Brazil: Brazilian Patent Statute Under Attack: An Overview Of Potential Changes (Part V) – ANVISA's "Prior Approval" On Pharmaceutical Patents

Last Updated: 26 October 2015
Article by Carlos Aboim

There are currently 30+ bills pending before the Brazilian Congress that were drafted for the purpose of amending the Brazilian Patent Statute (Law # 9,279/96)1. The House of Representatives conducted a study that resulted in the proposal of bill 5402 in 2013 ("PL 5402/2013"). The bill, also known as the 'Patent Reform Bill', triggered much debate within the IP community due its provisions on the reform of patent law. One of the controversial provisions in the patent reform bill, would have the effect of strengthening ANVISA's powers to deny pharmaceutical patents in the prior approval examination.

I. Background and current status of ANVISA's prior approval

The requirement of prior approval by ANVISA for pharmaceutical patent applications was created by the Provisional Measure # 2.006, enacted by the Executive Branch of the Government in 2009.This provisional measure, which was later ratified and consolidated by Law # 10.196 of 2001, included the following paragraph "c" to Art. 229 of Law # 9,279/96:

Art. 229-c: The grant of patents on pharmaceutical products or processes shall depend on the prior approval of the National Sanitary Surveillance Agency (ANVISA)."

Since the enactment of Art. 229-c, there has been a conflict between the BPTO and ANVISA with regard to the application of this provision, which was also challenged by a great number of applicants before Federal Courts in respect of the scope of ANVISA's "prior approval". The Brazilian Patent Office maintains that it has exclusive competence to examine patentability requirements, and the great majority of judicial decisions have limited ANVISA's analysis to matters of public health2. However, there has been no decision from the Superior Court of Justice3 or the Supreme Court4 on the issue to date. Despite the overwhelming number of judicial decisions, ANVISA insists on examining patentability requirements arguing that such analysis is important to prevent a negative impact on public health.

II. The proposed new legislation on ANVISA's prior approval

The justification in bill 5402/2013 for the amendment of Art. 229-c is very specific. The aim of the bill is to provide ANVISA with the capacity to deny prior approval for pharmaceutical applications based on the very same analysis of patentability requirements performed by the Brazilian PTO. The bill states that "certain inquiries have been raised about ANVISA`s role in the prior approval exercise"5. It goes on to state that "the strengthening of ANVISA's participation in the process of granting patents will bring social, economic, and technological benefits for Brazil".

The explanation in the bill is that "the participation of ANVISA in the analysis of pharmaceutical patents, besides preventing the grant of numerous invalid patents, already corrected dozens of imprecisions in applications that, in the view of the BPTO, were ready to be granted". Critics say that the bis in idem on the assessment of patentability requirements by two government bodies is designed to establish a control in the prosecution of patents that could harm the interests of the "national industry", which has close ties with the Sanitary Surveillance Agency6.

Therefore, the "patent reform bill" proposes changes to the legal capacity of ANVISA and also in Art. 229-c in the Patent Law:

Law no. 9782/99:

Article 7. [The Sanitary Agency shall implement and enforce the provisions set forth under sections II through VII of Art. 2 of this Law, and the Agency shall:]

XXVIII – participate in the process of examination of patent applications for pharmaceutical products and processes, including the analysis of the patentability requirements and the other criterion set forth under the specific legislation." (Emphasis added)

Patent Act:

"Art. 229-c. The granting of patents for pharmaceutical products and processes shall depend on the prior consent from the National Sanitary Agency – ANVISA, that shall examine the object subject to the patent application in light of public health.

§ 1 – A patent application shall be considered as contrary to public health, according to further regulation, where:

I – the product or pharmaceutical process in the patent application presents a health risk, or

II – the patent application for pharmaceutical product or pharmaceutical process is of interest to an access to medicines policy or to a pharmaceutical care program under the National Health System – SUS, provided that it does not meet the patentability requirements and the other criteria established by this law." (Emphasis added)

§ 2 – Following the prior consent examination and after the decision is published, ANVISA shall return the application to the Patent Office, that shall examine the approved application, and definitively archive the application that has not been approved."

The proposed amendments would provide ANVISA with the power to perform the same analysis of patentability requirements that is assigned by law to the Brazilian PTO. Moreover, such proposal would establish the dominance of ANVISA's analysis of patentability requirements, as the Brazilian Patent Office will be barred from analyzing pharmaceutical application without the "prior approval" of the Sanitary Surveillance Agency. The proposed legislation also leaves room for "further regulation" by ANVISA, creating additional uncertainty for patent applicants.

III. Conclusion

The proposed amendments aim to provide ANVISA with the capacity to analyze patentability requirements despite an overwhelming number of judicial decisions stating that its role in the "prior approval" of pharmaceutical patents is limited to the assessment of potential harm to public health. The patent reform bill also establishes that ANVISA's analysis of patentability requirements will trump the Brazilian PTO's, as the latter will be required to "definitively archive the application that has not been approved".

The participation of ANVISA in patent proceedings under any law can always be challenged before Federal Courts. The grant and issuance of a patent is not discretionary and all administrative acts during prosecution are subject to judicial review. The above described proposal to broaden the scope of ANVISA's role in "prior approval" does not modify the patentability requirements set forth in the patent statute7. At the very least, the intended "prior approval" requirement will create an unnecessary step in the analysis of patentability requirements, wasting already limited public resources. In the worst-case scenario, patent applicants will have to challenge politically biased decisions of the Brazilian FDA before Federal Courts.


1 Please check the previous issues of Prevail in order to find out more information about the bills seeking to amend the Patent Statute. A timeline of all bills is available at
2 "...the prior approval set forth on Art. 229-c of the IP Law must be limited to issues of public health, as only the Patent Office can analyze patentability requirements..." (appeal # 00364288320094013400, Federal Court of Appeals for the First Circuit, published on October 3rd, 2014); " order to conclude that a patent is being unduly granted for failing to meet patentability requirements, we cannot disregard the competence and legal attribution set forth on law for the federal agencies... ...we are not allowed to provide such a broad interpretation to law 9.782/99 [law that created ANVISA] to the point of allowing two agencies to decide contrary to one another on requirements of patentability..." (Appeal # 201202010081961, Federal Court of Appeals for the Second Circuit, decided on December 14, 2012).
3 Court sitting in Brasilia with jurisdiction to review decisions rendered by appellate courts as a matter of law to provide an uniform interpretation of Federal Law in Brazil. The leading case will be an appeal (appeal # REsp 1473970) filed by ANVISA against a favorable appellate court decision rendered for Abbott GMBH. Justice Campbell issued a decision sending the case to the chamber of Private Law (intellectual property) and we filed an internal appeal pointing out that the controversy is not about IP, but jurisdiction of federal agencies for assessment of patentability requirements, which is a matter of Public Law. A decision is still pending.
4 Court sitting in Brasilia with jurisdiction to review decisions rendered by appellate courts as a matter of law that may violate constitutional provisions. There is no appeal before the Supreme Court so far.
5 The expression "certain inquiries" is probably a reference to the overwhelming number of judicial decisions stating that the assessment of patentability requirements extrapolates ANVISA's legal attributions, and that its role in the prosecution of patents must be limited to issues of public health.
6 In an article published in 2011, Mr. Marcos Lobo de Freitas Levy mentions an interview given by the former Intellectual Property Coordinator at ANVISA, Mr. Luis Carlos Wanderley Lima, on the "prior approval" requirement (,MI140425,61044-Pela+manutencao+do+ injustificavel): "At the end of the interview, the interviewee states that without the prior approval requirement there will be less competition and higher prices, because when patents are not granted the field for introduction of generics is open. This claim reveals the real reason for the existence of the prior approval requirement. The fact is that some Brazilian health authorities and some national companies never agreed with the granting of patents for pharmaceuticals."
7 There are other proposed provisions in the "patent reform bill" PL 5402/2013 that may, for instance, raise the standard of inventive step, requiring it to be "significant". This will be the subject of another article about the proposed patent reform.

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 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
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). 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 & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd 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 or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at and we will use commercially reasonable efforts to determine and correct the problem promptly.