TY - JOUR

T1 - The EU regulatory data protection in the agrochemical industry

T2 - Towards a data sharing model in favour of sustainable market play and a sustainable environment

AU - Zemła-Pacud, Żaneta

AU - Lenarczyk, Gabriela

N1 - Publisher Copyright: © 2023 John Wiley & Sons Ltd.

PY - 2023

Y1 - 2023

N2 - Regulatory data protection is mandated in the Agreement on the Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement) for two kinds of goods: medicinal products and plant protection products (PPP). In the European Union (EU), the level of their protection has been set far beyond the minimum TRIPS standards and the adopted model of protection has been, for the most part, based on temporary exclusivity. Innovative plant protection products benefit from data exclusivity combined with a compulsory data sharing regime. Data exclusivity refers to products being authorised for the first time for the market of the EU on the grounds of a complete authorisation procedure, based on submission of a full data dossier. Within the period of exclusivity, these data may not be referred to in the authorisation procedure of a generic product—an equivalent to the reference one. In this way, data exclusivity creates a period of factual monopoly for the innovative products and constitutes a sui generis intellectual property right. This paper presents the regime of regulatory data protection in the European Union law as an instrument of legal protection for innovative products in the agrochemical industry. It first analyzes the purpose and functions of regulatory data protection in EU law and in the TRIPS Agreement. Then, the rules of protection by means of data exclusivity and compulsory data sharing are examined. This allows for further considerations on the role of regulatory data protection and compulsory sharing of data in the overall legal protection for innovative products in the agrochemical industry. In view of the above, this chapter discusses both the instruments of protection for PPP regulatory data and poses several questions concerning their rules, practical meaning and possible future modifications. In particular, it is considered whether data exclusivity is the optimal regime of protection for registration data and recommend that a data sharing approach could be used instead of the data exclusivity rule, as is the case with compulsory vertebrate data sharing, to the benefit of the industry and public interest. This chapter allows for evaluation and assessment of the economic and social value of data exclusivity in said areas for fostering primary and secondary innovation, while acknowledging other vital interests such as protection of public interest and safeguarding competition in the relevant markets. Finally, this chapter maps challenges of the current model of protection and indicates areas for further consideration in both creating a coherent and balanced framework of PPP data protection and the possible extrapolation of the data sharing rules to systems of data protection for other life science products.

AB - Regulatory data protection is mandated in the Agreement on the Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement) for two kinds of goods: medicinal products and plant protection products (PPP). In the European Union (EU), the level of their protection has been set far beyond the minimum TRIPS standards and the adopted model of protection has been, for the most part, based on temporary exclusivity. Innovative plant protection products benefit from data exclusivity combined with a compulsory data sharing regime. Data exclusivity refers to products being authorised for the first time for the market of the EU on the grounds of a complete authorisation procedure, based on submission of a full data dossier. Within the period of exclusivity, these data may not be referred to in the authorisation procedure of a generic product—an equivalent to the reference one. In this way, data exclusivity creates a period of factual monopoly for the innovative products and constitutes a sui generis intellectual property right. This paper presents the regime of regulatory data protection in the European Union law as an instrument of legal protection for innovative products in the agrochemical industry. It first analyzes the purpose and functions of regulatory data protection in EU law and in the TRIPS Agreement. Then, the rules of protection by means of data exclusivity and compulsory data sharing are examined. This allows for further considerations on the role of regulatory data protection and compulsory sharing of data in the overall legal protection for innovative products in the agrochemical industry. In view of the above, this chapter discusses both the instruments of protection for PPP regulatory data and poses several questions concerning their rules, practical meaning and possible future modifications. In particular, it is considered whether data exclusivity is the optimal regime of protection for registration data and recommend that a data sharing approach could be used instead of the data exclusivity rule, as is the case with compulsory vertebrate data sharing, to the benefit of the industry and public interest. This chapter allows for evaluation and assessment of the economic and social value of data exclusivity in said areas for fostering primary and secondary innovation, while acknowledging other vital interests such as protection of public interest and safeguarding competition in the relevant markets. Finally, this chapter maps challenges of the current model of protection and indicates areas for further consideration in both creating a coherent and balanced framework of PPP data protection and the possible extrapolation of the data sharing rules to systems of data protection for other life science products.

KW - commercial business information

KW - compulsory data sharing

KW - data confidentiality

KW - data exclusivity

KW - plant protection products

KW - Regulatory data protection

U2 - 10.1111/jwip.12280

DO - 10.1111/jwip.12280

M3 - Journal article

AN - SCOPUS:85153516771

VL - 26

SP - 458

EP - 476

JO - Journal of World Intellectual Property

JF - Journal of World Intellectual Property

SN - 1422-2213

IS - 3

ER -