Revised Guidelines for the Examination of Patent Applications in the Biotechnology field in force

The Revised Guidelines for the Examination of Patent Applications in the Biotechnology Field (Normative Instruction INPI/PR n° 118/2020) finally entered into force on December 1, 2020, after rounds of public hearings.

The Normative Instruction INPI/PR n° 118/2020 basically confirmed the BPTO’s position already informed in our Newsletters 03 and 17. The main differences between the former Guidelines and the revised ones are reproduced below:

• Better definition of undue experimentation in Biotechnology related inventions: Routine standardization methods are not necessarily considered as undue experimentation, even if such experimentation is laborious and/or tedious; 

• Degenerated sequences are acceptable, and it is not necessary to present each of the possible nucleotide sequences in the sequence listing, provided that they encode the same protein. However, this understanding is not applied for applications directed to the determination of preferential codons in poorly studied species, or the optimization of expression in specific organisms;

• The BPTO provides explicit guidance that when a DNA sequence is defined by the polypeptide sequence it encodes (which is not accepted), the Applicant is allowed to amend the claim to define the polynucleotide by its specific sequence, degenerate sequences being also allowed, as long as they encode the same polypeptide.

• The definition of “human body” encompasses from the embryo to adult forms, i.e., all stages of development of the human being;

• Applications directed to Markush formula of biological molecules must pay attention to issues related to unity of invention. In relation to the descriptive support in the specification for the alternatives of the Markush formula, the BPTO defines the following:

1. Markush formula for amino acid sequences.

It is necessary to evaluate:
(I) the physicochemical features (polarity, size, charge, etc.) of the amino acids claimed for each position, compared to what was embodied in specification; and
(II) the region where the modifications occur, since in critical areas for the polypeptide function, even conservative changes can render very different outcomes;
2. Markush formula for nucleotide sequences.
It is necessary to evaluate if the sequences encode the same protein, being acceptable only in the case of degenerated sequences. Otherwise, all the claimed sequences must be embodied.

• Regarding GURTs (Genetic Use Restriction Technologies), the BPTO clarified 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. Processes that use external chemical inductors that activate or deactivate genes related to plant fertility are also not allowed.

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