Patent Filing in Brazil and Protection Strategies
Gustavo de Freitas Morais
October 2013
[email protected]
dannemann.com.br
2013 Dannemann Siemsen. All rights reserved.
©©
2013 Dannemann Siemsen. All rights reserved.
1
Global PCT applications
vs
Brazilian patent applications
dannemann.com.br
© 2013 Dannemann Siemsen. All rights reserved.
2
Statistics on
Brazilian patent applications
dannemann.com.br
© 2013 Dannemann Siemsen. All rights reserved.
3
The Brazilian PTO
 Main current problem: patent backlog
 Faster prosecution expected in view of new examiners
 Fast track
• Potential infringement cases (warning letter to the alleged infringer)
 Article 40 of IP Law – 20 years from filing OR 10 years as of grant, whichever expires later
dannemann.com.br
© 2013 Dannemann Siemsen. All rights reserved.
4
ANVISA’s prior consent

Provisional Measure Nº 2006 of Dec 14, 1999

Law Nº 10,196 of Feb 14, 2001 
Art. 229‐C  “grant of patents to pharmaceuticals products and processes are subject to prior approval by ANVISA”
dannemann.com.br
© 2013 Dannemann Siemsen. All rights reserved.
5
Recent developments

Attorney General’s Office (AGU) Opinions:

Opinions Nº 210/PGF/AE/2009 and Nº 337/PGF/EA/2010 



Anvisa’s examination should be restricted to public health issues
Not yet signed by the Brazilian President and therefore not binding
Recent decisions from the Federal Courts in Rio and Brasilia
Report of interministerial group stating that patent applications should be sent first to Anvisa

Anvisa’s resolution 45/2008: regulates the administrative procedure

Anvisa’s ordinance nº 1.284 of May 26, 2010 – strategic drugs

Anvisa’s resolution 21/2013: define the criteria for analyzing a patent application
dannemann.com.br
© 2013 Dannemann Siemsen. All rights reserved.
6
Proposed Prior Consent Flow Chart
Administrative appeal or law suit
INPI
Application
Filing
Formal Examination Pharmaceutical Product or Process?
NO
Examination on the merits
Official INPI Publication in Patent Gazette
YES
Application is officially closed 0
and shelved
Application Sent to ANVISA for Review
ANVISA
Examination –
Review of Sanitary Effects on Public Health
Prior Consent?
Patent Application Returned to INPI
YES
Official Publication Granting Prior Consent
NO
dannemann.com.br
Patent Application Returned to INPI
© 2013 Dannemann Siemsen. All rights reserved.
Official Publication of Refusal to Grant Prior Consent
7
New rules for the analysis of pharmaceutical patent applications 
A pharmaceutical patent application is considered to be contrary to public health when its subject matter:
i.
is related to a substance which use has been prohibited in Brazil

ii.
is considered strategic for the Brazilian Universal Healthcare System (SUS), and does not comply with the requirements under Brazilian IP Law


The prohibited substances are listed in List F of Ordinance # 344/1998 from the Brazilian Ministry of Health
Ordinance # 1284/2010 from the Brazilian Ministry of Health: a product of high social significance or of high technological or economic value is considered strategic for SUS
A pharmaceutical patent application not related to (i) or (ii) will not undergo an examination on the merits by ANVISA and prior consent will be granted
dannemann.com.br
© 2013 Dannemann Siemsen. All rights reserved.
8
Litigation overview
Brazilian court system
 Dual structure
 IP rights infringement – State courts
 IP validity – Federal courts dannemann.com.br
© 2013 Dannemann Siemsen. All rights reserved.
9
Infringement actions
State courts
 Venue
 Generally defendant seat
 Where infringement occurs
 No IP specialized courts except in  Rio de Janeiro and
 São Paulo (appeal level)
 State appeal courts at the capital of each state
 IP infringement ‐ Crime and tort
dannemann.com.br
© 2013 Dannemann Siemsen. All rights reserved.
10
Patent infringement action
Typical procedure
 Possible prior criminal or civil search & seizure of samples or inspection (including of documents)
 No discovery
 Complaint filed at state court
 Preliminary injunction request
 Interlocutory appeal  Expert examination
 Trial sentence
 Appeal
dannemann.com.br
© 2013 Dannemann Siemsen. All rights reserved.
11
Patent enforcement in Brazil ‐ Myths and truths
 Difficult to obtain legal remedies?
 PI granted in more than 50% of the cases
 Easy to design around?
 Broad claim interpretation
 Statutory infringement by equivalence
 Slow court procedure?
 Lack of expertise of the judges?
 Bias against foreigners?
dannemann.com.br
© 2013 Dannemann Siemsen. All rights reserved.
12
Patent infringement lawsuits involving pharmaceuticals
 Only 38 lawsuits all at the state courts of São Paulo
 30 against distributors to gallenic (or compound) pharmacists
 8 against local laboratories
 Almost all formulation patents  Infringement by equivalence
 All still under technical examination  Patents tend to be respected!
dannemann.com.br
© 2013 Dannemann Siemsen. All rights reserved.
13
Patent infringement lawsuits involving pharmaceuticals
 Good chances of success if infringement is clear
 However, difficulties may arise if the measures to be taken by patentee are similar to those currently being investigated by the Brazilian competition authorities
dannemann.com.br
© 2013 Dannemann Siemsen. All rights reserved.
14
Thank you ! | Obrigado !
Gustavo de Freitas Morais
October 2013
[email protected]
dannemann.com.br
2013 Dannemann Siemsen. All rights reserved.
©©
2012 Dannemann Siemsen. All rights reserved.
15