The institution of data exclusivity serves as a key mechanism of modern pharmaceutical law, designed to balance the interests of the developers of originators, on the one hand, and the manufacturers of generic and biosimilar medicinal products, on the other. This mechanism allows generic and biosimilar manufacturers to rely on the originator data instead of conducting a full cycle of preclinical and clinical studies themselves, thereby avoiding significant costs. In return, the developer is granted a time-limited period of market protection necessary to recoup the investment in innovation.
The legal foundation of this institution at the international level is established by the provisions of Part 3, Article 39 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) of April 15, 1994.
Regulation at the Supranational Level within the EAEU
In the context of the supranational regulation within the Eurasian Economic Union (hereinafter – the Union, EAEU), it is important to note that the unified rules of the Union do not contain separate provisions specifically regulating the mechanisms for the protection of regulatory data from preclinical and clinical studies, nor do they establish a market exclusivity regime. Consequently, in practice, compliance with the data exclusivity period is governed directly by the provisions of the national legislation of the EAEU member states.
Nevertheless, requirements regarding the observance of intellectual property rights within the Union are implemented, inter alia, through the structure of Module 1 of the marketing authorization dossier prepared according to the Union rules. The key elements in this regard include: trade name certificates, a set of declarations from the prospective marketing authorization holder regarding patents valid in the territories of the Union member states, and a written confirmation from the applicant that the marketing authorization of the medicinal product does not infringe third-party intellectual property rights. Submission of false or unlawful information in these sections of the dossier constitutes grounds for the competent authority to reject the marketing authorization application.
National Specifics of Regulation in the EAEU Member States
Due to the absence of harmonized rules, it is useful to review the legislative framework and enforcement practices in key Union member states.
Russian Federation
In the Russian Federation, data exclusivity is regulated by Federal Law No. 61-FZ of April 12, 2010 "On the Circulation of Medicinal Products" (hereinafter – 61-FZ). The current provisions (Part 5.1–5.3 of Article 13, 61-FZ) also apply to all MA applications for new medicinal product submitted under the EAEU procedure (in accordance with Decision No. 78 of the EEC Council of November 3, 2016), provided that the reference country is the Russian Federation.
The legislation of the Russian Federation establishes the following periods:
• The submission of applications for generics is prohibited for 4 years from the date of marketing authorization of the reference medicinal product in the Russian Federation.
• The submission of applications for biosimilars is prohibited for 3 years.
• Data exclusivity applies for 6 years. During this period, other manufacturers are not permitted to refer to the results of the preclinical and clinical studies of the innovator for commercial purposes without the developer’s consent.
It should be noted that the current provisions of 61-FZ do not provide a direct answer regarding the applicability of the data exclusivity regime for the marketing authorization of medicinal products in cases of a drug shortage on the Russian market, or a threat of such a shortage, or cases of emergency.
Republic of Kazakhstan
In Kazakhstan, obligations for data protection arise from international agreements, particularly the Enhanced Partnership and Cooperation Agreement between the EU and the Republic of Kazakhstan of March 1, 2020, which establishes a six-year prohibition on granting marketing authorizations for generics based on the innovator's data. However, the concept of "data exclusivity" is currently not incorporated into the national legislation of the Republic of Kazakhstan.
A notable case involves AstraZeneca's medicinal product Forxiga (dapagliflozin). In October 2022, AstraZeneca attempted to challenge the authorization of the generic Dapaglisam in court, citing reliance on its data before the expiration of the six-year protection period. The Supreme Court of the Republic of Kazakhstan rejected AstraZeneca's cassation appeal, confirming the lawfulness of the expert review and the authorization of the generic. The Court effectively endorsed the approach according to which the data protection period is counted from the drug's international birth date, rather than from the date of its authorization in the Republic of Kazakhstan [1].
Thus, incorrect interpretation or the absence of explicit national provisions on the calculation of data exclusivity periods can negatively affect both the availability of medicines for the population and time-to-market for generics.
Republic of Armenia
In Armenia, data exclusivity is defined by the Law of the Republic of Armenia "On Medicines." According to Paragraph 15 of Article 16, when registering a generic medicinal product, the applicant is exempt from submitting preclinical and clinical study data if they confirm that the medicinal product is a generic of an originator authorized in Armenia or in an ICH member state no less than eight years ago (data exclusivity).
Market entry of such a generic is permitted ten years after the authorization of the originator. If one or more new indications are approved for the originator during this ten-year period, the protection period is extended by up to one additional year.
Furthermore, the applicant is exempt from submitting bioequivalence study data if they confirm that the product has been in use in Armenia or in an ICH member state for more than ten years. In such cases, it is sufficient to submit relevant data from the scientific literature.
Republic of Belarus
In Belarus, data protection is ensured through patent law (the standard patent term is up to 20 years). A specific data exclusivity regime is established by Law on Medicinal Products No. 13-Z of May 13, 2020.
Article 10 of the Law prohibits the use of preclinical and clinical study data of originators in the dossiers of generic and biosimilar medicinal products without the written consent of the owners for a period of four years from the date of marketing authorization of the originator in the Republic of Belarus. It is important to note that the legislation of the Republic of Belarus does not explicitly prohibit the filing of MA applications for generics during this period.
Conclusion
An analysis of the legislation of the EAEU member states demonstrates the absence of a harmonized approach to regulatory data protection. Exclusivity periods range from 4 to 8 years, and approaches to calculating these periods and the point from which an application may be filed vary across jurisdictions. This creates additional challenges both for originator Marketing Authorization Holders seeking to protect their investments and for manufacturers of generics planning market entry across the Union. Harmonization of legislation in this area remains a key task for the further development of the EAEU pharmaceutical market.
Respectfully,
The Raifarm Team
Author: Anastasia Kataeva