SECRETS OF PRODUCTION (KNOW-HOW) IN THE FIELD OF BIOTECHNOLOGY: THEORETICAL AND LEGAL ANALYSIS
Keywords:
biotechnology, intellectual property protection, trade secrets, production secrets, know-how, digital technologiesAbstract
The article aims to conduct a theoretical and legal analysis of trade secrets (know-how) in the field of biotechnology. Know-how encompasses practical knowledge, technical experience, and skills necessary for biotechnological production, but their legal regulation differs significantly across various jurisdictions. The research employs comparative legal analysis, doctrinal analysis, and case study methods to evaluate know-how protection systems in different countries. According to the study, in common law systems, know-how is protected within the broader framework of trade secrets, whereas the Russian Federation treats it as a separate intellectual property institution. The article demonstrates that Uzbekistan’s current legislation incorporates know-how within the framework of trade secret protection, while highlighting the need to improve regulation of production secrets specific to biotechnology, particularly regarding digital data protection, employee mobility in specialized technical fields, and legal protection mechanisms appropriate for complex biotechnological processes.
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References
Aplin, T. F., & Liddicoat, J. (2023). Discussion paper on the interplay between patents and trade secrets in medical technologies. SSRN Electronic Journal. https://doi.org/10.2139/ssrn.4606923
Bone, R. G. (1998). A new look at trade secret law: Doctrine in search of justification. California Law Review, 86(2), 241–313. https://doi.org/10.2307/3481143
Bone, R. G. (2009). Trade secrecy, innovation, and the requirement of reasonable secrecy precautions. Boston University School of Law Working Paper, 09-40. https://ssrn.com/abstract=1467723
Bosnyak, Z., Korn, M., Bielohuby, M., Wohlfart, P., & Tennagels, N. (2020). Nearly a century of insulin at Sanofi: Looking back over the decades of production and development. Pediatric Endocrinology Reviews, 17(1), 161. https://doi.org/10.17458/per.vol17.2020.bkb.sanoficenturyinsulin
Chugai Pharmaceutical Co., Ltd. (2017). Annual report 2017. https://www.chugai-pharm.co.jp/english/ir/reports_downloads/annual_reports/files/eAR2017_12_11.pdf
European Union. (2016). 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure. Official Journal of the European Union, L157/1. https://eur-lex.europa.eu/eli/dir/2016/943/oj/eng
Fierce Pharma. (2025, May 22). CDMO Samsung Biologics telegraphs spinoff of biosimil unit. https://www.fiercepharma.com/manufacturing/cdmo-samsung-biologics-telegraphs-spinoff-biosimilars-subsidiary-bioepis-citing
Genentech Inc. (2023). Annual report form 10-K: Trade secrets portfolio. U.S. Securities and Exchange Commission.
Civil Code of the Russian Federation. (2025, July). Part Four of December 18, 2006 No. 230-FZ. https://base.garant.ru/10164072/aca05a383e5fafa508271522dd5a4b23/
Hernandez, G. L. (2013). Trade secret protection… in the cloud. Entertainment Law Review, 7–24. https://ssrn.com/abstract=2912905
Intuition Labs. (2025, April 19). IBM’s role and relevance in the pharmaceutical industry (U.S. focus). https://intuitionlabs.ai/articles/ibm-relevance-pharma-industry?utm_source=chatgpt.com
Kamenova, P. V., & Lupandina, O. A. (2020). Legal protection of know-how in international commercial transactions. Moscow State University Journal of Law, 3, 78–4.
Kapczynski, A. (2022). The public history of trade secrets. UC Davis Law Review, 55. https://ssrn.com/abstract=4138402
Lemley, M. A. (2008). The surprising virtues of treating trade secrets as IP rights. Stanford Law Review, 61(2), 311–353.
Pooley, J. (2002). Trade secrets. Law Journal Press.
Singh, K. K. (2015). Biotechnology and intellectual property rights: Legal and social implications. Springer India. https://doi.org/10.1007/978-81-322-2059-6
Verma, V. (2024). Unveiling the power of blockchain in pharmaceutical supply chains: Strengthening security and improving drug traceability. El-Cezeri Journal of Science and Engineering, 11(2), 142–151. https://doi.org/10.31202/ecjse.1338782
World Intellectual Property Organization. (2020). Guide to trade secrets and innovation: Part II, Strategic roles of trade secrets in the innovation ecosystem. WIPO. https://www.wipo.int/web-publications/wipo-guide-to-trade-secrets-and-innovation/en/part-ii-strategic-roles-of-trade-secrets-in-the-innovation-ecosystem.html
World Trade Organization. (1994). Agreement on trade-related aspects of intellectual property rights (TRIPS), Article 39. WTO.
