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Brazilian Legal Infrastructure for further developing the Biotechnology/Innovation Industry. Edson Beas Rodrigues Jr. Buenos Aires, September 29, 2006. Relevant Legal Texts. Industrial Property Code as of 1996
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Brazilian Legal Infrastructure for further developing the Biotechnology/Innovation Industry Edson Beas Rodrigues Jr. Buenos Aires, September 29, 2006
Relevant Legal Texts • Industrial Property Code as of 1996 • Outcome: Expansion of the scope of patentability – more stringent standards of protection. • Theoretical beneficiaries: Biotech. and Pharma industry
INPI patentability guidelines on the biotech. and pharmaceutical fields: further expansion of the scope of patentability established by the Industrial Property Code Brazilian patentability guideline -> similar to the USPTO/EPO guidelines
Impacts of the Legal Framework Depletion of the Scientific Commons in Brazil
After the 10th anniversary of the Industrial Property Code, Should we celebrate? Brazilian Biotech. Industry: Facts and Figures
AGE OF BIOTECH FIRMS 1 to 3 years – start ups after 2000 = 3 (13%) 3 to7 years – New companies (after 96 – before 99 = 6 (26,1%) 7 years and more – Mature companies= 14 (untill 1996) = 60.9% Source: FINEP 2003
The Myth of more R&D and Foreign Direct Investment in R&D ORIGIN OF CAPITAL AND R&D BIOTECH INVESTMENTS source: DPP FINEP (2003) Derengowski
Despite strong Governmental investments, Stringent standards of patentability, the Brazilian biotech. Industry is struggling to emerge . But there are exceptions: BIOMINAS, CIATEC, etc.
2004 – shift in innovation policy Innovation Act – similar to the US Bayh Dole Act Innovation became a byword of IP entitlements
Foundations of the Innovation Act Foundations of the Innovation Act • Strategic alliances between public research organizations (Universities) and Companies Important: 90% of all scientists and qualified human resources are in the public University
Foundations • Universities and Public Research Centres have the legal obligation of setting up Offices of Transfer of Technology • Possible drawback: the draining of Public Resources. (R. Nelson and the US Bayh-Dole Act.)
FOUNDATIONS • Scientists involved in the projects are entitled to co-own of innovations and to receive from 5% to 33% of the royalties arising from the commercialization of the innovations • Private and Public enterprises based in Brazil are entitled to use the premises and laboratories of public universities and public research centers • Scientists are allowed to leave Universities and work in the private sector
Conclusions – Brazilian case study • Strong IP standards do not necessarily generate more R&D and innovation (J.Lerner) • The stronger the IP standards are, the heavier will be the transactions costs • Innovation Act may be a good stimulus, but it doesn´t tackle the challenge of developing products for the neglected needs of the South. Who are the real stakeholders of Innovation policies? • Need for independent IP policies in developing countries