. 21.
8 Similar considerations have led in the copyright domain, for
example, for some jurisdictions to require fixation of works as a
prerequisite for their protection; but as discussed in document
WIPO/GRTKF/IC/6/3, many jurisdictions do nonetheless protect unfixed
literary and artistic works.
9 See document WIPO/GRTKF/IC/5/5 and WIPO/GRTKF/IC/5/6
10 See “Intellectual Property Needs and Expectations of Traditional
Knowledge Holders: WIPO Report on Fact-finding Missions on
Intellectual Property and Traditional Knowledge (1998‑1999),
publication 768 (E/F/S)
11 Document WIPO/GRTKF/IC/4/14, Annex, p. 4.
12 WIPO/GRTKF/IC/1/5, Annex II, page 7.
13 Merrell Dow Pharmaceuticals Inc. v. H.N. Norton & Co. Ltd., [1996]
RPC 76, at 88 (per Lord Hoffmann)
14 For example, the working group reported in document WIPO/GRTKF/IC/5
15 Including the work of the SAARC Documentation Centre (SDC), and the
TK Digital Library and Health Heritage database that are accessible at
http://www.wipo.int/tk/en/databases/tkportal/index.html
16 See China TCM Patent Database, at
http://www.wipo.int/tk/en/databases/tkportal/index.html
17 http://www.biosafetynews.com/feb02/story15.htm
18 Beijing Round Table on Traditional Chinese Medicine, November 14,
2003.