Brazilian legal infrastructure for further developing the biotechnology innovation industry
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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 l.jpg

Brazilian Legal Infrastructure for further developing the Biotechnology/Innovation Industry

Edson Beas Rodrigues Jr.

Buenos Aires, September 29, 2006


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Relevant Legal Texts Biotechnology/Innovation Industry

  • Industrial Property Code as of 1996

  • Outcome: Expansion of the scope of patentability – more stringent standards of protection.

  • Theoretical beneficiaries: Biotech. and Pharma industry


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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


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Impacts of the Legal Framework pharmaceutical fields: further expansion of the scope of patentability established by the Industrial Property Code

Depletion of the Scientific Commons in Brazil


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After the 10th anniversary of the Industrial Property Code, Should we celebrate?

Brazilian Biotech. Industry: Facts and Figures


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AGE OF BIOTECH FIRMS Should we celebrate?

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


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The Myth of more R&D and Foreign Direct Investment in R&D Should we celebrate?

ORIGIN OF CAPITAL AND R&D BIOTECH INVESTMENTS

source: DPP FINEP (2003) Derengowski


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BIOTECHNOLOGY PATENTS IN BRAZIL Should we celebrate?


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GENOMIC PATENTS IN BRAZIL Should we celebrate?




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Despite strong Governmental investments, Should we celebrate?

Stringent standards of patentability, the Brazilian biotech.

Industry is struggling to emerge .

But there are exceptions: BIOMINAS, CIATEC, etc.


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2004 – shift in innovation policy Should we celebrate?

Innovation Act – similar to the US Bayh Dole Act

Innovation became a byword of IP entitlements


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Foundations of the Innovation Act Should we celebrate?

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


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Foundations Should we celebrate?

  • 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.)


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FOUNDATIONS Should we celebrate?

  • 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


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Conclusions – Brazilian case study Should we celebrate?

  • 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


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