Final report, May 2018 Effects of supplementary protection mechanisms for pharmaceutical products www.technopolis-group.com Effects of supplementary protection mechanisms for pharmaceutical products technopolis |group| May 2018 Thyra de Jongh* Alfred Radauer Sven Bostyn Joost Poort * Corresponding author. [email protected] About the authors Thyra de Jongh PhD, is a Senior Consultant Health & Life Sciences at Technopolis Group in Amsterdam. She specialises in analysis of health systems and policies, and research and innovation in the health and life sciences. She has a particular interest in pharmaceutical innovation and access to medicine. (thyra.dejongh@technopolis- group.com) Alfred Radauer, is Senior Consultant at Technopolis Group in Vienna and leads the Intellectual Property & Standards (IPS) group within Technopolis. His and the IPS group work elaborate on the interfaces between legal, technological and economic issues of IP and standards in innovation policy as well as the interaction of IP with regulation and other policy areas. ([email protected]) Sven Bostyn Lic.Jur, LL.M, PhD, is a senior lecturer in Intellectual Property Law at the University of Liverpool Law School. He is also an assistant professor at the Institute for Information Law, University of Amsterdam. He is one of the leading experts in Europe in patent law and related subjects in the areas of life sciences and pharmaceutical inventions, and has more than sixty single-authored publications. ([email protected]) Joost Poort PhD, is an associate professor in economics at the Institute for Information law, University of Amsterdam. He brings an economic perspective to various multidisciplinary research projects, with particular interest in intellectual property. ([email protected]) i Table of Contents About the authors ......................................................................................................................................... i Abbreviations ............................................................................................................................................. vii Executive Summary .................................................................................................................................... 8 Part A BACKGROUND ......................................................................................................................... 13 1 Introduction ....................................................................................................................................... 14 1.1 Pharmaceutical innovation and intellectual property rights ...................................................................... 14 1.2 Problem setting ............................................................................................................................................ 15 1.3 Structure of the report ................................................................................................................................. 15 2 Methodology ...................................................................................................................................... 17 2.1 Desk study .................................................................................................................................................... 17 2.2 Legal analysis ............................................................................................................................................... 17 2.3 Stakeholder interviews ................................................................................................................................. 17 2.4 Economic analysis ........................................................................................................................................ 17 2.4.1 Case selection ....................................................................................................................................... 17 2.4.2 Data sources ........................................................................................................................................ 18 2.5 Study limitations ......................................................................................................................................... 18 Part B Pharmaceutical R&D and policy in the Netherlands ..................................................... 20 3 The pharmaceutical landscape in the Netherlands ........................................................................... 21 3.1 Pharmaceutical R&D in academia ............................................................................................................... 21 3.2 Pharmaceutical R&D in industry ................................................................................................................ 22 3.2.1 Industry characteristics ...................................................................................................................... 22 3.2.2 Pharmaceutical R&D in the Netherlands ........................................................................................... 22 3.3 Alternative development models ................................................................................................................ 23 3.4 Generic drug industry ................................................................................................................................. 23 4 Pharmaceutical policy in the Netherlands ....................................................................................... 24 4.1 Regulatory approval and marketing authorisation .................................................................................... 24 4.2 Pricing and reimbursement policies ........................................................................................................... 25 4.2.1 External reference pricing .................................................................................................................. 25 4.2.2 Negotiated procurement ..................................................................................................................... 26 4.2.3 Reimbursement .................................................................................................................................. 27 4.2.4 Generic entry ...................................................................................................................................... 28 Part C STUDY FINDINGS .................................................................................................................. 29 5 Legal analysis .................................................................................................................................... 30 5.1 The SPC system ........................................................................................................................................... 30 5.1.1 Introduction ........................................................................................................................................ 30 5.1.2 SPC issues ........................................................................................................................................... 34 ii 5.1.3 Definition of a product – Art. 1(b) ...................................................................................................... 36 5.1.4 Definition of what is protected by a basic patent – Art. 3(a) ............................................................. 39 5.1.5 Requirement for having a valid marketing authorisation – Art. 3(b) ............................................... 45 5.1.6 Requirement that the ‘product’ has not been the subject of an earlier SPC – Art. 3(c) .................... 46 5.1.7 The issue of ‘secondary uses’ and Art. 3(d) with the requirement that there may be no earlier MA for the product as medicinal product .................................................................................................................. 51 5.1.8 SPC squatting ...................................................................................................................................... 55 5.2 Paediatric Regulation .................................................................................................................................. 56 5.2.1 Introduction ........................................................................................................................................ 56 5.2.2 Paediatric SPC extension scheme in greater detail ............................................................................ 57 5.3 Data exclusivity and market protection ...................................................................................................... 61 5.3.1 Concepts ............................................................................................................................................... 61 5.3.2 Legal issues identified ......................................................................................................................... 63 5.4 Orphan drug designation ............................................................................................................................ 73 5.4.1 Basic features ...................................................................................................................................... 73 5.4.2 How the system works .......................................................................................................................