Brazil: Positive Advances In Brazil

Last Updated: 6 November 2013
Article by Luiz Leonardos and Ricardo Dutra Nunes

Luiz Leonardos and Ricardo Dutra Nunes review the legal framework for patents in Brazil and recent developments in the system.

The Brazilian patent system is one of the oldest: it was created more than 200 years ago, in 1809, by royal decree. Since then, the country experienced many changes in this area, with several developments in our legal framework having occurred in the recent past.

Our federal constitution was enacted in 1988, establishing that "the law will guarantee a temporary privilege of use to authors of industrial inventions, as well as the protection of industrial creations (...), in view of the social interest and the technological and economic development of the country". Brazil is also a member of most of the international treaties governing patent protection. In fact, the current patent statute (Law # 9.279/96) was enacted in 1996, just after Brazil became a member of the World Trade Organization in 1995. The current statute was important to adapt the local rules to the minimum standards established by the WTO-TRIPS Agreement. For that reason, the Brazilian patent statute is reasonably similar to the ones in force in the US, Europe, and other WTO-members, although its implementation by the Brazilian executive and judiciary powers can be quite different.

In addition to the Federal Constitution, international treaties, and the patent statute, patents are also governed by regulation and guidelines enacted by the INPI (National Institute of Industrial Property), analogous to the US Patent and Trademark Office and the European Patent Office, in charge of examining patent applications.

Since Brazil joined the WTO, the INPI must issue patents in all fields of technology, including the pharmaceutical area, which was not allowed in light of the previous legal framework. The INPI must issue a patent as far as the application discloses a technical solution to a technical problem, complies with the technical requirements – such as novelty, inventive step and industrial applicability – and is not prohibited by the statute.

The patent system

The statute establishes some matters are not considered as inventions, and cannot be subject to patent protection, such as discoveries, scientific theories, mathematical methods, abstract concepts, business methods, software per se, methods of treatment, methods of diagnostic, surgical techniques, and natural living beings and biological material found in nature or isolated thereof, for example. Some other matters are considered "not patentable", such as anything contrary to public safety, order or health, some products and processes resulting from the transformation of the atomic nucleus, and living beings, except for transgenic microorganisms that are not mere discoveries.

Brazil has a first-to-file system, with a priority scheme that assimilates the Paris Convention and a 12-month grace period for disclosures made by the inventor or third parties (including the INPI) based on information received directly or indirectly from the inventor or as a result of his acts. Where a patent is granted, it gives the patent owner the right to prevent third parties from manufacturing, using, offering for sale, selling or importing the invention without his consent, for a period of 20 years as from the filing date. The extension of the protection is conferred by the claims, which are construed based on the specification and drawings.

The statute also provides for a few exceptions to patent rights, such as the experimental use exception and the Bolar exception, the later related to acts performed for the sole purpose of producing test results and data in order to obtain marketing registration for the patented product after the patent expires, which is especially relevant in case of pharmaceutical patents. Although extremely rare, a patent might be subject to compulsory licensing in some very specific circumstances.

Patent lawsuits in Brazil

In Brazil, patent infringement lawsuits are filed by the patent owner before state trial courts. Preliminary ex parte injunctions are available, allowing the trial court judge to immediately order the defendant to stop using or selling the patented invention, to conduct searches and seizures, or to order a recall of the infringing products, for instance. Depending on the amount of evidence the plaintiff presents with the complaint, to show the plaintiff will most likely prevail on the merits and that they may suffer irreparable harm – or a harm that is hard to repair – in cases where the injunction request is not granted, it is possible to obtain a preliminary ex parte injunction order in less than 24 hours after filing the case, as we have managed to obtain in the past on behalf of our clients. Declaratory non-infringement lawsuits are also available and must be filed before state trial courts as well.

Lawsuits challenging an act performed by the INPI, such as a decision issuing or rejecting a patent application, on the other hand, are typically filed before a federal district court in the city of Rio de Janeiro, where we have our main offices. Because the city has specialized district and appellate courts to deal with intellectual property matters, each case is randomly assigned to one of its four specialized IP district courts, and each appeal is assigned to one of its two specialized appellate divisions. We have learned from our experience that most of the few district court and appellate judges in charge of those cases in Rio de Janeiro are in general reluctant to overrule a decision issued by the INPI, and are frequently considered anti-patent judges. In light of that, our law firm developed an innovative – and successful – forum-shopping strategy to be able to file those lawsuits in Brasilia, our federal capital, where one of its more than fifty non-biased federal district court judges will deal with the case.

Data package exclusivity

In recent years, our law firm has also pioneered filing lawsuits to enforce our clients data package exclusivity rights, provided for both by the TRIPS Agreement and the local provisions regarding unfair competition. Such rights are especially relevant to research-based pharmaceutical companies, who must submit a huge amount of information to the ANVISA (the Brazilian Food & Drug Agency) to demonstrate their innovative products are safe and effective. In some situations, enforcing the mentioned data package exclusivity rights is the only way to avoid the free riding performed by generic industries seeking to rely on the innovator company's data package to obtain marketing approval to their generic versions, instead of performing their own clinical trials.

Another recent major change that affects pharmaceutical companies in Brazil is the new patent prosecution procedure for the analysis of pharmaceutical patent applications. Since the last decade, pharmaceutical patents cannot be issued without the ANVISA's prior consent. Until now, the INPI would examine a pharmaceutical application and forward it to the ANVISA only in cases where the examination performed by the INPI determined that the patentability requirements were met. There is no legal provision, however, expressly regulating the basis for the ANVISA to grant or reject its prior consent with regard to a patent application. Until recently, the ANVISA was insisting on reexamining the patentability requirements already examined by the INPI, denying prior approval in cases where it disagrees with the technical opinions issued by the INPI.

Two years ago, after our law firm filed many lawsuits on behalf of our clients to challenge such illegal understanding, the Attorney General's Office issued an opinion clarifying that the patentability analysis should only be performed by the INPI, and that the ANVISA should grant or deny prior approval exclusively based on issues related to public health. To avoid further controversy, the government decided to change the procedure with regard to pharmaceutical applications. Now, the application is filed with the INPI, which immediately forwards it to the ANVISA if the application is related to a pharmaceutical product or process. Subsequently, the ANVISA will examine the application in light of public health issues, granting or rejecting its prior approval. The application will then be returned to the INPI, which will shelve the application if the prior approval is denied by the ANVISA, or perform the examination of the patentability requirements if the prior approval is granted by the ANVISA, eventually issuing or denying the patent.

INPI activities

In recent years, the INPI has also taken a few important measures that affect the patent system. First of all, the INPI is doing a decent job at dealing with the huge backlog, even though its more than 400 patent examiners still take an average of 5.4 years to examine a patent application after an examination request is filed. The INPI's objective is to hire more patent examiners to decrease the average examination time to four years. This is crucial, especially because in some fields of technology, such as chemical, biotech and electric, an applicant might still have to wait more than ten years to have their patent application duly examined. Part of the success in dealing with the backlog was due to a modernization of the INPI's workflow and IT structure. Now a portion of its office actions are available online, and the INPI has just launched a system that will soon make it possible to file a patent application online.

In an attempt to contribute to the development of innovative green technologies, the INPI developed in April a fast-track procedure to examine some patent applications related to alternative energies and energy conservation, transportation, waste management and agriculture. This expedite procedure is already available and can dramatically reduce the time taken by the INPI to examine the application. Also, the INPI created a new optional procedure for applications originally filed in Brazil, allowing the applicant to request the INPI to perform a preliminary analysis and issue a preliminary opinion with regard to the patentability requirements. This preliminary opinion might be relevant to give the applicant more information about their chances of ultimately obtaining a patent.

In addition to that, the INPI drafted new general guidelines for the examination of patent applications, and society is currently reviewing this first draft to suggest insertions and adjustments. The INPI also drafted new guidelines for the examination of polymorphs, providing applicants with more legal certainty in this sophisticated field that was deemed to be a grey area before the specific guidelines were published, since some specialists were trying to sustain that polymorphic inventions were not patentable.

In spite of the many challenges faced by national and foreign companies with regard to the ever evolving Brazilian patent system, the country has witnessed some positive advances in recent years, as the executive, legislative and judiciary powers understand the importance of having a vigorous and practical structure that stimulates the technological and economic development of the country.

Originally published in The Patent Lawyer.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

Similar Articles
Relevancy Powered by MondaqAI
DANIEL Legal & IP Strategy
Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Related Topics
Similar Articles
Relevancy Powered by MondaqAI
DANIEL Legal & IP Strategy
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of

To Use you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions