BPTO publishes technical guidelines related to the patentability of transgenic plants

We inform you that on May 9, 2023, the BPTO published the Technical Note No. 01/2023, which deals with the patentability of inventions associated with transgenic plants. This technical note is the result of the public consultation held in 2022 that received comments and suggestions from users.

Said Technical Note aims to address issues not fully addressed in the Guidelines for Examination of Patent Applications in the Biotechnology Field, particularly, by providing technical guidance for examining the patentability of inventions associated with transgenic plants, in particular, elite events.

In a nutshell, said technical note:

  • brings the definition of an elite event as a process of genetic transformation (transgenesis) that has a superior technical effect when compared to other transformation events;
  • highlights that transgenic plants and their parts are non-patentable matter – even if a transgenesis event solves a given technical problem in a new and non-obvious way, falling under the provisions of article 18 (III) of the Brazilian Industrial Property Law (BIPL);
  • highlights that accessory inventions related to transgenic plants and their parts are patentable, since they meet the requirements and conditions of patentability. Once the non-obviousness of the main invention – i.e., transgenic plant – is recognized, patentability is extended to accessory inventions. In other words, examination of the main invention is necessary for the granting of accessory inventions, even if the main invention is a non-patentable matter;
  • presents non-exhaustive examples of accessory inventions related to elite events such as: (i) hybrid DNA molecules; (ii) methods to identify plants that comprise elite events; (iii) uses; and (iv) compositions;
  • highlights those inventions related to biological material, if isolated from transgenic plants, may be granted under the provisions of article 18 (III) of the BIPL, if they are not identical or indistinguishable from their natural counterpart. In this regard, claims directed to modified biological sequences, for example, must explicitly state that they are isolated, and not within the plant;
  • presents the criteria for assessing the novelty and non-obviousness requirements of transgenic events in plants; and
  • discuss the patentability of plant-based products.

The guidelines defined in the note will be immediately applied to the examination of applications in progress at the BPTO, including second-instance cases.

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