Stem Cell Patentability: Legal Challenges
DOI:
https://doi.org/10.69971/tipr.2.1.2024.19Keywords:
Stem cell, legal challenges, patentability, patents, EPO, USPTO, WIPOAbstract
Stem cells are versatile cells capable of self-renewal and differentiation into different specialized cell types. Their immense potential has led to a surge in research and practical applications medicine. Patentability of the stem cells has been a subject of controversy, with concerns that restrictions on access to crucial technologies could hinder the translation of research into practical medical applications. It is a promising field that's rapidly advancing and has the potential to revolutionize modern medicine. The patentability of stem cells faces several legal challenges, including ethical, moral, and religious concerns, as well as difficulties in obtaining a patent license. Patent protection is crucial for driving innovation and commercial success in regenerative medicine and life sciences. This article examines the patentability restrictions and specific challenges associated with human stem cell patents in Europe and the United States.
References
Agulnick, Alan, D'amour Kevin. 2014. In vitro differentiation of pluripotent stem cells to pancreatic endoderm cells (PEC) and endocrine cells. World Intellectual Property Organization https://patentimages.storage.googleapis.com/18/56/df/4a8445d522649a/WO2014160413A1.pdf
Andersson, Anna-Karin M. 2011. Embryonic stem cells and property rights. Journal of Medicine and Philosophy 36: 221-242.
Anversa, Piero, Leri Annarosa, Kajstura Jan. 2009. Methods of isolating non-senescent cardiac stem cells and uses there of U.S. Patent Application 12/324,031. https://patents.google.com/patent/CA2854242A1/de
Assen, LS, Jongsma KR, Isasi R, Utomo L, Tryfonidou M A, Bredenoord AL. 2023. Responsible innovation in stem cell research: using responsibility as a strategy. Regenerative Medicine 18: 275-284. https://doi.org/10.2217/rme-2022-0187
Bell, Leanne. 2010. Embryonic Stem Cell Patents. European Law and Ethics 434-436. https://doi.org/10.1093/medlaw/fwq016
Bhatia, Mickie, Eleftherios Sachlos, Ruth Muñoz RISUEÑO, Tony Collins. 2015. Screening assays for identifying and validating agents that target cancer stem cells. https://doi.org/10.1093/medlaw/fwq016
Bonetta, Laura. 2008. European stem cell patents: Taking the moral high road? European Law and Ethics 132: 514-516. https://www.cell.com/fulltext/S0092-8674(08)00220-1?large_figure=true
Chen, Hu, Wu Dongde, Bao Lequn, Yin Tao, Lei Dansheng, Yu Jing, Tong Xianli. 2019. 6PGD inhibition sensitizes hepatocellular carcinoma to chemotherapy via AMPK activation and metabolic reprogramming. Biomedicine and Pharmacotherapy 111: 1353-1358. https://doi.org/10.1016/j.biopha.2019.01.028
Colyvas, Jeannette A, Snellman Kaisa, Bercovitz Janet, Feldman Maryann. 2012. Disentangling effort and performance: a renewed look at gender differences in commercializing medical school research. The Journal of Technology Transfer 37: 478-489. https://link.springer.com/article/10.1007/s10961-011-9235-6
Cosson, Steffen, Otte Ellen A, Hezaveh Hadi, Cooper-White Justin J. 2015. Concise review: tailoring bioengineered scaffolds for stem cell applications in tissue engineering and regenerative medicine. Stem Cells Translational Medicine 4: 156-164. https://doi.org/10.5966/sctm.2014-0203
Dahlin, Jayme L, Inglese James, Walters Michael A. 2015. Mitigating risk in academic preclinical drug discovery. Nature Reviews Drug Discovery 14: 279-294. https://www.nature.com/articles/nrd4578.pdf
Davey, Sonya, Davey Neil, Gu Qian, Xu Na, Vatsa Rajet, Devalaraja Samir, Harris Paul, Gannavaram Sreenivas, Dave Raj, Chakrabarty Ananda. 2015. Interfacing of science, medicine and law: the stem cell patent controversy in the United States and the European Union. Frontiers in Cell and Developmental Biology 3: 71.
Dehghan, Samaneh, Mirshahi Reza, Shoae-Hassani Alireza, Naseripour Masood. 2022. Human-induced pluripotent stem cells-derived retinal pig-mented epithelium, a new horizon for cells-based therapies for age-related macular degeneration. Stem Cell Research and Therapy 13: 217.
Duarte, Rafael F, Labopin Myriam, Bader Peter, Basak Grzegorz W, Bonini Chiara, Chabannon Christian, Corbacioglu Selim, Dreger Peter, Dufour Carlo, Genney Adrew R, Kuball Jurgen, Lankester Arjan C, Lanza Francesco, Montoto Silvia, Nagler Arnon , Latour Régis Peffault de , Snowden John A, Styczynski Jan, Yakoub-Agha Ibrahim, Kröger Nicolaus, Mohty Mohamad. 2019. Indications for haematopoietic stem cell transplantation for haematological diseases, solid tumours and immune disorders: current practice in Europe, 2019. Bone Marrow Transplan-tation 54: 1525-1552.
Edinger, James W, Hariri Robert J, Wang Jia-Lun, Ye Qian, Faleck Herbert. 2013. Treatment of inflammatory diseases using placental stem cells. U.S. Patent 8, 460-650 chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://patentimages.storage.googleapis.com/a9/94/21/d9ceb8f64a0f16/US20110280845A1.pdf
Fendrick, Sarah E, Zuhn Donald L. 2015. Patentability of Stem Cells in the United States. Cold Spring Harbor Perspectives in Medicine 5: a020958.
Fiorina, Paolo. 2019. PD-L1 expressing hematopoietic stem cells and uses. U.S. Patent 10, 517, 899 https://patents.google.com/patent/WO2017015320A1/en
Fontes, Paulo A, Thomson Angus W. 1999. Stem cell technology. BMJ Global Health Journal 319: 1308. https://doi.org/10.1136/bmj.319.7220.1308
Forsberg, Ellen-Marie. 2012. Standardisation in the field of nanotechnology: some issues of legitimacy. Science and Engineering Ethics 18: 719-739. https://doi.org/10.1007/s11948-011-9268-0
Fryer, Benjamin, Laniauskas Daina, Blackmoore Marcia, Wang Haiyun, LiLova Kostadinka, Nelson Shelley, Rosocha Elizabeth. 2019. Methods for suspension cultures of human pluripotent stem cells. U.S. Patent 10,377,989. https://patents.google.com/patent/US10377989B2/en
Golden, John M. 2010. WARF's stem cell patents and tensions between public and private sector approaches to research. Journal of Law, Medicine and Ethics 38: 314-331.
Gordon, Jennifer. 2015. The impact of Myriad and Mayo: Will advancements in the biological sciences be spurred or disincentivized? (Or was biotech patenting not complicated enough?). Cold Spring Harbor Perspectives in Medicine 5: a020917.
Gori, Jennifer Leah. 2022. Optimized CRISPR/cas9 systems and methods for gene editing in stem cells. U.S. Patent 11,390,884. https://patents.google.com/patent/US11390884B2/en
Gott, Lawrence D, Diehr Diamond v. 1981. The patentability of processes and incorporated algorithms. Ohio NUL Revolution 8: 535. https://heinonline.org/HOL/LandingPage?handle=hein.journals/onulr8&div=39&id=&page=
Gschweng, Eric, Rajul JAIN, Ouyang Yong, GARCIA Arianne PEREZ, Roberts Margo, Rodriguez Ruben Alvarez, Smith Drake, Xingliang ZHOU. 2021. Modified pluripotent stem cells and methods of making and use.U.S. Patent Application 16/969,127, filed February 11, 2021. https://patents.google.com/patent/US20210040449A1/en
Hernández-Melchor, Dinorah, López-Bayghen Esther, Padilla-Viveros América. 2022. The patent landscape in the field of stem cell therapy: closing gap between research and clinic. F1000 Research 11.
Hoppe, Nils, and Denoon Alexander. 2011. An ethical framework for expanded access to cell-based therapies. Regenerative Medicine 6: 273-275.
Ilyas, Shoeb Ahmad. 2020. Review of Challenges in the Commercialization of Stem Cell Research Technologies 3: 12-15. https://ecronicon.net/assets/eccmc/pdf/ECCMC-03-00305.pdf
Karanu, Francis, Rezania Alireza. 2018. Methods for purifying cells derived from pluripotent stem cells. U.S. Patent 9,969,981. https://patents.google.com/patent/US10329534B2/en
Kaufman, Dan S, Knorr David A. 2019. Method for developing natural killer cells from stem cells. https://patents.google.com/patent/EP2841563B1/RED_FLAGS_Oct.2007_.pdf
Kiatpongsan, Sorapop. 2006. Intellectual property and patent in stem cell research era. Journal Medical Association of Thailand 89: 1984. https://pubmed.ncbi.nlm.nih.gov/17205886/
Kido, Tsuneo. 2015. Culture method to obtain and maintain a pure or enriched population of mammalian neural stem cells and/or neural/progenitor cells that are prone to differentiate into oligodendrocyte-lineage cells in vitro. In: Google Patents. United State Patent Office. https://patents.google.com/patent/US20120177614A1/en
Kolios, George, Moodley Yuben. 2012. Introduction to stem cells and Regenerative Medicine. Respiration 85: 3-10.
Lee, Jau-Nan, Lee Tony Tung-Ying, Lee Yuta, Tsai Eling-Mei 2017. Generation of neural stem cells from human trophoblast stem cells. https://patents.google.com/patent/AU2017200440B2/en
Leventhal, A, Chen G, Negro A, Boehm M. 2012. The benefits and risks of stem cell technology. Oral Diseases 18: 217.
Li, Ying, Hao Jie, Hu Zheng, Yang Yong-Guang, Zhou Qi, Liguang Sun, and Jun Wu. 2022. Current status of clinical trials assessing mesenchymal stem cell therapy for graft versus host disease: a systematic review. Stem Cell Research and Therapy 13: 93.
Lorenz, Elisabeth, Klatte Stephanie, Wendisch Volker F. 2013. Reductive amination by recombinant Escherichia coli: whole cell biotransformation of 2-keto-3-methylvalerate to L-isoleucine. Journal of Biotechnology 168: 289-294. https://doi.org/10.1016/j.jbiotec.2013.06.014
Loring, Jeanne F, Campbell Cathryn. 2006. Intellectual property and human embryonic stem cell research. Science 311: 1716-1717.
Magill, Gerard, B William. Neaves. 2009. Ontological and ethical implications of direct nuclear reprogramming. Kennedy Institute of Ethics Journal 19: 23-32. https://doi.org/10.1353/ken.0.0276
Meyer, Nathan, George Mathew, Stankewicz Casey, Rajesh Deepika. 2016. Priming of pluripotent stem cells for neural differentiation. Google Patents https://patents.google.com/patent/EP2694644A2/en
Minssen, Timo, Nilsson David. 2012. The US Supreme Court in Mayo v Prometheus–taking the fire from or to biotechnology and personalized medicine?: Supreme Court of the United States, Mayo Collaborative Services, dba Mayo Medical Laboratories, et al., Petitioners v Prometheus Laboratories, Inc, Queen Marry College of Intellectual Property 132 S. Ct. 1289. 2: 376-388.
Muffat, Julien, Li Yun, Jaenisch Rudolf. 2021. Culture medium for generating microglia from pluripotent stem cells and related methods. In: Google Patents. World Intellectual Property Organization https://www.nature.com/articles/nm.4189
Odorico, Jon, Xu Xiaofang. 2014. Methods and devices for differentiating pluripotent stem cells into cells of the pancreatic lineage. In: Google Patents. United Patent Office. https://patents.google.com/patent/US8685730B2/en
Park, Sung Sup, Kim Ji Yoen. 2021. Method for differentiation into retinal ganglion cells from stem cells. In: Google Patents. World Intellectual Property Organization. https://patentimages.storage.googleapis.com/75/fc/91/7e5657edfa94ed/WO2016032263A1.pdf
Park, Tae-E, Herland Anna, Fitzgerald Edward Anthony, Ingber Donald Elliot. 2022. Blood-brain barrier endothelial cells derived from pluripotent stem cells for blood-brain barrier models. In: Google Patents. National Library of Medicine. https://patents.google.com/patent/US11371022B2/en
Pitaru, Sandu. (2020). Pluripotent autologous stem cells from oral mucosa and methods of use. In: Google Patents. United States Patent Office. https://patents.google.com/patent/US20100080780A1/en
Plomer, Aurora, Taymor Kenneth S, Scott Christopher Thomas. 2008. Challenges to human embryonic stem cell patents. Cell Stem Cell 2: 13-17.
Plomer, Aurora.2012. After Brüstle: EU accession to the ECHR and the future of European patent law. https://eprints.whiterose.ac.uk/89386/1/After%20Brustle.pdf
Porter, Gerad, Denning Chris, Plomer Aurora, Sinden John, Torremans Paul. 2006. The patentability of human embryonic stem cells in Europe. Nation Biotechnology 24:653-655.
Prockop, Darwin J, Oh Joo Youn & Berkowitz Barry. 2017. Adult stem cells/progenitor cells and stem cell proteins for treatment of eye injuries and diseases. In: Google Patents. United States Patent Office. https://patents.google.com/patent/US9545428B2/en
Resnik, David B. 2007. Embryonic stem cell patents and human dignity. National Library of Medicine 15: 211-222. https://pubmed.ncbi.nlm.nih.gov/17922198/
Rezania, Alireza. 2019. Culturing of human embryonic stem cells at the air-liquid interface for differentiation into pancreatic endocrine cells. In: Google Patents. United States Patent office. https://patents.google.com/patent/US10344264B2/en
Robertson, John A. 2010. Embryo stem cell research: ten years of controversy. Journal of Law, Medicine and Ethics 38: 191-203.
Rossi, Derrick, Warren Luigi. 2017. Induced pluripotent stem cells with synthetic modified RNAs. In: Google Patents. United States Patent Office https://patents.google.com/patent/US9803177B2/en
Schoeler, Hans R, Sterneckert Jared L, Glatza Michael, Reinhardt Peter. 2015. Mammalian neural plate border stem cells capable of forming neural tube and neural crest cell lineages including central and peripheral neurons. Google Patents https://patents.google.com/patent/US20150010515A1/en
Shah, Khalid. 2018. Biodegradable matrix comprising stem cells that express soluble TRAIL. In: Google Patents. United States Patent Office.
Sheard, Andrew. 2014. Patenting stem cell technologies in Europe. Cold Spring Harbor Perspective in Medicines 5: a021089. https://www.nature.com/articles/nrg2701
Shi, Yufang, Ren Guangwen, Zhang Liying. 2015. Methods modulating immunoregulatory effect of stem cells. Google Patents https://patents.google.com/patent/CA2895148A1/en
Shroff, Geeta. 2017. Compositions comprising human embryonic stem cells and their derivatives, methods of use, and methods of preparation. In: Google Patents. European Patent Office https://patents.google.com/patent/EP2422801A3/en
Singh, Narendra Vikram. 2008. Patenting of the stem cell and ethical issue involved. Journal of Social Science Research Network https://papers.ssrn.com/sol3/papers.cfm?abstract_id=1857432
Spalding, Todd N, Simkin Michele M. 2007. How will patents impact the commercialization of stem cell therapeutics? Journal of Pharmaceutical Innovation 2: 23-28. http://dx.doi.org/10.1007/s12247-007-9001-3
Spranger, Tade Matthias. 2012. Case C-34/10, Oliver Brüstle v. Greenpeace eV, Judgment of the Court (Grand Chamber) of 18 October 2011. Journal of Common Market Law Review 49. http://dx.doi.org/10.54648/COLA2012044
Stice, Steven L, West Franklin D, Lu Yangqing. 2014. Avian induced pluripotent stem cells and their use. In: Google Patents. National Library of Medicine https://link.springer.com/protocol/10.1007/978-1-4939-2848-4_9
Swami, Meera. 2009. Mapping genome-wide chromosome interactions. Journal of Nature Review Genetics 10: 816-817. https://www.nature.com/articles/nrg2701
Terskikh, Alexey, Bajpai Ruchi. 2017. Methods for culture and production of single cell populations of human embryonic stem cells (HESCS). In: Google Patents. United States Patent. https://patents.google.com/patent/US7964402B2/en
Thomson, Jamesa, Rajesh Deepika, Dickerson Sarah J, Mack Amanda, Miller Michael. 2014. Reprogramming immortalized B-cells to induced pluripotent stem cells. Google Patents. United States Patent. https://patents.google.com/patent/US8765470B2/en
Toan, Thang Phan. 2021. Method of isolating mesenchymal stem cells from the amniotic membrane of the umbilical cord, a mesenchymal stem cell population isolated from the amniotic membrane of the umbilical cord and a cell culture medium for isolating mesenchymal stem cells from the amniotic membrane of the umbilical cord. In: Google Patents. https://patents.google.com/patent/BR112019005652A2/en
Wager, Rob, Miller Henry I. 2018. The future of food is genetic engineering. Journal of Commercial Biotechnology 24. https://robwager.com/admin/resources/articles/wager-miller-the-future-of-food-is-genetic-engineering.pdf
Wales, Michele, Cartier Eddie. 2015. The impact of myriad on the future development and commercialization of DNA based therapies and diagnostics. Cold Spring Harbor Perspectives in Medicines 5. https://pubmed.ncbi.nlm.nih.gov/26337114/
Wang, Xiaofang, Xu Ren-He. 2017. Mesenchymal-like stem cells derived from human embryonic stem cells, methods and uses thereof. In: Google Patents. Stem Cells. https://patents.google.com/patent/US9745551B2/en
West, Michael D, Chapman Karen B. 2017. Methods of modifying transcriptional regulatory networks in stem cells. In: Google Patents. Canadian Intellectual Property Office. https://patents.google.com/patent/US9732128B2/en
Wong, Alice Yuen-Ting, Mahalatchimy Aurelie. 2018. Human stem cells patents—Emerging issues and challenges in Europe, United States, China, and Japan. Journal of World Intellectual Property 21:326-355. https://doi.org/10.1111/jwip.12098 o
Xue, Qiwei Claire, Ouellette Lisa Larrimore. 2020. Innovation policy and the market for vaccines. Journal of Law and the Biosciences 7: lsaa026. https://doi.org/10.1093/jlb/lsaa026
Yuanyu, HU, Ng Huck Hui, Dan Yock Young. 2020. Derivation of hepatic stem cells and mature liver cell types and uses thereof. In: Google Patents. https://patents.google.com/patent/US11795436B2/en
Zachariades, Nicholas A. 2013. Stem cells: intellectual property issues in regenerative medicine. Stem Cells and Development 22: 59-62. https://doi.org/10.1089/scd.2013.0287
Zakrzewski, Wojciech, Dobrzyński Maciej, Szymonowicz Maria, Rybak Zbigniew. 2019. Stem cells: past, present, and future. Stem Cell Research and Therapy 10: 68-79. https://stemcellres.biomedcentral.com/articles/10.1186/s13287-019-1165-5
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