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Brazilian PTO clarifies patentability requirements for inventions related to transgenic plants, especially elite events

by , | Mar 25, 2022 | Articles, Brazil, Intellectual Property, Life Sciences, Patents, Pharma, Prosecution

Background: Based on the provisions of Article 10 (IX) of the Brazilian IP Law # 9,279/96, natural living beings (animals and plants), in whole or in part (such as cells), as well biological material, when found in nature or isolated therefrom are not considered to be inventions. Besides said Article 10 (IX), Article 18 (III) of the IP Law excludes from patent protection natural living beings, in whole or in part, even if modified/recombinant – it is only possible to seek protection for transgenic microorganisms.

In March 2022, the Brazilian PTO published a technical note clarifying the patentability requirements for inventions related to transgenic plants, especially elite events, since this matter is not fully covered by the current Biotechnology Guidelines, and stated that said additional clarifications should be promptly considered during the technical examination of the patent applications.

Initially, the PTO provided the following definition regarding an elite event (emphasis added): “An elite event is a plant transformation event (1) through the insertion of a transgene (2) using a genetic construct (3) in a stable form, wherein this insertion took place at a specific site of the plant genome (4) and it gives the plant a superior technical effect when compared to other transformation events (5)”.

The PTO explained that although transgenic plants are excluded from patent protection in Brazil in view of the provisions of Articles 10 (IX) and 18 (III) mentioned above, it is important to assess the patentability requirements (novelty and inventive activity) of the transgenic plants when they are the main invention and protection is intended to interconnected accessory inventions (such as, DNA molecule, method of identifying plants comprising said elite event, among others), since the inventiveness of the accessory inventions will depend on the inventiveness of the main invention.

For the assessment of novelty requirement of an elite event, the PTO stated that if all five features mentioned above ((1) to (5)) are already disclosed in a single prior art document, the elite event will be devoid of novelty. Otherwise, the inventiveness of the elite event will be examined, so that the technical problem to be solved and the closest prior art should be identified. For reference, the PTO provided the following examples of non-exhaustive evidence of inventive activity concerning a transgenic plant/elite event:
• a phenotype improvement (increased herbicide resistance or increased seed size); and
• an association by gene linkage of a phenotype (such as, glyphosate resistance) with another phenotype of interest (for example, increased yield).

Once the inventiveness of the transgenic plant/elite event (main invention) is determined, the following requirements must also be met by the accessory inventions:
• they must be isolated and different from the natural ones, that is, they must not fall within the provisions of Articles 10 (IX) and 18 (III) of Brazilian IP Law;
• they must be a direct consequence of the main invention for inventiveness purposes;
• they should be novel in view of their technical features, since the simple fact of being transgenic or associated with an elite event does not make them novel; and
• they must comply with accuracy, support and sufficiency of disclosure requirements, such as currently requested in the pending guidelines.

Finally, for illustrative purposes, the PTO provided the following examples of accessory inventions that are eligigle to patent protection in Brazil:

Accessory inventions Is it eligible of protection?
DNA molecules Yes, as long as they are isolated and different from the natural ones
Genome or genomic DNA Yes, as long as it is isolated and different from the natural ones
Biological materials Yes, as long as they are isolated and different from the natural ones
Pair of molecules Yes
Method of growing a transgenic plant characterized by comprising applying herbicide to a field planted with the transgenic plant Yes, as long as the technical effect of the transgenic plant that is the main invention addresses herbicide resistance
Method for controlling weeds by spraying the herbicide on a field planted with the plant genetically modified to be resistant to the herbicide characterized by spraying herbicide on the field Yes, as long as the technical effect of the transgenic plant that is the main invention addresses herbicide resistance
Method for protecting a transgenic plant against insect infestation characterized by comprising providing an insecticidally effective amount of the transgenic plant to the insect diet Yes, as long as the technical effect of the transgenic plant that is the main invention addresses insecticide production
Use of the transgenic plant comprising the SEQ ID NO: X for insect control Yes, as long as the technical effect of the transgenic plant that is the main invention addresses insecticide production
Method for detecting the elite event Yes
Method for producing the transgenic plant Yes

 

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