New Patent Applications Examination Guidelines related to Biotechnology Inventions in force as of December 1st, 2020

December 1, 2020

New Patent Applications Examination Guidelines related to Biotechnology Inventions in force as of December 1st, 2020

On December 1st, 2020 the BRPTO issued Normative Instruction #118 from November 12, 2020, which establishes the new version of the Patent Applications Examination Guidelines related to Biotechnology Inventions and revokes the previous guidelines (Rule #144/2015).

The main differences between the new (Normative Instruction #118/2020) and former (Rule #144/2015) Guidelines are outlined below:

i. for enablement purposes, standardization procedures (obvious or routine experiments, such as standardization of optimal conditions for a PCR reaction) for carrying out the invention may not be considered undue experimentation, unless specifically related to a technical problem;

ii. degenerated nucleotide sequences can be accepted as long as they generate the same protein and no undue experimentation to define the sequence is required;

iii. operative or surgical techniques and methods of treatment or diagnosis applied to embryos are now explicitly considered as non-statutory matter, as per article 10 (VIII) of the Patent Statute;

iv. biological sequences not disclosed in the application as originally filed cannot be included in the specification, even if they can be inferred from its disclosure, for being considered as addition of matter. However, when the biological sequence is known from the state of the art and duly referenced in the specification as filed, its later inclusion in the application is acceptable;

v. possibility of redrafting DNA and protein claims previously defined in terms of amino acid and nucleotide sequences, respectively, to duly reference their nucleotide and amino acid sequence, respectively, as long as previously disclosed in the original application;

vi. clarification on the support and unity of invention criteria for assessing Markush formulae of peptides and nucleotides;

vii. better definition of what is regarded as patentable matter in relation to antibodies and fragments thereof. For instance, if an antibody is obtained from an organism that is naturally exposed to the antigen, the antibody will also be considered of natural origin and will fall within the limitations of art. 10 (IX) of the Patent Statute. On the other hand, if the antibody can only be obtained through human intervention (for example, by an immunization protocol), then it is considered a statutory matter;

viii. processes for obtaining polyclonal antibodies are patentable, provided that all the steps of the process are sufficiently described in the patent application and are not of natural occurrence or invasive;

ix. monoclonal antibodies can be defined in the set of claims by their CDR sequences, particularly, the claim must recite all three CDR sequences of the light and heavy chains by their SEQ ID NO;

x. definition of the clarity, precision and support requirements for claiming chimeric, humanized and human antibodies and processes for obtaining the same;

xi. inclusion of the possibility of patenting inventions related to products, obtainment processes and uses of human embryonic stem cells;

xii. exclusion of processes for generation/multiplication of genetically modified plants involving genetic use restriction technology (GURTs), particularly those directed to the production of sterile reproductive structures, which encompass processes that act over the activation or inactivation of plants fertility genes with external chemical inductors from patentability, in compliance with the provisions of Article 6th (VII) of Biosafety Law (Law #11,105/2005). Processes restoring the fertility not involving external chemical inductors, however, are considered patentable; and

xiii. in the event of access to the national genetic heritage, the registration of the activity before the Genetic Heritage Management Council (CGEN) through the System for Genetic Heritage and Associated Traditional Knowledge Management is mandatory prior to the filing of the application.

The new Guidelines are available at the BRPTO’s website and can be downloaded from the following link: Patent Applications Examination Guidelines related to Biotechnology Inventions (original version in Portuguese).

For an English version of the new guidelines or more information on this matter, please contact us at, and we will be glad to assist you.