Update on Biotechnological Inventions – Brazil
The Brazilian patent office has recently (Dec ’20-Jan ’21) updated their guidelines for the examination of biotechnological inventions. In particular, these updates affect the disclosure and claiming of nucleotide and amino acid sequences.
Firstly, sequences that are not disclosed in the application as filed cannot be added or claimed at a later date, even if they can be inferred from that application. To do so would be considered added matter and is therefore not permitted.
For example, where an application as filed lists an amino acid sequence, a corresponding nucleic acid sequence cannot be added or claimed at a later date, despite it being possible to calculate such a sequence based on the amino acid sequence.
Conversely however, when the biological sequence was known before the priority date and duly referenced in the application as filed, its later inclusion in the specification is acceptable.
An exception to the above disclosure requirement is provided for degenerate sequences (different nucleic acid sequences which encode the same protein sequence): providing there is one such sequence in the application as filed, there is no need to present all possible permutations.
Additionally, all nucleotide and amino acid sequences must be presented in the application as filed in a sequence listing file or, in the event of small sequences (<10 nucleotides or <4 amino acids) in the text of the specification.
Finally, the Brazilian patent office are updating the rules for sequence listing methods: until January 1, 2022 either of the World Intellectual Property Organization (WIPO) ST.25 Standard (.TXT format) or ST.26 Standard (.XML format) is permitted, however after January 1, 2022 only the ST.26 Standard will be accepted.
A sequence listing using the ST.26 Standard may be created, edited and verified using the WIPO Sequence tool, available here.
The guideline updates also affect:
- Naturally derived antibodies are not considered to be patentable, however those obtained through human intervention (e.g. an immunisation protocol) are patentable. Additionally, the claiming of monoclonal antibodies via their CDR sequences is now permitted.
- Methods for the treatment or diagnosis of embryos are not patentable, and;
- Inventions related to products, obtainment processes and uses of human embryonic stem cells are patentable.