The BRPTO published on its website the technical note BRPTO/CPAPD #01/2022, dated March 16, 2022, which provides guidelines on the examination of inventions related to transgenic plants, particularly, elite events – topics not covered by the examination guidelines for patent applications in the Biotechnology field currently in force (Normative Instruction #118/2020).
In a nutshell, said technical note:
- indicates that an elite event is a process of genetic transformation (transgenesis) that has a superior technical effect when compared to other transformation events;
- stresses that transgenic plants and their parts are non-statutory matter – even if a transgenesis event solves a given technical problem in a new and non-obvious way, falling under the provisions of article 18 (III) of the Brazilian Patent Statute;
- points out that accessory inventions related to transgenic plants and their parts are patentable, provided that they meet the requirements and conditions of patentability. It is clarified that, once the non-obviousness of the main invention – i.e., transgenic plant – is recognized, patentability is extended to accessory inventions. In other words, examination of the main invention is necessary for the granting of accessory inventions, even if the main invention is non-statutory matter;
- presents non-exhaustive examples of accessory inventions related to elite events such as: (i) hybrid DNA molecules; (ii) method to identify plants that comprise elite events; (iii) use; and (iv) compositions;
- highlights that inventions related to biological material, if isolated from transgenic plants, may be granted under the provisions of article 18 (III) of the Brazilian Patent Statute, provided that they are not identical or indistinguishable from their natural counterpart. In this regard, claims directed to modified biological sequences, for example, must explicitly state that they are isolated, and not within the plant;
- presents the criteria for assessing the novelty and non-obviousness requirements of transgenic events in plants; and
- comments on the patentability of plant-based products.
The notice is available at the BRPTO’s website, and the original version (in Portuguese) can be downloaded here. In case you need further information on this matter, please contact us at patents@lickslegal.com. We will be glad to assist you.