On March 17, 2022, the BPTO released the INPI/CPAPD technical note No. 01/2022, which provides guidance on the patentability of inventions involving transgenic plants, with a focus on elite events.
In a transgenic process, an exogenous DNA is inserted into a living being, which will confer characteristics of interest. The aforementioned insertion of DNA into the genome of the host organism, through traditional techniques, occurs randomly, and it is not possible to know exactly where the gene construct will be inserted. Each of the insertions into the genome is known as a transformation event. The event that better performs is known as elite event.
The technical note defines an elite event as an event of plant transformation (1) through the insertion of a transgene (2) with the employment of a genetic construct (3) in a stable way, in which this insertion occurs at a specific location in the plant genome (4) and confers a superior technical effect when compared to the other transformation events (5).
For novelty assessment purposes, the five distinguishing features presented above should not be disclosed in a single document.
Transgenic plants, even from elite events, are not patentable in Brazil, according to Article 18 (III) of the Industrial Property Law (IPL). For the purpose of evaluating the inventive step, in accordance with the aforementioned technical note, it will be necessary to discuss about the patentability of the plant, as it is at the core of the inventive concept, linking the main invention to accessory inventions. Among the accessory inventions related to elite events it is possible to mention hybrid DNA molecules and elite event detection method, for example.
The inventive step of an accessory invention related to transgenic plants would come from the technical effect of the main invention. In this way, the recognition of the inventive activity of the transgenic plant would be extended to accessory inventions, which must still be examined in terms of other patentability requirements.