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.

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.

Innovation in the Polish health sector : A quality assessment

Geneve : World Intellectual Property Organization, 2019

Seria: Economic Research Working Paper 47

49 stron.

This working paper aims to present the specifics of innovation in the Polish health industry through the prism of the experiences and opinions of a representative group of 42 companies from both the pharmaceutical and medtech sectors. Through analysis of indepth interviews, it aims to illuminate the legal, economic and social mechanisms and phenomena that determine innovation in this sector. The survey examines which areas of the Polish health sector are most innovative, the understanding of innovation that prevails in the sector, and the characteristics of R&D activities carried out there. Subsequently, the study explores the general impact of intellectual property, and particularly of patent law on innovation, in the Polish health sector. Finally, it surveys the other economic and legal instruments currently stimulating innovation and how legal regulations and governmental policy could be modified to create an optimal pro-innovation environment. The conclusions include short legal and factual background of innovation in the Polish health sector, the summarized results of the conducted analysis and final comments concerning the level and culture of innovation within the examined industry.

Zarys Prawa Własności Intelektualnej.

Współautorstwo: Chomiczewski, Witold; Felchner, Krzysztof; Gniewek, Alicja; Kępiński, Jakub; Klafkowska-Waśniowska, Katarzyna; Kleban, Bartosz; Lubasz, Dominik; Namysłowska, Monika; Nestoruk, Igor B.; Sikorski, Rafał; Świerczyński, Marek; Kępiński, Marian; Kępiński, Jakub; Klafkowska-Waśniowska, Katarzyna; Sikorski, Rafał

Warszawa : C.H. Beck, 2015

Seria: Zarys Prawa Własności Intelektualnej 5

ISBN 9788325575700; 9788325575717 (ebook)

[XLII], 211 s. Bibliografia, indeks rzeczowy, wykaz orzecznictwa.