On 17 March 2015, the Brazilian Patent and Trademark Office (BPTO) published new guidelines for examination of patent applications related to biotech. The guidelines, which are the result of numerous internal and public consultations, as well as an analysis by the BPTO’s Federal Attorney, represent the current understanding of the BPTO as to the particularities of patent protection in the biotech field. The previous guidelines failed to cover the constant transformation in biotech and the technological advancement over recent years. The new guidelines, which apply from 17 March 2015, seek to fill this gap.
Specifically, the new guidelines have more definitions and examples of biotechnological subject matter, which are not explicitly mentioned in the current governing law, or which were not mentioned in the previous guidelines, such as single nucleotide polymorphism (SNP), promoters, complementary DNA (cDNA), expressed sequence tags (EST), open reading frames (ORF), fusion proteins, and chimeric/humanized antibodies.
In one of the mentioned examples, the new guidelines state that if a SNP is described as being natural, it cannot be protected. However, its use in an in vitro diagnostic method is entitled to protection.
With regard to promoters, it is necessary to present experimental data proving that they are able to promote the expression of a gene sequence, and such a sequence must be represented by its SEQ ID NO. cDNAs and ESTs may be protected provided that they are not equal to natural sequences. Moreover, the sequence must be associated with a function. Furthermore, it is not possible to protect ORFs, since they are considered a natural product.
Concerning fusion proteins, it is important to emphasize that all functional parts that form the final protein must be described in the patent application. Finally, the characterization of humanized antibodies requires the presentation of a SEQ ID NO containing the amino acid sequence of the variable portion of the antibody and the definition of the other elements (Fc portion).
The patentability of micro-organisms and issues regarding stem cells are also discussed.
BPTO’s update of the biotech guidelines is an essential step towards increasing the uniformity and predictability of patent application analysis. The new guidelines, which aim to better clarify the scope of protection available for biotechnological products and processes in Brazil, will be of interest to anyone seeking to protect biotech inventions in Brazil.
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