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The Export and Stockpiling Waivers

The Export and Stockpiling Waivers PDF Author: Xavier Seuba
Publisher:
ISBN:
Category :
Languages : en
Pages : 0

Book Description
Regulation (EU) 2019/933 of 20 May 2019 enacted two new exceptions applicable to supplementary protection certificates. Pursuant to these exceptions, and during the pendency of a certificate, it is possible to manufacture in the European Union with the goal to export to third countries where no patent protection exists, and it is also possible to manufacture and stockpile generic versions of a product protected by a certificate as to enable entry into the market as from day one after the expiration of the certificate. The objectives of the new Regulation touch the core of the economics of the pharmaceutical industry in terms of competitiveness, entry to market, job creation and public health protection. The impact is estimated in billions of Euros and tens of thousands of new jobs. The effect goes beyond Europe since one of the exceptions is intended to satisfy the needs of third countries. Moreover, the normative model developed may be transplanted by countries adopting similar types of sui generis exclusivity. This article examines the new legal regime and the legal challenges ahead.

The Export and Stockpiling Waivers

The Export and Stockpiling Waivers PDF Author: Xavier Seuba
Publisher:
ISBN:
Category :
Languages : en
Pages : 0

Book Description
Regulation (EU) 2019/933 of 20 May 2019 enacted two new exceptions applicable to supplementary protection certificates. Pursuant to these exceptions, and during the pendency of a certificate, it is possible to manufacture in the European Union with the goal to export to third countries where no patent protection exists, and it is also possible to manufacture and stockpile generic versions of a product protected by a certificate as to enable entry into the market as from day one after the expiration of the certificate. The objectives of the new Regulation touch the core of the economics of the pharmaceutical industry in terms of competitiveness, entry to market, job creation and public health protection. The impact is estimated in billions of Euros and tens of thousands of new jobs. The effect goes beyond Europe since one of the exceptions is intended to satisfy the needs of third countries. Moreover, the normative model developed may be transplanted by countries adopting similar types of sui generis exclusivity. This article examines the new legal regime and the legal challenges ahead.

A Practitioner's Guide to European Patent Law

A Practitioner's Guide to European Patent Law PDF Author: Paul England
Publisher: Bloomsbury Publishing
ISBN: 1509947663
Category : Law
Languages : en
Pages : 659

Book Description
This new edition is a comprehensive and practical guide to European patent law – a 'ius commune'. The book highlights the areas of consistency and difference between the most influential European patent law jurisdictions: the European Patent Office, England and Wales, France, Germany, and the Netherlands. The book also draws insights from further afield, with contributions from other, very active, patent jurisdictions, including Italy, Sweden, Denmark, and Switzerland. Uniquely, the book addresses European patent law by subject matter area, assessing the key national and EPO approaches together rather than nation by nation. Each chapter outlines the common ground between the national approaches and provides a guide for the possible application of European patent law in national courts and the UPC in the future. In addition to featuring content on new countries, the second edition includes new chapters dedicated to the substantive aspects of FRAND, declarations, and evidence. There is also an expanded commentary on construction, including common terms used in patent claims. A must-read for anyone working in the field of European patent law.

European SPCs Unravelled

European SPCs Unravelled PDF Author: Oswin Ridderbusch
Publisher: Kluwer Law International B.V.
ISBN: 9403532211
Category : Law
Languages : en
Pages : 898

Book Description
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.

Improving Intellectual Property

Improving Intellectual Property PDF Author: Susy Frankel
Publisher: Edward Elgar Publishing
ISBN: 1035310864
Category : Law
Languages : en
Pages : 541

Book Description
Undertaking the global project of improving intellectual property demands a critical and dynamic evaluation of its parameters and impacts. This innovative book considers what it means to improve intellectual property globally, exploring various aspects and perspectives of the international intellectual property debate and contemplating the possibilities for reform.

Seville’s EU Intellectual Property Law and Policy

Seville’s EU Intellectual Property Law and Policy PDF Author: Justine Pila
Publisher: Edward Elgar Publishing
ISBN: 1788976401
Category : Law
Languages : en
Pages : 773

Book Description
Carefully authored by Justine Pila, this significantly revised and expanded third edition of Catherine Seville’s classic text, presents a thorough and detailed treatise on EU intellectual property (IP) law, taking into account the many developments in legislation and case law since the second edition.

Supplementary Protection Certificates for Medicinal Products

Supplementary Protection Certificates for Medicinal Products PDF Author: Georgia A. Roussou
Publisher: Edward Elgar Publishing
ISBN: 1035309963
Category : Law
Languages : en
Pages : 267

Book Description
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.

The Export Administration Act

The Export Administration Act PDF Author: James V. Weston
Publisher: Nova Publishers
ISBN: 9781594542206
Category : Business & Economics
Languages : en
Pages : 160

Book Description
The book provides the statutory authority for export controls on sensitive dual-use goods and technologies, items that have both civilian and military applications, including those items that can contribute to the proliferation of nuclear, biological and chemical weaponry. This new book examines the evolution, provisions, debate, controversy, prospects and reauthorisation of the EAA.

Intellectual Property Ordering beyond Borders

Intellectual Property Ordering beyond Borders PDF Author: Henning Grosse Ruse-Khan
Publisher: Cambridge University Press
ISBN: 1009081160
Category : Law
Languages : en
Pages : 473

Book Description
During the past century, intellectual property (IP) law has expanded within and beyond national borders. The field of IP law was once a niche area concerning authors, inventors, and trademark owners. Today, IP law acts as a complex regime of instruments, institutions, and actors that negotiate overlapping, diverging, and occasionally competing public policies on a global scale. As IP continues to expand beyond borders, the instruments and tools utilised for its global protection rely on public international law as the common denominator and unifying frame. Intellectual Property Ordering Beyond Borders provides an evaluation of the most pertinent public international law questions raised by this multidimensional expansion. This comprehensive and far-reaching volume tackles problems such as generalist approaches under the law of treaties; custom and general principles; interfaces between IP and other normative orders, such as trade and investment; and interdisciplinary accounts from the economic, political, and social science perspectives. This title is also available as open access on Cambridge Core.

Patents as an Incentive for Innovation

Patents as an Incentive for Innovation PDF Author: Rafal Sikorski
Publisher: Kluwer Law International B.V.
ISBN: 9403524146
Category : Law
Languages : en
Pages : 474

Book Description
Patents as an Incentive for Innovation Edited by Rafal Sikorski & Zaneta Zemla-Pacud Patents are a reward for human inventiveness. A well-functioning patent system must provide incentives for innovation, safeguard dynamic competition and protect the public interest – a balancing act fraught with difficulty in the ‘connected’ global world. This ground-breaking book is the first to deeply analyse how patent law today performs its function of stimulating innovation in the crucial sectors of healthcare, agriculture, artificial intelligence and communications technology. Patent specialists, practitioners and scholars from various jurisdictions thoroughly describe how patent rights can be deployed to incentivize investments in researching and developing socially critical innovations without sacrificing the public’s interest in sharing the benefits that are produced. Among the emerging issues of patent rights investigated are the following: protectability and morality of according private rights over material derived from the human body; licensing on fair, reasonable and non-discriminatory (FRAND) terms; the supplementary protection certificate (SPC) manufacturing waiver; patent eligibility of artificial intelligence-related inventions; excessive enforcement of patents by patent assertion entities; enforcement of second medical use innovations; the so-called farmer’s privilege, the farm-save seed exemption, and breeders’ rights; international trade regulations and their influence on patent systems; human enhancement technologies and the consequences of patenting them; specifics of patent protection for biologic medicines; challenges posed by artificial intelligence for the disclosure requirement in patent law; and standard essential patent licensing, particularly in the context of the 5G standard. Perspectives taken into consideration by the authors include protectability criteria, length and scope of the granted protection, mechanisms for dealing with the friction between generalized application and specialized concerns, and rights enforcement. These aspects are analysed on the domestic, international and global levels. The COVID-19 pandemic has highlighted the urgent need to strike the right balance between innovation and access in healthcare and other technologies, a need rooted in patent law. Because the problems discussed – and solutions offered – in this collection of expert essays are of tremendous practical and cultural significance, the book will be of immeasurable value to practitioners, policymakers and researchers in patent law and other fields of intellectual property law.

Access to Medicines and Vaccines

Access to Medicines and Vaccines PDF Author: Carlos M. Correa
Publisher: Springer Nature
ISBN: 3030831140
Category : Health economics
Languages : en
Pages : 373

Book Description
"This book is an outcome of a partnership between the Max Planck Institute (MPI) for Innovation and Competition and the South Centre, which jointly organized a Global Forum on Intellectual Property, Access to Medicine and Innovation in Munich on 9-10 December 2019"--Page v