On 17 March 2022, the Brazilian PTO (INPI) published a technical note INPI/CPAPD nº 01/2022, which provides guidelines on the examination of inventions related to transgenic plants, focusing on elite events and ancillary inventions.

Said technical note aims to harmonize the technical understanding regarding transgenic plants, especially, elite events, as well as to standardize the procedures for examining the corresponding patent applications. Such matters were not fully covered in the INPI´s Guidelines for Examination of Patent Applications in the Biotechnology Field (Normative Instruction nº 118/2020).

In this sense, it is worth recalling that article 18, III, of the Law nº 9.279/96 (Brazilian IP Law) establishes that living beings except transgenic micro-organisms that are not discoveries are not patentable. Nevertheless, transgenic plants are at the center of the unique inventive concept that links the main invention to the accessory ones. Hence, there is still a need for discussing the patentability of the plant, as the patentability of ancillary inventions derives from the main invention.

Within this context, technical note INPI/CPAPD nº 01/2022 clarify the following, in brief:

  • Definition of an elite event: "An elite event is an event of transforming a plant (1) through 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 genome (4) and gives the plant a superior technical effect when compared to the other events of transformation (5)."
  • Assessment of novelty and inventive step: the assessment of these requirements must depart from the aforementioned definition of elite events.
  • Novelty: if all five distinctive features of the elite event are already revealed in a single prior art document, the elite event will lack novelty.
  • Inventive step: as a general rule, three steps must be employed to determine whether a claimed invention is obvious when compared to the prior art: (i) determine the closest state of the art; (ii) determine the distinctive features of the invention and/or the technical problem solved by the invention; and (iii) determine whether, given the technical problem considered and starting from the nearest state of the art, whether or not the invention is obvious to a person skilled in the art.
  • In relation to transgenic plants, the examiner should look for a plant of the same species with the same phenotype, or, if not possible, the examiner should look for plants of other species with the same phenotype, considering the evolutionary distance from the plant in examination. If it is not possible to find in vivo transformations, the examiner should look for in vitro descriptions.
  • Additionally, the technical note lists non-exhaustive indications of the presence of inventive step, such as: (i) phenotype improvement (e.g., increased herbicide resistance, increased size of the seed); and (ii) association by gene linkage of a phenotype (e.g., resistance to glyphosate) to another phenotype of interest (e.g., increased yield).
  • The following are non-exhaustive indications of lack of inventive step: (i) the simple fact that the transformation did not harm the agronomic characteristics of the plant or the mere selection of a plant by characteristics not linked to the transgene; (ii) molecular analysis of parameters such as integration of the inserted cassette in the genome, number of copies of the transgene, detection of the expression of the transgene, identification of the insertion site in the genome without association of these parameters to a non-obvious technical effect; and (iii) the existence of modifications in the transgene or in the construct per se, as well as information about a new insertion site in the genome, since even if it confers novelty, it does not necessarily confer inventiveness to the subject matter.

However, since the matter addressed by technical note INPI/CPAPD n° 01/2022 is of public interest, the INPI published on 01 June 2022 in the Federal Official Gazette n° 103 an announcement on the opening of the Public Consultation on said technical note. . As from the date of publication, interested parties will have a 30-day term, i.e., until 01 July 2022, to submit comments on the technical note before the INPI. At the end of the term, the INPI will present answers to the contributions and the final text of the technical note. Hence, the applicability of said technical note is stayed until the end of the Public Consultation.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.