LEGAL ASPECTS OF GENETIC MATERIAL AND GENETIC INFORMATION PROPERTY(ASPECTOS LEGALES DE LA PROPIEDAD DEL MATERIAL GENÉTICO Y DE LA INFORMACIÓN GENÉTICA)

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Abstract
In this paper the the legal aspects related to the intellectual property represented by the genetic material (resources) and the genetic information is summarized. Its relevance to samples and date developed in biodiversity studies is discussed. Also the conclusions reached in international discussions about such regulations are presented as a point of reference to be taken into account in the relations among countries. A special mention is made regarding the regulation of the commercial transfer of genetic material.
Resumen
En este trabajo se resume la situación actual con respecto a los aspectos legales relacionados con la propiedad intelectual del material genético y de la información genética. Tambien se presentan las coclusiones alcanzadas en discusiones internacionales sobre estas regulaciones para ser tomadas como punto de referencia en las relaciones entre países. Se hace una mención especial a la regulación de la transferencia comercial del material genético.

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LEGAL ASPECTS OF GENETIC MATERIAL AND GENETIC
INFORMATION PROPERTY
ASPECTOS LEGALES DE LA PROPIEDAD DEL MATERIAL GENÉTICO Y DE LA
INFORMACIÓN GENÉTICA
Cardellino, R.A.
Animal Production and Health Division.FAO. 00100 Rome. Italy.
E mail: Ricardo.Cardellino@fao.org
ADDITIONAL KEYWORDS PALABRAS CLAVE ADICIONALES
Biodiversity. Genetic resources. Intellectual Biodiversidad. Recursos genéticos. Propiedad
property. intelectual.
SUMMARY INTRODUCTION
In this paper the the legal aspects related to Some of the issues presented here
the intellectual property represented by the genetic are a summary of the paper by Carde
material (resources) and the genetic information llino (2003). There are at least three
is summarized. Its relevance to samples and date levels of legal instruments that are re
developed in biodiversity studies is discussed. levant to ownership and use of genetic
Also the conclusions reached in international resources:
discussions about such regulations are presented International treaties and conven
as a point of reference to be taken into account intions which the country or countries
the relations among countries. A special mention involved have signed.
is made regarding the regulation of the commercial - National legislation covering
transfer of genetic material.
genetic resources.
Material transfer agreements
(MTA) or commercial transactions
RESUMEN
between providers and users of genetic
resources, regulated by law.
En este trabajo se resume la situación actual
All these legal instruments must be
con respecto a los aspectos legales relacionados
in mutual agreement in order to achieve
con la propiedad intelectual del material genético
harmonious and practical proceduresy de la información genética. Tambien se presen
for regulating and protecting genetictan las coclusiones alcanzadas en discusiones
resources and the rights of partiesinternacionales sobre estas regulaciones para
involved, and prevent the proliferationser tomadas como punto de referencia en las
of bilateral litigation. It is desirablerelaciones entre países. Se hace una mención
that the most fundamental issues andespecial a la regulación de la transferencia co
mercial del material genético. basic principles for genetic resources
Arch. Zootec. 52: 201 206. 2003.CARDELLINO
are covered by multilateral agreements prohibited. There may be provisions
so that bilateral negotiation is greatly as to whether the resources or its
simplified and all countries have equalderivatives are allowed be commer
opportunity. Most international legal cialized or not. There may also be
instruments deal with plant genetic specifications as to generation of rights
resources. For animal genetic resources over the genetic resources or any other
the Convention on Biological Diversity resources derived from them. The
(CBD) and the Bonn Guidelines of thesharing of benefits must also be
CBD apply. There is no equivalent of specified. The second condition (prior
the International Treaty on Plant informed consent) means that the
Genetic Resources for Food and authority of the providing country, as
Agriculture (ITPGRFA) for animal a result from a request from an
genetic resources. There is also no applicant, can decide to grant or refuse
equivalent for animal genetic resources access to the genetic resource. The
of the global system of gene banks thatapplicant may be asked to provide
exists for plant genetic resources. Gene information concerning the purposes
flow and commercialization issues for for which the genetic resources are
plant genetic resources have many and required and to describe the proposed
important differences to those for ani arrangements for benefit sharing.
mal genetic resources. During this procedure the granting
The CBD requires parties to authority may set up consultations with
facilitate access and " ... not to impose local communities and national
restrictions that run counter to the stakeholders in order to protect their
objectives of the Convention ". Access rights.
must be on " mutually agreed terms" The Agreement on Trade Related
and subject to "prior informed con Aspects of Intellectual Property Rights
sent". The first requirement (mutually (TRIPS) is part of the agreements of
agreed terms) implies that both supplier the World Trade Organization (WTO,
and recipient of genetic material must 2003), and it requires all WTO Mem
agree on terms and conditions of the bers to provide minimum standards of
transfer. Here is an opportunity for theprotection for a wide range of IPRs
providing country to negotiate a share including copyright, patents, trade
of the benefits arising from this cession marks, industrial designs, geographical
and from the use of the specified genetic indications, and others. The full text is
resources by the recipient. This is available on line (www.wto.org/
generally done through a contract in english/docs_e/legal_e/27 trips.pdf).
the form of a Material Transfer Agree Among the issues raised by TRIPS
ment (MTA), a contractual arrange that have provoked the most discussion
ment executed bilaterally that sets the is the extent to which patents should be
conditions and the agreed terms under allowed on inventions relating to li
which the genetic material is to be ving forms, for example microorga
transferred. The MTA will specify nisms, and the requirement to provide
which uses of the genetic resources IP protection for plants, raising compa
provided are permitted and which are tibility questions with the CBD. Under
Archivos de zootecnia vol. 52, núm. 198, p. 202.LEGAL ASPECTS OF GENETIC PROPERTY
TRIPS, countries may exclude from of protecting ownership and property
patentability plants and animals and rights of the blood and DNA samples
essentially biological processes for transferred among participants to the
producing them, but not microor project. It is stated that the material
ganisms. It does not mention whether will remain the property of the indivi
or not genes should be patentable, dual providers. All parties to the
whether derived from plants, humans agreement recognize that no other use
or animals. It is not specified what of the material can be made without
constitutes an invention in relation to written permission from both the
genetic material. For example, it may relevant individual provider and the
be argued that genetic material country of origin.
identified in nature is patentable on The second agreement is a long
the grounds that isolating and purifying term one, regarding conservation and
it makes it different from an unpaten use of genetic material. Its preamble
table discovery. This is a matter left refers to the objectives of the research:
for national legislation. The only spe "... to demonstrate the benefits of an
cific requirement, other than for evaluation of genetic diversity in the
microorganisms, is that plant varieties European pig, taking into account both
be protected. commercial populations and local
The World Intellectual Property breeds in order to enhance utilization
Organization (WIPO, 2003) has as its and preservation for future genera
main objective to promote the protec tions..." and to " ... the importance to
tion of IP throughout the world and tohumanity of protecting and conserving
harmonize national legislation in this germplasm from animal genetic
field (www.wipo.int). Today its main resources...". Note is taken of the
function is to serve as a forum for provisions of the CBD, particularly
negotiation of international IP treaties. those pertaining to affirmation of
sovereign rights of nations over their
biological resources and access and
MATERIAL TRANSFER benefit sharing mechanisms. The
AGREEMENTS (MTA) AND importance of the project in FAO's
INTELLECTUAL PROPERTY strategic framework for animal genetic
PROTECTION (IPP) resources is also mentioned.
The contracting parties agree to a
EXAMPLE OF MTA AMONG MULTIPLE number of term definitions used
PARTNERS throughout the MTA: project, project
The example presented is an participants, owners, material provi
agreement for the long term conser ders, genetic material, management
vation and use of genetic resources group, DNA repositories, typing
arising from a Pig Biodiversity laboratories, analytical laboratories,
Research Project sponsored by the EU. stored DNA, material providers DNA,
It included initially 13 contracting project data, project raw data, project
partners, including FAO. There was summary data, country of origin,
an initial agreement with the purpose database, and user.
Archivos de zootecnia vol. 52, núm. 198, p. 203.CARDELLINO
The objectives of this agreement parties to the original project, and other
are (a) to facilitate the conservation ofusers wishing to utilize stored DNA
the genetic material collected under and project data. Following this
the project, to be used in future for section, the duties of each of the project
international R&D; (b) to clarify participants are described in detail.
property rights in all genetic material Stored DNA will be maintained for
sampled in the project; (c) to establisheach breed and animal using interna
a management structure which will tionally accepted methods, taking all
decide on the management and use of care without further responsibility, and
the stored DNA and project data. It is with the guidance of the Management
stated that the agreement shall be Group. The DNA repository will be
applied in a manner consistent with maintained secure from all comers and
the provisions of the CBD. from power failures, with a record of
The governance of the agreement is all people permitted to access the repo
done through a Management Group sitory and of their accessions, taking
representing the interests of all parties. all care without further responsibility,
The Group will take decisions on con under the guidance of the Management
trol to access to the stored DNA and Group. Similar provisions are detailed
project data, taking into account the regarding data maintenance, access,
provisions of the CBD and of FAO's reporting and use for further analysis.
global strategy for the management of The original project participants
farm animal genetic resources. The retain their rights to: (a) all original
basic principle covering access to the data relating to all breeds included in
stored DNA and project data is that the original project, to do further
these will be used as new techniques analyses of these data as they may
desire and separately decide upon; (b)and tools become available, which may
give much greater insight into diversity participate in decisions associated with
within or between the breeds in the the management and use of the stored
sample. The project data may be DNA; (c) assist in building upon the
utilized in further analyses which are data and results from the original
aimed at advancing understanding of project, in future research utilizing the
animal genetic resources, and the project DNA.
results published openly in recognized All intellectual property rights
technical journals. The Group will (IPRs) residing in or arising from the
receive advice from and report to the genetic material belong to the original
material providers and the country of material providers. All genetic mate
origin, and will seek advice and moni rial provided to this project by the
tor and guide the operation of the DNA material providers is of one of two
repositories, the data repository cu categories: (a) Stored DNA assigned
rator, the typing and analytical labora to the DNA repositories. Control and
tories, and contracts to the original access to this stored DNA for further
agreement. The Group will decide upon research resides with the Management
applications for the use of stored DNAGroup; (b) Material providers' DNA
and project data from the interested includes project DNA used in the
Archivos de zootecnia vol. 52, núm. 198, p. 204.LEGAL ASPECTS OF GENETIC PROPERTY
typing laboratories, or that still held EXAMPLE OF PROTECTION OF IPR
by the material providers. This remains IN A CONTRACT
the property of the original material
provider. Control and access to this The following are proposed clauses
material providers' DNA for further in Intellectual Property (IP) Arrange
research and any other use resides with ments for a continuation of the research
the original material provider. The project used previously as example.
project DNA which remains with the The ownership of, and access to, the
typing laboratories will be retained by project material (biological samples and
the typing laboratory or returned to thenucleic acids derived from them) is set
materials provider, as determined by out in the Material Transfer Agreement
the materials provider. Such transfers developed by the FAO as part of the first
of material provider DNA will use a Pig Biodiversity Project. All biological
simple MTA if this is required. samples will remain the property of the
The term of the MTA is for a period laboratory and country from which they
of 10 years. It will be automatically originated. The partners have agreed that
renewed for further periods of 5 years the interconnected nature of the project
unless notice of non renewal is given is such that all results will be jointly
before the expiration date. Any dispu owned by the Parties, and a consortium
te between the Contracting Parties agreement will be executed to this effect.
arising out of the interpretation or It is possible, although it is not a
execution of this Agreement shall be specific objective of the project, that
settled by mutual agreement. If the protectable IP may be generated by the
Contracting Parties are unable to reach project. In the case of protectable IP,
agreement on any question in dispute the partner(s) that obtain protectable
or on a mode of settlement other than IP should grant a free license to use the
arbitration, either party shall have the protected IP to the other Parties (con
right to request arbitration in accor sortium members). Partners will co
dance with the Arbitration Rules of theoperate in the licensing of the IP, and
United Nations Commission on Inter income will be shared based on the
national Trade Law (UNCITRAL), as at contributions made to the costs of pro
present in force. The Contracting Par tection on a country by country basis.
ties agree to be bound by any arbitration Those partners contributing to the costs
award rendered in accordance with the of protection will be termed Partici
above, as the final adjudication of any pating Partners. Participating Partners
such dispute. The present Agreement may grant royalty bearing licenses to
shall be governed by general principles third parties in their country of origin.
of law, to the exclusion of any single This license will not include the right
national system of law. The Contrac to sublicense. In addition, the consor
ting Parties may propose that the tium will seek to exploit the technology
Agreement be amended by giving no on a wider basis by granting royalty
tice thereof. In case of mutual agreementbearing licenses. All license income
in this respect, the amendment shall will be shared equally between the
enter into force on whatever date is set. Participating Partners.
Archivos de zootecnia vol. 52, núm. 198, p. 205.CARDELLINO
REFERENCES
Cardellino, R.A. 2003. Ownership and use of WIPO. 2003. World Intellectual Property
biological material from a cryobank. In: Organization (www.wipo.int). Web Page.
Workshop on Cryopreservation of Animal WTO. 2003. Agreement on Trade Related Aspects
Genetic Resources in Europe, Paris, February of Intellectual Property Rights (TRIPS) is part
23, 2003. D. Planchenault, Ed., Bureau de of the agreements of the World Trade
Resources Génétiques, Paris, France. p.123 Organization (www.wto.org/english/docs_e/
132. legal_e/27 trips.pdf). Web Page.
Archivos de zootecnia vol. 52, núm. 198, p. 206.