ABS, Intellectual Property, and Poverty Alleviation: International and Brazilian Law
INTERNATIONAL LAW CBD ♦ Article 15 rules the acess to genetic resources that shall be previosly consented and the benefits arising from their commercial use of shall be shared in a fair and equitable way.
INTERNATIONAL LAW CBD ♦ Article 2 Use of Terms
“genetic resources” means any material of plant, animal, microbial or other origin containing functional units of heredity.
INTERNATIONAL LAW CBD ♦ CBD
doesn’t define what is units of
heredity but it means GENES.
INTERNATIONAL LAW CBD ♦ GENES are biological molecules made of DNA and RNA in retrovirus.
INTERNATIONAL LAW CBD
♦ Genetic Resources = DNA/RNA
INTERNATIONAL LAW CBD ♦ However others biological molecules, that are NOT
genetic
resources
might
have
huge
economic value to develop new medicines but they were put outside the ABS system as it is expressed in the text of article 15, that refers only to GENETIC RESOURCES.
INTERNATIONAL LAW CBD CAPTOPRIL: CAPTOPRIL - a peptide isolated from venom of Jararaca - 1965: Sérgio Ferreira (USP) - 1975: Squibb develop a anti-hipertensive medicine and obtained a patent - profits of U$$ 4 billions
INTERNATIONAL LAW CBD ♦ Actually these other biological molecules derivates from DNA (genetic resources).
INTERNATIONAL LAW CBD Article 8(j) determines the equitable sharing of the benefits arising from the use of traditional knowledge relevant for the sustainable use of biological diversity. - It doesn’t use the term “genetic resources” but only “biological diversity” so this knowledge is related not only to genetic resources but to the other biological molecules existing in the biodiversity as well.
BRAZILIAN LAW PROVISIONAL MEASURE 2.186/01
- regulates the CBD- article 8.j and article 15 application in Brazil. - it establishes the ABS in Brazil and the requirement of a State authorization to do bioprospection in Brazil.
BRAZILIAN LAW PROVISIONAL MEASURE 2.186/01 (PM 2.186/01)
-
Establishes
concession material
as
based
condition on
to
Brazilian
patent genetic
and/or traditional knowledge the
complience of all PM determinations AND also the disclosure of the origin of such material and knowledge.
BRAZILIAN LAW - since 2006 the Brazilian patente office (National Institute for Industrial Property) is demanding this requirement to patent applications. - the penalty for failure in the disclosure of origin is suspension or canceling the patent (PM 2.186/01 article 30).
BRAZILIAN LAW
- Brazilian law text also refers ABS only to genetic and traditional
knowledge
excluding
another
biological
molecules for ABS purposes harming Brazil interests.
INTERNATIONAL LAW Patent Cooperation Treaty (PCT) Article 27 National Requirements (1)
No national law shall require compliance
with requirements relating to the form or contents
of
the
international
application
different from or additional to those which are provided for in this Treaty and the Regulations.
INTERNATIONAL LAW Patent Cooperation Treaty (PCT) - However PCT, neither its Regulations, requires origin disclosure of genetic resource/traditional knowledge. - Brazil signed PCT in 1970 and ratified it in 1978. => so Brazil is not complying PCT what results i i t
ti
l li bilit f
B
il
INTERNATIONAL LAW Patent Cooperation Treaty (PCT)
- 2003 Switzerland did a proposal to amend PCTRegulations to enable the Parties to require the disclosure of origin of genetic resources and/or traditional knowledge if an invention is directly based on such resource and knowledge.
INTERNATIONAL LAW Patent Cooperation Treaty (PCT)
This
proposal
is
not
enough
to
attend
the
megadiverse countries interests because: - also exclude the biological molecules without DNA nature it means that are not genetic resources. - this disclosure requirement would not be not compulsory to the Parties and should be.
INTERNATIONAL LAW Patent Cooperation Treaty (PCT)
-
doesn’t
establishes
to
the
Parties
the
possibility to demand complying the ABS as patent requirement, just allow them to demand to
declare
the
source
of
the
resource/traditional knowledge used.
genetic
INTERNATIONAL LAW AGREEMENT ON TRADE-RELATED ASPECTS OF INTELLECTUAL PROPERTY RIGHTS (TRIPS)
- Brazil and others megadiverses countries also proposed to amend the TRIPS to include the disclosure of origin as patent requirement but only of genetic resources/traditional knowledge.
INTERNATIONAL LAW MAINLY DEVELOPED COUNTRIES POSITIONS - EU’s position includes a proposal to “examine” a
requirement
that
all
patent
applications
disclose the source of origin of genetic material BUT with legal consequences of not meeting this requirement remaining OUTSIDE the scope of patent law.
INTERNATIONAL LAW MAINLY DEVELOPED COUNTRIES POSITIONS - this proposal problem is that will not be effective against biopiracy since the patent obtained in this way will remains valid. - in a analogy would be similar to identify a robber but allow him to keep the subject stolen.
INTERNATIONAL LAW MAINLY DEVELOPED COUNTRIES POSITIONS - Depending on the profit the risk to do biopiracy would be quite acceptable (economic evaluation of cost/benefits) do biopiracy.
INTERNATIONAL LAW MAINLY DEVELOPED COUNTRIES POSITIONS - USA
argue
that
national
legislation
and
contractual arrangement could be better to guarantee the ABS to megadiverse countries.
INTERNATIONAL LAW MAINLY DEVELOPED COUNTRIES POSITIONS - the problem of this proposal is obvious: the enterprises that do biopiracy intend to patent such material mostly in developed countries. If a contract is no complied and the enterprise obtain a patent from a genetic resource in EUA, how will the country of origin realize it? Even if realize how will suspend or cancel this patent in EUA or obtain benefit sharing?
CONCLUSIONS - the CBD text should be amended in way to substitute the term “genetic resource” by “biological resource” or “biological molecules” or even “genetic resources and its derivates” in way to include all kind of biological molecules.
CONCLUSIONS - the bioprospection colect a very small amount of
biologic
material
to
the
biotechnology
industry obtain a patent of this material isolated from organisms (US and EU law allow it) or develop new products and process so is a VERY SUSTANAIBLE way to use the biodiversity.
CONCLUSIONS - if the TRIPS and PCT are amended to include the disclosure of origin of biological molecules AND the proof of compliance with ABS, as patent requirement, the CBD’s ABS system would be more effective what doesn’t seems to be currently at least in Brazil.
CONCLUSIONS - if the CBD’s ABS system becomes more effective,
government
and
people
megadiverse developing countries
in
might
give more value to the biodiversity and adopt more effective policies and laws to protect it since it’s a source of incomes.
CONCLUSIONS - if the CBD’s ABS system become more effective,
the
resulting
income
might
contribute in a significant way to poverty alleviation
in
developing
megadiverse
countries and their traditional communities.
RECOMMENDATION - Germany should try to change EU’s position to amend TRIPS and PCT including disclosure of origin and ABS as patent requirements with legal consequences INSIDE patent system. It would be a way to contribute to poverty alleviation
