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PATENT PROSECUTION STRATEGY IN BRAZIL
Daniela Fasoli (dfasoli@clarkemodet.com.br)

IP LEADERS IN SPANISH AND PORTUGUESE SPEAKING COUNTRIES
AGENDA
 Brazil
 Key Protection Issues
 Backlog and best practice to accelerate granting of
patents
 Recent developments in Pharma cases - ANVISA

YOUR GATEWAY TO LATIN AMERICA

© 2013 Clarke, Modet & Cº
BRAZIL

YOUR GATEWAY TO LATIN AMERICA

© 2013 Clarke, Modet & Cº
Brazil

Population
193,946,886

Surface
8,515,767 km2

Inflation
5.84% (2012)

Gross Domestic Product (PIB)
US$ 4.4 trillions (2012)

PIB per capita
US$ 12,144 (2011)

Unemployment rate
5.4% (September 2012)

YOUR GATEWAY TO LATIN AMERICA

© 2013 Clarke, Modet & Cº
PATENT PROSECUTION

YOUR GATEWAY TO LATIN AMERICA

© 2013 Clarke, Modet & Cº
Term of Protection &
Patentability Requirements

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




Inventive Step / Activity



Industrial Application


YOUR GATEWAY TO LATIN AMERICA

Novelty

Sufficient Description (?)
© 2013 Clarke, Modet & Cº
Non-Statutory Subject-Matter
The following subject-matter is not considered to be
protected by a patent:


Discoveries, scientific theories and mathematical models



Abstract Conceptions



Business Methods



Literature, Architectural, Artistic and Scientific Works



Computer Programs



Game Rules



Therapeutic or diagnostic methods (humans or animals)



Essentially biological processes. Natural living beings, in
whole or in part, and biological material, when found in
nature or isolated therefrom

YOUR GATEWAY TO LATIN AMERICA

© 2013 Clarke, Modet & Cº
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

YOUR GATEWAY TO LATIN AMERICA

© 2013 Clarke, Modet & Cº
Challenges in the Patent
Prosecution

Backlog

-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

YOUR GATEWAY TO LATIN AMERICA

© 2013 Clarke, Modet & Cº
How to accelerate the granting
of patents
 Potential infringement ;
 Applicant is 60 years old or older;
 The grant of the patent is a condition

for obtaining financial resources from
official national fostering or credit
institutions.
 National emergency or public interest

 green patents -pilot
 preliminary opinion on patentability-

pilot
 cases "of interest of" the National

Health System
 HIV, cancer and neglected tropical

diseases
YOUR GATEWAY TO LATIN AMERICA

© 2013 Clarke, Modet & Cº
ANVISA

YOUR GATEWAY TO LATIN AMERICA

© 2013 Clarke, Modet & Cº
ANVISA - events

ANVISA

Law 10.196/01
Union's Attorney General (AGU) opinion
- public health issues
Report from the IP Inter-ministerial Working
Group - New flow
New resolution RDC 21/2013

Civil Action aiming at the nullity of AGU’s Opinion
is dismissed by the first instance's judge

YOUR GATEWAY TO LATIN AMERICA

© 2013 Clarke, Modet & Cº
Argentina - Brasil - Chile - Colombia - Mexico - Portugal - Peru – Spain - Uruguay - Venezuela
© 2013 Clarke, Modet & Cº. . All rights reserved. Clarke, Modet & Co. refers to the network of subsidiaries of Clarke, Modet y Compañía S.L. each of which is a separate and independent legal entity

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Patent Prosecution Strategy in Brazil - Daniela Fasoli - Senior Patent Attorney Clarke, Modet & Cº Brazil

  • 1. PATENT PROSECUTION STRATEGY IN BRAZIL Daniela Fasoli (dfasoli@clarkemodet.com.br) IP LEADERS IN SPANISH AND PORTUGUESE SPEAKING COUNTRIES
  • 2. AGENDA  Brazil  Key Protection Issues  Backlog and best practice to accelerate granting of patents  Recent developments in Pharma cases - ANVISA YOUR GATEWAY TO LATIN AMERICA © 2013 Clarke, Modet & Cº
  • 3. BRAZIL YOUR GATEWAY TO LATIN AMERICA © 2013 Clarke, Modet & Cº
  • 4. Brazil Population 193,946,886 Surface 8,515,767 km2 Inflation 5.84% (2012) Gross Domestic Product (PIB) US$ 4.4 trillions (2012) PIB per capita US$ 12,144 (2011) Unemployment rate 5.4% (September 2012) YOUR GATEWAY TO LATIN AMERICA © 2013 Clarke, Modet & Cº
  • 5. PATENT PROSECUTION YOUR GATEWAY TO LATIN AMERICA © 2013 Clarke, Modet & Cº
  • 6. Term of Protection & Patentability Requirements 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   Inventive Step / Activity  Industrial Application  YOUR GATEWAY TO LATIN AMERICA Novelty Sufficient Description (?) © 2013 Clarke, Modet & Cº
  • 7. Non-Statutory Subject-Matter The following subject-matter is not considered to be protected by a patent:  Discoveries, scientific theories and mathematical models  Abstract Conceptions  Business Methods  Literature, Architectural, Artistic and Scientific Works  Computer Programs  Game Rules  Therapeutic or diagnostic methods (humans or animals)  Essentially biological processes. Natural living beings, in whole or in part, and biological material, when found in nature or isolated therefrom YOUR GATEWAY TO LATIN AMERICA © 2013 Clarke, Modet & Cº
  • 8. 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 YOUR GATEWAY TO LATIN AMERICA © 2013 Clarke, Modet & Cº
  • 9. Challenges in the Patent Prosecution Backlog -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 YOUR GATEWAY TO LATIN AMERICA © 2013 Clarke, Modet & Cº
  • 10. How to accelerate the granting of patents  Potential infringement ;  Applicant is 60 years old or older;  The grant of the patent is a condition for obtaining financial resources from official national fostering or credit institutions.  National emergency or public interest  green patents -pilot  preliminary opinion on patentability- pilot  cases "of interest of" the National Health System  HIV, cancer and neglected tropical diseases YOUR GATEWAY TO LATIN AMERICA © 2013 Clarke, Modet & Cº
  • 11. ANVISA YOUR GATEWAY TO LATIN AMERICA © 2013 Clarke, Modet & Cº
  • 12. ANVISA - events ANVISA Law 10.196/01 Union's Attorney General (AGU) opinion - public health issues Report from the IP Inter-ministerial Working Group - New flow New resolution RDC 21/2013 Civil Action aiming at the nullity of AGU’s Opinion is dismissed by the first instance's judge YOUR GATEWAY TO LATIN AMERICA © 2013 Clarke, Modet & Cº
  • 13. Argentina - Brasil - Chile - Colombia - Mexico - Portugal - Peru – Spain - Uruguay - Venezuela © 2013 Clarke, Modet & Cº. . All rights reserved. Clarke, Modet & Co. refers to the network of subsidiaries of Clarke, Modet y Compañía S.L. each of which is a separate and independent legal entity