On March 17, 2022, the Brazilian Patent and Trademark Office (BPTO) has issued specific guidance regarding the examination of inventions related to plant transformation events (Elite events) and accessory inventions related to Elite events, namely, BPTO’s Technical Note INPI/CPAPD n° 01/2022.
The main concepts thereof are summarized below:
1-Definition of Elite Event
An Elite Event is defined by means of the following five technical characteristics:
- a transformation event of a plant
- by inserting a transgene
- using a genetic construct in a stable manner
- where this insertion is present in a specific location in the plant genome, and
- gives the plant a superior technical effect compared to other transformation events
However, like any transgenic plant, the plants that originated from the Elite event are not patentable according to Section 18 (III) which excludes from patentability the whole or part of living beings, except transgenic microorganisms.
2-Patentability requirements of the Elite Event
An Elite Event lacks novelty when all five distinctive features are already disclosed in a single prior art document.
In addition, an Elite Event lacks an inventive step when it is derived in an obvious way from the prior art.
3-The following are Non-exhaustive indicators of the presence of inventive steps:
- improvement in phenotype (e.g., increased herbicide resistance, increased seed size, etc.); and
- association by gene linkage of a phenotype (e.g., resistance to glyphosate resistance) to another phenotype of interest (e.g. increased yield).
4-The following are non-exhaustive indicators of the absence of inventive steps:
- the mere fact that the transformation did not impair agronomic characteristics of the plant, or the mere selection of a plant for characteristics that are not associated with the transgene;
- molecular analysis of parameters, such as integration of the inserted cassette into the genome, transgene copy number, detection of transgene expression, identification of transgene expression, identification of the insertion site in the genome without associating these parameters to a non-obvious technical effect; and
- the existence of modifications in the transgene or construct per se, as well as information about a new insertion site in the genome, while conferring novelty, do not necessarily confer inventiveness to the subject matter. Hence, experimental data which demonstrate that these modifications are associated with a non-obvious technical effect should be provided, otherwise, the new gene, the new construct, or the new location will be considered equivalent to those described in the prior art and, therefore, they will be considered obvious.
5-Accessory inventions related to transgenic plants
The inventiveness of the accessory inventions related to transgenic plants derives from the technical effect generated by the main invention (transgenic plant).
Once the inventive step of the main invention, in this case, a transgenic plant, is recognized, it extends to the accessory inventions related to the main invention.
The accessory inventions often associated with Elite events are, for example, the following:
- The hybrid DNA molecules in which one part of the molecule corresponds to a portion of the chromosome and the other part corresponds to the DNA of the inserted genetic construct.
These molecules are useful as identifiers of the Elite event, as their presence reflects the insertion of a transgene in a specific location in the genome.
- Methods for identifying plants comprising such events. Such a method comprises, for example, the use of said hybrid DNA molecule as a probe that allows detecting whether a plant comprises the specific Elite event.
- Methods comprise designing a pair of primer molecules, for use in the PCR technique,
6-The incidence of accessory inventions on the provisions of Sections 10 (IX) and 18 (III) of LPI
Section 10 of Industrial Property Law establishes that the following shall not be considered inventions or utility models:
IX – all or part of natural living beings and biological materials found in nature, or isolated therefrom, including the genome or germplasm of any natural living being and the natural biological processes”.
Hence, when the living being is not natural but obtained through direct human intervention in its genetic composition to express a trait not normally attainable by the species under natural conditions, it does not fall under the provisions of Section 10 (IX) of the IPL.
However, Section 18 (III) of the IPL states that “The following shall not be patentable:
II – living beings, whole or in part, except for transgenic microorganisms meeting the three requirements of patentability – novelty, inventive step, and industrial application – provided for in article 8 and which are not mere discoveries.
“For the purposes of this law, transgenic microorganisms are organisms, except for plants or animals, whole or part, that due to direct human intervention in their genetic composition, express a characteristic that cannot be normally achieved by the species under natural conditions”.
Consequently, modified living beings such as transgenic plants are not patentable (except for transgenic microorganisms).
Additionally, Section 18 (III) does not determine an exclusion of patentability for isolated biological material, as does Section 10 (IX), so it is concluded that the isolated biological materials, when modified and distinct from natural ones, are patentable if they meet the patentability requirements and conditions established in the IPL.
In other words, when the living being is natural, according to Section 10 (IX) of the IPL, it is not considered an invention:
(a) in its entirety (the whole), (b) in its parts, such as, for example, a seed or a leaf, and (c) in its intra-cellular biological materials, such as proteins and other molecules, even if isolated from the living being.
Consequently, DNA molecules consisting of the junction region between insert and chromosome, as long as they are isolated from the living being, are patentable.
It is worth emphasizing that such molecules, for being hybrid, in principle, are not found as such in nature and, therefore, do not fall within the matter that is not considered an invention as established in section 10 (IX) of the LPI.
If these junction molecules are integrated into the genome of the plant or parts thereof, they are inseparable from it, and therefore, they are not patentable under the provisions of section 18 (III) of the LPI.
Plant genome and genomic DNA are understood as synonyms and may be patentable if they are different from the natural ones and if they are isolated from the plant.
If they are inserted in the plant, it is understood that they are part of the plant; therefore, they are not susceptible to patent protection, according to section 18 (III) of the IPL.
In consequence, the PTO establishes that the term, “isolated” must be included in the claims to avoid the subject matter being excluded from protection.
If the word “isolated” is not present in the claims, it is understood that the DNA molecule and the genome can be inserted in a plant or in its parts. In this case, they are not susceptible to patent protection due to the provisions of Section 18 (III) of LPI.
7-Novelty and inventive step of accessory inventions associated with plants
The novelty of the accessory inventions must be examined by their technical characteristics, for example, their chemical formula or their biological sequence.
The mere fact that a product was obtained through transgenesis or that it is associated with an Elite event does not automatically add novelty to the product.
The inventiveness of the accessory inventions is always derived from the inventive step of the main invention and must be assessed by means of the latter since the main invention is the technical solution proposed by the invention, however, it is necessary that the accessory invention be a direct consequence of this solution.
8-Sufficiency, rationale, clarity and precision of the plant-related accessory inventions
As an accessory invention is related to the transgenic plant, for the purposes of the sufficiency of disclosure according to Section 24 of LPI), it will always be necessary to deposit the seed with a Biological Material Depositary Center to allow the reproducibility of the main invention.
When the claimed subject matter is directly obtained from the plant or its parts thereof or uses them (for example an oil or a method of extracting an oil), for purposes of support of the claim in the description (Section 25 of IPL), the information related to the deposit number must additionally be defined in the wording of claims.
Additionally, for sufficiency of description as to the insertion site of the transgene in the genome, in addition to the upstream and downstream flanking chromosomal regions, it is necessary that the application reveals the entire sequence used in the gene construction, i.e. both the coding region and the regulatory elements of gene expression, by means of SEQ ID.
If the application as filed contains an unambiguous reference to such sequences by reference to prior art documents, these may be subsequently incorporated into the application and identified by the specific SEQ ID No.
For purposes of clarity and precision (Section 25 of LPI), the claims referring to biological sequences should be characterized by means of their SEQ ID NO:
9-Wording of accessory inventions
9.1-Pair of initiators or primers molecules
A pair of initiator or primer molecules are understood to be a composition containing two ingredients. This is because such molecules do not occur together in nature and when used together have the function of amplifying the insertion region of the transgene in the genome, because one molecule hybridizes with the genome and the other molecule hybridizes with the insert.
Consequently, said pair of initiators must be defined by their characteristic sequences.
9.2-Methods involving a transgenic plant
Claims related to methods associated with the cultivation of transgenic plants should be examined based on the inventive feature related to the transgenic plant.
Claims for cultivation methods in which the transgenic plant itself produces an insecticide component can also be granted, provided that the plant is considered to be new and inventive.
Claims related to methods for the detection of plants comprising Elite events (being applicable to the plant or to a sample) may also be protected.
Claims related to methods involving the crossing of at least one transgenic plant are patentable.
It is concluded that, even if the transgenesis event solves a given technical problem in a new and inventive way, the plants and their parts (i.e., seeds, cells, etc.) that contain it are not patentable according to Section 18 (III) of IPL.
However, when the inventive concept contains, in addition to the transgenesis event (main invention), other inventions, such as methods, uses, compositions and biological sequences, these are considered accessory inventions. In this case, the patentability of the plant must be assessed, given that the inventiveness of the accessory inventions depends on the inventiveness of the main invention.