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Unveiling Crispr Dispute Between Eu and Us: Suggesting Sci- Entific Policy, Legal Framework for the Future

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Unveiling Crispr Dispute Between Eu and Us: Suggesting Sci- Entific Policy, Legal Framework for the Future Turkish Journal of Physiotherapy and Rehabilitation ; 32(3) ISSN 2651-4451 | e-ISSN 2651-446X UNVEILING CRISPR DISPUTE BETWEEN EU AND US: SUGGESTING SCI- ENTIFIC POLICY, LEGAL FRAMEWORK FOR THE FUTURE. Barkha Dodai 1, Shreya Bajpai 2, Chhaya Sikarwar 3, Ramanpreet Kaur Sandhawalia 4, Nuvita Kalra 5 ABSTARCT In 2012, Jennifer Doudna from the University of California (UC) Berkeley first published the use of the CRISPR-Cas9 complex to specifically target and remove sections of DNA from the bacterial genome. Just a year later, Feng Zhang of the Broad Institute documented that the CRISPR technology could be used to de- lete and replace harmful DNA segments in human cells, demonstrating the platform‘s breakthrough therapeu- tic potential in the context of human health. With CRISPR research accelerating worldwide at a groundbreak- ing rate, several questions remain to be answered in the realms of science, law, and policy. In addition to var- ious bioethical concerns raised by the revolutionary technology, legal troubles soon arose, as both Doudna and Zhang hoped to protect their ideas through the patent system. While both were granted patents in the United States, with the UC patent only covering use in unicellular applications and therefore a broad patent covering the broader use of CRISPR in human contexts, both patent applications remain uncertain in Europe. More specifically, the debate in the USPTO was centered around the genus v. species doctrine, while the EPO presented semantic policy issues. The European Patent Office‘s ruling, to some degree, parallels the EU‘s general adherence to the Precautionary Principle, restricting research presenting even negligible human health and safety risks. This paper illustrates how differing biotechnology regulatory frameworks can have drastic results on R&D output in the gene-editing space through a comparative discussion of intellectual property regimes and innovation ecosystems in the United States and European Union. With some degree of policy harmonization between the US and the EU, concerns regarding mortality and innovation can be better balanced globally. KEYWORDS: Genome editing, CRISPR patent dispute, human germline engineering, gene patents, bio- technology innovation, stem cell therapies. METHOD :This study was legal research that particularly aimed to find the reason for the long-running battle over CRISPR, the powerful genome-editing tool. The research aimed to figure out the main issue between two scientists Jennifer Doudna and Feng Zhang regarding the release of the first proof that the bacteria- derived CRISPR system could cut specific DNA. To conclude this study various Doctrinal methods were used to learn different biotechnology frameworks, their R& D policies, the statutory and comparative ap- proaches regarding Comparative study of the Intellectual Property Rights regimes in the US and EU. I. INTRODCUTION (CRISPR: A NEW SCIENTIFIC FRONTIER) A. Overview of CRISPR Technology Clustered Regularly Interspaced Short Palindromic Repeats with Cas9, or ―CRISPR-Cas9,‖ is a state-of-the-art genome editing technology. The CRISPR locus and its function were first discovered in bacteria by Spanish re- searcher Francisco Mojica in 1993. Over a decade later, in studies of the unique CRISPR locus in Streptococcus thermophilus bacteria, French researcher Bolotin identified the endonuclease Cas9, an enzyme capable of cleav- ing DNA for bacterial immune protection. However, it was not until 2013 that researchers at the Broad Institute in the United States identified a way to harness CRISPR-Cas9 – indeed, a natural mechanism for adaptive bacte- rial immunity – for targeted genome editing in human cells. At a high level, gene-editing technology modifies the genome (the complete set of DNAs in an organism) by add- ing, removing, or changing the genetic material at different sites. This form of technology has tremendous impli- cations for improving health outcomes by treating or preventing diseases originating from mutations in the genet- ic code. Of course, experimental validation and proof-of-concept testing must first be done in cell lines and ani- www.turkjphysiotherrehabil.org 4258 Turkish Journal of Physiotherapy and Rehabilitation ; 32(3) ISSN 2651-4451 | e-ISSN 2651-446X mal studies. In the laboratory setting, targeted genetic engineering methods allow for cell lines and animal models with specific ―knocked-out‖ genes. Such models enable a better understanding of how mutations in disease- related genes may affect development and physiology in humans. However, conventional techniques of genetic modification, including zinc finger proteins (ZNFs) and transcription activator-like effector nucleases (TALENs), have been costly, time-consuming, and lacking in both accuracy and efficiency. Likened to ―the search function in modern word processors,‖ CRISPR-Cas9 has offered a solution to the limita- tions of previous methods of gene editing. The technology consists of two overarching subparts: short ―guide‖ RNA sequences that target specific segments and genes on DNA, and an enzyme (generally Cas9 but possibly others like the more recently characterized and precise Cpf1) that binds to DNA and cuts/edits it at sites of modi- fication (see Figure 1 below). Although ZNF and TALEN technology also relies on the action of engineered nu- clease enzymes to cleave DNA; their target binding ability is based on the development and confirmation of dis- tinct, complex protein structures for each experiment, a process that is both highly time- and cost-intensive (on the order of thousands of US dollars for ZNFs). Guide RNA engineering in CRISPR-Cas9 technology, on the other hand, is far more rapid and less expensive (on the order of tens of US dollars), offering a significant ad- vantage over other existing forms of genetic modification. Furthermore, compared to previous methods that first require time-intensive culturing and isolation of cell lines in which targeted genetic modifications are introduced and expanded, studies on mouse models have indicated that CRISPR-Cas9 can modify the genome when injected directly into an embryo and lead to mutant individuals within four weeks. Additionally, CRISPR-Cas9 demon- strates enhanced efficiency through its ability to modify multiple regions of the genome simultaneously, a phe- nomenon that has previously not been achieved. With its unprecedented ability to engineer the mammalian ge- nome, CRISPR-Cas9 has gained immense traction in the global scientific community. It indeed constitutes a sci- entific paradigm shift. Figure 1: CRISPR/Cas9 technology consists of two overarching subparts: short ―guide ‖ RNA sequences that can be engineered (synthetic dsRNA in this figure) to target specific segments and genes on DNA and an enzyme (Cas9 in this figure) that binds to DNA and cuts/ edits it at targeted sites of modification. In this case, the target DNA has been cut and modified to render a targeted mutation. The PAM sequence indicated in the figure is a short sequence on the target DNA that is a few base pairs downstream of the targeted cut and is required for Cas9‘s cleavage function. (Image Source: Pros and Cons of ZNFs, TALENs, and CRISPR/Cas). B. Applications and Limitations of CRISPR Technology The possibilities and potential of gene therapy via targeted genome editing are pronounced, as mutations in single DNA base pairs because 32,000 human diseases caused by genetic mutations. And while growth in CRISPR- related biotechnology is on the rise, there are challenges scientists have worked to address to improve the ability of the CRISPR system to produce specific and high-fidelity genome editing. When Cas9 cleaves DNA to produce double-stranded DNA breaks, the process by which the ―blunt ends ‖ are rejoined and repaired – non-homologous end joining (NHEJ) – is error-prone and often introduces random muta- tions at the site of cleavage. While such mutations may lead to the desired mis-activation of target genes, they are www.turkjphysiotherrehabil.org 4259 Turkish Journal of Physiotherapy and Rehabilitation ; 32(3) ISSN 2651-4451 | e-ISSN 2651-446X random and highly variable, preventing the detailed introduction of specific mutants for study at the cleavage site. Moreover, variations in target sites can cause large deletions and rearrangements in DNA. Such challenges are being addressed by newly found or engineered Cas enzymes like Cpf1, which cleave DNA in a way that enhanc- es the specificity and precision of DNA repair. Such enzymes potentiate the highly targeted process of base edit- ing, in which individual DNA base pairs can be precisely edited. Ensuring safe and effective therapeutic delivery represents an additional challenge for CRISPR-Cas9 researchers. Initial studies of direct introduction of guide RNA + CRISPR-Cas9 complex into cell lines via transfection rea- gents showed imperfect integration into the host genome and activated host immune responses impeding genome editing. However, great strides have been made recently. Editas Medicine, for example, received FDA approval to start the first-in-human clinical testing of retinal gene therapy via viral vector delivery for patients with Leber‘s congenital amaurosis type 10, a rare and severe eye disorder. As recently as February 2019, Vertex Pharmaceuti- cals and CRISPR Therapeutics announced the first infusion of CTX001, their novel ―CRISPR-Cas9 gene-edited hematopoietic stem cell therapy ,‖ in a patient for treatment of beta-thalassemia. Meanwhile, other studies have demonstrated the role of lipid
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