The new Technical Note INPI/CPAPD No. 01/2023 issued by the Brazilian Patent Office aims at deepening and harmonizing the technical understanding with a view to greater predictability of the acts issued by said agency with respect to the patentability of elite events.
This Technical Note does not bring any legal innovation, addressing only issues not fully contemplated in the Guidelines for the Examination of Patent Applications in the Area of Biotechnology, established by Normative Instruction INPI/PR/No 118/2020.
What is an Elite Event?
An elite event refers to a plant modification that involves the insertion of exogenous DNA using molecular tools, such as a gene construct. This insertion must occur at a specific location in the plant genome, explicitly determined by the polynucleotide sequences flanking the insertion. Moreover, the elite event should confer a superior technical effect to the plant compared to other transformation events, demonstrating that it is not the result of arbitrary selection. The selection process of the elite event varies based on the desired objective and characteristics to be conferred to the organism.
Patentability of Elite Events:
Although plants originating from the elite event are not patentable by force of art. 18 (III) of the IP Law (IPL), patents for inventions accessory to transgenic plants and their parts may be granted, provided that they meet the requirements and conditions for patentability.
Analyzing Inventive Step:
For cases of transgenic plants, when searching, it is indicated to look for a plant of the same species with the same phenotype. If the same plant is not found, it is indicated to search for plants of other species with the same phenotype, taking into account the evolutionary distance in relation to the plant under study, and if no transformations are found in the plants, it is indicated to search for other descriptions, such as transformations in plant cells, yeasts, bacteria, etc., in order to establish the state of the art.
Determining Inventive Step:
To determine whether a claimed invention is obvious, the following steps are recommended:
- determine the closest prior art.
- determine the distinguishing features of the invention and/or the technical problem that the invention solves; and
- determine whether, in view of the technical problem posed and starting from the closest prior art, the invention is obvious to a person skilled in the art.
Non-exhaustive Indications of Inventive Step:
- enhancement of phenotype (e.g., increased herbicide resistance, increased seed size, etc.); and
- evidence of genetic linkage of one phenotype (e.g., glyphosate resistance) to another phenotype of interest (e.g., increased yield).
Non-exhaustive Indications of Lack of Inventive Step:
- the simple fact that the transformation does not impair the agronomic characteristics of the plant or the mere selection of a plant for characteristics not linked to the transgene;
- molecular analysis of parameters, such as integration of the inserted cassette in the genome, number of transgenic copies, detection of transgene expression, identification of the insertion site in the genome without associating these parameters with a non-obvious technical effect; and
- the existence of modifications in the transgene or in the construction itself, as well as information on a new insertion site in the genome, although they confer novelty, do not necessarily confer inventiveness to the subject matter; for this, experimental data are needed that relate these modifications to the non-obvious technical effect obtained, otherwise, the new gene, new construction or new location will be considered equivalent to those described in the prior art and, therefore, not inventive.
Reversing the Lack of Inventive Step:
The understanding of the lack of inventive steps can be reversed by presenting, during the examination, additional experimental data, if these are inherent to the deposited descriptive report. Additionally, highlighting the technical problem that was overcome in a non-obvious way compared to the state of the art can strengthen the case for inventive step.
Accessory Inventions and their Inventiveness:
Once the inventive step of the transgenic plant, which is the main invention, is recognized, it extends to the interrelated inventions.
Accessory inventions associated with elite events often include hybrid DNA molecules in which one part of the molecule corresponds to a part of the plant chromosome and the other part to the DNA of the inserted gene construct. These molecules are useful as identifiers of elite events since their presence reflects the insertion of the transgene at that specific location in the genome.
The novelty of accessory inventions must be examined by their own technical characteristics, while their inventive step derives from the inventive step of the main invention, and is appreciated through the latter, since the technical solution proposed by the application is the main invention. However, it is necessary that the accessory invention is directly related to the main invention.
Even if the transgenesis event solves a given technical problem in a new and inventive way, the plants and their parts (i.e. seeds, cells, etc.) containing it are not patentable by force of art. 18 (III) of the IPL, as is the case for any transgenic plant.
However, when the inventive concept contains, in addition to the transgenesis event (main invention), other inventions, such as methods, uses, compositions and biological sequences, these are considered accessory inventions. In this case, the technical effect achieved by the plant must be evaluated for the purpose of assessing the inventive step, since the inventiveness of the accessory inventions depends on the inventiveness of the main invention.
Finally, if the main invention is considered inventive, the accessory inventions derived from it will also be inventive, since they belong to the same inventive concept. However, in order to be granted, they must be new and, in addition, meet the other patentability requirements.