Del 0 - Elgar Monographs in Intellectual Property Law

Regulatory Protection in the Pharmaceutical and Life Science Industries

Challenges, Opportunities and Ongoing Reform

Inbunden, Engelska, 2025

1 939 kr

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This book comprehensively elaborates on the EU framework for regulatory protection in life science industries. Żaneta Zemła-Pacud discusses the rules governing regulatory exclusivities and rewards for both innovative life science products and the regulatory data underlying them. The analysis focuses primarily on pharmaceuticals, such as reference medicinal products, orphan drugs and paediatric medicines, but it also encompasses goods from the agrochemical and food sectors, such as plant protection products, novel food, genetically modified food and feed.The book illustrates how regulatory exclusivities and rewards are granted, what protection they confer, and how they can be enforced. Recognising their practical importance, it further presents how regulatory protection is integrated into IP strategies and what challenges this may pose. Against this background, the author presents and comments on coming changes to the system and provides an up-to-date analysis of the legislation driving EU reform of pharmaceutical regulation. To complete the picture of regulatory protection in the EU, the book situates the system within the framework of other protective regimes, including the protection of regulatory data against disclosure. Finally, referring to European civil law tradition, the author carefully analyses the framework’s normative legal bases and proposes categorising regulatory protection as a sui generis instrument of protection for Intellectual Property.This book is an insightful and stimulating contribution to the literature on intellectual property and pharmaceutical law. It is an essential read for scholars in those fields and policymakers involved in the legal reform of the pharmaceutical sector. Practising lawyers, judges, and national regulators will greatly benefit from timely insights into the field.

Produktinformation

Utgivningsdatum2025-06-20
Mått156 x 234 x undefined mm
FormatInbunden
SpråkEngelska
SerieElgar Monographs in Intellectual Property Law
FörlagEdward Elgar Publishing Ltd
ISBN9781035332274

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ContentsRegulatory protection in the pharmaceutical and life scienceindustries: an introduction ixPART I Regulatory protection for medicinal products1 Introduction to the regulation of market authorisation formedicinal products 2 Data and market exclusivity for reference medicinal products 3 Regulatory exclusivities and rewards for paediatric products 4 Regulatory protection for orphan drugs PART II Reform of the EU pharmaceutical regulation5 The EU Pharmaceutical Strategy and the context of theongoing reform 6 Revision of the regulatory protection for reference medicinalproducts 7 Revision of the regulatory protection for paediatric medicines 8 Revision of the regulatory protection for orphan medicinalproducts 9 Transferrable vouchers for new antimicrobial medicines 10 Regulatory data protection for repurposed medicinal products PART III Regulatory exclusivities as a part of the legal protectionfor intellectual property in life sciences11 Regulatory protection in different sectors of the life sciences 12 Exclusivity versus confidentiality of regulatory data 13 Regulatory protection in the light of TRIPS 14 Regulatory exclusivities in the EU: their legal categorisationunder civil law Bibliography

‘This book is a timely and important contribution to the scholarship and practice of intellectual property and pharmaceutical law. With clarity and depth, it brings to light an often-underexplored yet increasingly pivotal element of the life sciences innovation ecosystem: regulatory exclusivities. While patents and supplementary protection certificates have long dominated discourse around innovation incentives, this work reveals how regulatory data protection and market exclusivity have come to play an equally, if not more, decisive role in determining when generic competition can enter the market.