Pharmaceutical Patents Under The Spc Regulation

Written by an experienced European Patent Attorney and scholar, this book sets out in detail the framework for protection of pharmaceutical innovation under the SPC Regulation. With a focus on both biotechnological innovation and secondary innovation, and through extensive reference to the case law, Ulla Klinge surveys the court’s evolving interpretation of legal and technical eligibility for this extended term of protection. This book provides clear and pragmatic tools to reflect and guide future practice, while offering key explanations and insights as to why and how technological developments challenge the legal SPC framework.

The supplementary protection certificate (SPC) prolongs the term of patents for pharmaceutical products for a maximum of five additional years. The SPC's legal bases are two European SPC Regulations and the SPC is based upon European or national patents. SPCs protect some of the most valuable products in the pharmaceutical industry where each day of additional protection may be worth millions of Euros. Despite the economic relevance SPCs have obtained in recent years, there exists only limited detailed literature on the subject. German jurisprudence on SPCs is of special importance, as this has often been the basis for decisions of the European Court of Justice (ECJ) and the German market is one of the leading markets for pharmaceuticals and thus for SPCs. This book is addressed to patent attorneys - in particular in-house and external - working for pharmaceutical companies, and attorneys-at-law specialising in patent law, especially in Europe but essentially worldwide.

Public health, safety and access to reasonably priced medicine are common policy goals of pharmaceutical regulations. As both the context for innovation and competitive structure change, industry actors dynamically challenge the balance between the incentive for protection and the achievement of those policy goals. Considering the arguments from the perspectives of innovation, competition law and patent law, this book explores the difficult question of balancing protection with access, highlighting the difficulties in harmonization and coordination. The contributors to this book, including academics, judges and practitioners from Europe, the US and Japan, explore to what extent patent strategies and life-cycle management practices take advantage of patent laws and health-care regulation and disrupt the necessary balance between incentives for innovation and access to affordable medicine and health care. Addressing fundamental questions in the field of pharmaceutical innovation, this book will appeal to scholars and practitioners in intellectual property, competition law and life sciences regulation, as well as pharmaceutical companies and regulators.

AIPPI Series, Volume Number 2. The second edition of Patent Protection for Second Medical Uses is a practical guide on the ever-relevant and controversial topic ‘Second Medical Use’ (SMU) patents, which play a significant role in the potential second-line patent protection and have become increasingly important. This edition’s analysis sheds light on the availability of protection for second medical use claims and its legal basis, followed by a detailed look at the specifics of various jurisdictions. Following the abandoning of ‘Swiss-type claims’ at the European Patent Office (EPO), applicants had to develop new filing strategies while such claims are still allowable in a number of national jurisdictions worldwide; the consequences of this have not yet fully been explored in practice. Jurisdictions around the world show significant differences in the treatment of such claims, although they share common approaches in patent law overall. This second edition furnishes a detailed and elaborate analysis, providing clarity, insight and guidance on legal issues and practical implications of SMU claims in twenty-four jurisdictions (the EPO and twenty-three individual countries). What’s in this book: This book, published under the aegis of the esteemed International Association for the Protection of Intellectual Property (AIPPI), contains a chapter-wise analysis by carefully chosen authors known for their expertise and experience in this field. Each chapter highlights such issues and topics as the following: availability and scope of protection; validity of claims; enforcement; infringement and investigations; and procedural aspects and tactical recommendations. The AIPPI studied certain aspects of second medical use claims on the occasion of its Congress in Toronto in 2014. This led to its Resolution Q 238 – ‘Second medical use and other second indication claims’, which triggered this comparative law analysis and a copy of which is found at the end of this book. How this will help you: This book is an enlightening compendium of contributions from across the globe. It not only renders guidance to interested legal practitioners when filing a patent application and assessing risks of conflict with existing patents or patent applications but also explains the key issues and contains practical advice when enforcing such claims or defending against an action. Also, this book will prove to be of immense practical interest for patent lawyers and patent attorneys and for the industries involved, applicants for pharmaceutical patents and third parties.

While supplementary protection certificates (SPCs) are governed by the same substantive rules in all Member States of the European Union and the European Economic Area, they are national IP rights. The formal requirements and procedural practices of the national patent offices granting SPCs still differ significantly, and these divergences can have a substantial impact in the prosecution of SPCs across Europe. This one-of-a-kind handbook provides an easily accessible overview of SPC law in Europe, covering all substantive and procedural aspects of prosecution, enforcement and invalidation, as well as SPC-related aspects of unfair competition law. Following an overarching European chapter, which addresses general considerations and the relevant European Union law, including the jurisprudence of the Court of Justice (CJEU) and the EFTA Court, this book contains separate national chapters for eleven key jurisdictions ? i.e., Germany, the United Kingdom, France, the Netherlands, Belgium, Italy, Spain, Portugal, Sweden, Iceland, and Switzerland, as well as a concluding chapter summarizing the fundamentals of SPC law and practice in sixteen further European countries. The contributors to this book, all experts in the field of SPCs in their respective jurisdictions, provide clear and hands-on guidance on a range of specific topics of practical and strategic relevance, including: • What is or is not an ‘active ingredient' amenable to SPC protection? • What is required for an active ingredient to be ‘protected' by a basic patent? • What relevance has the ‘core inventive advance' of the basic patent? • Can SPCs be obtained for ‘loose' combinations of separately formulated active ingredients? • Which basic patent should be chosen for an SPC filing? • Which types of marketing authorizations can be relied upon? • Under which conditions can SPCs be obtained for a new specific salt, ester or other derivative of a previously approved active ingredient, for a new specific enantiomer of a previously approved racemate, and for new therapeutic applications of previously approved active ingredients? • Can affiliated companies obtain several SPCs for the same product? • Does the revocation of an SPC enable the filing of a new SPC for the same product? • What are the limits to the filing of ‘unfriendly' SPCs based on third-party marketing authorizations? • What relevance does the product definition of an SPC have for its scope of protection? • What is the scope of protection of an SPC in relation to derivatives of an active ingredient? • How is the SPC term calculated, and how can an erroneous term be corrected? • How can SPCs and paediatric extensions be invalidated, and which grounds of invalidity can be invoked? • What pitfalls must be avoided in terms of unfair competition law? This book provides invaluable assistance to IP practitioners in devising successful pan-European SPC filing strategies. Its practice-oriented, country-by-country format makes it easy to compare the national practices and the respective national case law of the different European countries.

This Sixth Edition of The Generic Challenge provides important new updates on current regulatory, legal and commercial issues affecting brand and generic pharmaceutical products, including new laws establishing generics for biologics, and changes brought about by the recently enacted America Invents Act. It explains clearly and understandably the roles of patents, FDA regulation of drugs and the Hatch Waxman Act in commercial drug development in light of generic challenges and how improvements in innovative drug products provide benefits to patients while extending the commercial lives of the drugs. There is simply no other book of its kind on this important subject.

This book explores whether the judicial developments related to the Supplementary Protection Certificate (SPC) regulation correspond to the objectives of the European legislator. Examining the role of SPCs for medicinal products in the European patent system, it highlights both the jurisprudence of the Court of Justice of the European Union and the respective judgements of the member states’ national courts.