Opening of the Public Consultation on INPI/CPAPD Technical Note Nº 01/2022 on Guidelines for Examination of Transgenic Plants, Including Elite Tests – Patent
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On March 17, 2022, the Brazilian OPT (INPI) published an INPI/CPAPD Technical Note No. 01/2022, which provides guidelines on reviewing inventions related to transgenic plants, focusing on elite events and ancillary inventions.
This technical note aims to harmonize technical knowledge concerning transgenic plants, in particular elite tests, as well as to standardize the procedures for examining the corresponding patent applications. These issues were not fully covered by the INPI Guidelines for the Examination of Patent Applications in the Field of Biotechnology (Normative Instruction No. 118/2020).
In this sense, it should be remembered that Article 18, III, of Law No. 9.279/96 (Brazilian Intellectual Property Law) establishes that living beings, with the exception of transgenic microorganisms that are not discoveries, are not patentable. Nevertheless, transgenic plants are at the center of the unique inventive concept which links the main invention to the ancillary inventions. Therefore, it is always necessary to discuss the patentability of the plant, because the patentability of ancillary inventions follows from the main invention.
In this context, the INPI/CPAPD technical note nº 01/2022 briefly specifies the following:
- Definition of an elite event: “An elite event is an event of transformation of a plant (1) by the insertion of a transgene (2) using a genetic construct (3) in a stable form, in which this insertion takes place at a specific location in the plant’s genome (4) and gives the plant a superior technical effect compared to other transformation events (5).”
- Assessment of novelty and inventive step: the assessment of these requirements must deviate from the aforementioned definition of elite events.
- Novelty: If the five distinctive characteristics of the elite event are already revealed in a single prior art document, the elite event will lack novelty.
- Inventive step: In general, three steps must be followed to determine whether a claimed invention is obvious from the prior art: (i) determine the closest prior art; (ii) determine the distinguishing features of the invention and/or the technical problem solved by the invention; and (iii) determining whether, given the technical problem under consideration and starting from the closest state of the art, whether or not the invention is obvious to a person skilled in the art.
- With regard to transgenic plants, the examiner should look for a plant of the same species with the same phenotype, or, if this is not possible, the examiner should look for plants of other species with the same phenotype, taking into account the evolutionary distance of the plant in consideration. If it is not possible to find in vivo transformations, the examiner should look for in vitro descriptions.
- In addition, the technical note lists non-exhaustive indications of the presence of an inventive step, such as: (i) improvement of the phenotype (eg, increased resistance to herbicides, increased seed size); and (ii) association by gene linkage of one phenotype (eg, glyphosate resistance) to another phenotype of interest (eg, increased yield).
- The following are non-exhaustive indications of lack of inventive step: (i) the simple fact that the transformation did not affect the agronomic characteristics of the plant or the simple selection of a plant by characteristics unrelated to the transgene; (ii) molecular analysis of parameters such as the integration of the inserted cassette into the genome, the number of copies of the transgene, the detection of the expression of the transgene, the identification of the site of insertion in the genome without association of these parameters have an obvious technical non-effect; and (iii) the existence of modifications in the transgene or in the construct itself, as well as information on a new insertion site in the genome, since even if it confers the novelty, it does not necessarily confer the inventiveness to the object.
However, the subject dealt with by the technical note INPI/CPAPD n° 01/2022 being of public interest, the INPI published on June 01, 2022 in the Federal Official Journal n° 103 a notice of opening of the Public Consultation on the said technical note. . . From the date of publication, interested parties will have 30 days, i.e. until July 01, 2022, to submit their comments on the technical note to the INPI. At the end of the term, the INPI will present the responses to the contributions and the final text of the technical note. Therefore, the applicability of said technical note is suspended until the end of the Public Consultation.
The content of this article is intended to provide a general guide on the subject. Specialist advice should be sought regarding your particular situation.
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