Brazil: Biotechnology Patents In Brazil: Current Situation And Expectations

Last Updated: 14 August 2018
Article by Kene Gallois

Biotechnology is a multidisciplinary science that integrates concepts of Biology, Chemistry, Engineering and Informatics, based on the use of living organisms and biological systems for the production of improved products and processes with applications in agriculture, food and human health. The development of new vaccines, drugs and hormones is also related to Biotechnology.

The market was dominated for many years by purely synthetic chemical drugs which consist of small molecules endowed with a simple structure. With the rise and understanding of complex mechanisms linked to the modification of genes and the use of cells and microorganisms, provided by Biotechnology, the production of biological drugs represented by larger molecules and complex structures became possible. As a result, inventions directed at biological products and processes have shown promise in the treatment and prevention of a wide range of diseases such as cancer, multiple sclerosis, rheumatoid arthritis and asthma, among others.

Processes and products derived from Biotechnology could be measured in the last decade by a considerable increase in patent application filings in this area. Among the most prominent biologics in the context of patents are monoclonal antibodies, which act mainly as molecules capable of locating substances of interest precisely and fighting them in a better and successful way. It is worth noting that, given the complexity of the biologics, cells and various genetic materials are usually involved in the processes of their generation. Such a situation often gives rise to different patent applications related to the same biological drug involving many technologies worthy of patent protection, such as DNA, RNA, protein, vector, expression cassette, antibody and hybridoma, among others, and microorganisms modified by human intervention, such as bacteria and yeast. To obtain a patent in Brazil, these technologies need to be genetically modified and different from their natural counterparts.

In order to keep up with innovations in Biotechnology, the National Institute of Industrial Property ("the Brazilian Patent Office") published Resolution 144 in 2015, establishing Guidelines for the Examination of Patent Applications in the Biotechnology area. It is a well-known fact that the main problem currently facing the Brazilian PTO is the backlog (or delay in the examination of patent applications), where the time scale for the issuance of a technical opinion is excessively long and ends up delaying a final decision on the application.

The Brazilian PTO has announced measures in recent years to reduce the backlog. The promise of creating the e-Patent electronic filing system has been kept and it is already in operation and the review of internal procedures has been strengthened. A program called "Task Force" is set to get underway in 2016 and will bring together groups of public employees, divided by strategic areas, to speed up the examination of the admissibility of patent applications via the Patent Cooperation Treaty (PCT), examination of industrial designs, trademarks and patents, including appeals and request for administrative nullity. An Executive Order for the creation of the Working Groups involved was signed by the President of the Brazilian PTO, Luiz Otávio Pimentel, recently. As a result , a greater number of pending decisions under the Brazilian PTO is expected, with a subsequent reduction in the backlog of patents applications under examination.

Backlog in the Biotechnology area: according to data and charts published by the Brazilian PTO, 67% of patents granted in 2014 were filed over 10 years ago. Furthermore the Brazilian PTO reports that the average time for granting patents in the Biotechnology area is around 12 years.

How does the term of the patent work in view of the backlog?

The backlog issue is a reality, particularly for patent applications that cover biological products. In this sense, the granting of patents in this specific area has benefited from the sole paragraph of Article 40 of the Industrial Property Law (or IPL) 9,279 of May 14, 1996 , which determines that the length of the protection of a patent shall be a minimum period of 10 years from the date of granting it, except in the case of the Brazilian PTO being prevented from proceeding to examine the merits of the application due to a proven pending litigation or force majeure.

What is the current situation of patent applications directed at drugs in Brazil?

There are currently over 14 drugs protected by patents that benefit from the provisions of the sole paragraph of Article 40 of the IPL, especially a biologic drug consisting of monoclonal antibody for treatment of autoimmune diseases. It is estimated that more than 40 drugs in Brazil whose patent applications are pending in the Brazilian PTO are likely to fall within Article 40 of the IPL.

From the perspective of domestic and foreign companies, Biotechnology is currently the source of greatest innovation of their products. However, there is a need for a large investment in research and development (R&D) in biologics, which is influenced primarily by the need for long and complex laboratory studies, and material and reagents, which ensure the maintenance of adequate means to obtain the final biological product. Therefore, considering the time needed in research to obtain a tested safe and effective biological drug, it is natural to expect that the Brazilian patent system should be dynamic and efficient in the granting of patents in the Biotechnology area.

With the recent news and plans of action and goals published by the Brazilian PTO, there is a strong tendency to align the patent system to innovations brought by domestic and foreign companies through a more responsive policy of granting patents. Simplification and flexibility in the processes are essential to meet the demands in the patent area.

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
Luiz Leonardos & CIA
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
Luiz Leonardos & CIA
Related Articles
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please 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