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.