The completion of the human genome project led to the significant advancement of genetics and molecular biology along with many other fields of science. Since the 1990s, when the project began, to now, there has been an astronomical amount of patent applications for new human gene sequences in the United States. Scientists and researchers wanted to protect their discoveries with a patent. When applying for a patent, full disclosure of the product and its function is required, but there was no assurance that they would be granted a patent by the government; scientists and researchers did not want to release all their data and research without having any guarantee of legal protection. Many of these applications for patents were denied because they did not fully reveal the function of the DNA strands (Pozo 2017). This led to the development of the Biotech Directive in 1998 which ensured legal protection of biotechnological inventions if the industrial capability and applications of the gene sequences were fully reported on the patent application (Pozo 2017). Because of this directive, functionality-related protection was also granted for all types of genetic patents. The scope of protection provided by the Biotech Directive is restricted to only the functions disclosed on the patent application; it does not cover functions of gene sequences that were not disclosed or discovered prior to sending in the application (Pozo). Protection for genes and genetically modified organisms (GMOs) is also issued by Section 101 of the U.S. Patent Act to “who[m]ever invents or discovers any new and useful process[es], machine[s], manufacture[s], or composition[s] of matter, or any new and useful improvements thereof” (2017). This statement leads to the logical conclusion that if the invention is not a new or useful process, machine, manufacture, or composition of matter, it cannot be patented. But a patent itself does not prevent other people from independently discovering the same genomic sequences or functions because patents only protect the owner of a patent when someone else uses it. They do not protect the expression of that idea or the idea itself. (Koepsell 102).
Intellectual property is a term used to refer to the creativity of the mind. This property is different from others in that the expression of the idea, in this case a gene expression or genetically modified organism, being created or replicated by someone else is completely fine. The limitation to other people’s usage of the patented object is that only the owner can exclude certain uses of the item (Koepsell 106). The ultimate goal of research is to disseminate knowledge for the benefit of the public, so keeping research and innovations a secret in order to protect them from being used by others is counterproductive; this brought about the creation of intellectual property laws (Koepsell 106,107). Intellectual properties are protected by the U.S. Patent Act and the Biotech Directive. Intellectual property laws are different from other properties in that its scope and length of enforcement is not enough for researchers to start making a profit on their work which is ironic considering how much time and various resources are poured into researching genetics and the genomic sequences of organisms (Hughes 291). There is pressure within the market system insisting that the biotechnology industry profits from their research because of the considerable investments necessary for research and the development of technology (Caulfield 2000). The “idea/expression dichotomy” of intellectual properties is that secret-keeping is replaced with full disclosure (Koepsell 107). Because of this full disclosure, the gene sequences or GMOs are much more likely to be discovered by someone else. Gene sequences and genetically modified organisms (GMOs) are considered to be a type of intellectual property which is protected by the U.S. Patent Act and the Biotech Directive. Currently, it is legal to patent these intellectual properties, but just because it is legal to patent genes and GMOs does not mean that they should be patented (Koepsell 102). As new research and discoveries are being made in the field of genetics nearly every single day, people must consider the moral and ethical implications of having exclusive ownership of some of the most fundamental properties of life.
Caulfield, A. T., & Gold, E. R. (2000). Genetic Testing, Ethical Concerns, and the Role of Patent
Hughes, J. (1988). The philosophy of intellectual property. Georgetown Law Journal 77(2), 287-366.
Koepsell, D. (2015). Who Owns You?: Science, Innovation, and the Gene Patent Wars. MA: John Wiley & Sons.
Pozo, D. M. (2017). Patenting Genes: The Requirement of Industrial Application. MA: Edward Elgar Publishing, Inc.
U.S. Patent Act of 1790, 35 U.S.C. § 101 (2017).