Regulatory Protection in the Pharmaceutical and Life Science Industries : Challenges, Opportunities and Ongoing Reform

Cheltenham : Edward Elgar Publishing, 2025

Seria: Elgar Monographs in Intellectual Property Law

ISBN 9781035332274

268 stron.

This book examines the EU framework for regulatory protection in life science industries, with a particular focus on the pharmaceutical sector. Żaneta Zemła-Pacud discusses the rules of regulatory exclusivities and rewards for innovative life science products and the regulatory data underlying them. The author presents the framework's meaning for the sector as a sui generis instrument of protection of intellectual property (IP) and provides an up-to-date analysis of the legislation driving EU reform of pharmaceutical regulation. The author outlines basic principles of pharmaceutical regulation relevant to regulatory protection of innovative medicinal products, orphan and paediatric drugs, and delves into the complexities of regulatory protection for them. The book depicts how regulatory exclusivities and rewards are granted and enforced, how they are used in IP strategies and what challenges they bring. Against this background, the author presents and comments on coming changes to the system. To complete the picture of regulatory protection in the EU, the book presents how it functions in other life science sectors, including agrochemical and food industries. It also depicts the system of regulatory protection in the context of other protective regimes, especially in light of the protection of regulatory data against disclosure. Finally, it categorises regulatory protection within European civil law tradition.

A global landscape of patenting activity in COVID-19 vaccines

Vaccine 2025, t. 67, poz. 127866, s. 1-7.

Współautorstwo: Mercadante, Eduardo; Minssen, Timo; Shadlen, Kenneth C.; Zimmeren, Esther van; Matthews, Duncan

This paper analyses global patent filings for COVID-19 vaccines to identify where vaccine candidates were developed and where patent protection was being sought, as well as to investigate the patterns of collaboration among applicants. The paper builds on a 2023 report from the World Intellectual Property Organization (WIPO), selecting 1178 relevant patent families across eight categories of vaccine platforms, and using WIPO's data on applicants' countries and three types of applicants: corporate applicants, individual inventors, and universities and research organisations (UROs). We searched for applications in 126 jurisdictions, combined into three groups: the G7, G20 nations not in the G7, and non-G20 nations. G20 nations not in the G7 were the most common destination of filings, and applications originating in these countries constitute the greatest number of families, including those covering novel vaccine platforms. Corporate applicants dominated the G7 and the non-G20 but were as relevant as UROs for the non-G7 in G20. Applications from UROs were relatively more focused on conventional platforms, while corporate applicants were more focused on novel platforms. We repeated the analysis for pharmaceutical and biotechnological patent families more broadly in order to provide a reference point for interpreting the results for COVID-19 vaccine patents. Comparison of the two samples reveals unique patterns of patenting activity for COVID-19 vaccines, including more frequent collaboration, especially between corporate applicants and UROs.

Orka na ugorze, czyli o mankamentach ochrony regulacyjnej innowacji rolno-spożywczych

Współautorstwo: Zimny, Tomasz

Sensum, non verba spectamus : księga jubileuszowa Profesor Urszuli Promińskiej / redakcja naukowa Wojciech J. Katner, Mateusz Balcerzak, Julia Chlebny, Jakub Janeta. Łódź : Warszawa : Wydawnictwo Uniwersytetu Łódzkiego ; Wolters Kluwer, 2024, s. 704-723.

The Significance of Provisional Patent Applications in Protecting Early-Stage Inventions : A Legal and Empirical Analysis

IIC - International Review of Intellectual Property and Competition Law 2024, t. 55, s. 1381-1413.

Współautorstwo: Martinez, Catalina; Belowska, Joanna

This article critically examines the role of Provisional Patent Applications (PPAs) as strategic tools within the intellectual property framework, particularly highlighting their significance in safeguarding early-stage inventions. By allowing inventors to secure a priority date while still developing their inventions, PPAs provide a time frame when additional funding can be sought and further development can be pursued without losing the claim to the original invention date. This is especially important in industries like information and communication technology and the life sciences, where development timelines are lengthy and investment-intensive. PPAs serve not only as a cost-effective initial step in patent filing but also as a protective mechanism against premature disclosure, safeguarding the novelty of the invention. PPAs do not undergo formal examination and do not result in a granted patent unless followed by a standard patent application. However, they establish a legal placeholder that can be crucial for securing further patent rights. This study explores the legal framework of PPAs across various jurisdictions. The analysis also delves into the specific benefits and strategic considerations associated with drafting and filing PPAs, including their role in facilitating additional research and refinement of the invention. In addition, it presents novel empirical evidence on the growth of PPAs in the United States and their use as priorities in regular USPTO and EPO patent applications. Despite their advantages, PPAs come with limitations, such as the limited time available to convert them into standard patent applications (typically one year) to benefit from their priority date and the precise requirements for subsequent standard patent applications, which this article addresses. Through a detailed exploration of both the theoretical framework and practical applications of PPAs, the article contributes to a deeper understanding of their role in broader patent strategies, advocating for their careful and informed use in the innovation process.

The European Medicines Agency's path to greater access to pharmaceutical regulatory data : Balancing intellectual property rights and the right to privacy

Współautorstwo: Matthews, Duncan; Lenarczyk, Gabriela

Kritika: Essays on Intellectual Property. T. 6 / edited by Hanns Ullrich, Peter Drahos, and Gustavo Ghidini. - Cheltenham : Edward Elgar Publishing, 2024. :, s. 164–192 .

This chapter relates to the question of whether the European Medicines Agency’s (EMA) policy on access to its documents, including, crucially, clinical study reports, infringes the fundamental rights of companies submitting data for market authorization, in particular companies’ right to protection of personal data under the Charter of Fundamental Rights of the EU and their right to protection of commercial confidential information. The question arises because, despite advances in data transparency, withholding information on the grounds of commercial confidentiality constitutes a major barrier to the access to clinical trial data the importance of which cannot be overstated. There are, indeed, numerous rationales for access to data contained in dossiers submitted to regulatory agencies by clinical trial sponsors and marketing authorization applicants. The conflict between the individual right to privacy as, arguably, including the protection of commercial confidential information and the public interest in transparency of clinical trial data has resulted in litigation before the General Court of the EU and in changes of the EMA’ policy on access. Yet, in our analysis, more open and better-balanced rules on access still need to be developed.