Description
Bloomsbury Publishing (UK) Evergreening Patent Exclusivity in Pharmaceutical Products: Supplementary Protection Certificates Orphan Drugs Paediatric Extensions and ATMPs by Frantzeska Papadopoulou
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 Regulation. 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.