New guidelines for the examination of patent applications in the field of biotechnology in Brazil

4月 2021

On 1 December 2020, INPI/PR Normative Instruction No. 118/2020 was published in the Industrial Property Journal (RPI) and came into force, which establishes the new Guidelines for the Examination of Patent Applications in the Field of Biotechnology in Brazil.

These new guidelines are fundamental for the country given that Brazil has a very strong performance with biodiversity and agribusiness. In addition, it receives several foreign patents for analysis.

The main objective of this new text is to improve the understanding of what is and what is not eligible for patent protection in the area of biotechnology, being the most notorious changes the division in the aspects related to the level of descriptive sufficiency and the unit of invention of nucleotide sequences and Markush formulas (both amino acids and nucleotides), antibodies, the specification of the meaning of “human or animal body” and the aspects related to the Biosafety Law (Law nº 11.105/05)[1].

Breakdown of the new additions to the guidelines:

  • Sufficiency of disclosure

“7. It must be ensured that the application contains sufficient technical information to enable a person skilled in the subject to put the invention into practice, without undue experimentation (see point 2.15 of the Guidelines for the examination of patent applications, Block I).

8. In the field of biotechnology, it is understood that it is tolerable to carry out standardization experiments to enable the person skilled in the art to reproduce the invention, without necessarily involving undue experimentation. In this sense, it is not considered improper to carry out experiments which are obvious and/or routine for a person skilled in the art at the time of application, even if such experimentation is laborious and/or tedious (e.g. standardization of optimal conditions for PCR reaction, where the technical problem solved by the invention does not lie in the specific adjustment of such conditions).”

This first addition is made to prevent examiners from requiring experiments that are considered routine for technicians in the fields.

Thus, although paragraph 8 appears to contradict paragraph 7, it is from the general guideline and was being used to require experimental data and information that in the field of biotechnology can be obtained routinely. This denotes a recognition that this field is inherently laborious and that being so is not synonymous with not allowing the invention to be reproduced.

However, one major exception is made: “where the invention lies specifically in the adjustment of otherwise routine techniques”. In this case, for obvious reasons, the description must be detailed.

  • Biological material deposit

As regards the deposit of biological material, it should be noted that, although Brazil is not a party to the Budapest Treaty, it can only accept deposits in one of the deposit centers admitted to the Treaty until it becomes a party or builds its own center. This is stated in item 2.18 of the General Guideline which also states that the deposit must be made before the filling date (or priority date) and this information must be an integral part of the description.

The INPI has therefore taken the opportunity of the update of the Biotechnology Guidelines to align this guideline with the General Guideline.

It is important to highlight that, although the filing must be made before the filing date of the application, its certificate of support may be attached later, as compliance with the requirements, as long as it contains the information on the filing date.

  • Sequence listing

The new guidelines specify that degenerate nucleotide sequences can be accepted as long as they generate the same protein and the protein is precisely defined. In this case, the reference nucleotide sequence should be given in the description as a filler.

Paragraph 70 makes an exception for cases where the expert would not be able to determine the sequences without undue experimentation, such as preferred codons in species without sufficiency and studies or optimization of gene expression in specific organisms.

It was also made clear that proteins cannot be defined by the nucleotide sequence of the genes that encode them. Paragraph 66 of the guidelines explicitly states that a DNA or RNA will be defined by its nucleotide sequence, whereas a protein will be defined by its amino acid sequence.

Thus, biological sequences that are not disclosed in the description as completed cannot be accepted as fulfilling a requirement, even if it can be deduced by the expert according to Article 32, except when it is part of the prior art and properly referenced in the description.

The reference to the Sequence Listing Resolution that had changed has also been updated making it explicit that the Sequence Listing must be filled in according to the Resolution in force, i.e. the current Resolution No. 187/2017.

It should not be forgotten at this point, the modification of point 6.1.1 in relation to Markush sequences, where attention is drawn to the unity of the invention, to the possibility of natural occurrences and to the need for concreteness in the description, including for conservative amino acid changes in critical areas of the polypeptide.

In the case of nucleotide sequences, alternative sequences generating the same protein may be accepted without experimental data, but in the case of promoters and enhancers, only specific inventions may be accepted because physico-chemical differences and similarities in bases are not sufficient to foresee the effects of the modifications.

  • Matter not considered as invention

Article 10 (VIII) of the Brazilian Industrial Property Law considers surgical techniques and methods, as well as therapeutic or diagnostic methods, for application to the human or animal body.

In this sense, the new Biotechnology Guidelines have made it explicit that the human or animal body includes not only adult forms, but all stages of development from the embryo onwards.

  • Antibodies

The most important changes were made in the antibody section (point 6.4.6).

Paragraphs 164 and 165 are introduced to make it clear that an antibody will only be considered natural and therefore covered by Article 10 if its sequence is found in the search as natural or if it is made clear in the description that the antibody is obtained from an organism naturally exposed to the antigen. If it is demonstrated that the antibody would not exist without significant human intervention, then the antibodies and their elicitation processes are not considered natural.

Likewise, polyclonal antibodies, which were previously considered natural products isolated from nature, are now considered to lack clarity and precision (Art. 25) and reproducibility, because even if the process is repeated, the set of antibodies will not be the same (Art. 24). In this case, even if the process is patentable, if it is not natural, its product is not.

The technologies for obtaining monoclonal antibodies have also been updated and the necessary link between hybridoma and antibody has been eliminated.

And finally, the examples of acceptable and non-acceptable claims have been updated to read as follows:

“Example 35: Drafting of the claims of protected antibodies.

Claim: Monoclonal antibody against protein X characterized in that it is produced by the hybridoma HHH, deposited under the number YYYYY.

Claim: An antibody characterized in that it comprises complementarity determining regions (CDR1; CDR2; CDR3) consisting of SEQ ID NO: X, SEQ ID NO: Y and SEQ ID NO: Z in the light chain and SEQ ID NO: A, SEQ ID NO: B and SEQ ID NO: C in the heavy chain and human chain constant regions.

When examining this type of claim, the issues related to Art. 10 (IX) IPL mentioned above must be observed (see § [164]).

Example 36: NON-acceptable antibody claims.

a) Claim: Antibodies characterized as being specific for protein X.

b) Claim: Human monoclonal antibody characterized in that it recognizes protein X and that it has an affinity of 2×10-9 M.

c) Claim: Monoclonal antibody and fragments thereof characterized in that they are capable of binding to protein X.

(d) Claim: A monoclonal antibody characterized in that it comprises the complementarity determining region (CDR3) consisting of SEQ ID NO: X on the light chain and SEQ ID NO: A on the heavy chain and constant regions of the human chain.

By not clearly and precisely defining the claimed antibodies, and/or fragments, these claims cannot be accepted as infringing art. 25 of the IPL. In the case of the statement of point d) above, it is necessary to define at least the sequences of the 3 (three) CDRs of the chains present, in order to clearly and precisely define the said antibody.

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Natalia Menezes (Menezes Gomes) for Giró Martínez SLP