The BRPTO issues new guidelines related to transgenic plants

On March 16 2022, the BRPTO published the technical note, namely, BRPTO/CPAPD nº 01/2022, which provides guidelines on the examination of inventions related to transgenic plants, particularly, elite events – topics not covered by the examination guidelines for patent applications in the Biotechnology field currently in force (Normative Instruction nº 118/2020).

The main provisions of the technical note nº 01/2022:

• Elite Event is defined as a process of genetic transformation (transgenesis) that provides the plant a superior technical effect when compared to other transformation events.
• Transgenic plants and their parts remain excluded from patentability in view of the provisions of Art. 10 (IX) and 18 (III) of the Brazilian IP Law # 9,279/96– even if the transgenesis event solves a given technical problem in a new and non-obvious way.
• Nonetheless, accessory inventions related to transgenic plants and their parts are patentable, provided that they meet the requirements and conditions of patentability. Thus, examination of the main invention is necessary for the granting of accessory inventions, even if the main invention (i.e transgenic plant) is excluded from patentability.
• Non-exhaustive examples of accessory inventions related to elite events that are eligible to patent protection in Brazil: (i) isolated biological material (i.e. hybrid DNA molecules); (ii) method to identify plants that comprise elite events; (iii) methods of controlling weeds in a field of inventive herbicidal resistant transgenic plants (iv) use; and (v) compositions.
• Inventions related to biological material, if isolated from transgenic plants, may be granted under the provisions of article 18 (III) of the Brazilian Patent Statute, provided that they are not identical or indistinguishable from their natural counterpart and in addition, it must explicitly state that they are isolated, and not within the plant

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