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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

Brazilian Legal Infrastructure for further developing the Biotechnology/Innovation Industry

Edson Beas Rodrigues Jr.

Buenos Aires, September 29, 2006

relevant legal texts
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
slide3
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
Impacts of the Legal Framework

Depletion of the Scientific Commons in Brazil

after the 10th anniversary of the industrial property code should we celebrate
After the 10th anniversary of the Industrial Property Code, Should we celebrate?

Brazilian Biotech. Industry: Facts and Figures

slide6
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

slide7

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

slide14

Despite strong Governmental investments,

Stringent standards of patentability, the Brazilian biotech.

Industry is struggling to emerge .

But there are exceptions: BIOMINAS, CIATEC, etc.

slide15

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

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
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.)
foundations18
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
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