Concerns About Gene Patenting

Concerns About Gene Patenting
Question 6:
We Should Allow Human Genes to be Patented Without Restriction? The Strict Application of the Novelty and Industrial Applicability Should be Sufficient to Resolve all the Reasonable Concerns about Gene Patenting
The human gene is a fundamental physical and functional unit of heredity. Genes are segments made up of deoxyribonucleic acid that provide a mandate to the cell for making a particular protein that carries a particular function in the human body but not all genes code for proteins. According to Anderson (2019), proteins are the building blocks for everything in the human body. They help human bodies grow, function properly, and stay in good health. Each gene in the human body can make at least ten different proteins. In humans, genes differ in size from a few hundred bases of deoxyribonucleic acid (DNA) to not less than 2 million bases. Approximately all humans possess the same genes, roughly arranged in the same order, and more than 99.9% of their DNA series is identical to others. Humans are estimated to have approximately 20,000 to 25,000 genes. On average, a human gene has 1 to 3 letters differing from another person. These deviations are enough to alter the shape and function of a protein, the quantity of protein made, and when and where it is made.
The differences in genes to different extents determine the eyes, hair, and skin color. Genes may also instigate a person's risk of developing diseases and their response to medication. Each person has two copies of every gene, one received from each parent. Each parent possesses two copies of each gene and donates one copy to the child to make up their genes. Children may have health problems when missing or containing an extra part of genes. Some of the gene problems are inherited from parents, meaning that if a parent donates an altered gene that is needed for the formation of a particular protein to their child, then there are higher chances that the child may suffer from a condition that results from the deficiency of that protein. Research is still underway for gene therapy, a new kind of medicine that will use genetic engineering technology to treat diseases caused by genes that may have changed in any way. One of the ways this therapy will involve is trying to replace changed genes with new and healthy ones. This paper focuses on why human gene patenting should be allowed.
Argument and Court Cases Pro-Human Gene Patenting
Human gene patenting should be allowed because it gives ownership of laboratory-developed genes to the developer. A gene patent is a sole right to a specific series of genes granted by the government to an individual, organization, or corporation claiming to have first discovered the gene. Therefore, the patent holder gives directions on how the gene can be used and in what capacity. Du’s (2018) article on patenting human genes and the portrayal of gene patents states that patent protection of genes can foster inventions and shield inventors. Inventors, especially those without financial muscle, will not have to worry about competition, but they get ample time to analyze the genes. Du (2018) also highlights that commercializing gene-based technology will attract market profits, reaping more in global markets.
According to Feeney (2018), using patents will hasten the arrival of technology by promoting innovation and investment. Companies and individuals can invest in patented gene technology, facilitating financial support to cater to other valuable innovations. It can take millions of dollars to introduce new technology and even a drug to the market. However, small companies with financial constraints who possess the ability to innovate may not be able to introduce the new technology but relying on investors for financial assistance may mitigate the challenge. A way of attracting investors is by granting gene patents to them. Based on these facts, human gene patenting should be allowed without limitations.
Court Cases Supporting Gene Patenting
A small Utah-based biotechnology company found itself in a storm after it decided to commercialize a hereditary breast cancer diagnostic test. According to Gold (2010), one out of nine women develop breast cancer during their lifetime, and 1 out of 27 will succumb. Approximately 5% to 10% of affected women are carriers of mutated alleles, dominantly transmitted, and affiliated with a high risk of breast cancer. The breast cancer occurrence in BRCA 1 or BRCA 2 mutation carriers fluctuates between 3% and 10%. The Utah-based biotechnology company developed diagnostic tests for the mutations with this knowledge. Thus, creating the possibility of preventive management for breast and ovarian cancer. The Utah-based biotechnology company was granted a legal monopoly for the invention in the 1980s.
Hirschler’s (2011) article on UK courts backing patents linked to HGS, a GSK drug, states that courts supported patenting on a gene sequence held by Human Genome Science Inc. This support was from its development of the new lupus drug, Benlysta, in their victory for the apprehension of patents on early-stage research. HGS identified a protein known as neutrokine-alpha and filed a patent for it in 1996 despite having limited ideas of how the discovery would be put to practical use. Later, with the discovery of neutrokine-alpha, HGS partnered with the British drug maker GlaxoSmithKline Plc to develop Benlysta for treating Lupus, a chronic, life-threatening autoimmune disease. The use of the Benlysta drug for treating Lupus was later approved by European drug regulations following a green light from regulators in the United States. Following the court ruling, it was upheld and warranted a patent on neutrokine-alpha. It showed a sign of encouraging confidence in early-stage inventions.
Novelty of Patents
Novelty is essential for the validity of a patent claim. If the public knew about the invention even before the filing dates of the request filed or the date of priority, if the applicant asserts the importance of a previous patent application, then the story is not novel and cannot be patented. The need for novelty exists so that previously patented ideas cannot be granted patent protection. To be given patent protection, each claim must be new. If the invention was known to the public before the application was submitted or the higher associated, or if priority is asserted from a previous new patent, the discovery is not innovative and cannot be protected (Andra, Bhatraju, and Ruddaraju, 2022). There is a slight delay of up to a year from the initial date of public revelation in the United States, a relatively novelty nation. So, one has a full year from the time of first publication or commercial sale to submit a patent application. The novelty requirement for a patent application does not consider the year after the filing date (Krieger and Papanikolaou, 2022). Therefore, it would be wise to keep one’s concept under wraps until all necessary jurisdictions have been filed.
There is no leniency period in most European and Asian nations, considered absolute novelty countries. Public publication may have occurred without one’s permission, yet they may still be granted a patent under certain circumstances in European nations. Within six months, one must submit their paperwork. Novelty is a prerequisite for a patent claim to be patentable. An invention should be novel, important, and not common to be granted a patent (Deng et al., 2018). The United States Patent and Trademark Office allows a grace period of up to one year from the initial date of public disclosure. The one year is not considered as part of novelty, and novel status still applies. The novelty of a patent gives the innovator legal rights to the innovation, whereby a third party cannot take up the idea and claim its ownership. Novelty being an important element in legal criteria for patenting human genes was stipulated under section 102 of article 35 of the United States Constitution and article 54 of the Engineering, Procurement and Construction laws (He & Luo 2017). Thus, there is an increasing call for a computational and data-driven evaluation of design novelty.
Industrial Applicability in Patents
The term industrial applicability in a patent refers to an innovation susceptible to industrial application. Application, as defined by the relevant patent legislation of a given country, is an innovation that may be created or employed in an industry. A patent may only be issued for an invention susceptible to industrial application, as defined by the relevant patent legislation of a given country, that is, an innovation that may be created or employed in an industry. Any innovation created or utilized in any form of industry, including agriculture, as defined by the European Patents Convention EPC, is eligible for patent protection (Matthews, 2022). According to judgment T 870/04, just because a drug may be manufactured in principle does not indicate that article has been met. It is because the existence of a profitable use for the substance is also required.
Lack of practicality in industry results from a supposed invention that violates fundamental physical principles. For instance, if a trademark application must divulge the innovation in a way sufficiently clear and comprehensive for it to be performed by a person knowledgeable in the art, then the various industrial condition is connected to the adequacy of disclosure. In patent law, the industrial applicability of innovation is a copyright necessity, and general patents are given for important innovations used in industries. The industrial application is part of the patentability requirements, and without it can lead to revocation of the patent (Clayton et al., (2019). Nonetheless, the United States patent law utility requirement is used in place of industrial applications. A patent needs an industrial design protected through various forms of intellectual property, along with patents and trademarks.
Human Genes Patenting on Novelty and Industrial Applicability
Gene patents have been an essential contributor to the development of the biotechnology sector during the past twenty years, leading to the firm's establishment in the industry (Millan, 2022). However, questions have been raised concerning the patentability of individual genetic material through public demonstrations and diplomatic pronouncements, but these efforts have not produced the desired result. This article analyzes some of these issues. The patent authority has given them answers and approaches to resolve these difficulties and take the discussion ahead while using the legal frameworks now in place. For better or worse, patenting human genes has not swayed the organizations that do the awarding. Since the genome sequencing project's commencement, patent o...