Completing the sequencing of the nucleic acid sequence of the human genome led to the mass patenting of genes in the United States. The phrase “What can be patented is purified DNA containing the sequence of the gene and techniques that allow the study of the genes.” has a rather specific meaning. The object of patenting can be a sequence of nucleotides isolated from one or another organism, as well as particular methods or technologies for isolating and purifying this DNA (Sampat & Williams, 2019). Ownership of a patent and ownership of the object of the patent as property should be separated. A patent on a gene does not grant ownership rights to organisms containing that gene. Not only because the patented object is different from what is found in nature but also because patent rights do not provide positive ownership rights.
A gene patent is an exclusive right to a particular biological sequence granted to a person directly related to the identification of this sequence or work on its transformation. Depending on the patent legislation of a specific country, the patent owner is given the right to determine who and under what conditions can use the patented object (Sampat & Williams, 2019). As a rule, patents on genes related to the development of various diseases were issued (Sampat & Williams, 2019). It should be noted that the patented DNA fragments were unevenly distributed throughout the genome. Many patents fell on studied areas, for example, targets of any drugs or marker areas studied in disease diagnosis, while interest was weaker in areas with less obvious functionality.
One of the most famous examples of gene patenting is Myriad Genetics’ patents on the BRCA1 and BRCA2 genes, tumor suppressors whose various mutations increase the risk of developing breast and ovarian cancer. These patents gave Myriad Genetics exclusive rights to create and conduct diagnostic tests based on locus data. This company’s monopoly on conducting such tests has led to heated debates on patents’ legal and ethical status on parts of the human genome (Aboy et al., 2017). Now the sequences are patented less often, but patents are issued for their use in the industry while creating new methods and technologies.
When evaluating the novelty of an invention related to biological sequences, the question may arise about the number of changes made in the process of identification and extraction. The argument here can be that it is not the DNA inside the cells being patented. Still, the isolated and purified molecules, which include the areas necessary for specific purposes, such as markers of any diseases, have no such molecules (Aboy et al., 2017). They are based on new methods that can be considered an invention. Isolated and modified DNA may have new or altered functions and some improved properties different from those found in DNA alone in the body. Therefore, taking into account the work involved in the isolation and identification of a gene and the changes made to it, the patented DNA regions should be separated from the DNA in living organisms. In addition, the definition of the boundaries of the sequence, at which it can, for example, perform its function more effectively, can be considered an invention.
On the one hand, gene patenting can give companies with patented sequence data time to explore the subject of the patent without competition. These companies do not have to worry about other companies competing with them to make discoveries. With the help of patenting, small organizations with limited financial support can gain competitiveness. Obtaining patents on biological sequences in the next 30 years can contribute to developing the research direction in entrepreneurship and increase investments in this industry. Legislations of several countries include the possibility of scientific research of patented objects and the impossibility of only their commercial use (Nicol et al., 2019). In some countries, special agreements are concluded during patenting, thanks to which researchers can study proprietary genes.
On the other hand, obtaining patents on genes can inhibit research in potentially essential areas of science and hinder its development. Such patents give owners exclusive intellectual property rights over the patented sequences for decades, which is unethical. This can lead to the monopolization of genetic constructs and increase secrecy in the scientific environment, leading to a slowdown in scientific progress (Sampat & Williams, 2019). Other companies will not be allowed to work with the patented genes, because of which opportunities to make important discoveries may be lost. Due to overlapping patents, companies may overlook essential research topics and may lack the incentive to invest in discoveries unless they are guaranteed patent protection. In addition, the exclusivity of the right to biological sequences can lead to delays in obtaining practical diagnostic tools. This will happen due to the unwillingness or inability of other companies to pay deductions and work on new methods only for the patent owner. It is much less effective in the absence of possible competition and collaboration. Due to a financial factor associated with gene patenting, studying areas that do not lead to direct economic benefit, such as basic research, can be slowed down.
Thus, the permission to patent genes can lead to the monopolization of this industry and the ban – to a reduction in the number of companies interested in its development. Only by carefully considering all aspects of gene patent policy can a societal agreement that promotes scientific progress and considers all possible dangers. Governments must maintain an optimal balance between the use of patents to protect and encourage genuine inventions and the value of genetic information. It must be openly available so that scientists can widely use it in research and innovation for the benefit of humanity as a whole.
References
Aboy, M., Liddicoat, J., Liddell, K., Jordan, M., & Crespo, C. (2017). After Myriad, what makes a gene patent claim markedly different from nature?Nature Biotechnology, 35(9), 820-825. Web.
Nicol, D., Dreyfuss, R. C., Gold, E. R., Li, W., Liddicoat, J., & Van Overwalle, G. (2019). International Divergence in Gene Patenting. Annual review of genomics and human genetics, 20, 519–541. Web.
Sampat, B., & Williams, H. L. (2019). How do patents affect follow-on innovation? Evidence from the human genome. American Economic Review, 109(1), 203-36. Web.