Protection of registration data in European intellectual property law

Projekt finansowany ze środków NCN, realizowany od 12 kwietnia 2019 r. do 11 kwietnia 2022 r.

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General information

The subject of the proposed study is the protection of registration data as an instrument of legal protection of pharmaceutical products, plant protection products and so-called novel foods.

Traditionally, it is patents that have been used to protect innovations in the life science sector by granting a temporary market monopoly to the right holders. Over the last few decades, however, other legal instruments have been introduced in the European Union to serve the same purpose: supplementary protection certificates (SPCs) and a system of data exclusivity. The latter is the focus of this research project.

The subject of data exclusivity in the EU is specific data: the results of clinical and pre-clinical tests, which must be submitted by manufacturers of innovative medicines before they are authorised. Manufacturers of generic medicines do not have to file the results of such tests themselves, but may refer to previously submitted data of the corresponding innovative medicine. However, the reference to those data can only be made after the data exclusivity period has expired. The generic medicine itself can only be marketed after a separately defined period of so-called market exclusivity. Thus, data exclusivity effectively prevents generic medicines from entering the market, even if they are not covered by patent protection. Hence, it is very important for the protection of innovative medicines and for the development of legal conditions in the drug market, in particular to ensure a balance between the protection of the interests of different stakeholders, i.e. mainly the innovative and generic industry, patients and public institutions providing health services.

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Project objectives

The aim of the project is to analyse and discuss the EU regulation of data exclusivity as broadly as possible, covering the following research questions and issues: What is the role of data exclusivity in the legal protection of medicines given its links to patents and SPCs? What is the significance of data exclusivity in the patent strategies and market practices of pharmaceutical companies? What are the tenets of data exclusivity in the US and how do they differ from data exclusivity in the EU? Are the tenets of data exclusivity the same in different EU countries? What changes to the current data exclusivity regime should be advocated? How is data exclusivity regulated in free trade agreements?

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Research

The research will cover Polish, EU and international law acts as well as judgments of national courts and the Court of Justice of the European Union, decisions of patent offices and institutions authorising medicinal products. Comparative legal research will take into account relevant regulations of the United States law.

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Importance of the study for law making and law enforcement

The Polish literature on this subject is very fragmentary. The monograph that will result from the project will be a comprehensive and innovative study of data exclusivity as an instrument of legal protection of innovative medicines. The findings of the research will also be presented at several international conferences and published in several articles in English-language journals, and thus made available to a wide audience: researchers and practitioners, national and supranational drug approval authorities, as well as national and international policy makers in the field of pharmaceutical and intellectual property law.