Patent portfolios and pharmaceuticals: a European perspective

Patent portfolios and pharmaceuticals: a European perspective PDF Author: AREZZO EMANUELA
Publisher: Giappichelli
ISBN:
Category : Law
Languages : en
Pages : 0

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Book Description
This book describes undertakings’ tendency today to protect their intangible technical property through a portfolio of patents. Such trend is in part triggered by the very same feature of modern innovation which, being today complex and cumulative, demands for more patents to efficiently protect its inventive trail. At the same time, undertakings have come to realize that the patent portfolio vests its owner with a set of strategic advantages which exceed by far the mere excluding powers conferred by the patents contained therein. The latter circumstance igniting a vicious circle, whereby firms patent more and more. While fully compliant with patent law, portfolios may cause dangerous drawbacks for competing innovators, as the cluster builds up entry barriers sometimes very hard to surpass. This all the more so in the pharmaceutical sector where the portfolios can be successfully implemented against both originators and generic companies, hence threatening the entrance of generic drugs and biosimilars. The book provides for an in-depth analysis of patent law substantive – as well as procedural – provisions allowing to build patent portfolios in the pharmaceutical sector. It then moves to analyze cases where patent portfolios have been implemented to the goal of foreclosing access to competitors, and the different outcomes provided with by patent law and by competition law.

Patent portfolios and pharmaceuticals: a European perspective

Patent portfolios and pharmaceuticals: a European perspective PDF Author: AREZZO EMANUELA
Publisher: Giappichelli
ISBN:
Category : Law
Languages : en
Pages : 0

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Book Description
This book describes undertakings’ tendency today to protect their intangible technical property through a portfolio of patents. Such trend is in part triggered by the very same feature of modern innovation which, being today complex and cumulative, demands for more patents to efficiently protect its inventive trail. At the same time, undertakings have come to realize that the patent portfolio vests its owner with a set of strategic advantages which exceed by far the mere excluding powers conferred by the patents contained therein. The latter circumstance igniting a vicious circle, whereby firms patent more and more. While fully compliant with patent law, portfolios may cause dangerous drawbacks for competing innovators, as the cluster builds up entry barriers sometimes very hard to surpass. This all the more so in the pharmaceutical sector where the portfolios can be successfully implemented against both originators and generic companies, hence threatening the entrance of generic drugs and biosimilars. The book provides for an in-depth analysis of patent law substantive – as well as procedural – provisions allowing to build patent portfolios in the pharmaceutical sector. It then moves to analyze cases where patent portfolios have been implemented to the goal of foreclosing access to competitors, and the different outcomes provided with by patent law and by competition law.

Pharmaceutical Patents in Europe

Pharmaceutical Patents in Europe PDF Author: Bengt Domeij
Publisher: BRILL
ISBN: 9004481478
Category : Law
Languages : en
Pages : 365

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Book Description
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.

Pharmaceutical Innovation, Competition and Patent Law

Pharmaceutical Innovation, Competition and Patent Law PDF Author: Josef Drexl
Publisher: Edward Elgar Publishing
ISBN: 0857932462
Category : Law
Languages : en
Pages : 347

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Book Description
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.

Patent Settlements in the Pharmaceutical Industry under US Antitrust and EU Competition Law

Patent Settlements in the Pharmaceutical Industry under US Antitrust and EU Competition Law PDF Author: Amalia Athanasiadou
Publisher: Kluwer Law International B.V.
ISBN: 9403501146
Category : Law
Languages : en
Pages : 520

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Book Description
Reverse payment settlements or “pay-for-delay agreements” between originators and generic drug manufacturers create heated debates regarding the balance between competition and intellectual property law. These settlements touch upon sensitive issues such as timely generic entry and access to affordable pharmaceuticals and also the need to preserve innovation incentives for originators and to strengthen the pipeline of life-saving pharmaceuticals. This book is one of the first to critically and comparatively analyse how such patent settlements and various other strategies employed by the pharmaceutical industry are scrutinised by both United States (US) and European courts and enforcement authorities, and to discuss the applicable legal tests and the main criteria used for their assessment. The book’s ultimate objective is to provide guidance to the pharmaceutical industry regarding the types of patent settlements, strategies and conduct which may be problematic from US antitrust and European Union (EU) competition law perspectives and to assist practitioners in structuring settlements which are both efficient and compliant. To this end, an exhaustive legal analysis of some of the most controversial issues regarding pharmaceutical patent settlements is provided, including: – the lengthy split among US Circuit Courts on the issue of pay-for-delay settlements, its resolution by the US Supreme Court in FTC v. Actavisand subsequent jurisprudence; – the decision of Lundbeck v. Commissionby the European General Court and the Servier decision of the European Commission; – the Roche/Novartisdecision of the European Court of Justice and the most important decisions by National Competition Authorities on pharma patent settlements in the EU; – an overview of other types of strategies such as product-hopping and product reformulations, no-authorised generic commitments, problematic side-deals, mechanisms affecting generic substitution; – the rejection of the “scope of the patent” test in both the US and the EU and the balancing of patent law and antitrust law considerations in the prevailing applicable tests; – the benefits of settlements and the main criteria for assessing their legitimacy under US antitrust and EU competition law. The analysis provides concrete examples of both illegitimate and legitimate settlements and strategies, emphasising on conduct that falls within a grey zone and on the circumstances and criteria under which such conduct could be deemed problematic from an antitrust perspective. This book will serve as a valuable guide for pharmaceutical companies wishing to minimise the risk of engaging in conduct that could potentially infringe US antitrust and EU competition law. It further aims to save courts and enforcement agencies and also practitioners and academics considerable time and resources by providing an exhaustive analysis of the relevant caselaw, with the ultimate goal to increase legal certainty on the most controversial aspects of patent settlements in the pharmaceutical industry.

Competition Law and IP Rights in Pharmaceuticals and Biotechnology

Competition Law and IP Rights in Pharmaceuticals and Biotechnology PDF Author: Björn Lundqvist
Publisher: Oxford University Press, USA
ISBN: 9780198724827
Category : Law
Languages : en
Pages : 576

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Book Description
A comprehensive analysis of European competition law and intellectual property law issues affecting the pharmaceutical and biotechnology sectors, offering both theoretical and practical perspectives.

Patents for Chemicals, Pharmaceuticals, and Biotechnology

Patents for Chemicals, Pharmaceuticals, and Biotechnology PDF Author: Philip W. Grubb
Publisher: Oxford University Press
ISBN: 9780198765202
Category : Law
Languages : en
Pages : 448

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Book Description
The chemicals, pharmaceuticals and biotechnology industries worldwide rely upon being able to patent inventions in order to protect investment in research and development, and to reap commercial rewards. This book guides the reader through the legal and procedural complexities of the British, European, Japanese and US patent systems, and explains in detail the role of patent practitioners (both in-house and in private practice) in maximising the commercial potential of their client's or company's innovative products. This is the third edition of the author's highly acclaimed Patents for Chemists. It provides vital updating and much expanded coverage, while retaining the focus upon the relevant technology and industry practices that sets it apart from more general books on patent law and procedure. Patents for Chemicals, Pharmaceuticals and Biotechnology provides a complete description of the techniques and industry know-how that underlie successful patent practice and portfolio management and will be invaluable to all patent agents and practitioners working in the area of patent law. With its lucid and accessible presentation and practical approach, this book will also be welcomed by scientists, researchers and managers without a legal background. FROM THE REVIEWS OF PREVIOUS EDITIONS `Dr Grubb thoroughly exposes the patent system in a way with which few of his professional peers will quarrel, and his book should be in every chemical/biological patent department library' European Intellectual Property Review `an excellent book for anyone interested in patents' International Review of Industrial Property and Copyright Law `a sensible, practical appraisal of the case law and decisions - easy to read and very informative' CIPA Journal `[A] sterling feature of this work is its truly global perspective' Journal of the Patent and Trademark Office Society (US)

Patent Strategy in Pharmaceutical Industry

Patent Strategy in Pharmaceutical Industry PDF Author: Monica Donghi
Publisher:
ISBN: 9783845251288
Category : Drugs
Languages : en
Pages : 85

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Book Description
Dieses Buch untersucht die Lifecycle-Management-Strategien, die von Pharma-Unternehmen eingesetzt werden, um den Wert ihres Produktportfolios zu maximieren. Solche Strategien werden manchmal von Generika-Unternehmen als "evergreening" bezeichnet. Die Analyse erfolgt anhand zwei zufällig ausgewählter "Blockbuster"--Medikamente, Taxotere und Xalatan und konzentriert sich auf zwei dieser Strategien, nämlich die Produktverbesserung und die Produktlinienerweiterung. Reihe Munich Intellectual Property Law Center - MIPLC - Band 20.

The Global Politics of Pharmaceutical Monopoly Power

The Global Politics of Pharmaceutical Monopoly Power PDF Author: Ellen F. M. 't Hoen
Publisher:
ISBN: 9789079700066
Category : Agreement on Trade-Related Aspects of Intellectual Property Rights
Languages : en
Pages : 136

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Book Description
In The Global Politics of Pharmaceutical Monopoly Power, researcher and global advocate Ellen 't Hoen explains how new global rules for pharmaceutical patenting impact access to medicines in the developing world. The book gives an account of the current debates on intellectual property, access to medicines, and medical innovation, and provides historical context that explains how the current system emerged. This book supports major policy changes in the management of pharmaceutical patents and the way medical innovation is financed in order to protect public health and, in particular, promote access to essential medicines for all. The Open Society Institute provided support to translate this report into Russian.

Guidelines for Preparing Patent Landscape Reports

Guidelines for Preparing Patent Landscape Reports PDF Author: World Intellectual Property Organization
Publisher: WIPO
ISBN: 9280525298
Category : Law
Languages : en
Pages : 131

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Book Description
These Guidelines are designed both for general users of patent information, as well as for those involved in producing Patent Landscape Reports (PLRs). They provide step-by-step instructions on how to prepare a PLR, as well as background information such as objectives, patent analytics, concepts and frameworks.

Intellectual Property Strategy

Intellectual Property Strategy PDF Author: John Palfrey
Publisher: MIT Press
ISBN: 026229799X
Category : Law
Languages : en
Pages : 260

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Book Description
How a flexible and creative approach to intellectual property can help an organization accomplish goals ranging from building market share to expanding an industry. Most managers leave intellectual property issues to the legal department, unaware that an organization's intellectual property can help accomplish a range of management goals, from accessing new markets to improving existing products to generating new revenue streams. In this book, intellectual property expert and Harvard Law School professor John Palfrey offers a short briefing on intellectual property strategy for corporate managers and nonprofit administrators. Palfrey argues for strategies that go beyond the traditional highly restrictive “sword and shield” approach, suggesting that flexibility and creativity are essential to a profitable long-term intellectual property strategy—especially in an era of changing attitudes about media. Intellectual property, writes Palfrey, should be considered a key strategic asset class. Almost every organization has an intellectual property portfolio of some value and therefore the need for an intellectual property strategy. A brand, for example, is an important form of intellectual property, as is any information managed and produced by an organization. Palfrey identifies the essential areas of intellectual property—patent, copyright, trademark, and trade secret—and describes strategic approaches to each in a variety of organizational contexts, based on four basic steps. The most innovative organizations employ multiple intellectual property approaches, depending on the situation, asking hard, context-specific questions. By doing so, they achieve both short- and long-term benefits while positioning themselves for success in the global information economy.