Current barriers to biotech in Brazil

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22 Οκτ 2013 (πριν από 3 χρόνια και 9 μήνες)

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LEGAL UPDATE
22
LSIPR Newsletter 07:13
www.lifesciencesipreview.com
Current barriers
to biotech in Brazil
Gabriel Di Blasi
outlines the existing
impediments to
developing new
biotechnology
products in Brazil,
and considers recent
efforts to improve the
situation.
The Brazilian government intends to
improve regulation for patents, especially
in the biotechnology sector. Last March, the
Brazilian Minister of Development, Industry
and Foreign Trade announced measures
to improve the Brazilian regulations
related to patents, especially in the field
of biotechnology, mainly with regard to
changing the rules of IP law and permits for
research in biotech.
The ultimate purpose of these changes is to
enhance opportunities for researchers and
investors in biotech, providing full access
to Brazilian genetic resources, as well as
the development of related inventions,
but the current legislation presents several
bureaucratic hurdles that may hamper the
development of the patent process.
Currently, the regulating laws of this matter
are: i) Industrial Property Law No. 9,279 of
1996; ii) Provisional Measure No. 2,186-16 of
2001, which regulates access to the Brazilian
genetic heritage; and iii) Resolution No. 69 of
2013 of the Brazilian patent and trademark
office (INPI), which deals with patents
derived from the genetic heritage.
Provisional Measure No. 2,186-16, which
focuses on protecting biodiversity against
bio-piracy, was enacted at the beginning of
the last decade, because the number of cases
related to the use of Brazil’s natural resources
without control had increased considerably.
According to the Provisional Measure, in order
to collect, access and, if necessary, send abroad
any Brazilian genetic resource, the user must
obtain the necessary authorisations from the
relevant Brazilian entities, such as the Genetic
Heritage Management Council (CGEN) and
the Brazilian Institute for the Environment
and Renewable Natural Resources (IBAMA).
It means that almost any manipulation
requires public authorisation.
As stated in this Provisional Measure, genetic
resource means any genetic information
contained in samples of the whole or part of a
plant, fungal, microbial or animal specimen,
in the form of molecules and substances of
the metabolism of these living beings and of
extracts obtained from these living or dead
organisms, found in situ conditions, including
domesticated or kept in ex situ collections,
provided they were collected within the
Brazilian national territory, on the continental
shelf or in the exclusive economic zone.
In addition, the Provisional Measure regulates
access to genetic resources, the obtaining
of genetic component samples for scientific
research, technological development and bio-
“The applicant for
a patent the object
of which has been
obtained as a result
of access to samples
of components of
genetic heritage, must
inform the INPI of
the origin.”
prospecting purposes, with the ultimate aim
of industrial application.
In order for a company to use a Brazilian
genetic resource for the development of a
product, several steps have to be followed.
First, it is necessary to obtain, through
a corresponding research institution, an
authorisation to collect samples at the
IBAMA through the system of authorisation
and information on biodiversity (SISBIO).
This system is responsible for providing
users with authorisation to collect biological
material within the Brazilian territory.
After overcoming this step at SISBIO, the
user has to request authorisation for access
to genetic resources before the CGEN. Also,
with regard to scientific research, it will
be necessary to deposit a sample with the
accredited depositary authority. It is worth
mentioning that foreign companies cannot
directly carry out this research. In other
words, it is necessary to be associated with a
CGEN-accredited entity such as a Brazilian
university or company, through formal
agreements for this purpose.
Further authorisations are necessary, such
as permission from Brazilian communities
(indigenous, native-born or the owner of the
area), if the genetic resource is to be collected
or accessed at this place.
However, in the event that any commercial
component in the research arises, besides the
request for authorisation to access the genetic
resource, it will be necessary to execute several
documents, such as an agreement for benefit-
sharing resulting from the sale of the products
with the community or owner of the area where
the material will be accessed. Also, there is the
need to execute a statement of material transfer
and the deposit of the sample, obtained at an
entity accredited by the CGEN.
All these procedures can take nearly three
years, and only after fulfilling all of them
can the company or university carry out the
research and development of the genetic
resource.
LSIPR Newsletter 07:13
LEGAL UPDATE
23
www.lifesciencesipreview.com
in due time, are subject to large fines from
the Brazilian government, which is ultimately
inhibiting and preventing the development of
the biotech sector in Brazil.
Provisional Measure No. 2,186-16 has not
only raised a number of obstacles preventing
universities, researchers and companies accessing
genetic resources for research and development,
but has also prevented new domestic and foreign
investments in biotechnology in Brazil.
Therefore, considering that Brazil is one of the
countries with the greatest natural resources for
research and bio-prospecting, there is a need to
change the current rules and procedures related
to obtaining authorisation for the collection
of and access to genetic resources in order to
develop new biological products, and to share
benefit from such access.
In order to change this scenario, and since
Brazil is becoming more attractive for
domestic and foreign investment in the
biotechnology field, the Brazilian Ministry of
the Environment along with other players in
Brazilian industry, including pharmaceutical
companies, research entities and associations
of industries, is engaged and committed to
“Companies that use
a genetic resource
in their products
or technologies
without holding
the authorisation to
collect or access it
or not receiving the
authorisation in due
time, are subject to large
fines from the Brazilian
government, which is
ultimately inhibiting
and preventing the
development of the
biotech sector in Brazil.”
elaborate a bill for the collection and access
to Brazilian genetic resources.
Recent reform
The idea is to review legal and technical
concepts, simplifying the procedure
to apply for an authorisation to collect
and access genetic resources, as well as
material transfer and depositing a sample,
giving the opportunity to regularise
pending authorisations for collection and
access, including cases related to patent
applications, to expedite the examination of
the authorisation by CGEN, and bring more
transparency to the benefit-sharing rules.
The new legislation intends to reduce
bureaucracy and the time taken to grant
authorisations for collecting and having
access to the genetic resource. Moreover,
it will improve the landscape of biotech in
Brazil, promoting the use of genetic resources
for the benefit of several sectors, including
biofuel, feed in general, and drugs.
Q
Gabriel Di Blasi is a senior partner of Di Blasi,
Parente & Associados. He can be contacted at:
gabriel.diblasi@diblasi.com.br
In parallel, regarding the effects on
patent applications related to products or
processes derived from a genetic resource,
such applications must demonstrate the
corresponding authorisations, otherwise the
INPI cannot examine the patent application,
leading to its shelving. According to Article
31 of Provisional Measure No. 2,186-16, duly
regulated by INPI Resolution No. 69 of 2013,
the applicant for a patent the object of which
has been obtained as a result of access to
samples of components of genetic heritage,
as of June 30, 2000, must inform the INPI
of the origin of the genetic material and the
corresponding access authorisation.
Nevertheless, in view of the bureaucratic
burden, most genetic resources used in
patent applications in this technological
field have not been authorised by CGEN
or IBAMA. Thus, in view of the lack of
authorisation, the vast majority of patent
applications are going to be shelved.
Finally, companies that use a genetic
resource in their products or technologies
without holding the authorisation to collect
or access it or not receiving the authorisation