Advances in molecular biology have contributed to benefits in the areas of medicine, agronomy, and biotechnology. It is no different in the field of patents, with advances in the area concomitant with patent applications and, often, fierce and complex disputes over protection rights.
On the one hand, the end of a patent term means that technologies can be used without a license, on the other hand, the increase in competition, and the need to prevent third parties from copying and benefiting from the invention makes the patent system continue to drive technological development, in order to make possible, in the case of molecular biology, increasingly simpler, faster and more economical techniques.
A clear example lies with the PCR (Polymerase Chain Reaction) technique, which revolutionized molecular research, being the most well-known and successful technology for genetic isolation and analysis, which had its patent (US 4,683,202) granted in 1987 and has expired in the US in 2007. During the term, obligations and royalties were paid to patent holders and investments were made in technological development, which culminated in significant advances, such as the invention of quantitative real-time PCR (qPCR), an innovation created from PCR, which addressed many of the practical limitations associated with the technique.
Currently, CRISPR - Cas 9 (Clustered Regularly Interspaced Short Palindromic Repeats -associated protein Cas 9) is a gene editing technique that has been used in a wide range of applications, from basic research to therapeutics techniques and genetic modification of plants. In the main, they are repeated sequences of nucleotides that can be oriented to locate specific portions in the genome of any organism and cut the DNA. This is what makes gene editing possible (see more at i).
This CRISPR- Cas 9 sequence system, which is present in the bacterial and archaeal genomes, works as a defense mechanism against virus, identifying and cutting viral DNA, was studied by researchers Emmanuelle Charpentier and Jennifer Doudna who published an article (Jinek et al., 2012)ii, where they showed the applicability of CRISPR- Cas 9 to cut target DNA. In the same year of publication of the article, Doudna, Charpentier, and coworkers applied for a patent on this invention (US 10,266,850) in the name of the University of California (UC Berkeley). However, months later, the researcher Feng Zhang from Broad Institute Inc. of Massachusetts Institute of Technology - MIT also filed a patent on CRISPR.
It should be noted that in the year of both filings, 2012, the USPTO granted patents to those who first invented the technology (first to invent), instead of considering who first applied for the patent (first to file). The following year, the USPTO changed its procedures, considering, in the case of a priority dispute, the first to file the invention 1.
Zhang's patent (US 8,697,359 ) was granted in 2014, which prompted a UC Berkeley application to the US Patent Trial and Appeal Board - PTAB), which forms part of the United States Patent and Trademark Office (USPTO), to determine who pioneered the CRISPR-Cas 9 invention, suggesting that certain claims identified by UC Berkeley in its filing were of the same invention as claims in the Broad Institute patent.
In 2017 the PTAB decided that the UC Berkeley and the Broad Institute patents for the use of CRISPR-Cas 9 were separate, being both patentable. Zhang's patent was considered new and nonobvious for a person skilled in the art to achieve the same invention using the teachings of previous works such as Jinek et al. (2012). The justification for this decision was due to the fact that Doudna and Charpentier's invention was related to CRISPR applications in vitro, , in any type of cell, while Zhang's would be directed and with functional application in eukaryotic cells (such as human cells). In the examiner's wordsSpecifically, the evidence shows that the invention of such systems in eukaryotic cells would not have been obvious over the invention of CRISPR-Cas9 systems in any environment, including in prokaryotic cells or in vitro, because one of ordinary skill in the art would not have reasonably expected a CRISPR-Cas9 system to be successful in a eukaryotic environment. This evidence shows that the parties' claims do not interfere" 2Thereafter, further interference appeals were filed with the PTAB by UC Berkeley, and in February 2022 the PTAB decided that the Broad Institute researchers were pioneers in the application of CRISPR - Cas 9 in eukaryotic cells.
Cas -related patent applications have been filed and granted to both research groups. Since advances in research promise the development of many other technologies, once different enzymes can be used, modifications in the technique adapted for different targets, CRISPR systems from other bacteria and archaea can be studied and incorporated into new approaches related to CRISPR technology.
According to the Brazilian law that regulates rights and obligations relating to industrial property - LPI (Law 9.279/96), any invention that meet the requirements of novelty, inventive step, and industrial application can be patentable3. However, in addition to innovative ideas, until we reach the right product for the market, years of research and major financial investments are needed. And between tests and publications, the invention may lose one of the necessary criteria for patentability, that is, novelty. Attention should be paid to the possibility that another research group is studying the same topic and previously applying for a patent.
Such a possibility demonstrates the importance of drawing up a plan based on market strategies to protect the invention, from the pioneer invention, as well as its developments. Thus, the application of technologies in new contexts and uses can generate a new invention and demand new protection, provided that the new technical effects achieved are sufficiently described and proven, as in the example of qPCR. Also, new applications, such as CRISPR- Cas, can be used in basic research in vitro assays, clinical studies, eukaryotic cells, biomedicine, environmental technologies, etc.
It should be noted that in the area of Biological Sciences, the Brazilian law of trademarks and patents - LPI does not consider an invention "natural living beings, in whole or in part, and biological material, including the genome or germplasm of any natural living being, when found in nature or isolated therefrom, and natural biological processes" 4However, exceptions are made for transgenic microorganisms meeting the patentability requirements and which are not mere discoveries5 . Since transgenic microorganisms, according to Law 9.279/96, "are organisms, except the whole or part of plants or animals, that exhibit, due to direct human intervention in their genetic composition, a characteristic that can not normally be attained by the species under natural conditions" 6.
Thus, in Brazil, processes, and products based on genetic engineering are subject to protection, where it is possible to verify significant technical intervention for the final result 7However, it is necessary to have a technical basis with specifications describe the invention in sufficient detail, so that a person skilled in the art would reasonably understand and reproduce the object of the patent without undue experimentation, as well as the best way of executing the invention(best mode known), in addition to a set of claims that covers the scope of protection that the applicant wishes to obtain, considering the state of the art.
Footnotes
1 Idem publicação Disponível em: USPTO. https://www.uspto.gov/patents/first-inventor-file-fitf-resources.
2 Idem publicação Patent Interference No. 106048. Disponível em: USPTO https://acts.uspto.gov/ifiling/DispatchServlet , pg.2, Linha 7-12.
3 Artigo 8 da Lei da Propriedade Industrial - LPI (Lei 9279 de 14 de maio de 1996).
4 Artigo 10, inciso IX, da LPI.
5 Artigo 18, inciso III, da LPI.
6 Parágrafo único da LPI.
7 Diretrizes de Exame de Pedidos de Patente na Área de Biotecnologia. Revista da Propriedade Industrial Nº 2604. 2020.
i Texto. Disponível em: https://pt.linkedin.com/pulse/o-poderoso-crispr-cas-michele-pittol
ii Jinek, M. et al. A programmable dual RNA-guided DNA endonuclease in adaptive bacterial immunity. Science, 337(6096): 816-821, 2012.
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