![download[4]](https://jurnal.stiki-indonesia.ac.id/public/site/images/adminjurnal/template_jurnal_tosca1.png)
Email this article Navigating the Complexities of Cellular Therapy Patents: Regulatory Challenges, Ethical Implications, and Global Trends
Abstract
New ways of therapeutic methods have now altered modern medicine. Modern cellular therapies, from stem cell and CAR-T therapies to CRISPR-based gene editing therapy, provide new ways to tackle difficult-to-treat diseases. These breakthrough therapies bring a complex web of regulatory, ethical, and legal challenges. These are also in relation to intellectual property. The patenting of such therapies raises a multitude of unresolved questions ranging from the challenges of balancing innovation with access and ensuring equity while incentivizing research to navigating the complex global patent systems. This article aims to investigate the diverse regulatory frameworks for patenting cellular therapy in major jurisdictions. Discussions on ethical concerns regarding the modification of human cells and seeks to balance innovation with access to life-saving treatments will be done at great length. This paper will also provide insight into the potential evolution of the global patent system to address the distinctive challenges posed by cellular therapies. Key cases and providing forward-thinking recommendations will also be discussed.
Keywords
Full Text:
PDFReferences
Abinader, Luis Gil, and Jorge L Contreras, ‘The Patentability of Genetic Therapies: CAR-T and Medical Treatment Exclusions around the World’, Am. U. Int’l L. Rev., 34 (2018), 705
Chapman, Audrey R, The Ethical Challenges of the Stem Cell Revolution (Cambridge Scholars Publishing, 2020)
Dhini, Chrisstar, Novika Maharani, and Reza Amarulloh, ‘Harmonisasi Buku III Kitab Undang-Undang Hukum Perdata Dengan Convention on Contracts for the International Sales of Goods Dan United Nation Commission on International Trade Law Terhadap Kontrak Dagang Internasional’, Privat Law, 3.2 (2016), 163537
Doudna, Jennifer A, and Emmanuelle Charpentier, ‘The New Frontier of Genome Engineering with CRISPR-Cas9’, Science, 346.6213 (2014), 1258096
Hernández-Melchor, Dinorah, Esther López-Bayghen, and América Padilla-Viveros, ‘The Patent Landscape in the Field of Stem Cell Therapy: Closing the Gap between Research and Clinic’, F1000Research, 11 (2023), 997
Kurnianingrum, Trias Palupi, ‘Pelindungan Hak Paten Atas Pengetahuan Obat Tradisional Melalui Pasal 26 UU No. 13 Tahun 2016 Tentang Paten’, Jurnal Negara Hukum, 10.1 (2019), 49–65
Moradi, Vahid, Elnaz Khodabandehloo, Mehdi Alidadi, Azadeh Omidkhoda, and Naser Ahmadbeigi, ‘Progress and Pitfalls of Gene Editing Technology in CAR-T Cell Therapy: A State-of-the-Art Review’, Frontiers in Oncology, 14 (2024)
Salter, Brian, ‘Patents and Morality: Governing Human Embryonic Stem Cell Science in Europe’, Global Biopolitics Research Group, Centre for Biomedicine and Society, King’s College London, 2009
Sharpe, Michaela, and Natalie Mount, ‘Genetically Modified T Cells in Cancer Therapy: Opportunities and Challenges’, Disease Models & Mechanisms, 8.4 (2015), 337–50
Sherkow, Jacob S, and Henry T Greely, ‘The History of Patenting Genetic Material’, Annual Review of Genetics, 49.1 (2015), 161–82
Song, Yang, Liyue Shen, Lei Xing, and Stefano Ermon, ‘Solving Inverse Problems in Medical Imaging with Score-Based Generative Models’, ArXiv Preprint ArXiv:2111.08005, 2021
Vaverka, Tomáš, ‘Intellectual Property Protection for Startups: A Law and Economics Perspective’, 2023
DOI: http://dx.doi.org/10.30659/akta.v11i4.40933
Refbacks
- There are currently no refbacks.
Copyright (c) 2024 JURNAL AKTA
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
Jurnal Akta has been indexed by:
Editorial Office: Jurnal Akta Room 2nd Floor Imam As Syafei Building Faculty of Law Universitas Islam Sultan Agung. Jln. Kaligawe KM. 4, Semarang City, Central Java, Indonesia. Phone +62 24 6583584 Fax +62 24 6582455
Email: jurnalakta@unissula.ac.id