The emergence of new breeding technologies (NBTs) has been transforming agricultural production. One of the most prominent NBTs is the CRISPR/Cas system, which allows for precise genome editing, without the need to insert foreign genes into a desired plant to be edited. Essentially, this technology combines the use of clustered regularly interspaced short palindromic repeats (CRISPR), which is a guide RNA (gRNA) designed to complement a specific DNA sequence, with an endonuclease (Cas9) that cleaves the DNA strand in a very precise way¹.

Specifically, the CRISPR/Cas system consists of removing, adding, or altering sections of the DNA sequence, by employing a mechanism of genome editing that can be divided into three steps: recognition, cleavage, and repair. For this, two molecules are used to enable genome editing through DNA cleavage: Cas9, a nuclease that can cleave both strands of DNA at a specific location in the genome; and a guide RNA (gRNA), a short piece of RNA sequence located within a longer RNA structure. This RNA molecule “guides” Cas9 to the part of the genome that needs to be cut and is capable of pairing with the bases of a target sequence. Thus, the system previously knowing a sequence in the DNA that needs to be changed, provides a complementary gRNA to bind to that specific region. The gRNA guides Cas9 to this complementary sequence, which is then cleaved. After this cleavage, the organism's intrinsic molecular machinery, responsible for correcting errors in the genome, is used to alter the DNA sequence, adopting the modification. Using the CRISPR/Cas9 system it is possible to induce the DNA repair system. In this way, the system can repair, silence, and repress genes, among other genomic changes.

Such precision technology enables significant enhancements in crop plants’ resistance against abiotic/biotic stress, such as the defense of plants against pathogens, phytophagous organisms, or weeds. By using CRISPR/Cas technology, it is also possible to improve or even silence specific characteristics of the plant, thus, resulting in crops with enhanced quality².

The advantages of the CRISPR/Cas system extend beyond its technical capabilities. This technology is not only safer due to its precision in genome targeting but is also more economical since it requires less time to be concluded when compared to standard types of genome editing, such as cross-breeding or transgenic breeding. Besides that, in Brazil, plants modified by the CRISPR technology may not be classified as a genetically modified organism (OGM)³, which means that they may not need to be approved by the National Technical Commission on Biosafety (CTNBio) to be commercialized, saving both time and money of the investors in this technology⁴.

The impact of the CRISPR/Cas system on agriculture is reflected in the increment in the number of patent applications related to genomic editing over the last decade worldwide. According to the recently launched BRPTO’s Technology Radar⁵, which focuses on gene editing and mapping of patents associated with CRISPR technologies and their applications in agriculture and livestock, in the IP worldwide scenario, there were identified 4,322 patent application families specifically related to the CRISPR technology in the agriculture. These applications were first filed between 2010 and 2023, mainly before the Chinese Patent Office (CNIPA) and the United States Patent Office (USPTO) (both represent 84% of the total number of applications), indicating the global interest and investment in this technology⁶.

Despite the global increase, the situation in Brazil is still evolving. Out of the 4,322 identified patent families, only 345 have a Brazilian counterpart. Although this number is small in percentage terms, Brazil is emerging as a promising market for future advancements in this field, attracting investment in innovation that will lead to an increase in national patent application filings. Undoubtedly, our greatest competitive advantage lies in our rich biodiversity and agricultural heritage.

Along with our key competitive advantage mentioned above, Brazil has also shown remarkable progress in the protection sector, particularly in reducing the backlog of patent application examinations. Statistics indicate that the backlog at the BRPTO’s art unit responsible for examining CRISPR technology inventions in agriculture (i.e., Food, plants, and akin – DIALP) has been steadily decreasing over the years (see Figure 1).

Additionally, it is also encouraging to note that the allowance rate for this BRPTO’s art unit has significantly increased over the past decade (see Figure 2).

As for the subject matter eligible for patent protection in Brazil directed to CRISPR-CAS inventions, it is worth mentioning that it is currently limited to methods for gene editing, chimeric RNA-DNA guide polynucleotide, and guide polynucleotide/endonuclease complex. Due to the prohibitions established by the Brazilian Patent Statute (Law #9,279/96), plants, whole or in part (such as cells and seeds), even if modified or recombinant, as well as biological materials, such as germplasm and oligonucleotides, whether found in nature or isolated therefrom, are not patentable eligible.

By analyzing the patents granted by the BRPTO, it is possible to illustrate the following example of claim language deemed acceptable for CRISPR technology inventions:

“1. Chimeric RNA-DNA guide polynucleotide characterized by comprising:

(i) a first nucleotide sequence domain that is complementary to a nucleotide sequence in a target DNA; and,

(ii) a second nucleotide sequence domain that interacts with a Cas endonuclease, wherein the first nucleotide sequence domain and the second nucleotide sequence domain are composed of deoxyribonucleic acids (DNA), ribonucleic acids (RNA), or a combination thereof, wherein the guide polynucleotide comprises DNA.” (BR 11 2016 003776 6)

Although the BRPTO has required the definition of the SEQ ID NO of the biological sequences recited in the above claim during the prosecution, said objection was overcome by arguing, among others, that the chimeric RNA-DNA guide polynucleotide covers a general structural concept of having a DNA base on a guide RNA that complexes with CRISPR-Cas nucleases and that the specification provides data to evidence its functionality.

CRISPR-CAS-based inventions hold significant promise for enhancing competitiveness among the key players in the agricultural sector, positively impacting the provision of services, products, and processes for society. The investments in this technology are expected to increase over the coming years, resulting in a higher number of filings of Brazilian patent applications, and, consequently, leading to extended discussion about the patentability of this cutting-edge technology.