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The pharmaceutical industry and patent legislation are inextricably linked. Pharmaceutical companies could not exist without some guarantee that they can recoup the cost of developing a new product. European patent law offers this opportunity, as it allows companies to exclude competition for a specific product for a fixed time scale. In Pharmaceutical Patents in Europe the current legal patent situation is examined by a detailed analysis of case law from the European Patent Office (EPO), the international body created with the signing of the European Patent Convention (EPC). Aspects of European patent law not primarily regulated in the EPC, for example Supplementary Protection Certificates and infringement matters, are examined in the setting provided by EC law and domestic laws of European states. This book is written for the reader who understands the main characteristics of patent law and is looking for a practitioner's text on the European pharmaceutical patent law scene. Moreover, the author's remarks can help all readers to look at the field with fresh eyes.
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.
The book engages with a broad range of new case studies, providing a detailed examination of options for the resolution of access-to-medicine issues at global, national and local levels. In addition, the book reflects the significant progress in international and national patent law and in international policy-making in this area.
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.
Editors --Contributors --Foreword --Preface --Pharmaceutical Patents and Competition Issues --What Is Going on in National Systems?
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.
This book is a highly readable and entertaining account of the co-evolution of the patent system and the life science industries since the mid-19th century. The pharmaceutical industries have their origins in advances in synthetic chemistry and in natural products research. Both approaches to drug discovery and business have shaped patent law, as have the lobbying activities of the firms involved and their supporters in the legal profession. In turn, patent law has impacted on the life science industries. Compared to the first edition, which told this story for the first time, the present edition focuses more on specific businesses, products and technologies, including Bayer, Pfizer, GlaxoSmithKline, aspirin, penicillin, monoclonal antibodies and polymerase chain reaction. Another difference is that this second edition also looks into the future, addressing new areas such as systems biology, stem cell research, and synthetic biology, which promises to enable scientists to ?invent? life forms from scratch.Contents: Seven Tales of a Patent; Patents and the Life Science Industries in the Modern Economy; Past: Dyes, Drugs and Domagk; Adrenaline Rushes ? Isolate, Purify ? and Patent; Science and Drug Discovery ? Ignorance, Serendipity and Rational Drug Design; Aspirin; Insulin; Penicillin and the Antibiotics; Cortisone and the Steroids; Polymerase Chain Reaction; The Gene Patent Wars; Innovations without Patents? The Polio Vaccine and Monoclonal Antibodies; Present: Big Pharma, Small Biotech; Crises, Backlashes and Counter-backlashes; Would We Have Got Where We are Today without Patents?; Future: Systems Biology, Stem Cells, ?Synbio? and the Future of Patents.
Seminar paper from the year 2003 in the subject Business economics - Operations Research, grade: A, Vrije University Brussel (Vesalius College), course: Economics, language: English, abstract: The health of their population has always been a great concern for governments of Post-War Europe. In order to achieve their goals they had to work closely together with the pharmaceutical Industry. With the phenomenon of the aging population the importance of development of new drugs is increasing. The increasingly old population of Europe creates a big market for pharmaceutical companies. The pharmaceutical Industry is a very complex sector with close links to other Industries. The chemical Industry for example is an important supplier for materials needed in the process of creating new drugs. Furthermore is the market for pharmaceuticals characterized by extremely little concentration and a huge variety of products. Globally in 1998, the 300 best-selling products held a share of less than 45% of the worlds market. The top two products held 1.3% of the market each.1 This fact creates a necessity for the companies to research new, so called "Blockbuster drugs" to succeed on this market with a high competition. The data on the various methods of drug discovery is enormous and sophisticated. In this paper the structure of the Research & Development sector of the European pharmaceutical industry will be examined, which is of increasing importance for the success of the individual companies. The specific data on the R & D section will be given a general character. Furthermore it will give a brief overview of the different regions in Europe and their individual differences. In the end, the difficulties and challenges of R & D in the pharmaceutical industry will be described and compared to other pharma markets abroad. [1 Data taken from "Combining discovery with development" by Dr. Peter Eddershaw; World pharmaceutical frontiers 2003/2004 ]