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.

Description

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.

Sujets

• Biodiversity
• Intellectual Property
• Biodiversidad
• Propiedad intelectual

Informations

• Publié par: erevistas
• Publié le: 01 janvier 2003
• Nombre de lectures: 10
• Langue: English

Extrait

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: [e-mail]
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 metho