Challenges in the Patent Prosecution in Brazil: - Opportunities - Intellectual Properties Developments - Term of Protection & Patentability Requirements - Challenges in the Patent Prosecution - New Prosecution Flow for Pharma related inventions

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PATENT PROSECUTION STRATEGY IN BRAZIL
Igor Simões

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BRAZIL

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Population
193,946,886
Surface
8,515,767 km2
Inflation
5,84% (2012)
Gross Domestic Product (PIB)
US$ 2,367 trillions (2011)
PIB per capita
US$ 12,144 (2011)
Unemployment rate
5,4% (September 2012)
Brazil

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 Brazilians have seen changes in the Brazilian Regulatory
Framework for the Electricity Business, forced control of
gasoline prices and expansion of domestic credit.
 Brazil's Finance Minister, Mantega, expects GDP results for
2013 would show growth of at least 4%.
 Brazil leads the ranking of attractiveness for establishing
operations in Latin America.
Source: VALOR ECONÔMICO Newspaper
August 8th, 2012
Brazil 2012 Facts - Overview
 Brazil is the second most popular destination in the world in value of FDI (foreign direct
investment) and fifth in number of projects.
Global FDI
(US$ trillions)
Source: UNCTAD
 Brazil has experienced payroll exemption for many sectors,
fall of the Selic rate at its record low, tax reduction and
reduction in banking spreads.

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Coprights: FernandoAH
Brazil - Opportunities
 A growing middle class, strong domestic demand and great
unexplored reserves of natural resources.
 Government policy incentives, simplification of licensing
procedures and the regulatory environment.
 Brazil will host the 2014 FIFA World Cup and the 2016 Olympics.
 A large domestic market and growth path of long-term.
Source: VALOR ECONÔMICO Newspaper
August 8th, 2012

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Source: THE ECONOMIST. Print Edition
November 3rd, 2012
 Today Brazil’s laws on patents, copyright and
trademarks are in line with other big trading
nations.
 Software and music piracy is slowly declining in
Brazil.
 The discovery of oil in ultra-deep waters offshore
has helped to change attitudes.
 Firms drilling in the new fields must spend 1% of
gross revenues locally on research and development.
 More judges now understand intellectual-
property law, and an appeal court has been set
up in Rio de Janeiro to handle such cases.
 2004 law granted universities greater rights to
exploit spin-offs from publicly funded research.
Brazil 2012 – IP Developments

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PATENT PROSECUTION

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 Novelty
 Inventive Step
 Industrial Application
 Sufficient Description (?)
Invention 20 years from the filing date OR 10 years from
the date of grant, which is the longer*
Utility
Model
15 years from the filing date OR 7 years from the
date of grant, which is the longer
Term of Protection &
Patentability Requirements

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▪ Product;
▪ Process;
▪ Product directly obtained from a process
(product by process claims) - ?
▪ Use claims
▪ Second use claims?
• Mechanisms of action
• Relationship between therapeutic
activity and chemical structure
• Etiologies of target diseases
▪ Polymorphs?
Protection

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The following are not considered to be inventions or utility models:
I - discoveries, scientific theories and mathematical models;
II - purely abstract concepts;
III - schemes, plans, principles or methods of a commercial,
accounting, financial, educational, publishing, lottery or fiscal nature;
IV - literary, architectural, artistic and scientific works or any
aesthetic creation;
V - computer programs per se;
VI - presentations of information;
VII - rules for games;
VIII – operating or surgical techniques and therapeutic or diagnostic
methods, for use on the human or animal body; and
IX - natural living beings, in whole or in part, and biological material,
including the genome or germ plasm of any natural living being, when
found in nature or isolated therefrom, and natural biological
processes.
Protection

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Challenges in the Patent
Prosecution
Amendments
Due to a “strict” position adopted by
the Brazilian Patent Office, any
amendment that extend or change the
scope of protection of the
invention, performed in the set of
claims after requesting examination, is
being objected by the BRPTO.
Divisional applications?
Best/Safest Practices

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Challenges in the Patent
Prosecution
Backlog Patent applications filed in ~2002 are starting
to be examined
-New team of examiners (2013)
- 5 different lines for examination:
1. Utility models
2. First filing in Brazil (non PCT)
3. PCT with Brazil as International Authority
4. other PCTs
5. e-PEC applications (Argentina, Chile,
Colombia, Ecuador, Paraguay, Peru, Suriname,
Uruguay
First choice in the lines: priority examination,
green patents (pilot), preliminary opinion on
patentability (pilot)

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ANVISA

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New Prosecution Flow for Pharma related
inventions

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ANVISA – public consultation
The patent application is considered contrary to public
health when:
I - The pharmaceutical product or process involved in the
application is a risk to health;
II - The product or process is of interest to pharmaceutical
policies for access to medicines and pharmaceutical care
within the SUS and does not meet the patentability
requirements and other criteria established by the IP Law

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