Biotechnology, Patents and Human Rights in Europe : Innovations Concerning the Human Body

Współautorstwo: Żakowska-Henzler, Helena; Zimny, Tomasz

London : Edward Elgar Publishing, 2023

ISBN 9781803920252; 9781803920269

266 stron.

This innovative book explores the complex interplay between intellectual property for biotechnological innovations and human rights. Examining the clash between the drive to incentivise innovations that can fulfil human needs and the desire to grant global access to healthcare technologies, it presents thoughtful solutions to the challenges of protecting the human rights of all parties impacted by biotechnological patents and other relevant IP rights.

Redakcja:

Ad cuius bonum? : o wartościach i interesach zasługujących na ochronę prawną : księga jubileuszowa Profesor Heleny Żakowskiej-Henzler

Współredaktorstwo: Zimny, Tomasz

Warszawa : Wydawnictwo INP PAN, 2023

ISBN 9788366300828

660 stron. Bibliografia przy rozdziałach.

To Have Your Cake and Eat It Too : Sufficient Disclosure of Inventions in the Light of the Polish Supreme Administrative Court’s Judgment of 24 April 2022, II GSK 1724/18

International Review of Intellectual Property and Competition Law 2023, nr 54, s. 1105-1115.

The subject matter of this opinion is the Polish Supreme Administrative Court’s judgment on the invalidity of a patent concerning a calcium-magnesium fertiliser due to its insufficient disclosure. This paper presents the course of the invalidation proceedings before the Polish Patent Office and administrative courts against the background of the Polish Industrial Property Law and the Polish Patent Office’s Guidelines concerning sufficient disclosure of inventions. It also briefly refers to the EPC and EPO practice on the standards of sufficient disclosure, including the recent EPO decision G2/21. Finally, it offers approving comments on the judgment itself, notices the practical impossibility of remedying the failure to disclose enough and mentions current systemic challenges to the requirement of sufficient disclosure as a fundamental rule of patent systems.

Kwalifikacja wyłączności regulacyjnych na gruncie prawa polskiego

Ad cuius bonum? : o wartościach i interesach zasługujących na ochronę prawną : księga jubileuszowa Profesor Heleny Żakowskiej-Henzler / redakcja naukowa Żaneta Zemła-Pacud, Tomasz Zimny. Warszawa : Wydawnictwo INP PAN, 2023, s. 243-294.

In view of the growing economic importance of regulatory exclusivities, its expansion into new sectors and the advanced legislative work to revolutionise pharmaceutical regulation, a clear theoretical qualification of the instrument of regulatory exclusivity is necessary to ensure legal certainty for stakeholders in life science markets. This article presents the purpose and function of regulatory exclusivities, their legal construction and the rules of protection that they confer. In particular, it delves into the protected subject matter, the entitlements resulting from data and market exclusivity and the way rightsholders can assert them. These features of regulatory exclusivities serve as the basis for classifying regulatory exclusivity into well-established legal categories under Polish law.

The EU regulatory data protection in the agrochemical industry : Towards a data sharing model in favour of sustainable market play and a sustainable environment

Journal of World Intellectual Property 2023, t. 26, nr 3, s. 458-476.

Współautorstwo: Lenarczyk, Gabriela

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.

Clinical Trial Data Transparency in the EU : Is the New Clinical Trials Regulation a Game-Changer?

International Review of Intellectual Property and Competition Law 2023, t. 54, nr 5, s. 732-763.

Współautorstwo: Lenarczyk, Gabriela

The benefits of access to clinical trial data are related to their inestimable value from the perspective of clinical trial participants, society as a whole, public health systems and scientific progress. In light of the development of innovative data analysis technologies, access to raw clinical trial data opens up an ever-widening array of possibilities: it can profoundly facilitate machine data analysis for, inter alia, hypothesis generation, risk modelling, counterfactual simulation and – finally – drug repurposing and development. The enactment of the new Clinical Trials Regulation (EU) No. 536/2014 (CTR) and introduction of the Clinical Trials Information System (CTIS) were heralded as ensuring a level of transparency in clinical trials that is sufficient to contribute to protecting public health and fostering the innovation capacity of European medical research, while recognizing the legitimate economic interests of sponsors. This paper presents the hitherto binding rules for the disclosure of clinical trial data and, against this background, their new framework, introduced by the CTR. In addition to assessing whether the CTR’s objectives are fulfilled, this paper examines whether the latest changes impact the hitherto existing rules on protection of regulatory data via regulatory exclusivities. Finally, it points out concerns regarding whether data gathered in the CTIS can be efficiently used by innovative data analysis technologies for further processing for both commercial and non-commercial purposes.

A shifting paradigm of regulatory data transparency in Europe : How to reconcile the irreconcilable

Improving Intellectual Property : A Global Project / Susy Frankel, Margaret Chon, Graeme B. Dinwoodie, Barbara Lauriat, Jens Schovsbo (eds.) – Cheltenham: Edward Elgar Publishing, 2023, s. 330-339.

This chapter focuses on the confidentiality of regulatory data in Europe. The current policy of the EU regulatory bodies on access to the results of registration studies for medicines, food, and plant protection products shows a continuing trend towards greater transparency in the interests of public health and freedom of research. Concurrently, other developments on both the EU and national level aim at safeguarding the secrecy of pharmaceutical data that has the utmost commercial significance for their sponsors and holders. This paper presents the recent changes in European policies, legislation and jurisprudence striving to create a well-balanced framework of transparency and confidentiality concerning regulatory data. It points to the diverse rules of data confidentiality in particular life science industries and recommends achieving their uniformity. It also takes proposes such interpretations of the current normative framework that would lead to greater coherency in access to protected knowledge under emergency circumstances.

Cross-border patent litigation under the EPC

Współautorstwo: Targosz, Tomasz

European Patent Law : The Unified Patent Court and the European Patent Convention / Duncan Matthews and Paul Torremans (eds.) – Berlin, Boston: De Gruyter, 2023, s. 27-42.

This paper presents the outline of the currentstatus quo in cross-border patent litigation in Europe. This status quo results from an interplay of different factors, primarily jurisdictional rules, private international law rules and, to some extent, the extraterritorial scope of national patent rights. It elaborates on the submission that the current litigation system of cross-border conflicts regarding a single European patent in different jurisdictions has many drawbacks. Sometimes it results in contradictory decisions; other times, it encourages abuse of the litigation system by the parties, both on the attacking and defending side. While some features of the current system could be improved, in a mosaic of many jurisdictions and patents, no ideal solutions can be found.