Download or read book Supplementary Protection Certificates for Medicinal Products written by Georgia A. Roussou and published by Edward Elgar Publishing. This book was released on 2023-01-20 with total page 267 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Supplementary Protection Certificates SPC written by Marco Stief and published by . This book was released on 2015-07 with total page 350 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book European SPCs Unravelled written by Alexa von Uexküll and published by Kluwer Law International B.V.. This book was released on 2018-11-08 with total page 712 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Supplementary Protection Certificates SPC written by Marco Stief and published by . This book was released on 2021 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Supplementary Protection Certificates Supplementary protection certificates (SPC) extend the effects of patents for medicinal products by a maximum of five and a half years, i.e. the certificate becomes effective at a time when the respective pharmaceutical is widely known on the market and thus generates the maximum revenue. This explains the enormous economic value of SPCs. They protect some of the most valuable products in the pharmaceutical industry. The legal basis for the SPC for medicinal products is a European Regulation. The obtaining provisions of that Regulation, the scope of protection etc. are highly disputed and have been the subject of numerous decisions of the CJEU. This handbook provides valuable insights into the world of SPCs and the most significant case law and legal sources at EU and national level of Germany, the UK, France, Italy, the Netherlands and Switzerland. The second completely revised edition specifically addresses recent developments of SPCs including manufacturing waivers and the implications of “Brexit”
Download or read book Supplementary Protection Certificates SPC written by Marco Stief and published by . This book was released on 2021-12-31 with total page 300 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book European SPCs Unravelled written by Oswin Ridderbusch and published by Kluwer Law International B.V.. This book was released on 2021-06-18 with total page 898 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 (EEA), they are national intellectual property 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 on the prosecution of SPCs across Europe. This one-of-a-kind handbook provides an in-depth review 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 detailed national chapters for all European states that provide SPCs − i.e., the twenty-seven EU Member States (Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden), the EEA/EFTA states Norway and Iceland, as well as the United Kingdom, Switzerland/Liechtenstein, Serbia, Bosnia and Herzegovina, Albania, and North Macedonia. The contributors to this book, all seasoned experts in the field of SPCs in their respective jurisdictions, provide clear and hands-on guidance on the most pertinent SPC-related topics of practical and strategic relevance. The considerably expanded second edition of this handbook offers a comprehensive analysis of European SPC law and practice, covering all European states with SPC systems in detailed national chapters. As such, this book provides invaluable assistance to IP practitioners in devising successful pan-European SPC filing and litigation strategies. Its practice-oriented approach, in combination with a country-by-country format where all chapters follow the same structure, makes it easy to compare the national practices and the respective national case law of the different European countries. ‘The present work fills a gap and provides, for the first time, an overview of the SPC practice in the EU Member States, which despite the intended harmonization by the respective EU legislation is still decidedly inconsistent in some areas. Altogether, this successful work, with its streamlined structure and clear language that is immediately comprehensible even to non-native speakers, functions not “only” as a source of information for European attorneys, authorities and courts. It also conveys – perhaps not at all intended by the authors – the unique diversity of this European legal regime, which for many exerts a special fascination. The present Practitioner’s Guide can be recommended without reservation and should not be missing in any specialist library.’ – Jürgen Schell, Judge at the German Federal Patent Court, on the first edition of this book.
Download or read book 3D Printing of Pharmaceuticals written by Abdul W. Basit and published by Springer. This book was released on 2018-08-06 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: 3D printing is forecast to revolutionise the pharmaceutical sector, changing the face of medicine development, manufacture and use. Potential applications range from pre-clinical drug development and dosage form design through to the fabrication of functionalised implants and regenerative medicine. Within clinical pharmacy practice, printing technologies may finally lead to the concept of personalised medicines becoming a reality. This volume aims to be the definitive resource for anyone thinking of developing or using 3D printing technologies in the pharmaceutical sector, with a strong focus on the translation of printing technologies to a clinical setting. This text brings together leading experts to provide extensive information on an array of 3D printing techniques, reviewing the current printing technologies in the pharmaceutical manufacturing supply chain, in particular, highlighting the state-of-the-art applications in medicine and discussing modern drug product manufacture from a regulatory perspective. This book is a highly valuable resource for a range of demographics, including academic researchers and the pharmaceutical industry, providing a comprehensive inventory detailing the current and future applications of 3D printing in pharmaceuticals. Abdul W. Basit is Professor of Pharmaceutics at the UCL School of Pharmacy, University College London. Abdul’s research sits at the interface between pharmaceutical science and gastroenterology, forging links between basic science and clinical outcomes. He leads a large and multidisciplinary research group, and the goal of his work is to further the understanding of gastrointestinal physiology by fundamental research. So far, this knowledge has been translated into the design of new technologies and improved disease treatments, many of which are currently in late-stage clinical trials. He has published over 350 papers, book chapters and abstracts and delivered more than 250 invited research presentations. Abdul is also a serial entrepreneur and has filed 25 patents and founded 3 pharmaceutical companies (Kuecept, Intract Pharma, FabRx). Abdul is a frequent speaker at international conferences, serves as a consultant to many pharmaceutical companies and is on the advisory boards of scientific journals, healthcare organisations and charitable bodies. He is the European Editor of the International Journal of Pharmaceutics. Abdul was the recipient of the Young Investigator Award in Pharmaceutics and Pharmaceutical Technology from the American Association of Pharmaceutical Scientists (AAPS) and is the only non-North American scientist to receive this award. He was also the recipient of the Academy of Pharmaceutical Sciences (APS) award. Simon Gaisford holds a Chair in Pharmaceutics and is Head of the Department of Pharmaceutics at the UCL School of Pharmacy, University College London. He has published 110 papers, 8 book chapters and 4 authored books. His research is focused on novel technologies for manufacturing medicines, particularly using ink-jet printing and 3D printing, and he is an expert in the physico-chemical characterisation of compounds and formulations with thermal methods and calorimetry.
Download or read book Intellectual Property Law written by Lionel Bently and published by Oxford University Press, USA. This book was released on 2014 with total page 1441 pages. Available in PDF, EPUB and Kindle. Book excerpt: 'Intellectual Property Law' is the definitive textbook on this subject. It clearly sets out the law in relation to copyright, patents, trade marks, passing off and confidentiality, whilst enlivening the text with illustrations and diagrams.
Download or read book A Practitioner s Guide to European Patent Law written by Paul England and published by Bloomsbury Publishing. This book was released on 2019-10-17 with total page 551 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by a team of lawyers with long-standing experience in patent litigation in Europe, this book is a comprehensive and practical guide to European patent law, highlighting the areas of consistency and difference between the most influential European patent law jurisdictions: the European Patent Office (EPO), England & Wales, France, Germany and the Netherlands. It is frequently the case that the decisions and approaches of these courts are cited by European patent lawyers of all jurisdictions when submitting arguments in their own national courts. The book is therefore intended to provide a guide to patent lawyers acting in the national European courts today. The book also looks to the future, by addressing all the areas of patent law for which the proposed Unified Patent Court (UPC) will need to establish a common approach. Uniquely, the book addresses European patent law by subject matter area, assessing the key national and EPO approaches together rather than in nation-by-nation chapters; and provides an outline in each chapter of the common ground between the national approaches, as a guide for the possible application of European patent law in the UPC.
Download or read book Technology Transfer written by Mark Anderson and published by Bloomsbury Publishing. This book was released on 2020-03-20 with total page 1123 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covers the laws surrounding commercial transactions that involve the development, use of commercialisation of technology and associate intellectual property rights. Types of transactions that fall within this category are research and development contracts and intellectual property licences and these form the main focus of the book. Written by experts and describing the many different areas of law that affect technology agreements such as IP, contract law, competition law and tax, this is the leading guide to this complex area of law. The new Fourth Edition has been brought completely up to date including: - Coverage of EU Horizon 2020 replacing Framework 7 funding scheme - General Data Protection Regulation (GDPR) - Updates in line with the Charities Act 2011 - New section on different types of standard agreements available (Lambert, NIHR, EU consortium agreements) - New material dealing with variety of relevant patent legislation: Unitary Patent and Unified Patents Court, the Intellectual Property Act 2014, Legislative Reform (Patents) Order 2014, Patents (Supplementary Protection Certificates) Regulations) 2014 - New material on the EU Trade Secrets Directive - Coverage of Regulations No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC - Addition of research exception (new section 22A) from freedom of information from 1 October 2014 (Freedom of Information Act 2014) - Coverage of Technology Transfer Regulation, 316/2014 and related guidelines
Download or read book Guide to EU and UK Pharmaceutical Regulatory Law written by Sally Shorthose and published by Kluwer Law International B.V.. This book was released on 2023-01-10 with total page 840 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the European Union (EU), its Member States and the United Kingdom (UK) post-Brexit, as elsewhere, the marketing of pharmaceuticals is subject to an ever more complex web of legislation and regulation, resulting from the intense scrutiny necessary to ensure such essential products are not only efficacious but also safe. This useful volume lays out this system with extraordinary clarity and logic. Adopting a Europe-wide perspective on the law governing pharmaceuticals, expert authors from the law firm Bird & Bird LLP map the life cycle of a medicinal product or medical device from development to clinical trials to product launch and ongoing pharmacovigilance, offering comprehensive and unambiguous guidance at every stage. Following a brief overview of how the exit from the EU by the UK currently affects the regulatory regime, as well as an introductory overview focusing on the regulatory framework for pharmaceuticals in Europe – from its underlying rationales to the relevant committees and agencies – each of the following twenty-one incisive chapters examines a particular process or subject. Among the many topics and issues covered from both an EU and UK perspective are the following: clinical trials; stages and standards for creating a product dossier; obtaining a marketing authorisation; how and when an abridged marketing authorisation procedure can be used; criteria for conditional marketing authorisations; generic products and ‘essential similarity’; paediatric use and the requisite additional trials; orphan medicinal products; biologicals and ‘biosimilars’; homeopathic, herbal and similar medicines; medical devices; pandemics, epidemics and vaccines; pharmacovigilance; parallel trade; advertising; and relevant competition law, intellectual property rights and data protection regulation. In addition, sample forms and URLs for the most important reference materials are included. Pharmaceutical lawyers and regulatory advisers, both in-house and in private practice, will welcome this unique book. It offers immeasurable value for all who need to understand the process of bringing a medicinal product or medical device to market and the continuing rights and obligations.
Download or read book EU Law of Competition and Trade in the Pharmaceutical Sector written by Pablo Figueroa and published by Edward Elgar Publishing. This book was released on 2019 with total page 733 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a systematic analysis of the law and practice of EU competition and trade in the pharmaceutical sector. Authored by leading private practitioners, economists, scholars and high-level officials at competition regulators, this work provides valuable insider knowledge on the application of law and policies to the pharmaceutical industry. The work contains extensive commentary on the legislation and the latest case law and administrative precedents in this sector, at both EU and national level, including certain significant jurisdictions (e.g., the US, China). Coverage of various key developments includes the recent pay-for-delay antitrust investigations, the perennial issues around parallel trade, and an examination of mergers among pharmaceutical companies and medical devices manufacturers. In addition to the legal analysis, it offers vital economic and business perspectives to ensure that the reader has the full range of tools with which to prepare for cases and conduct transactions within the pharmaceutical industry.
Download or read book Pricing of Prescription Drugs written by Elizabeth R. Nesbitt and published by DIANE Publishing. This book was released on 2000 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Global Regulations of Medicinal Pharmaceutical and Food Products written by Faraat Ali and published by CRC Press. This book was released on 2024-07-05 with total page 373 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medicine regulation demands the application of sound medical, scientific, and technical knowledge and skills, and operates within a legal framework. Regulatory functions involve interactions with various stakeholders (e.g., manufacturers, traders, consumers, health professionals, researchers, and governments) whose economic, social, and political motives may differ, making implementation of regulation both politically and technically challenging. This book discusses regulatory landscape globally and the current global regulatory scenario of medicinal products and food products comprehensively. Features: Discusses how recent developments of medicinal and food products have opened up innovative solutions for many of the current challenges societies face presently. Explores the manifold variations between the regulatory bodies in different countries that have not previously been collected to this extent. Presents details on the substantial progress in analytical methodologies for labelling applications and the creation of appropriate test criteria for pharmaceuticals and their safety analysis. Reviews how more worldwide collaboration and cooperation in the regulatory area is still required.
Download or read book Patent Protection for Second Medical Uses written by Jochen Bühling and published by Kluwer Law International B.V.. This book was released on 2020-10-13 with total page 806 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Evergreening Patent Exclusivity in Pharmaceutical Products written by Frantzeska Papadopoulou and published by Bloomsbury Publishing. This book was released on 2021-09-23 with total page 298 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book European Patent Law written by Duncan Matthews and published by Walter de Gruyter GmbH & Co KG. This book was released on 2023-10-04 with total page 590 pages. Available in PDF, EPUB and Kindle. Book excerpt:
