The product-oriented and the process-oriented legal approaches to the regulation of genome editing technologies, CRISPR/Cas9 in particular, are considered. The relevant legislation of the United States and the European Union and some international treaties are analyzed. The issue of genome editing that is within the scope of GMO legislation and general legislation on risk assessment and regulation is addressed. The issue of patenting of gene editing technologies in the legislation of the United States and the European Union and under international law is considered. “Patent wars” between research teams that developed the CRISPR/Cas9 technology are described. The possibilities of obtaining patent protection for plants produced by genome editing are considered.
This is a preview of subscription content, access via your institution.
Buy single article
Instant access to the full article PDF.
Tax calculation will be finalised during checkout.
Kurakov, F.A., The phenomenon of fixation of rights to industrial application of the results of intellectual activity at the stage of fundamental research, Economics Sci., 2017, vol. 3, no. 2, pp. 116–125.
Gaj, T., Gersbach, C.A., and Barbas, C.F., ZFN, TALEN and CRISPR/Cas-based methods for genome engineering, Trends Biotechnol., 2013, vol. 31, no. 7, pp. 397–405.
Kamburova, V.S., Nikitina, E.V., Shermatov, S.E., Buriev, Z.T., Kumpatla, S.P., Emani, C., and Abdurakhmonov, I.Y., Genome editing in plants: an overview of tools and applications, Int. J. Agr., 2017, vol. 2017, article ID 7315351. doi doi 10.1155/2017/7315351
Feldman, R., The CRISPR revolution: What editing human DNA reveals about the patent system’s DNA, UCLA L. Rev. Disc., 2016, vol. 64, pp. 393–409.
Georges, F. and Ray, H., Genome editing of crops: a renewed opportunity for food security, GM Crops Food, 2017, vol. 8, no. 1, pp. 1–12.
Scheben, A., Wolter, F., Batley, J., Puchta, H., and Edwards, D.C., Towards CRISPR/Cas crops—bringing together genomics and genome editing, New Phytol., 2017, vol. 216, no. 3, pp. 682–698.
EASAC, Genome Editing: Scientific Opportunities, Public Interests and Policy Options in the European Union, EASAC Policy Report 31, March 2017.
Bhat, S.A., Malik, A.A., Ahmad, S.M., Shah, R.A., Ganai, N.A., Shafi, S.S., and Shabir, N., Advances in genome editing for improved animal breeding: a review, Vet. World, 2017, vol. 10, no. 11, pp. 1361–1366.
Salsman, J. and Dellaire, G., Precision genome editing in the CRISPR era, Biochem. Cell Biol., 2017, vol. 95, no. 2, pp. 187–201.
Yin, H., Kauffman, K.J., and Anderson, D.G., Delivery technologies for genome editing, Nat. Rev. Drug. Discov, 2017, vol. 16, no. 6, pp. 387–399.
Zhang, Z., Zhang, Y., Gao, F., Han, S., Cheah, K.S., Tse, H.-F., and Lian, Q., Crispr/cas9 genome-editing system in human stem cells: current status and future prospects, Mol. Ther. Nucleic Acids, 2017, vol. 9, pp. 230–241.
Schinkel, H. and Schillberg, S., Genome editing: intellectual property and product development in plant biotechnology, Plant Cell Rep., 2016, vol. 35, no. 7, pp. 1487–1491.
United States Patent and Trademark Office, Decision on motions, Patent interference No. 106,048, 15 February 2017, 51 p.
Brinegar, K., Yetisen, A., Choi, S., Vallillo, E., Ruiz-Esparza, G.U., Prabhakar, A.M., Khademhosseini, A., and Yun, S.-H., The commercialization of genomeediting technologies, Crit. Rev. Biotechnol., 2017, vol. 37, no. 7, pp. 924–932.
Custers, R., The Regulatory Status of Gene-Edited Agricultural Products in the EU and Beyond, Emerging Topics in Life Sciences, 2017. doi https://doi.org/10.1042/ETLS20170019
Whelan, A.I. and Lema, M.A., A research program for the socioeconomic impacts of gene editing regulation, GM Crops Food, 2017, vol. 8, no. 1, pp. 74–83.
Gallo, M., Sargent, Jr.J., Sarata, A., and Cowan, T., Advanced Gene Editing: CRISPR-Cas9, CRS Report, April 28, 2017.
Waltz, E., Gene-edited CRISPR mushroom escapes US regulation, Nature, 2016, vol. 532, no. 7599, p. 293.
Smyth, S., Canadian regulatory perspectives on genome engineered crops, GM Crops Food, 2017, vol. 8, no. 1, pp. 35–43.
Sprink, T., Eriksson, D., Schiemann, J., and Hartung, F., Regulatory hurdles for genome editing: process vs. product-based approaches in different regulatory contexts, Plant Cell Rep., 2016, vol. 35, no. 7, pp. 1493–1506.
Ishii, T. and Araki, M., A future scenario of the global regulatory landscape regarding genome-edited crops, GM Crops Food, 2017, vol. 8, no. 1, pp. 44–56.
Spranger, T.M., Legal analysis of the applicability of Directive 2001/18/EC on genome editing technologies, commissioned by the German Federal Agency for Nature Conservation, 2015.
Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC, Official J. Eur. Union L 106, 2001, vol. 44, pp. 1–39.
The Cartagena Protocol on Biosafety to the Convention on Biological Diversity (2000), United Nations Treaty Series, 2005, vol. 2226, pp. 208–360.
Davison, J. and Ammann, K., New GMO regulations for old: determining a new future for EU crop biotechnology, GM Crops Food, 2017, vol. 8, no. 1, pp. 13–34.
Fears, R. and Ter, MeulenV., How should the applications of genome editing be assessed and regulated?, eLife, 2017. doi doi 10.7554/eLife.26295
Abbot, A., Europe’s genetically edited plants stuck in legal limbo, Nature, 2015, vol. 528, no. 7582, pp. 319–320.
Tagliabue, G., The EU legislation on “GMOs” between nonsense and protectionism: An ongoing Schumpeterian chain of public choices, GM Crops Food, 2017, vol. 8, no. 1, pp. 57–73.
Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, Official J. Eur. Communities, 1998, vol. 213, pp. 13–21.
Commission Notice on certain articles of Directive 98/44/EC of the European Parliament and of the Council on the legal protection of biotechnological inventions, Official J. Eur. Union, 2016, vol. 411, pp. 3–14.
Convention on the Grant of European Patents (1973), United Nations Treaty Series, 1978, vol. 1065, pp. 255–509.
Directorate General Internal Market, Industry, Entrepreneurship and SMEs, Final Report of the Expert Group on the development and implications of patent law in the field of biotechnology and genetic engineering (E02973), May 17, 2016.
Agreement on Trade Related Aspects of Intellectual Property Rights (1994), United Nations Treaty Series, 1999, vol. 1869, annex 1C, pp. 299–400.
Jewel, K. and Balakrishnan, V., The battle to own the CRISPR–Cas9 gene-editing tool, WIPO Magazine, 2017, vol. 2, pp. 26–32.
European Commission, High Level Group of Scientific Advisors, New Techniques in Agricultural Biotechnology, Explanatory Note 02, April 28, 2017.
Decision adopted by the Conference of the Parties to the Convention on Biological Diversity XIII/17, Synthetic Biology, CBD/COP/DEC/XIII/17, December 16, 2016.
Decision adopted by the Conference of the Parties to the Convention on Biological Diversity XII/24. New and emerging issues: synthetic biology, UNEP/CBD/COP/DEC/XII/24, October 17, 2014.
Outline of guidance on risk assessment of living modified organisms developed through synthetic biology, Note by the Executive Secretary, UNEP/CBD/BS/COP-MOP/8/8/Add.3, September 14, 2016.
Report of the Ad hoc technical expert group on synthetic biology, UNEP/CBD/SYNBIO/AHTEG/2015/1/3, October 7, 2015.
LaBarbera, A., Proceedings of the international summit on human gene editing: a global discussion, J. Assist. Reprod. Genet., 2016, vol. 33, no. 9, pp. 1123–1127.
Original Russian Text © M.O. Medvedieva, Ya.B. Blume, 2018, published in Tsitologiya i Genetika, 2018, Vol. 52, No. 3, pp. 47–60.
About this article
Cite this article
Medvedieva, M.O., Blume, Y.B. Legal Regulation of Plant Genome Editing with the CRISPR/Cas9 Technology as an Example. Cytol. Genet. 52, 204–212 (2018). https://doi.org/10.3103/S0095452718030106
- genome editing
- CRISPR/Cas9 technology
- legal regulation
- EU legislation
- US legislation
- international law