Global Patent Protection and Enforcement of In Vitro Diagnostic Inventions PDF Download

Author: Lisa Mueller
Publisher: Kluwer Law International B.V.
ISBN: 9041199861
Category : Law
Languages : en
Pages : 357

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Book Description
Like all inventors, developers of in vitro medical diagnostic tests depend on patent protection that is enforceable against alleged infringers and ensures royalties and other payments. Due to recent United States (US) court decisions that have made the patentability of such tests untenable in the US, there is an expectation that patent applications for in vitro diagnostic inventions will increase in commercially important countries that provide broader protection. Accordingly, this book thoroughly describes the patentability requirements and enforcement challenges faced by in vitro diagnostic inventions in nine major worldwide markets, providing practical tips on how to overcome these challenges and build a globally enforceable patent portfolio for such inventions. For each of nine jurisdictions – Australia, Canada, China, the European Union, India, Japan, Russia, South Africa and the US – an author knowledgeable in the patent law of his or her country examines such elements as the following: subject matter eligibility; specific patentability hurdles; recent and relevant cases; specific issues relating to enforcement; and exceptions to infringement. Specific examples of types of claims (both immunohistochemistry and molecular in vitro diagnostics) are provided, along with tips for drafting and prosecuting applications and best practices for forestalling rejections based on subject matter eligibility and prior art. This book is the first to provide a comprehensive global examination of the patentability of in vitro diagnostic tests. The editor, a patent attorney globally known for her work with the pharmaceutical industry, has assembled a compendium of international expertise that will prove indispensable to patent practitioners (prosecution as well as litigation), corporate research teams, pharmaceutical and other companies and academics throughout the world.

Author: World Intellectual Property Organization
Publisher: WIPO
ISBN: 9280523082
Category : Law
Languages : en
Pages : 259

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Book Description
This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.

Author: World Intellectual Property Organization
Publisher: WIPO
ISBN: 9280530070
Category : Law
Languages : en
Pages : 156

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Book Description
The first report in a new flagship series, WIPO Technology Trends, aims to shed light on the trends in innovation in artificial intelligence since the field first developed in the 1950s.

Author: Claude E. Barfield
Publisher: A E I Press
ISBN: 9780844742564
Category : Law
Languages : en
Pages : 116

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Book Description
American patent law has reached an unprecedented crossroads, prodded by a landmark Supreme Court decision this spring and the prospect of sweeping new federal legislation this fall. At this critical time, Biotechnology and the Patent System: Balancing Innovation and Property Rights provides a timely look at the complex issues involved in making patent law for cutting-edge high-tech industries such as the biotechnology and computer software sectors.

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309158060
Category : Medical
Languages : en
Pages : 442

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Book Description
Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

Author: Jürgen Meier
Publisher: Kluwer Law International B.V.
ISBN: 9403542063
Category : Law
Languages : en
Pages : 707

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Book Description
Antibodies have revolutionized medicine and biotechnology, and have become indispensable tools in therapy, diagnostics, analytics, and research. Therapeutic antibodies, for example, have become firmly established in the ranks of blockbuster drugs, currently accounting for about half of the top 10 best-selling medicines. At the same time, a body of case law dealing specifically with the patentability of antibody-related inventions and the enforcement of antibody patents has emerged in major jurisdictions. The, at times, significant divergences between different jurisdictions have been compounded by recent decisions in the United States, which have severely curtailed the possibilities to obtain broad antibody patents. It is therefore essential to understand how antibody inventions are assessed in different jurisdictions in order to secure an optimal patent protection and to successfully enforce such patents. This book provides practitioners with a comprehensive resource elucidating all aspects of the patenting of antibodies from initial drafting and prosecution to enforcement, using a country-by-country format. The updated and expanded Second Edition covers more than 30 of the most important IP jurisdictions worldwide – i.e., the European Patent Office, Belgium, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, the Netherlands, Poland, Spain, Sweden, Switzerland, the United Kingdom, the United States of America, Canada, Mexico, the Andean Community (Bolivia, Colombia, Ecuador, and Peru), Argentina, Brazil, Chile, China, India, Israel, Japan, Singapore, South Korea, Taiwan, Australia, and New Zealand. The 49 contributors to this book, all distinguished experts in this field, provide clear and practice-oriented advice on a range of topics including: • Which types of antibody inventions are patent-eligible? • Which types of functional and structural features are accepted for claiming antibodies? • What needs to be considered when defining antibodies in terms of their antigen, target affinity, binding specificity, epitope, competitive binding and other characteristics in relation to reference antibodies, as well as their effects on the target? • Which pitfalls must be avoided when defining amino acid sequences, chemical modifications or glycosylation patterns, and when relying on cell line deposits? • Which breadth of claims is accepted for antibody inventions, and what experimental support is required? • Which specific medical applications of antibodies can be claimed? • How is inventive step assessed in the specific case of antibody inventions? • What has to be considered when enforcing antibody patents, including in relation to biosimilars as well as the doctrine of equivalence? All chapters follow the same structure, which makes this book easily accessible and allows a direct comparison between different jurisdictions. Practitioners will find the much-needed tools and guidance to secure the best possible patent protection for antibody inventions in more than 30 of the most important jurisdictions worldwide. This book is the fifth volume in the AIPPI Law Series which has been established together with the International Association for the Protection of Intellectual Property (AIPPI), a non-affiliated, non-profit organization dedicated to improving and promoting the protection of intellectual property at both national and international levels.

Author: Australia. Law Reform Commission
Publisher: Virago Press
ISBN:
Category : Genes
Languages : en
Pages : 690

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Book Description
Report of an inquiry concerned with two broad issues: the patenting of genetic materials and technologies, and the exploitation of these patents and the distinction that can and possibly should be made between discoveries and inventions when referring to claims over genetic sequences.

Author: Kewal K. Jain
Publisher: Springer Science & Business Media
ISBN: 1607616858
Category : Medical
Languages : en
Pages : 509

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Book Description
Of the thousands of biomarkers that are currently being discovered, relatively few are being validated for further applications, and the potential of a biomarker can be quite difficult to evaluate. To aid in this imperative research, Dr. Kewal K. Jain’s Handbook of Biomarkers thoroughly describes many different types of biomarkers and their discovery using various "-omics" technologies, such as proteomics and metabolomics, along with the background information needed for the evaluation of biomarkers as well as the essential procedures for their validation and use in clinical trials. With biomarkers described first according to technologies and then according to various diseases, this detailed book features the key correlations between diseases and classifications of biomarkers, which provides the reader with a guide to sort out current and future biomarkers. Comprehensive and cutting-edge, The Handbook of Biomarkers serves as a vital guide to furthering our understanding of biomarkers, which, by facilitating the combination of therapeutics with diagnostics, promise to play an important role in the development of personalized medicine, one of the most important emerging trends in healthcare today.

Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309498511
Category : Medical
Languages : en
Pages : 103

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Book Description
To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.

Author: Nuffield Council on Bioethics
Publisher:
ISBN:
Category : Bioethics
Languages : en
Pages : 132

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Book Description
This paper questions whether the application of the patent system to DNA sequences achieves its goals of stimulating innovation for the public good and rewarding people for useful new inventions. Even if DNA sequences are considered eligible for patenting, they must also be novel, inventive, and useful. The application of these criteria has not been stringently applied. In future, patents asserting rights over DNA sequences should become the exception rather than the norm.