Brazil: Anvisa's Interference In Brazilian's Patent Prosecution: Is It Coming To An End?

Last Updated: 11 May 2017
Article by Luisa R. Castro and Silvia Costa

Historic on ANVISA/BRPTO double tier examination in Brazil

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) was executed in 1994 as a result of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT). Among several other topics, such Agreement ruled the inclusion of several technological fields as patentable statutory matter in countries that previously did not recognized the same; one remarkable example was the pharmaceutical patents in Brazil.

Brazilian Law 10.196 dated February 14, 2001 modified Law 9.279/96 (Brazilian IP Law) including a provision that establishes that the allowance of pharmaceutical patents requires the prior consent from ANVISA (Brazilian Health Surveillance Agency – equivalent to American FDA) along with the usual examination performed by the Brazilian Patent Office (BRPTO).

Although the BRPTO and most experts claimed that ANVISA's analysis should be limited and focused on a "health risk" analysis, ANVISA has been always analyzing patentability requirements in addition to the analysis on what is contrary/unsafe to health (the so-called "health risk" analysis).This led to a double tier examination procedure, in which both autarchies analyze the patentability requirements of the same patent application. In view of that, both federal authorities has been in a dispute since then for the role of examining patents.

At the first moment, the applications were analyzed by the BRPTO and if such autarchy understood that the application complied with the patentability requirements, the case was sent to ANVISA for the prior consent analysis, i.e. to a re-examination of the same patentability requirements.

In case of conflicting results, (i.e. the BRPTO considered the case as patentable and ANVISA disagreed), filing Lawsuits against ANVISA's decisions was the only available option to get the case granted.

In 2012, a new workflow for the examination of the pharmaceutical patents was established by Ordinance 1065 of May 25, 2012 developed by a Working Group formed by several Brazilian Ministries. Such workflow is in force until today and defines that a pharmaceutical application should be sent to ANVISA for prior consent before being examined by the BRPTO and, in case ANVISA denies the prior consent, this application should be returned to the BRPTO in order to be shelved, something that in practice never happened.

Inconsistencies between the patentability analysis of BRPTO and ANVISA

As mentioned above, not always the result of the double tier examination handled by ANVISA and by the BRPTO lead to the same result.

In this sense, it should be pointed out that the criteria for approving patents under ANVISA was never clear to the applicants nor to the BRPTO since ANVISA has never published examination Guidelines.

In fact, according to RDC 21/2013, rule that guided ANVISA's analysis during these years, not all pharma patent applications should be examined. Prior consent should be denied to:

  • applications disclosing a pharmaceutical product/process which involves a health risk; and
  • applications disclosing a pharmaceutical product/process of interest to the policies of the Brazilian public health care system (so called SUS), and that does not meet with the patentability requirements and other criteria established by Brazilian Law # 9.279/96

As per the rule above, it is clear that ANVISA usually analyzes the patentability criteria based on the called "public health interest", i.e., "of interest of SUS".

In this sense, it is important to point out that Brazilian Constitution of 1988 stablishes that it is mandatory for the Brazilian Government to provide free medicine to population, which, according to several experts, explains ANVISA's analysis.

On January 13, 2016 the BRPTO made a statement in a Lawsuit that Abbvie INC filed against ANVISA (in which Abbvie questions ANVISA's role to analyze patentability requirements related to KALETRA®) which seems to be the clearest and strongest assertion ever made by the BRPTO against ANVISA. Some of the most relevant BRPTO's assertions, were:

  • that the BRPTO feels discredited by ANVISA's patentability analysis;
  • that there are no legal basis assigning to ANVISA the responsibility of analyzing the patentability requirements;
  • that ANVISA itself issued a Resolution assigning such responsibility when there is an IP Law stating that such responsibility is of the BRPTO, thus contravening the Principle of Legality;
  • that in case the BRPTO is obliged to publish the definitive shelving of a patent application in consequence of an ANVISA's decision of denying the prior consent, such procedure would not allow the submission of an appeal (since the BRPTO would not be entitled to review ANVISA's Technical Report) and, thus, this would contravene Brazilian IP Law

Recent legal decisions

In 2015, the ABBVIE INC. filed a Lawsuit requesting a preliminary injunction to withdraw ANVISA's decision of denying the prior consent of patent applications PI0609173-3 and BR122012002864-9 which refer to KALETRA® as indicated above.

The company argued that ANVISA does not have the right of analyzing patentability requirements and the prior consent must be restricted solely to aspects related to public health, for instance, if the subject matter of the application refers to a substance prohibited in Brazil. As indicated above, the BRPTO applied for his entry as an interested third party and file an amicus curiae brief defending that BRPTO is the only autarchy authorized to evaluate patentability criteria.

Federal judge Márcia Nunes rejected the arguments of the Plaintiff and denied the preliminary injunction. The Plaintiff file an interlocutory appeal requesting an advance relief, which was granted by the Superior Court Judge. However, this decision was shortly thereafter reverted and the final decision of the subsequent appeal is pending.

Still on this matter, in later 2016, ABBVIE BIOTECHNOLOGY LTD. filed a similar Lawsuit requesting a preliminary injunction to annul the ANVISA's decision of denying the prior consent of applications BR1120130116994, PI0920027-4 and PI0716762-8 that covers HUMIRA®.

The company filed identical arguments in this case, and Federal Judge Caroline Somensom granted the injunction and compelled ANVISA to grant the prior consent of said applications and send the files back to the BRPTO for examination.

Although in some cases the decision is unfavorable to the Plaintiff, the jurisprudence is far favorable for decisions annulling the denial of prior consent of ANVISA. The judges who are favorable to ANVISA's interference in the double tier examination of patentability requirements seem to be a minority.

The opinion of the Union's Attorney General (AGU)

In March 27, 2015, an opinion of the Federal Attorney General's Office (0006/2015- AGU/PGF/PFE/INPI/COOPI-LBC-1.0) was approved by the chief prosecutor. Said opinion established the BRPTO's procedure over applications that were submitted to ANVISA's prior consent analysis. In this sense, the scenarios are the following:

  1. If ANVISA denies the prior consent based on patentability criteria, the BRPTO should consider the ANVISA's opinion as third parties' observation and BRPTO's examiners may or may not take into consideration the content thereof;
  2. If ANVISA denies the prior consent based solely in public health criteria, the BRPTO should definitively shelve the application

It is important to highlight that the above mentioned Federal Attorney General's Office opinion was clear in indicating that these procedures are valid for applications of both flows, i.e., applications that are examined by the BRPTO before the ANVISA stage (previous workflow) and applications that will be examined by the BRPTO after the ANVISA stage (new workflow).

In view of said document, the BRPTO issued (on April 20, 2016) the memorandum MEMO/INPI/DIRPA/Nº 055/2016 that ratifies the understanding of the Federal Attorney General's Office opinion, however it would be applied only to applications classified as being in the previous flow.

Despite the above, so far the BRPTO did not change its practice, and the applications for which ANVISA evaluated patentability requirements (denying or not the prior consent) are in a limbo state, i.e., the BRPTO is keeping then in standby.

Recent developments

Faced with the impasse that emerged from differences in the understanding of the attributions of each of the government agency, the BRPTO and ANVISA finally reached an agreement whose terms were defined by Joint Ordinance 01/2017 (April 12, 2017). Said ordinance defined the responsibilities of each entity in the examination of pharmaceutical patent applications.

As announced, the new workflow would determine that ANVISA will be responsible for the analysis of aspects related to public health and, then, the BRPTO would evaluate patentability criteria. The denial of ANVISA's prior approval should be issued only when pharmaceutical product comprises, or the pharmaceutical process results in, a substance whose use has been prohibited in Brazil. In this case, the application will return to BRPTO to be definitively shelved.

Patent applications containing a pharmaceutical product or process considered to be of interest of SUS may have the patentability criteria analyzed by ANVISA, however, the opinion issued by said agency will be considered as third party observations for the BRPTO examination.

In view of the above, this impasse between ANVISA and BRPTO seems to have ended by definitively defining the role of each autarchy. The Brazilian patent community is closely following the developments of this Joint Ordinance 01/2017.

Clarke, Modet & Co - BRAZIL

Rio de Janeiro
Av. Marechal Câmara, 160, 12º andar (Ed. Le Bourget), RJ 20020-080
Tel: +(55-21) 3223-9500

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.

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
Related Articles
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