Study on the Options for a Unified Supplementary Protection Certificates (SPCs) System in Europe PDF Download

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Publisher:
ISBN: 9789276285069
Category :
Languages : en
Pages : 0

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Book Description
The study deals with the options for creating a unified procedure for examining or granting SPCs on the basis of a regional application, and to this effect considers primarily two options: a PCT model, where a single authority examines a regional application for an SPC by drafting a single examination report, but the NPOs decide whether to grant or refuse the certificate taking into account the report on hand; and an EPC model, where the decision-making power is transferred from the NPOs to the central body and the single authority decides whether a certificate shall be granted or refused. The analysis considers the institutional options for implementing the two models, their respective advantages and drawbacks, their implications for judicial review as well as possible safeguards to mitigate the concerns of some NPOs that the unified procedure could result in lowering the bar for granting certificates currently ensured by their practice.

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

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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.

Author:
Publisher:
ISBN: 9789284811236
Category :
Languages : en
Pages : 0

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Book Description
In April 2023, the European Commission adopted regulatory proposals introducing a Unitary Supplementary Protection Certificate (SPC) and a centralised assessment procedure for SPCs for medicinal products. This study analyses the potential impacts of these proposals on access to medicines, the administrative burden to applicants and the cost to national health systems. This document was prepared by Policy Department for Citizens' Rights and Constitutional Affairs at the request of the JURI Committee.

Author: Duncan Matthews
Publisher: Walter de Gruyter GmbH & Co KG
ISBN: 3110781719
Category : Law
Languages : en
Pages : 396

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Book Description
This book provides a comprehensive overview of European Patent Law. It presents a critical analysis of the European patent law system and the proposed changes to it. The book explores the strengths and weaknesses of the European Patent Convention, and the interaction between the national and the European level, as well as across borders.

Author: Hoffmann · Eitle
Publisher: Hoffmann · Eitle
ISBN:
Category : Law
Languages : en
Pages : 580

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Book Description
A new patent right for Europe (the European Patent with Unitary Effect) and a new European enforcement and invalidation regime (the Unified Patent Court) are expected to come into operation soon, potentially as early as 2015. Existing patents granted by the European Patent Office (EPO), as well as those granted in the future, will automatically come under the jurisdiction of the new Court, unless opt-out rights are exercised. These measures represent one of the most complex and ambitious legal reforms in the field of European intellectual property since the creation of the EPO in 1977. For applicants and proprietors used to the current European system of national patents and national courts, the new system will present both opportunities and challenges in developing, maintaining and leveraging a cost-effective patent portfolio. For manufacturers, distributors and end-users, the new system will subject their activities to the jurisdiction of a new court, with unique and possibly unfamiliar powers and procedures. Decisions must therefore be made as to how best to take advantage of the possibilities afforded by the new system. Applicants and proprietors are already asking themselves questions such as: Should I start to register European patents as European Patents with Unitary Effect when they become available, or should I continue with national validation? For which European patents and applications should I make use of the opt-out to keep litigation in the national courts? Should I consider reverting to national filings instead of using the EPO? How will the new Unified Patent Court be structured, and how will it work? What choices will I have in future as to where to litigate – should I choose a national court or the UPC to enforce or invalidate a European patent? This Handbook provides both guidance for the strategic decisions which will have to be taken and a detailed reference manual to the law and practice of the new system.

Author: Faraat Ali
Publisher: CRC Press
ISBN: 1040044824
Category : Medical
Languages : en
Pages : 373

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Book Description
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.

Author: Luc Desaunettes-Barbero
Publisher: Ledizioni
ISBN: 8855269356
Category : Law
Languages : en
Pages : 412

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Book Description
As of 1st of June 2023, after years of negotiations, setbacks and postponements, the Unitary Patent Package (UPP) enters into force: the European patent with unitary effect (EPUE) becomes a reality and the Unified Patent Court (UPC) starts its activities.Regrettably, the patent regime put in place is not a genuine EU system. Adopted through an enhanced cooperation procedure, it firstly does not include all EU Member States. Secondly, the conditions and the procedure for granting EPUE is in the hands of the European Patent Office, an international organization to which EU is not a party. Lastly, the substantive provisions and the litigation proceedings are defined by an international treaty (the UPC Agreement) to which EU is not a member, and by national laws for the remaining aspects. Such system carves patent law out of the EU legal and judicial orders and reduces the roles of the EU Parliament and Court of Justice. Challenges are numerous in terms of complexity, harmonization objectives, legality, business advantages and wider societal, economic and legal concerns, to name a few.With twenty-eight contributions from academics and practitioners, this book starts with putting the new system into historical, comparative and institutional contexts (Part I) before highlighting some issues under EU law and the perspective of EU integration (Part II). The institutional, jurisdictional and procedural questions raised by the UPC are then addressed (Part III), as well as the innovation and markets issues (Part IV). The last contributions discuss possible improvements and alternatives to the Unitary Patent Package (Part V).

Author: Xavier Seuba
Publisher:
ISBN:
Category :
Languages : en
Pages : 0

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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.

Author: Paul England
Publisher: Bloomsbury Publishing
ISBN: 1509928618
Category : Law
Languages : en
Pages : 551

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Book Description
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.

Author: Mckee
Publisher: McGraw-Hill Education (UK)
ISBN: 0335226442
Category : Medical
Languages : en
Pages : 312

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Book Description
While there may be consensus on the broader issues of the core objectives of the health care system, expectations differ between EU countries, and European national policy-makers. This book seeks firstly to assess the impact of the enlargement process and then to analyse the challenges that lie ahead in the field of health and health policy.