The Patentability of Gene Related Inventions in Personalized Medicine Under European and US Patent Law PDF Download

Author: Ayben Işılay Özdoğan
Publisher:
ISBN:
Category :
Languages : en
Pages : 0

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Book Description
Personalized medicine defines an individualized healthcare system based on patients' unique characteristics, such as genetic information. It aims to reduce the predictable risk of disease and improve response to treatment by applying a specific therapy. This particular field brings along the gene related patent applications. In recent years, ethical sides, policy considerations on patent applications in gene sequences, and gene related diagnostic and treatment methods led to many debates among biotech/pharma companies, patent stakeholders, researchers, clinicians, and patients. Although the patent system is an incentive for the dissemination of the innovation by providing recovery to the companies for their investments, it is claimed that gene related patents are violating human rights by removing the information (gene sequences are like large databases) from the public domain. Patent protection for gene related inventions is treated differently, relying on diverse grounds in different countries, and there is no consistency in different patent laws in terms of patentability for these inventions. In Europe, the boundaries are set clearly in EPC and the Biotech Directive, whilst in the US, patent protection for gene related inventions is mostly assessed under eligibility criteria. The subject matter eligibility requirements are defined under 35 U.S.C. § 101 in the US. A draft bill, planned to reform the patent eligibility in the US, was introduced on May 22, 2019, and came along with many debates. The fear is that if enacted, decisions of some prominent cases such as Mayo and Myriad may be opened to discussions again. However, there is uncertainty whether this draft bill will ease the patentability of genetic inventions or not, it will be clear only after several decisions of the CAFC or the Supreme Court. On the other hand, this draft legislation may meet the long-felt need after Mayo and Myriad cases which may contribute to the development of bioeconomy in the US. The bill questions the patent system in the US independent from its enactment. At this stage, it is hard to estimate the possible influence of this bill on Europe. Nevertheless, it is commonly accepted that this proposal will approximate the US patent law to European patent law.

Author: Thea Snøfrid Bygjordet Sveen
Publisher:
ISBN:
Category : Biotechnology
Languages : en
Pages : 65

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Book Description
Following the U.S. Supreme Court decisions in Mayo Collaborative Services v. Prometheus Labs. Inc. and Ass’n for Molecular Pathology v. Myriad Genetics, Inc., the future of patentability of genetic material is uncertain. In the U.S., the decision in Myriad which allowed the patenting of cDNA molecules seems to have limited the force of the concerned voices from the genomic research community that had called for substantial limitations on the patenting genetic material based on the argument that these patents seriously inhibit genomic research and prevent broader provision of genetic diagnostic tests to the public. In the EU, and in markets under the EPC, the patentability issue remain unclear due to lack of judicial guidance. This status quo coincides with the ambitions of governments in both sides of the Atlantic for incentivising research and investment in personalised medicine, a field that is dependent on genetic diagnostic tests and promises radical improvement in public healthcare provision, but also potentially lots of profit and tax. In the light of all these, this paper explores social, political and more particularly legal issues surrounding developments in genomic technologies and personalised medicine, and offers an extensive overview of the limits of substantive patent law in the patenting of genetic inventions in the U.S. and Europe. The paper concludes that the approach of the Biotechnology Directive under EU law setting an over-arching industrial applicability requirement for gene patents offers a balanced response to the challenges created by these patents. Other solutions such as widening the scope of compulsory licensing or the experimental use exception, or creating a sui generis gene right are also visited. Finally, new CRISPR technology that might further challenge the existing legal frameworks is briefly introduced.

Author: Shubha Ghosh
Publisher: Cambridge University Press
ISBN: 1107011914
Category : Law
Languages : en
Pages : 231

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Book Description
This book provides an overview of developments in personalized medicine patenting and explores its normative implications to suggest policies to best regulate it.

Author: Eddy D. Ventose
Publisher: Edward Elgar Publishing
ISBN: 1781001782
Category : Medical
Languages : en
Pages : 233

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Book Description
'On the heels of his earlier work Medical Patent Law – The Challenges of Medical Treatment, Ventose makes another significant contribution to the literature. In his earlier work, he devoted a chapter to medical patents under US law. In Patenting Medical and Genetic Diagnostic Methods he expands that chapter into an entire text. No easy feat, to be sure. Nonetheless, his "treatment" of the jurisprudential terrain is sophisticated and rigorous. Scholars, practitioners and students seriously interested in the evolution of medical patents under US law will find Ventose's latest work to be invaluable.' – Emir Crowne, University of Windsor, Canada, Law Society of Upper Canada and Harold G. Fox Intellectual Property Moot 'This work provides a timely exploration of patent battles over biotechnology, medicine, diagnostic testing, and pharmacogenomics. Such conflicts are critically important at the dawn of a new era of personalised medicine.' – Matthew Rimmer, The Australian National University College of Law and ACIPA, Australia 'The debate on the patent eligibility of diagnostic and medical methods has raged recently in the United States and there seemed to be far less certainty about the outcome than in Europe. Gene patents for diagnostic methods clearly stirred the debate, but this is not a new debate. It goes back a century. This book gets to the bottom of the debate and provides an in depth insight, both of the history and of the recent developments. A fascinating tale. . .' – Paul Torremans, University of Nottingham, UK This well-researched book explores in detail the issue of patenting medical and genetic diagnostic methods in the United States. It examines decisions of the Patent Office Boards of Appeal and the early courts on the question of whether medical treatments were eligible for patent protection under section 101 of the Patents Act. It then traces the legislative history of the Medical Procedures and Affordability Act that provided immunity for physicians from patent infringement suits. After considering the Supreme Court's jurisprudence on patent eligibility, the book then comprehensively sets out how the Federal Circuit and the Supreme Court have dealt with the issue, paying close attention to the Supreme Court's recent decision in Bilski and Prometheus. Being the first book to comprehensively cover patenting medical methods, it will appeal to patent agents, patent attorneys, solicitors and barristers working in patent and medical law worldwide, medical practitioners and healthcare professionals, in-house legal and regulatory departments of pharmaceutical companies. Researchers and managers in the chemical, medical, pharmaceutical and biotechnology industries, as well as academics specializing in medical law or patent law, will also find much to interest them in this book.

Author: OECD
Publisher: OECD Publishing
ISBN: 9264034730
Category :
Languages : en
Pages : 112

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Book Description
Few topics in the life sciences today provoke as much debate as the availability of patent protection on "genetic inventions". Some hold that protection is essential to encourage innovation and development of new products. Others argue that patents ...

Author: Kalyan C. Kankanala
Publisher: Manupatra
ISBN: 8189542265
Category : Biotechnology
Languages : en
Pages : 232

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Book Description
The ambiguity and uncertainty inherent in the field ofgenetic science poses challenges in the application oftraditional patent principles to genetic inventions. Thisbook unravels the complex doctrines of Patent Law.

Author: Luigi Palombi
Publisher: Edward Elgar Publishing
ISBN: 1848447434
Category : Science
Languages : en
Pages : 411

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Book Description
It s really excellent: an invaluable source of information and highly readable too. Sir John Sulston, University of Manchester, UK and Winner of the 2002 Nobel Prize in Physiology or Medicine . . . this is a book that every policymaker even remotely connected to issues of patents, economics, and biotech should read. This book is essential ammunition for those who oppose gene patenting, and lays out the legal case expertly. David Koepsell, Delft University of Technology, The Netherlands, reviewed in SCRIPTed The book is of interest to judges, patent attorneys and lawyers and policy-makers in this field. . . The first part is a fascinating and well researched historical study of patenting. . . The second part of the book is interesting and the author raises some very important points. . . a very valuable contribution to the debate of the scope of patent monopolies. David Rogers, Legal Member, Boards of Appeal, European Patent Office, Germany, reviewed in European Intellectual Property Review Gene Cartels is a truly magisterial and important book. It shows how we need to bring together the discrete threads around intellectual property law (ie patent, copyright, etc) so there can be a clear spotlight on the important public policy issues. Terry Cutler, Principal, Cutler & Company and Chair, Review of the National Innovation System, Australia . . . provides an estimable addition to a growing library of texts diagnosing the maladies of the existing IPR system and offering well attested cures. [It] demands the widest possible readership not just amongst the IPR community, but amongst economists and social scientists, policy officials in both developed and developing countries, and business people everywhere. John A. Mathews, LUISS Guido Carli University, Italy Gene Cartels is a valuable book for the scientist providing, in an elegantly scholarly style, deep insights into the origins, history, evolution and current status of patent systems. It also discloses features that can lead, in effect, to a misuse of power. From the foreword by Baruch S. Blumberg, Fox Chase Cancer Center, Philadelphia and University of Pennsylvania, US and Winner of the Nobel Prize in Physiology or Medicine 1976 Starting with the 13th century, this book explores how patents have been used as an economic protectionist tool, developing and evolving to the point where thousands of patents have been ultimately granted not over inventions, but over isolated or purified biological materials. DNA, invented by no man and once thought to be free to all men and reserved exclusively to none , has become cartelised in the hands of multinational corporations. The author questions whether the continuing grant of patents can be justified when they are now used to suppress, rather than promote, research and development in the life sciences. Luigi Palombi demonstrates that patents are about inventions and not isolated biological materials, which consequently have no bona fide purpose in the innovations of biotechnological science. This book will be important reading for anyone who has an interest in the role that patents have played in economic development particularly historians, economists and scientists. It will also be of great interest to law academics, lawyers, judges and policymakers.

Author: Li Westerlund
Publisher: Springer
ISBN:
Category : Business & Economics
Languages : en
Pages : 386

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Book Description
An academic work, this volume examines patent and intellectual property laws with reference to the biotechnical industries in both Europe and the United States.

Author: F. Vogel
Publisher: Springer
ISBN:
Category : Law
Languages : en
Pages : 264

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Book Description
Biotechnology is one of the most promising fields of technology, especially since molecular biology methods have enhanced our knowledge of genes, their structure, and their action. This knowledge makes it possible to change genetic material and construct new varieties of cultural plants and animals for various purposes such as nutrition, scientific and medical experimentation, and treatment of human diseases. Such inventions may even include human genes. The understandable desire to have legal protection in this domain has created new problems - especially from the viewpoint of the law and acquiring patents for these new inventions. These problems are under wide discussion and are often controversial. This volume provides a unique overview of the current problems and opinions in this controversial field.

Author: Marta Díaz Pozo
Publisher:
ISBN: 9781786433947
Category : Biotechnology
Languages : en
Pages : 0

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Book Description
This book constitutes a fascinating and in-depth analysis of the significance of the requirement of industrial application within gene patenting and how this influences innovation in Europe and the US. The author addresses an area normally overlooked in biotechnology patenting due to the predominance of the ethical debate and, in doing so, produces a unique approach to dealing with concerns in this field. Patenting Genes: The Requirement of Industrial Application is the result of extensive research into the legal history of the industrial application requirement as well as exploration of the broad range of decisions on DNA patentability. This requirement has taken a prominent role within DNA patenting decisions in Europe since the 1998 Biotech Directive, which Dr Diaz Pozo argues has worked efficiently to control claims to human gene sequences and encouraged progress in genetic research. A broad selection of decisions on the patentability of DNA in both European Union and US courts is discussed, emphasizing the mirroring of the European approach in US cases. Academics and students of patent law and biotechnology innovation, as well as policy formulators, will find this book of great interest and value. Activists and practitioners interested in the patentability of human gene inventions in Europe and the US will also benefit from this original work.