After a public consultation process that took approximately 1 year, the Brazilian PTO made public on May 9, 2023 its technical guidelines to be followed by its examiners in examining the patentability of inventions associated with transgenic plants and eventually including an elite event.
Point of some controversy, the aforementioned technical note had been originally published in early 2022 without any official notification to users of the patent system and society and containing several restrictions to the patenting of inventions related to transgenic plants, such as the interpretation that any biological material that was or could be inside a living being, natural or not, would be considered unpatentable (e.g. non-natural DNA constructs). The alternative provided by the INPI in this first guideline would be that the term “isolated” should be included in all claims defining non-natural DNA sequences.
Soon after, the Brazilian PTO removed the technical note from its list of regulations in the patent field and opened a formal process of public consultation of the technical note where associations and IP Firm, including our office, Guimarães.IP, were able to present their criticisms and suggestions.
In this way, the Technical Note INPI/CPAPD nº 01/2023 was finally published and, fortunately, the Brazilian PTO considered that some of its original positions confronted the provisions of the Brazilian Industrial Property Law (LPI). The Law clearly defines that the whole or part of living beings, natural and non-natural, are not subject to patenting. However, certain non-natural biological materials (including the genome and germplasm) and non-natural biological processes are authorized and thus become formally recognized for patenting by the Brazilian PTO.
Thus, in cases where the invention originates from a transgenic plant with surprising technical effects (elite event), there will be a need to discuss the novelty and the inventive activity of the plant, although it is not patentable, since the patentability of accessory inventions will be derived from the plant, main invention. When the inventive concept contains, in addition to the transgenesis event (main invention), other inventions, such as methods, uses, compositions and biological sequences, these will also be considered accessory inventions.
Also, the need to insert the term “isolated” in claims containing non-natural DNA constructs was removed (preventing several problems that would arise in patent infringement actions from occurring). The technical note also defines that when the patent application claims material that, at the time of filing/priority, was obtained by processes whose reproduction involved randomness, according to the descriptive report, it is necessary to deposit the propagation material with a Depositary Center of Biological Material authorized by the INPI (Budapest Treaty).
The technical note will be applied to all ongoing processes, including those under appeal and administrative nullity processes.
Public consultation process can be found by clicking here.