New technical guidelines for patentability of inventions associated with transgenic plants with focus on elite events in Brazil

April 2022

Last March, the Brazilian National Institute of Industrial Property (INPI) published a Technical Note (INPI/CPAPD No. 01/2022), to which you can access below, with the objective of clarifying the patentability of inventions involving transgenic plants, especially, in elite events.

What is a transgenic or GM plant?

A transgenic or GM plant is a plant that has been genetically altered. However, the reason for this alteration does not necessarily have to have a scientific origin, it is possible that the genes transfer occurs by nature itself. For example, if a plant suffers a cut or a wound, the bacterium inserts itself inside the plant and transfers its genes to the plant.

Now, considering that we are talking about invention patents, which can only be created by the human mind –at least, at the moment–, where is the scientific connection? Basically, the connection is founded because of the procedure used by this bacterium in nature is the same as the one used by scientists.

However, the difference lies in the fact that when the transfer is carried out naturally, it is inevitable that, in addition to the gene that the plant needs, other unwanted genes will be transmitted. Genetically engineered transgenic plant varieties, although, have the advantage that only the specific gene that is desired can be included in them, and the plant itself can maintain its genetic information without any differences.

Put in a more technical way, it is a transgenic process in which, through the insertion of exogenous DNA into a living being, it will be given characteristics of interest through traditional techniques. However, this insertion is random and it is not possible to know exactly where the gene construct will be inserted. Therefore, each insertion is referred to as a “transformation event”, and to the event that best performs the labor is known as the elite event.

What are elite events?

Elite events are those that show the best performance among the plant transformation events. These events are related to the process of transgenesis: the process of genetic alteration in which an exogenous DNA fragment is introduced into the genome of a living being, as explained in the previous section, to confer a characteristic of interest to a plant, such as herbicide resistance.

Technical guidelines for the patentability of inventions associated with transgenic plants in elite events

In Brazil, following INPI/CPAPD Technical Note No. 07/2022, the INPI has clarified the patentability issues of inventions involving these plants with a focus on elite events. This Note defines:

(1) an elite event as a plant transformation event,

(2) through the insertion of a transgene,

(3) through the use of a genetic construct, or

(4) in a stable manner, in order that the insertion occurs at a specific location in the plant genome; and

(5) that confers a superior technical effect compared to other transformation events.

Now, there are several factors that influence the outcome of genetic transformation protocols. Thus, viable transformation events are those that result in the modified plants retaining the characteristics of the wild organisms on the one hand, and acquiring the distinguishing characteristic provided by the transgenic process on the other. In this sense, the selection of such viable processes is carried out on the basis of the following parameters:

– pattern of integration of genetic insertion into the genome;

– transgene gene expression profile; and

– location of the insert in the genome, so that the trait can be transmitted in subsequent crosses of a given plant.

Article 18 of Brazil’s Industrial Property Law 9.279/1996 stipulates that only transgenic micro-organisms are subject to patent protection, which excludes the possibility of protecting any animal or plant cell, the whole or part of living beings and biological materials.

Therefore, the Technical Note aims to assess the patentability of transgenic plants for elite events.

One of the main clarifications is that DNA molecules consisting of the junction between insert and chromosome as hybrid molecules (as long as they are isolated from cells) are patentable, but from the perspective of accessory inventions.

On the other hand, the novelty requirement would be shown when such accessory inventions have their own characteristics, with respect to chemical formulae or biological sequences; the fact that it has been obtained through transgenesis is not sufficient.

In relation to the inventive step in accessory innovations -understood as “methods, uses, compositions and biological sequences”- it is important to highlight that this depends directly on the inventive step in the main invention; but, in turn, it is necessary for the accessory invention to be a direct consequence of the main invention, as this is the technical solution proposed by the application. However, if the main invention is considered novel, the resulting accessory inventions will also be novel, as long as they belong to the same inventive concept, provided that the application complies with the other patentability requirements.

Therefore, through the clarifications provided in this Technical Note, the Brazilian office intends to demonstrate the relevance and intention of making these examination procedures more flexible and standardized in the biotechnological field, in order to provide greater legal certainty, whether the applicants are nationals or foreigners in the country.

Eduardo Zamora