Technique edition of genes CRISPR/Cas9, legal challenges for regulation and use in Colombia
Técnica de edición de genes CRISPR / CAS9. Retos jurídicos para su regulación y uso en Colombia
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Lamprea Bermúdez, N. and Lizarazo-Cortés, Óscar 2016. Technique edition of genes CRISPR/Cas9, legal challenges for regulation and use in Colombia. Revista La Propiedad Inmaterial. 21 (Jun. 2016), 79–110. DOI:https://doi.org/10.18601/16571959.n21.04.
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Abstract
The gene editing technique CRISPR/Cas9 has appeared on the horizon and Colombian researchers are beginning to understand the technique and employ it. This article explains how the technology works and its field of applications, certain debates surrounding bioethical issues, a pending patent application and others considerations on its regulation according to the genetic material that is employed. The explanation mentioned above aims to provide an initial glance at the legal landscape of the use of this tool in Colombia. Regarding the pending patent application, it seeks to protect the gene editing system with variants of its basic elements and multiple uses; its study of patentability by the Colombian patent office is a challenge for the analysis of patentability exceptions that might apply. Moreover, the regulation on genetic manipulation in humans, including embryos is only permitted if modifications are performed for therapeutic or research purposes. Finally, it remains to be seen whether the traditional regulation of GMOS is applicable to plants, animals and microorganisms modified through this technique. The limitations of criminal patent law are evident, therefore the paper suggests the establishment of an integrate regulation.
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Church George (2015). “Encourage the innovators”, Nature, vol. 3, diciembre, vol. 528: S7.
Doudna, Jennifer A. y Emmanuelle Charpentier (2014). “The new frontier of genome engineering with CRISPR/Cas9”, Science, vol. 346 (6213): doi: 10.1126.
Doudna, Jennifer (3 de diciembre de 2015). “Embryo editing needs scrutiny”, Nature, vol. 528: S6.
Fuentes Contreras, Edgar Hernán (2010). “La manipulación genética en el contexto global y su restricción penal en el ordenamiento jurídico colombiano: perspectivas de la investigación genética y la protección del bien jurídico tutelado”, Análisis Internacional, (2): 103-128, disponible en [http://revistas.utadeo.edu.co/index.php/rai/article/viewFile/19/27].
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Gantz V.; Jasinskiene, N.; Tatarenkova, O.; Fazekas, A.; Macias, V.; Bier, E. y James A. (2015). “Highly efficient Cas9-mediated gene drive for population modification of the malaria vector mosquito Anopheles stephensi”, PNAS, vol. 112 (49): E6736-E6743.
González de Cancino, Emilssen (2002). “El nuevo Código Penal colombiano y la Biotecnología”, Revista de Derecho y Genoma Humano, vol. 16: 107-130.
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Hammond, A. et al. (2016). “A CRISPR/Cas9 gene drive system targeting female reproduction in the malaria mosquito vector Anopheles gambiae”, Nature Biotechnology, january, vol. 34 (1): 78-83.
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Lash, Alex (2014). “Intrigue and Outdated Rules Complicate Big Biotech Patent Fight”, Portal Xconomy, en [www.xconomy.com/national/2014/12/16/intrigueand-outdated-rules-complicate-big-biotech-patent-fight/].
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Ledford, Heidi (2015). “The Landscape for human genome editing”, Nature, vol. 526 (7573): 310.
Liang, P. et al. (2015). “CRISPR/Cas9-mediated gene editing in human tripronuclear zygotes”, Protein & Cell, vol. 6(5), 363-372, en [http://doi.org/10.1007/s13238-015-0153-5].
Long, C. et al. (2014). “Prevention of muscular dystrophy in mice by CRISPR/Cas9-mediated editing of germline dna”, Science, vol. 345(6201):1184-8.
Makarova K. S. et al. (2011). “Evolution and classification of the crispr-Cas systems”, Nature Rev. Microbiol, vol. 9: 467-477.
Mesa, Jesús (2015). “El descubrimiento del año: la edición de genes para curar enfermedades”, El Espectador, 23 de diciembre, en [www.elespectador.com/noticias/salud/el-descubrimiento-del-ano-edicion-de-genes-curar-enfermarticulo-607467].
Mueller, Janice M. (2001). No “Dilettante Affair”: Rethinking The Experimental Use Exception to Patent Infringement for Biomedical Research Tools, Washington Law Review Association, vol. 76:1, 2001.
OMPI (4 de febrero de 2009). “SCP/13/3. Exclusiones de la materia patentable y excepciones y limitaciones a los derechos conferidos por las patentes”, Documento preparado por la Secretaría, en [www.wipo.int/patents/en/topics/exceptions_limitations.html].
Posada Maya, Ricardo (2015). Delitos contra la vida y la integridad personal, t. II, Bogotá, Universidad de los Andes y Grupo Editorial Ibáñez.
Regalado, Antonio (2014). “El hallazgo biotecnológico del siglo está envuelto en una guerra de patentes”, mit Technology Review, diciembre, en [www.technologyreview.es/read_article.aspx?id=46583].
Restrepo Ibiza, Juan Lucas (16 de marzo de 2016). “Peluquería genética”. Portafolio, en [http://m.portafolio.co/opinion/juan-lucas-restrepo-ibiza/peluqueriagenetica-492703].
Romeo Casabona, Carlos María (2009). Genética, biotecnología y ciencias penales. Bogotá, Universidad Javeriana y Grupo Editorial Ibáñez.
Rueda, Gabriela y Monsores de Sá, Natan (2015). “Impacto de la ausencia del Consejo Nacional de Bioética Colombiano”, Revista Latinoamericana de Bioética, vol. 15 (2), 29: 144-155.
Schwank, G. et al. (2013). “Functional repair of cftr by CRISPR/Cas9 in intestinal stem cell organoids of cystic fibrosis patients”, Cell Stem Cell, vol. 13: 653-658.
Shan, Q.; Wang, Y.; Li, J. y Gao, C. (2014). “Genome editing in rice and wheat using the crispr/Cas system”, Nat Protoc, vol. 9: 2395-241.
Sherkow, Jacob (2015). “Law, history and lessons in the crispr patent conflict”, Nature biotechnology, vol. 33 (5): 256-257.
Sherkow, Jacob (2015). “The crispr Patent Interference Showdown Is On: How Did We Get Here and What Comes Next?”, Law and Bioscience blog.
Stanford Law School, december 29, en [https://law.stanford.edu/2015/12/29/ the-crispr-patent-interference-showdown-is-on-how-did-we-get-here-andwhat-comes-next/].
Siddique, Haroon (febrero de 2016). “British researchers get green light to genetically modify human embryos”. The Guardian, en [www.theguardian.com/science/2016/feb/01/human-embryo-genetic-modify-regulator-greenlight-research].
Sun, Y. et al. (2016). “Engineering Herbicide Resistant Rice Plants through CRISPR/Cas9-mediated Homologous Recombination of the Acetolactate Synthase”, Mol Plant, jan 5. pii: S1674-2052(16)00002-2. doi: 10.1016/j.molp.2016.01.001.
Tabebordbar, M. et al. (2015). “In vivo gene editing in dystrophic mouse muscle and muscle stem cells”. Science (New York, N.Y.), en [http://science.sciencemag.org/content/early/2015/12/29/science.aad5177].
Travis, John (2015). “Making the cut crispr genome-editing technology shows its power”, Science, vol. 350 (6267):1456-1457.
Velasco, Nancy (2012). “Manipulación Genética: Análisis científico, ético y legal”, Revista Criminalidad, violencia y naturaleza, vol. 47 (08): 30-36.
Wang, T.; Wei, J. J.; Sabatini, D. M. y Lander, E. S. (2014). “Genetic screens in human cells using the CRISPR/Cas9 system”, Science (New York, N.Y.), vol. 343(6166): 80-84, en [http://doi.org/10.1126/science.1246981].
WIPO, SCP, Standing Committee on the Law of Patents Twentieth Session Geneva, january 27 to 31, 2014 Exceptions and Limitations to Patent Rights: Experimental Use And/or Scientific Research Document prepared by the Secretariat [www.wipo.int/edocs/mdocs/patent_policy/en/scp_20/scp_20_4.pdf ].
Wolt, J. D.; Wang, K. y Yang, B. (2015). “The regulatory status of genome-edited crops”, Plant Biotechnol J. aug 7. doi: 10.1111/pbi.12444.
Wright, A.; Núñez, J. y Doudna, J. (2016). “Biology and Applications of crispr Systems: Harnessing Nature’s Toolbox for Genome Engineering”, Cell, vol. 164, January 14: 29-44.
Wu, Y. et al. (2013). “Correction of a genetic disease in mouse via use of crispr- Cas9”, Cell Stem Cell, vol. 13, 659-662.
Zhai X, Ng V y Lie R. (2016). “No ethical divide between china and the west in human embryo research”, Developing World Bioethics, 1471-8847. USPTO Assignment, en [http://assignment.uspto.gov/#/search?q=20140068797].
Barbosa, C. A. y Gómez C. A. (2002). Estudio de Bioderecho, Colección de Pensamiento Jurídico n.º 5, Derecho Penal, Procuraduría General de la Nación.
Belhaj, K.; Chaparro-García, A.; Kamoun, S.; Patron, N.; Nekrasov, V. (2015). “Editing plant genomes with CRISPR/Cas9”, Current Opinion in Biotechnology, vol. 32: 76-84.
Botero, L. y Gómez, R. M. (2013). “Uso de animales de laboratorio en Colombia: reflexiones sobre aspectos normativos y éticos”, Rev. Med. Vet. Zoot, vol. 60 (III), septiembre-diciembre: 213-219.
Callaway, Ewen (2016). “UK scientists gain licence to edit genes in human embryos”, Nature, vol. 530 (7588): 18.
Camacho, Alex; Deynze, Allen van; Chi-Ham, Cecilia y Bennett, Alan B. (2014) “Genetically engineered crops that fly under the US regulatory radar”, Nature Biotechnology, vol. 32: 1087-1091 doi:10.1038/nbt.3057.
Chen B., et al. (2013). “Dynamic imaging of genomic loci in living human cells by an optimized crispr/Cas system”, Cell, vol. 155: 1479-1491.
Church George (2015). “Encourage the innovators”, Nature, vol. 3, diciembre, vol. 528: S7.
Doudna, Jennifer A. y Emmanuelle Charpentier (2014). “The new frontier of genome engineering with CRISPR/Cas9”, Science, vol. 346 (6213): doi: 10.1126.
Doudna, Jennifer (3 de diciembre de 2015). “Embryo editing needs scrutiny”, Nature, vol. 528: S6.
Fuentes Contreras, Edgar Hernán (2010). “La manipulación genética en el contexto global y su restricción penal en el ordenamiento jurídico colombiano: perspectivas de la investigación genética y la protección del bien jurídico tutelado”, Análisis Internacional, (2): 103-128, disponible en [http://revistas.utadeo.edu.co/index.php/rai/article/viewFile/19/27].
Gaj, T.; Gersbach, C. A. y Barbas, C. F. (2013). “zfn, talen and crispr/Casbased methods for genome engineering”, Trends in Biotechnology, 31(7): 397-405, [http://doi.org/10.1016/j.tibtech.2013.04.004].
Gantz V.; Jasinskiene, N.; Tatarenkova, O.; Fazekas, A.; Macias, V.; Bier, E. y James A. (2015). “Highly efficient Cas9-mediated gene drive for population modification of the malaria vector mosquito Anopheles stephensi”, PNAS, vol. 112 (49): E6736-E6743.
González de Cancino, Emilssen (2002). “El nuevo Código Penal colombiano y la Biotecnología”, Revista de Derecho y Genoma Humano, vol. 16: 107-130.
Granahan, Patricia y Loughran, Chelsea A. (2014). “crispr/Cas-9: An Exciting Addition to Genomic Editing”, Life Sciences Law & Industry Report, March, [www.wolfgreenfield.com/files/granahan_and_loughran__crispr_cas9_.pdf ].
Hammond, A. et al. (2016). “A CRISPR/Cas9 gene drive system targeting female reproduction in the malaria mosquito vector Anopheles gambiae”, Nature Biotechnology, january, vol. 34 (1): 78-83.
Harris, John (2016). “Germline Modification and the Burden of Human Existence”, Cambridge Quarterly of Healthcare Ethics, vol 25: 6-18.
Hsu, P.; Lander, E. y Zhang, F. (2014) “Development and Applications of CRISPR/Cas9 for Genome Engineering”, Cell, vol. 157, June 5: 1262-1278.
Hu, W. et al. (2014). “rna-directed gene editing specifically eradicates latent and prevents new hiv-1 infection”, pnas, vol. 111 (31): 11461–11466. doi:10.1073/pnas.1405186111.
Jiang, W. et al. (2013). “Demonstration of CRISPR/Cas9/SGRNA-mediated targeted gene modification in Arabidopsis, tobacco, sorghum and rice”, Nucleic Acids Res. 41: e188.
Jinek, M. et al. (2012). “A programmable dual-RNA-guided DNA endonuclease in adaptive bacterial immunity”, Science, vol. 337: 816-821.
Kang, X. et al. (2016). “Introducing precise genetic modifications into human 3PN embryos by crispr/Cas-mediated genome editing”, Journal of Assisted Reproduction and Genetics, en [http://dx.doi.org/10.1007/s10815-016-0710-8].
Kirsten, Didi (29 de junio de 2016). “A Scientific Ethical Divide Between China and West”, The New York Times, en [www.nytimes.com/2015/06/30/science/ascientific-ethical-divide-between-china-and-west.html?_r=0].
Kuzma, Jennifer (10 de marzo de 2016). “Reboot the debate on genetic engineering”, Nature, vol. 531: 165-167.
Lamprea, Natalia y Lizarazo-Cortés, Óscar (marzo de 2015). “Tecnología crispr/CAS9 presente y futuro en biotecnología, y controversias de sus patentes”, Boletín virtual del Departamento de la Propiedad Intelectual, Universidad Externado de Colombia, en [http://propintel.uexternado.edu.co/tecnologia-crisprcas9-presente-y-futuro-en-biotecnologia-y-controversias-de-sus-patentes/].
Lash, Alex (2014). “Intrigue and Outdated Rules Complicate Big Biotech Patent Fight”, Portal Xconomy, en [www.xconomy.com/national/2014/12/16/intrigueand-outdated-rules-complicate-big-biotech-patent-fight/].
Lash, Alex (2014). “With Atlas Cash and Berkeley Tools, Intellia Joins the crispr Fray”, Portal Xconomy, en [www.xconomy.com/boston/2014/11/18/with-atlascash-and-berkeley-tools-intellia-joins-the-crispr-fray/].
Lash, Alex y Ready, Aim (2015). “crispr: Will Gene-Editing Tools Hit Their Targets?”, Portal Xconomy, en [www.xconomy.com/national/2015/02/17/ready-aim-crispr-will-gene-editing-tools-hit-their-targets/].
Ledford, Heidi (2015). “The Landscape for human genome editing”, Nature, vol. 526 (7573): 310.
Liang, P. et al. (2015). “CRISPR/Cas9-mediated gene editing in human tripronuclear zygotes”, Protein & Cell, vol. 6(5), 363-372, en [http://doi.org/10.1007/s13238-015-0153-5].
Long, C. et al. (2014). “Prevention of muscular dystrophy in mice by CRISPR/Cas9-mediated editing of germline dna”, Science, vol. 345(6201):1184-8.
Makarova K. S. et al. (2011). “Evolution and classification of the crispr-Cas systems”, Nature Rev. Microbiol, vol. 9: 467-477.
Mesa, Jesús (2015). “El descubrimiento del año: la edición de genes para curar enfermedades”, El Espectador, 23 de diciembre, en [www.elespectador.com/noticias/salud/el-descubrimiento-del-ano-edicion-de-genes-curar-enfermarticulo-607467].
Mueller, Janice M. (2001). No “Dilettante Affair”: Rethinking The Experimental Use Exception to Patent Infringement for Biomedical Research Tools, Washington Law Review Association, vol. 76:1, 2001.
OMPI (4 de febrero de 2009). “SCP/13/3. Exclusiones de la materia patentable y excepciones y limitaciones a los derechos conferidos por las patentes”, Documento preparado por la Secretaría, en [www.wipo.int/patents/en/topics/exceptions_limitations.html].
Posada Maya, Ricardo (2015). Delitos contra la vida y la integridad personal, t. II, Bogotá, Universidad de los Andes y Grupo Editorial Ibáñez.
Regalado, Antonio (2014). “El hallazgo biotecnológico del siglo está envuelto en una guerra de patentes”, mit Technology Review, diciembre, en [www.technologyreview.es/read_article.aspx?id=46583].
Restrepo Ibiza, Juan Lucas (16 de marzo de 2016). “Peluquería genética”. Portafolio, en [http://m.portafolio.co/opinion/juan-lucas-restrepo-ibiza/peluqueriagenetica-492703].
Romeo Casabona, Carlos María (2009). Genética, biotecnología y ciencias penales. Bogotá, Universidad Javeriana y Grupo Editorial Ibáñez.
Rueda, Gabriela y Monsores de Sá, Natan (2015). “Impacto de la ausencia del Consejo Nacional de Bioética Colombiano”, Revista Latinoamericana de Bioética, vol. 15 (2), 29: 144-155.
Schwank, G. et al. (2013). “Functional repair of cftr by CRISPR/Cas9 in intestinal stem cell organoids of cystic fibrosis patients”, Cell Stem Cell, vol. 13: 653-658.
Shan, Q.; Wang, Y.; Li, J. y Gao, C. (2014). “Genome editing in rice and wheat using the crispr/Cas system”, Nat Protoc, vol. 9: 2395-241.
Sherkow, Jacob (2015). “Law, history and lessons in the crispr patent conflict”, Nature biotechnology, vol. 33 (5): 256-257.
Sherkow, Jacob (2015). “The crispr Patent Interference Showdown Is On: How Did We Get Here and What Comes Next?”, Law and Bioscience blog.
Stanford Law School, december 29, en [https://law.stanford.edu/2015/12/29/ the-crispr-patent-interference-showdown-is-on-how-did-we-get-here-andwhat-comes-next/].
Siddique, Haroon (febrero de 2016). “British researchers get green light to genetically modify human embryos”. The Guardian, en [www.theguardian.com/science/2016/feb/01/human-embryo-genetic-modify-regulator-greenlight-research].
Sun, Y. et al. (2016). “Engineering Herbicide Resistant Rice Plants through CRISPR/Cas9-mediated Homologous Recombination of the Acetolactate Synthase”, Mol Plant, jan 5. pii: S1674-2052(16)00002-2. doi: 10.1016/j.molp.2016.01.001.
Tabebordbar, M. et al. (2015). “In vivo gene editing in dystrophic mouse muscle and muscle stem cells”. Science (New York, N.Y.), en [http://science.sciencemag.org/content/early/2015/12/29/science.aad5177].
Travis, John (2015). “Making the cut crispr genome-editing technology shows its power”, Science, vol. 350 (6267):1456-1457.
Velasco, Nancy (2012). “Manipulación Genética: Análisis científico, ético y legal”, Revista Criminalidad, violencia y naturaleza, vol. 47 (08): 30-36.
Wang, T.; Wei, J. J.; Sabatini, D. M. y Lander, E. S. (2014). “Genetic screens in human cells using the CRISPR/Cas9 system”, Science (New York, N.Y.), vol. 343(6166): 80-84, en [http://doi.org/10.1126/science.1246981].
WIPO, SCP, Standing Committee on the Law of Patents Twentieth Session Geneva, january 27 to 31, 2014 Exceptions and Limitations to Patent Rights: Experimental Use And/or Scientific Research Document prepared by the Secretariat [www.wipo.int/edocs/mdocs/patent_policy/en/scp_20/scp_20_4.pdf ].
Wolt, J. D.; Wang, K. y Yang, B. (2015). “The regulatory status of genome-edited crops”, Plant Biotechnol J. aug 7. doi: 10.1111/pbi.12444.
Wright, A.; Núñez, J. y Doudna, J. (2016). “Biology and Applications of crispr Systems: Harnessing Nature’s Toolbox for Genome Engineering”, Cell, vol. 164, January 14: 29-44.
Wu, Y. et al. (2013). “Correction of a genetic disease in mouse via use of crispr- Cas9”, Cell Stem Cell, vol. 13, 659-662.
Zhai X, Ng V y Lie R. (2016). “No ethical divide between china and the west in human embryo research”, Developing World Bioethics, 1471-8847. USPTO Assignment, en [http://assignment.uspto.gov/#/search?q=20140068797].
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