Recent Debates about Patenting CRISPR Technology (Article Critique Sample)
Critically evaluate the extent to which recent debates about the patenting of CRISPR technologies raise legal and ethical issues that have similarities with earlier attempts to patent stem cell invention. Illustrate your answer with reference to the relevant case law discussing the actual or potential advantages for society of permitting the patentability of stem cell and CRISPT technologies.source..
Critically evaluate the extent to which recent debates about the patenting of CRISPR technologies raise legal and ethical issues that have similarities with earlier attempts to patent stem cell invention. Illustrate your answer with reference to the relevant case law discussing the actual or potential advantages and disadvantages for society of permitting the patentability of stem cell and CRISPR technologies.
Since the 1990s, a number of innovative, more accurately focused tools for gene editing have been created, the most recent and most well-known of which being CRISPR, which is presently gaining widespread attention. Many of these new approaches, which are often referred to as "gene editing" or, in the agricultural setting, "novel plant breeding approaches," provide a significant challenge to researchers. Using gene-editing approaches based on transcription factors and synthetic nucleases, researchers have been able to modify gene expression and sequence in a targeted manner. Their applications include direct gene transfer for medicinal reasons, knocking off genes related with illnesses, and correcting harmful mutations in genetically modified organisms. Each of these modular proteins, TALENs and ZFN, interacts with a particular base pair in the main grooves of the double helix structure of DNA to detect that particular base pair. When interacting with DNA, every zinc finger module binds with three nucleotides, whereas TALEN subunits only engage with single base pairs. It is able to target almost all potential nucleotide triplets with ZFN, despite the fact that particular zinc fingers might have context-dependent impacts.[Matthews, Duncan, Abbe Brown, Emanuela Gambini, Timo Minssen, Ana Nordberg, Jacob S. Sherkow, Jakob Wested, Esther van Zimmeren, and Aisling McMahon. "The role of patents and licensing in the governance of human genome editing: a white paper." Queen Mary Law Research Paper 364 (2021).]
Comparisons between stem cell and genome editing (CRISPR) to good effect
Stem cells are unique human cells that have the ability to differentiate into various types of cells. Cells ranging from brain cells to muscle cells might be affected by this. They are also capable of repairing damaged tissues in rare instances. It is possible, according to experts, that stem cell-based treatments might well be utilized to treat major ailments such as Alzheimer's and paralysis disease in the future. Treatments like bone marrow transplants highly depend on these cells for their viability. They are able to assist patients with cancer in producing new blood cells when their individual hematopoietic stem cells are damaged by chemotherapy or radiotherapy. Additionally, they could be used to treat persons who suffer from illnesses such as Fanconi anemia, which is a blood disorder that results in the failure of the body's bone marrow.
Stem cells need a significant amount of research before their use. Scientists must first have a better understanding of the development of embryonic stem cells. As a result, they will better grasp how to manage the sort of cells that are produced from them. Another obstacle is that the embryonic stem cells which are now accessible are prone to be affected by the human body. Furthermore, some individuals believe that using stem cells derived from embryos is unethical on moral grounds. There are several ways in which stem cells could benefit human health in the future, as well as numerous innovative therapies that may be developed. Researchers believe that stem cells will be employed to assist in the regeneration of new tissue. In the future, healthcare personnel may be able to treat patients suffering from severe heart disease.[Sterckx, Sigrid, and Julian Cockbain. "Assessing the Morality of the Commercial Exploitation of Inventions concerning Uses of Human Embryos and the Relevance of Moral Complicity: Comments on the EPO's WARF Decision." SCRIPTed 7 (2010): 83]
Genome editing (CRISPR)
A collection of technologies known as genome editing (also known as gene editing) provide scientists with the power to change the organism’s DNA. The methods allow the removal, addition, or modification of genomic information at particular sites in the DNA using a number of methods. There are various means of genome editing established. Genome editing has attracted the interest of a number of scientists who are concerned in the treatment and prevention of human illnesses. Presently, genome editing is being employed in research laboratories to better understand disorders using cells and experimental animals. In order to discover if this approach is successful and safe for use in human beings, researchers are at present conducting an investigation.[Sherkow, Jacob S. "Inventive steps: the CRISPR patent dispute and scientific progress: The recent patent decisions about CRISPR tell us a lot about how advances in biology are actually made—and how they are not." EMBO reports 18, no. 7 (2017): 1047-1051.]
It is being investigated in research and clinical trials for a broad range of illnesses, including single-gene diseases like hemophilia, multiple sclerosis and sickle cell anemia, as well as multigene disorders. Similarly, there is a promising future as they can also be used in prevention and treatment of more complicated illnesses, like heart disease, cancer, human immunodeficiency virus (HIV) and mental illness. The CRISPR pioneer, genome editing has the potential to overcome the pest and nutritional concerns confronting agriculture, especially in light of population expansion and climate change. Due to the obvious technology's dependability, the USDA decided earlier this year not to classify approximately a dozen crops treated using CRISPR as genetically modified organisms (GMOs). CRISPR, on the other hand, requires a lot of time.[Cook, Trevor. "11. Gene Editing and the Regulation of Genetic Modification in Europe." Bio-Science Law Review (2017):]
There are certain labs that do not have a genome editing workflow already in place. If users work in a lab that does not yet have a CRISPR-Cas9 genome editing pipeline, but they have determined that CRISPR-Cas9 genome editing is the best technique for furthering their research, it is likely that the principal investigator will assign users the task of developing and refining the protocol. A CRISPR-Cas9 protocol optimization project might be a complex and time-consuming undertaking. But experts can achieve it if they have the necessary skill, experience, and determination,
Ordre public and morality exceptions in the EPC and EU
Any innovation whose commercialization would be in violation of the "ordre public" or morals is expressly barred from patentability under the law. The goal of this is to limit innovations that are likely to cause rioting or public unrest, or that will lead to violent or other widely unpleasant activities. The morality-based and 'ordre public' exclusions in the realm of human germline editing must not be used in a manner that produces in results that are counter intuitive to the objective of striking a balance between the protection and innovation of higher norms in the social and cultural community. Although the avoidance of children that are undesirable due to specific characteristics (sex, color, health) and for economic considerations may be perfectly lawful for domestic animals, it would be in violation of the "ordre public" or morals if it were applied to people. It should be established on a thorough grasp of both the fundamental research and the larger ethical, legal, social and policy aspects. This will allow for case-by-case choices which will serve as the foundation for patent claims modifications and nuanced purpose-bound protections.[Matthews, Duncan, Timo Minssen, and Ana Nordberg. "Balancing innovation,‘ordre public’and morality in human germline editing: A call for more nuanced approaches in patent law." European Journal of Health Law 1, no. aop (2022): 1-27.] [PlomerI, Aurora. "Stem cell patents in a global economy: the legal challenges."