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On February 6, 2019, the Brazilian Patent and Trademark Office (“BPTO“) published a notice in the Official Gazette, regarding an upcoming public hearing concerning to amend the Guidelines for Examination of Biotechnology Patent Applications (“Public Hearing“). The Public Hearing will be open until April 6, 2019.

The Public Hearing focuses on proposals to amend the current guidelines contemplated by BPTO Resolution No. 144/2015 and seeks to offer a more consistent and certain examination of biotechnology patent applications. In addition to clarify the current wording, the BPTO has included some significant changes in the updated Guidelines. Among other things, the proposal seeks to: 

• Adds new sufficiency description requirements for patent applications, specifying what will not be deemed undue experimentation, including in case of applications for amino acid and/or nucleotides sequence listings.(Section 2.2);  
• Adds the definition of “human or animal body” to the non-patentable section in order to include every development stage from embryo to adult forms (Section 4.1);
• Further explain how to describe biological sequences for inventions that depend on amino acid or nucleotide sequences. It also clarifies that a DNA or an RNA are defined by their nucleotide sequence, whereas a protein is defined by its amino acid sequence. (Section 6.1);
• Modify how to identify the percentage of similarity between two protein sequences. Under the new Guidelines, instead of a sum, a ‘calculation’ should take into consideration identic and similar matches of protein sequences (Section 6.2);
• Establish circumstances in which antibodies and their development are deemed natural, and, therefore, non-patentable, in accordance with the Brazilian Intellectual Property Law (Law No. 9,279/1996). (Section 6.4.6);
• Modify the definition of stem cells and clarify that there is no legal obstacle to granting patents to products, development processes, and applications of human embryonic stem cells, pursuant the opinion issued by the Specialized Federal Attorney’s Office connected to the BPTO (Section 7.1);
• Introduces a section dedicated to genetic use restriction technologies and the prohibition from patenting any processes of human intervention to generate/ multiply genetically modified plants in connection with plant’s sterility, provided in the Biosecurity Law (Law No. 11,105/2005).  (Section 7.4); 
• Modify the section concerning patent applications involving components of the national genetic heritage in compliance with  Law No. 13,123/2015 which establishes conditions for the granting of intellectual property rights on end products or reproductive material obtained by means of access to genetic heritage or traditional knowledge prior to registration or authorization by the Genetic Heritage Management Council. (Section 8).

In summary, the amended Guidelines propose to better clarify he BPTO’s views on Biotechnology and to keep up to date with current technology and legislation.

Suggestions should be submitted by email in Portuguese to saesp@inpi.gov.br. We are available to assist you should you wish to participate in the public hearing.