Following the public consultation made in 2019, the Brazilian Patent and Trademark Office (BPTO) published on December 1st, 2020 the Normative Instruction No. 118/2020, which establishes the new Guidelines for Examination of Biotech Patent Applications.
The main differences between the former Guidelines and the current ones can be found below:
– better definition of undue experimentation: standardization procedures (obvious or routine experiments, such as standardization of optimal conditions for a PCR reaction) for carrying out the invention are not necessarily considered as undue experimentation;
– degenerated sequences: can be accepted, and it is not mandatory to mention all possible sequences in the application, as long as they generate the same protein and that such protein is precisely defined. However, said understanding is not applied to applications related to the determination of preferential codons in poorly studied species, or the optimization of expression in certain organisms.
– drafting of claims related to DNA and proteins: when a DNA sequence is defined by the polypeptide sequence it encodes (which is not accepted), the new guidelines allows the Applicant to amend the claim(s), in order to define the polynucleotide by its specific sequence.
– Markush formulae of biological molecules: the Applicant must pay attention to the unit of invention criteria specifically related to the Markush groups.
– Genetic Use Restriction Technologies (GURTs): the new guidelines establishes that human intervention processes for the generation/multiplication of genetically modified plants resulting in the production of sterile reproductive structures are not eligible to patent protection, as well as processes that use external chemical inductors that activate or deactivate genes related to plant fertility.
The periodic update of the Guidelines for Examination of Biotech Patent Application is essential, given the intense dynamism, the great technological development and the strategic importance of this sector for the protection of Brazilian biodiversity. Although it has been in force for a few days, new studies have already started for a future update.
The new Guidelines for Examination of Biotech Patent Applications (in Portuguese) are available here.
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