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Pharmaceutical Patents under the SPC Regulation

Pharmaceutical Patents under the SPC Regulation
Author: Callesen Klinge, Ulla
Publisher: Edward Elgar Publishing
Total Pages: 287
Release: 2022-10-07
Genre: Law
ISBN: 1803927380

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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.


Supplementary Protection Certificates

Supplementary Protection Certificates
Author: Marco Stief
Publisher: Beck/Hart
Total Pages: 250
Release: 2016-01-14
Genre: Law
ISBN: 9781849464864

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The supplementary protection certificate (SPC) prolongs the term of patents for pharmaceutical products for a maximum of five additional years. The SPC's legal bases are two European SPC Regulations and the SPC is based upon European or national patents. SPCs protect some of the most valuable products in the pharmaceutical industry where each day of additional protection may be worth millions of Euros. Despite the economic relevance SPCs have obtained in recent years, there exists only limited detailed literature on the subject. German jurisprudence on SPCs is of special importance, as this has often been the basis for decisions of the European Court of Justice (ECJ) and the German market is one of the leading markets for pharmaceuticals and thus for SPCs. This book is addressed to patent attorneys - in particular in-house and external - working for pharmaceutical companies, and attorneys-at-law specialising in patent law, especially in Europe but essentially worldwide.


Contemporary Issues in Pharmaceutical Patent Law

Contemporary Issues in Pharmaceutical Patent Law
Author: Bryan Mercurio
Publisher: Taylor & Francis
Total Pages: 258
Release: 2017-02-17
Genre: Law
ISBN: 1317389794

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This collection reflects on contemporary and contentious issues in international rulemaking in regards to pharmaceutical patent law. With chapters from both well-established and rising scholars, the collection contributes to the understanding of the regulatory framework governing pharmaceutical patents as an integrated discipline through the assessment of relevant laws, trends and policy options. Focusing on patent law and related pharmaceutical regulations, the collection addresses the pressing issues governments face in an attempt to resolve policy dilemmas involving competing interests, needs and objectives. The common theme running throughout the collection is the need for policy and law makers to think and act in a systemic manner and to be more reflective and responsive in finding new solutions within and outside the patent system to the long-standing problems as well as emerging challenges


Pharmaceutical Patent Issues

Pharmaceutical Patent Issues
Author: United States. Congress. Senate. Committee on the Judiciary
Publisher:
Total Pages: 314
Release: 1997
Genre: Law
ISBN:

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Patent Protection for Second Medical Uses

Patent Protection for Second Medical Uses
Author: Jochen Bühling
Publisher: Kluwer Law International B.V.
Total Pages: 556
Release: 2016-08-24
Genre: Law
ISBN: 9041182780

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When a party develops a ‘second medical use’ for a known substance or compound, special issues of patentability arise. Jurisdictions around the world vary significantly in their treatment of such claims. This detailed country-by-country analysis provides clarity, insight, and guidance on the legal issues and practical implications of second medical use claims in nineteen jurisdictions worldwide as well as the European Union. The authors of the country chapters have been carefully selected based on a broad basis of experience and in-depth knowledge about medical patents in their respective jurisdictions. Each chapter considers such issues and topics as the following: • availability of protection; • validity of claims; • scope of protection; • enforcement; and • infringement. A general chapter about the practice of the European Patent Office (EPO) addresses in particular the latest changes in the format of second medical use claims from the “Swiss-type claims” to the “EPC 2000 claims”. Specific issues and national peculiarities which deviate from the EPO practice are explained in the various national European chapters, while chapters on jurisdictions outside Europe cover both prosecution and enforcement of patents with second medical use claims. As a comparative law study and a collection of contributions from around the world on an important and controversial field, this book will prove of tremendous practical interest for the industry involved and for the public. Applicants for pharmaceutical patents, third parties, and interested legal practitioners will benefit greatly from its thorough comparative analysis and guidance. This book is the second volume in the AIPPI Law Series which has been established together with the International Association for the Protection of Intellectual Property (AIPPI).


Supplementary Protection Certificates for Medicinal Products

Supplementary Protection Certificates for Medicinal Products
Author: Georgia A. Roussou
Publisher: Edward Elgar Publishing
Total Pages: 267
Release: 2023-01-20
Genre: Law
ISBN: 1035309963

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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.


Pharmaceutical Innovation, Competition and Patent Law

Pharmaceutical Innovation, Competition and Patent Law
Author: Josef Drexl
Publisher: Edward Elgar Publishing
Total Pages: 347
Release: 2013-01-01
Genre: Law
ISBN: 0857932462

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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 Rights in Pharmaceuticals in Developing Countries

Patent Rights in Pharmaceuticals in Developing Countries
Author: Jakkrit Kuanpoth
Publisher: Edward Elgar Publishing
Total Pages: 257
Release: 2010-01-01
Genre: Medical
ISBN: 1849808953

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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.