The growing presence of technology has created significant changes within the healthcare industry. With the ubiquity of these technologies, there is now an increasing need for more advanced legal procedures. Patent Law and Intellectual Property in the Medical Field is a pivotal reference source for the latest research in support of developing convergent and interoperable systems to increase awareness and applicability of legal aspects in the medical field. Featuring extensive coverage on relevant areas such as compulsory licensing, parallel importing, and protection law, this publication is an ideal resource for researchers, medical and law professionals, academics, graduate students, and practitioners engaged in medical practice.

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).

Pharmaceutical and Biotech Patent Law provides you with the legal, scientific, and technical information you need to help clients obtain, defend, and challenge patents in these important business areas. This practical guide shows you how to craft problem-free patent applications, including how to partner with the government to bring patented inventions quickly to the marketplace - invalidate competitors' patents by proving that they fail to meet key requirements - protect against various forms of patent infringement - and successfully rebut charges of infringement. It includes detailed checklists that help you resolve thorny patent problems in the complex pharmaceutical and biotech fields, and is regularly updated to reflect Federal Circuit rulings and other significant court decisions.

Across the world, developing countries are attempting to balance the international standards of intellectual property concerning pharmaceutical patents against the urgent need for accessible and affordable medicines. In this timely and necessary book, Monirul Azam examines the attempts of several developing countries to walk this fine line. He evaluates the experiences of Brazil, China, India, and South Africa for lessons to guide Bangladesh and developing nations everywhere. Azam's legal expertise, concern for public welfare, and compelling grasp of principal case studies make Intellectual Property and Public Health in the Developing World a definitive work. The developing world is striving to meet the requirements of the World Trade Organization's TRIPS Agreement on intellectual property. This book sets out with lucidity and insight the background of the TRIPS Agreement and its implications for pharmaceutical patents, the consequences for developing countries, and the efforts of certain representative nations to comply with international stipulations while still maintaining local industry and public health. Azam then brings the weight of this research to bear on the particular case of Bangladesh, offering a number of specific policy recommendations for the Bangladeshi government—and for governments the world over. Intellectual Property and Public Health in the Developing World is a must-read for public policy-makers, academics and students, non-governmental organizations, and readers everywhere who are interested in making sure that developing nations meet the health care needs of their people.

Ventose makes a fresh, lively and incredibly thorough contribution to the literature in this work. He canvasses the European, English and American authorities in a systematic, methodical and dare I say surgical manner. The book is a must read for practitioners, academics and students alike interested in patentable subject matter, public policy and medico-legal ethics. It will be a welcome addition to any legal collection. Emir Aly Crowne, University of Windsor, Barrister & Solicitor, Law Society of Upper Canada and Co-Founder and Co-Chair, Harold G. Fox Intellectual Property Moot Medical patents are a matter of life and death. Such patents have a critical impact upon patient care, medical research, and the administration of healthcare (and, indeed, are in part responsible for ballooning health care budgets). This comprehensive book by Eddy D. Ventose provides a systematic comparative analysis of medical patents. The work explores the historical taboo against patenting methods of human treatment; charts the spectrum of policy positions on medical patents, ranging from permissive to prohibitive; and examines contemporary battles over patenting methods of medical correlation in the Supreme Court of United States. Matthew Rimmer, The Australian National University College of Law and ACIPA, Australia This book provides a detailed and comparative examination of medical patent law and the issues at the heart of the medical treatment exclusion for therapeutic treatments, surgical treatments and diagnostic methods. It firsts considers the historical basis for exclusion and the development of law and policy in Europe, the United States and other commonwealth countries. The book goes on to provide a detailed analysis of the issues related to new medical technologies, such as gene therapy, dosage regimes, and medical diagnostics, in light of the medical treatment exclusion. Medical Patent Law will strongly appeal to patent agents and attorneys, solicitors and barristers working in patent and intellectual property law and medical law worldwide, as well as medical practitioners and healthcare professionals; scientists, researchers and managers in the chemicals, medical; pharmaceuticals and biotechnology industries. Postgraduates on LLM medical law and intellectual property courses and academics specializing in medical law or patent law, will also find much to interest them.

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

The history of patent harmonization is a story of dynamic actors, whose interactions with established structures shaped the patent regime. From the inception of the trade regime to include intellectual property (IP) rights to the present, this book documents the role of different sets of actors – states, transnational business corporations, or civil society groups – and their influence on the structures – such as national and international agreements, organizations, and private entities – that have caused changes to healthcare and access to medication. Presenting the debates over patents, trade, and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), as it galvanized non-state and nonbusiness actors, the book highlights how an alternative framing and understanding of pharmaceutical patent rights emerged: as a public issue, instead of a trade or IP issue. The book thus offers an important analysis of the legal and political dynamics through which the contest for access to lifesaving medication has been, and will continue to be, fought. In addition to academics working in the areas of international law, development, and public health, this book will also be of interest to policy makers, state actors, and others with relevant concerns working in nongovernmental and international organizations.