Skip to content
Home/ Evergreening Patent Exclusivity in Pharmaceutical Products: Supplementary Protection Certificates, O
Evergreening Patent Exclusivity in Pharmaceutical Products: Supplementary Protection Certificates, O

Evergreening Patent Exclusivity in Pharmaceutical Products: Supplementary Protection Certificates, O

No customer reviews yet ISBN 9781509950287 Hart Publishing

This book analyses 4 central pieces of EU pharmaceutical regulation: the Orphan Drugs Regulation, the Paediatric Regulation, the Supplementary Protection Certificate Regulation, and the ATMP (Advanced Therapy Medicinal Products) Regulation. These four regulatory instruments constitute focal points in the pharmaceutical industry's approach to modern business and legal strategy. Their central role is justified by the way these regulatory instruments interact with each other and with the patent system, and by the considerable impact they (as a whole) have for the evergreening of exclusive rights on pharmaceutical products.

The book guides the reader through the latest case law and legislative developments and discusses how these influence strategic legal and business choices in the pharmaceutical industry. It brings to the forefront the often-overlooked significance of the legislative architecture of the EU pharmaceutical regulatory framework, and evaluates its results through the lens of the efficiency test.

The book is an important resource for academics and practitioners interested in updated case law and an in-depth analysis of these four regulations. It is also important for those interested in legislative studies, evaluation of legislation and a critical approach to legislative architecture.

About the author

Product details

BrandHart Publishing
Pub dateOct 21, 2021
ISBN-101509950281
ISBN-139781509950287
LanguageEnglish
Dimensions9.21 × 1 × 6.14 in
Weight1 lb
Last updated 2026-09-07 23:29
$156.23
In stock — ships in 24 hours with free tracking
Delivery by Monday, September 14, 2026
Qty
Sign in to Add to Saved list
Free delivery on orders over $35.
15-day returns. Any reason.
Secure checkout. We never store card details.

Readers who bought this also bought

More from Intellectual Property - Patent
See all
Inclusive Innovation in the Age of AI and Big Data
As artificial intelligence and big data analytics reshape economies and societies, the promise of innovation is increasingly shadowed by concerns over inclusion, equity, and global justice. This accessible, interdisciplinary volume brings together established and emerging voices from across the world to critically examine issues lying at the intersection of innovation, intellectual property, and inequality in the age of artificial intelligence and big data. <p/>Featuring empirical studies, legal analyses, policy critiques, interdisciplinary perspectives, and global insights, <em>Inclusive Innovation in the Age of AI and Big Data</em> underscores the tremendous impact gender, race, and other socioeconomic factors have on innovation and intellectual property ecosystems. This volume also explores structural barriers in these ecosystems, diversity initiatives in the patent area, metrics for measuring inclusivity and diversity in innovation, changes brought about by artificial intelligence and big data, and the evolution of the global innovation and intellectual property systems. <p/>In an era marked by rapid technological change, extraordinary opportunities, and deepening inequality, this volume offers carefully designed reform strategies and policy recommendations to make innovation and intellectual property ecosystems more equitable, effective, and socially responsive. <p/>This is an open access title available under the terms of a CC BY-NC-ND 4.0 International license. It is free to read on the Oxford Academic platform and offered as a free PDF download from OUP and selected open access locations.
$186.84