Brazil: New Guidelines For The Examination Of Biotechnology Inventions In Brazil Provide Useful Support For Applicants

Last Updated: 11 August 2014
Article by Alexandre Santos and Gabriel Di Blasi

Biotechnology had its beginning with fermentation, the use of which coincides with the very beginning of the Christian era, mingling with the history of humanity. The Sumerians and Babylonians had known about the production of alcohol by fermentation of cereal grains prior to the year 6,000BC.

Around the year 2,000BC the Egyptians, who had already used yeast to brew wine, also employed it to make bread. However, it was from the 1950s that biotechnology came into existence, with the discovery of the chemical synthesis of DNA and genetic manipulation techniques.

Biotechnology involves a number of ethical questions, in particular with respect to intellectual property protection, such as those involving the protection of living organisms, including human genes and chimeras. This mainly raises the discussion of the limits of patent protection and the direction in which biotechnology is heading.

The development of biotechnology largely depends on high-risk investments. Attracting such investments requires a safe business environment, and the protection of IP is key to the creation of such an environment. In view of this, patent protection must be effective, and grant should be swift. As such, it is imperative that the examination of a patent application in the area of biotechnology be as judicious as possible.

There are two documents that govern the examination of patent applications in the area of biotechnology in Brazil: 1) Instruction No. 17/2013, previously called Normative Act No. 127 of March 5, 1997; and 2) the Guidelines for Examination of Patent Applications in the areas of Biotechnology and Pharmaceuticals filed after December 31, 1994, published in the Industrial Property Journal No. 1648 of August 6, 2002.

The National Institute of Industrial Property (INPI), seeking greater uniformity and predictability in examination analysis, is in the process of preparing new guidelines for the examination of patent applications in the biotechnology field. The INPI recently released a draft of the proposed guidelines for public comment in relation to the text that will form the basis of the new guidelines.

New approach

The proposed guidelines reflect an innovative approach in that they refine some of the terms in biotechnology, such as "biological materials found in nature", "natural biological process", "therapy", "surgery", terms that neither Brazilian Patent Law (BPL) nor the current guidelines include, providing a better overall scope of interpretation when it comes to patent examination.

The proposed guidelines released by the INPI also clarify when an applicant is required to file a sequence listing attached to the application. Such clarification does not exist in the current guidelines. Thus, when the subject matter of the invention includes the sequence, or when the set of claims includes "protein", "polypeptide", "nucleic acid" or any other term designating a biological sequence, it will be considered an essential part of the invention, and the attachment of the sequence listing will be required.

On the other hand, when the molecule in question is only one example, a specific sequence would not be considered an essential part of the invention, and no sequence listing would need to be presented as part of the application.

Additionally, it is worth mentioning that the proposed guidelines include definitions of oligonucleotides (or primers): promoters; vectors; complementary DNA; expressed sequence tags (ESTs); and open reading frames (ORFs), where such definitions are not interpreted in, or are less embodied in, the current guidelines.

"ESPECIALLY NOTEWORTHY IN THE PROPOSED GUIDELINES IS THE SPECIFICATION THAT REACH-THROUGH CLAIMS ARE NOT PATENTABLE IN BRAZIL—THE CURRENT GUIDELINES HAVE BEEN SILENT ON THE ISSUE."

Another positive aspect of the proposed guidelines is to establish norms regarding genetic heritage in patent applications. Examples of some of the references are "organisms" (plants, animals, fungi, bacteria, archaea, etc); parts of organisms (sheets, nails, skin, mucus, blood, roots, extracts, organs, oils, poisons, fangs, etc); and molecules isolated from organisms (DNA, RNA, proteins, sugars, lipids, etc), and their corresponding synthetics.

The proposed guidelines better define the following as being patentable, provided that the requirements of novelty, inventive step and industrial application are satisfied: hybridomas, monoclonal antibodies and chimeric/humanised antibodies, transgenic microorganisms, nucleotide and amino acid sequences that do not exist in nature, microbiological processes, methods of obtaining transgenic plants and the use of stem cells in the preparation of compositions.

With regard to the industrial application requirement, it is important to be aware that for the biologic sequence listing, this requirement is met if a utility or use is identified for such listing. Therefore, if the patent application identifies, through homology, a new sequence listing and this homologous sequence is part of the prior art and has a known function, the new biologic sequence listing will fulfil the industrial application as long as its function or utility has already been mentioned in the description of its patent application.

Regarding an amino acid sequence listing, its claims should be defined with clarity and precision. The set of claims should refer to the proteins in question by the corresponding "Seq ID No". The proposed guidelines also bring attention to the use of the terms "consists of or comprises", which results in differences in the scope of protection.

The terms "consist of" and "consisting of" and their derivatives are regarded as closed terms of defining the invention. For example, if a claim is a "composition characterised in that it consists of components A, B and C", the presence of additional components is excluded, whereas the terms "comprise", "contain", "encompass" and "include" as well as derivatives thereof are considered open terms of defining the invention, which in the example above (the composition "comprising components A, B and C") is not limited to these elements.

Especially noteworthy in the proposed guidelines is the specification that reach-through claims are not patentable in Brazil—the current guidelines have been silent on the issue. According to the proposed guidelines, the subject matter of reach-through claims typically does not exhibit sufficient disclosure, clarity and accuracy, as required under Articles 24 and 25 of the BPL.

The proposed guidelines seem to reflect an interpretation of legislation which, unfortunately, does not come with the dynamism of biotechnological inventions. For example, the proposed guidelines continue to exclude patent protection for synthetic products, and even recombinant products, based on a starting material naturally occurring, even in its isolated form, which runs contrary to the criteria adopted by examiners around the world.

In summary, although the proposed guidelines in question do not entirely correspond with the wishes of the biotech community, they do not cause any regression and so bring a better attempt to delimit the scope of interpretation for patent applications for biotechnological products and processes. It is expected that the proposed guidelines will attract new biological innovation to Brazil.

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 Mondaq.com.

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

Authors
 
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
Tools
Print
Font Size:
Translation
Channels
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
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (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 www.mondaq.com

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 Mondaq.com’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.

Disclaimer

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.

Registration

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 unsubscribe@mondaq.com 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.

Cookies

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.

Links

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.

Mail-A-Friend

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.

Security

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 webmaster@mondaq.com.

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 EditorialAdvisor@mondaq.com.

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 enquiries@mondaq.com.

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