Brazil: Updates on patenting of transgenic plants and elite events

Brazil: Updates on patenting of transgenic plants and elite events

In Brazil, natural living beings, in whole or in part, and biological material, including the genome or germ plasm of any natural living being, when found in nature or isolated therefrom, and natural biological processes are not even considered to be inventions; needless to say that as a result they consist of unpatentable subject matter. Moreover, living beings, in whole or in part, except transgenic micro-organisms, which are not mere discoveries, are not patentable in Brazil. Said transgenic micro-organisms are considered to be organisms, except the whole or part of plants or animals, that exhibit, due to direct human intervention in their genetic composition, a characteristic that cannot be normally attained by the species under natural conditions. These statutory prohibitions are foreseen according to the provisions of Articles 10 (IX) and 18 (III and Sole Paragraph) of current Brazilian Industrial Property Law nr. 9,279/1996.

On the other hand, the bright side is that related embodiments or “accessory inventions”, as for instance DNA molecules, genome, genomic DNA’s, their compositions and uses, methods for the introgression of traits, methods for producing, growing and/or protecting transgenic plants, methods for detecting traits and other examples of accessory inventions have no bar in the IP Law and are patentable accordingly.

Therefore, although transgenic plants themselves and parts thereof (e.g. cells, seeds, leaves, seedlings, fruits, roots, etc.) are considered by the Brazilian Patent and Trademark Office to be unpatentable, related technologies can find patent protection in Brazil. Even though the law is quite clear in this regard, transgenic plant-related matters are often a sensitive theme when we are talking about patent protection, specially within the agricultural field and ultimately the food, pharmaceutical and cosmetic industries.

On March 17, 2022, the Brazilian PTO issued specific rule Technical Note nr. 01/2022 in connection with examination of patent applications claiming plant transformation events, i.e. elite events. A series of technical definitions and delimitations of scope have been established in said Technical Note.

Said rule consolidated the Brazilian PTO’s position on the analysis of elite events but, due to its importance and impact on transgenic plant-related inventions, about three months later the PTO suspended its applicability and called for a public consultation in order to receive comments and suggestions, aiming at improving and reinforcing the contents thereof.

As a result of said public consultation, on May 09, 2023, the Brazilian PTO issued Technical Note nr. 01/2023, effective immediately for all pending patent applications, including those at appeal phase. In a nutshell, the new rule mainly states that:

1. Elite events are considered to represent events of modification of plants (i) through the insertion of an exogenous DNA, (ii) with the use of molecular tools, as for instance a genetic construct, (iii) said insertion being in a stable way and taking place at a specific site in the plant genome that is determined explicitly through disclosing the polynucleotide sequences flanking the insert, (iv) providing the plant with a superior technical effect when compared to other transformation events, but not being a result of an arbitrary selection.

2. Term “isolated” used to be required for distinguishing the transgenic plants themselves from transgenic plant-related inventions in terms of scope, but it is no longer advisable.

3. Biological materials can be eligible as an invention, thus being patentable, provided that they differ from those found in nature or isolated therefrom. Moreover, biological materials like DNA molecules and genomes should be characterized by their corresponding SEQ ID NO., which should relate to the junction sequence of insert/genome, as well as the assertion that they are inserted into a plant or any parts thereof, thus making clear that they do not confer protection to the plant itself. Such an insertion is a mere additional feature, since the SEQ ID NO. is what characterizes the molecules/genome.

4. Article 24 of the IP Law already provides for the criteria of sufficient disclosure (enablement) and, in case of biological material essential for the practical execution of the claimed invention, which cannot be described in the form of said Article and which has not been accessible to the public, the patent application should be supplemented by a deposit of the material in an institution authorized by the PTO or indicated in an international agreement. The new Technical Note further clarifies that the deposit of the biological material is needed to allow its reproducibility when the claimed invention has been obtained by a process which reproduction involved randomness until filing the patent application. On the other hand, said deposit is not necessary when the claimed invention is reproducible from its sequence as initially filed in the application. No new matter is allowed in Brazil. Although Brazil neither has any Depositary Center nor is a member of the Budapest Treaty, the PTO usually accepts deposit certificates from the ATCC – American Type Culture Collection, DSMZ – German Collection of Microorganisms and Cell Cultures and other International Depositary Authorities.

Examples of embodiments susceptible to patent protection:

. DNA molecules, genome, and genomic DNA;

. Biological materials, if different from those of natural occurrence;

. Pair of DNA molecules (primers);

. Methods of controlling weeds in a field of inventive herbicidal-resistant transgenic plants;

. Uses of inventive transgenic plants expressing an insecticidal protein in the control of insect pests;

. Methods of detecting plants comprising inventive events;

. Methods of crossing at least one inventive transgenic plant.

Examples of claim languages related to embodiments susceptible to patent protection:

. DNA molecule, characterized by comprising SEQ ID NO.: X (provided that said SEQ ID NO. refers to the insert/genome junction sequence);

. Plant genome, characterized by comprising SEQ ID NO.: X (provided that said SEQ ID NO. refers to the insert/genome junction sequence);

. DNA molecule, characterized by comprising SEQ ID NO.: X (provided that said SEQ ID NO: refers to the insert/genome junction sequence) and by being inserted into the genome/chromosome of a plant or parts thereof (e.g. seeds, cells, etc.; such an insertion is considered to be a mere additional feature, since the SEQ ID NO. is what characterizes the molecule);

. Genome, characterized by comprising SEQ ID NO.: X (provided that said SEQ ID NO. refers to the insert/genome junction sequence) and by being inserted into a plant or parts thereof (e.g. seeds, cells, etc.; such an insertion is considered to be a mere additional feature, since the SEQ ID NO. is what characterizes the genome).

It is worth highlighting that the new PTO’s Technical Note brings a clearer and very important guidance on the scope of unpatentable “parts” of living beings by allowing eligibility of patentability for biological materials contained therein. For example, these new official rules do not raise any doubts as to whether the unauthorized use of plant seeds containing a patented DNA molecule is an infringement of patent rights.

So far Technical Note nr. 01/2023 has been received positively by patent practitioners and users, as it makes clear and harmonizes the Brazilian PTO’s position on this particular subject matter, thus reducing dubieties and improving the Brazilian patent system. It is expected that there will be more legal certainty and a more straightforward prosecution of patent applications claiming transgenic plant-related inventions.