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Patenting Medical and Genetic Diagnostic Methods

Patenting Medical and Genetic Diagnostic Methods
Author: Eddy D. Ventose
Publisher: Edward Elgar Publishing
Total Pages: 233
Release: 2013-01-30
Genre: Medical
ISBN: 1781001782

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'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.


Patenting Genetic Diagnostic Methods

Patenting Genetic Diagnostic Methods
Author: Charles Lawson
Publisher:
Total Pages: 0
Release: 2015
Genre:
ISBN:

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This article reviews the problems posed by patent claims to genetic diagnostic methods associated with genome-wide association studies (GWAS) adopting methodologies using next generation sequencing (NGS) and single nucleotide polymorphism (SNP). These problems are essentially about experimental reproducibility and the credibility and veracity of reported developments. An analysis of the relevant law demonstrates that the current Australian and United States laws about suitable patentable subject matter differ, and that the current reproducibility (sufficiency, enablement and inutility) standards are unlikely to address these problems. The article concludes that following the United States approach excluding these genetic diagnostic method claims from patenting is one solution. Failing this, improving analysis and quality controls that are now being adopted in the basic research will reduce the nature of the problems, although this will remain problematic for patent examiners and the broader public.


Gene Patents and Public Health

Gene Patents and Public Health
Author: Geertrui van Overwalle
Publisher: Emile Bruylant
Total Pages: 250
Release: 2007
Genre: Genetic engineering
ISBN:

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Personalised Medicine and Patent Law

Personalised Medicine and Patent Law
Author: Thea Snøfrid Bygjordet Sveen
Publisher:
Total Pages: 65
Release: 2017
Genre: Biotechnology
ISBN:

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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.


Intellecual Property Rights and High Quality Genetic Testing

Intellecual Property Rights and High Quality Genetic Testing
Author: Geertrui Van Overwalle
Publisher:
Total Pages: 0
Release: 2012
Genre:
ISBN:

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Over the last years, the patenting of genetic tests sparked significant interest worldwide. Newspapers commented on patent cases and, quite often, portrayed patents as a negative story. The commotion surrounding the current patent framework for genetic testing is hardly surprising. Although patents on human genes and diagnostics are not novel, patents on genes for diagnostics are indeed a rather special combination. And although licensing has become daily routine in genetics to gain access to patented technology, the emergence of patent clusters and the restrictive licensing behaviour of some patent proprietors has been experienced as quite disturbing. In an attempt to provide a better understanding of the contentious patent issues at stake in genetic testing, the present contribution first surveys the current legal framework for patenting genetic tests, thus sketching the patent regime from a patent holder's perspective. The paper then examines strategies to gain freedom to operate in the genetic field, thus zooming in on the patent landscape from a patent user's perspective. Generally speaking, genetic testing relates to identifying changes in chromosomes, genes, or proteins to find changes that are associated with inherited disorders. More narrowly, medical genetic testing aims at probing genetic material for disease associated geno or karyotypes (medical applications of cytogenetics, DNA & biochemical tests). The present contribution focuses, even more specifically, on medical genetic DNA/RNA testing, and reviews patent and licensing issues related to genes and diagnostic methods and tools from an international and European perspective, illustrated with a concrete, real life example, namely the well known BRCA-case dealing with diagnostic testing for early onset breast and ovarian cancer based on the genes BRCA1 and BRCA2. The paper concludes that the impasses identified and the criticism voiced is not always directed to the existence of the patent system as such, but rather to some excesses in the exercise of patent rights and the unrestrained behaviour of individual patent owners, in an effort to maximize profit. It is hoped that the new compulsory license for public health will address undesirable effects and unreasonable behaviour from patent holders in an adequate manner, thanks to its preventive and dissuading effect towards patent holders applying (extremely) restrictive licensing policies. It is also to be expected that new models of collaborative licensing may contribute to facilitating access to genetic testing when clusters of patents are rendering access to genetic testing technology too complex and uncertain.


Global Patent Protection and Enforcement of In Vitro Diagnostic Inventions

Global Patent Protection and Enforcement of In Vitro Diagnostic Inventions
Author: Lisa Mueller
Publisher: Kluwer Law International B.V.
Total Pages: 357
Release: 2019-11-01
Genre: Law
ISBN: 9041199861

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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.


Gene Patents and Collaborative Licensing Models

Gene Patents and Collaborative Licensing Models
Author: Geertrui van Overwalle
Publisher: Cambridge University Press
Total Pages: 517
Release: 2009-06-11
Genre: Law
ISBN: 0521896738

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The cost of patent licenses needed to design a new genetic test or treatment may ultimately prevent research projects getting started, as individual components are protected by different patent owners. This book examines legal measures which might be used to solve the problem of fragmentation of patents in genetics.


Genes and Ingenuity

Genes and Ingenuity
Author: Australia. Law Reform Commission
Publisher: Virago Press
Total Pages: 690
Release: 2004
Genre: Genes
ISBN:

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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.


Will Gene Patents Derail the Next-Generation of Genetic Technologies?

Will Gene Patents Derail the Next-Generation of Genetic Technologies?
Author: Christopher M. Holman
Publisher:
Total Pages: 0
Release: 2013
Genre:
ISBN:

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Judge Bryson recently asserted in Association for Molecular Pathology v. US Patent and Trademark Office (dissenting-in-part) that human gene patents "present a significant obstacle to the next generation of innovation in genetic medicine -- multiplex tests and whole-genome sequencing." His concern over the impact of gene patents on genetic testing, which coincides with his position that certain gene patents should be declared patent ineligible, reflects a widely held misperception that 20% of human genes are patented in a manner that would necessarily result in infringement by whole genome sequencing and other forms of genetic testing. In fact, the myth that 20% of human genes are patented is based on a gross misreading of a single "Policy Perspective" article published in Science in 2005, and an unfortunate tendency among many commentators to consider gene patents in abstract terms that disregard the critical role of patent claims in limiting the scope of a patent owner's right to exclude. Analysis of the claims of 533 of the of the patents identified in the Science article as "covering" human genes reveals that most do not include a single claim that would be infringed by whole genome sequencing and other forms of genetic testing. In fact, it seems quite likely that, were they to be litigated, few if any of these gene patents would be found to cover genetic testing or whole genome sequencing. Furthermore, a variety of practical limitations on enforcement and remedies appear to render it unlikely that the owners of these patents would be motivated to assert them against providers of whole genome sequencing and other next-generation diagnostic technologies in a manner that would impede progress in this area. There have been numerous instances in which fears that patents would harm biomedical research and medicine have proven in retrospect to have been greatly exaggerated, and history counsels against overreacting to the current controversy over gene patents. Ironically, it might be the case that the next generation of genetic diagnostic testing innovation will be adversely impacted not by too many patents, but by a lack of adequate patent protection.


A Fundamental Rights Perspective on the Patentability of Diagnostic Genes

A Fundamental Rights Perspective on the Patentability of Diagnostic Genes
Author: Sameera Ebrahim-Cassim
Publisher:
Total Pages:
Release: 2019
Genre:
ISBN:

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Technological advances in the medical domain are critical in finding effective diagnostic and therapeutic instruments for curing genetic conditions. These advances include developing diagnostic tools used to diagnose such conditions. Diagnostic gene tests are an example of such a tool. These tests are developed using a gene that corresponds with identified disease-causing genes. The creation and development of diagnostic tests results in the patenting of genetic material becoming a general occurrence which raises the question on whether genetic material, being part of the human body and naturally occurring, could in fact qualify as patentable subject-matter. Several global intellectual property systems do accept and include genes, more specifically, diagnostic genes, as patentable subject matter. This results in overpriced diagnostic gene tests being put on the market remaining economically unavailable to most of the public. The discussion observes the benefits and limitations of patents in the field of biotechnology and explores alternative options including but not limited to patent exemptions and licences. The study then seeks to address the issue by analysing the right to property and health care, in order to find a universal application that allows for both the protection of, and accessibility to, innovation. Despite the public having the right to access health care, including access to diagnostic tests, inventors also have a right to property and seek to protect their invention. The discussion suggests that intellectual property laws, specifically those relating to diagnostic gene tests, should be observed and interpreted with the aim to balance the rights to access to health care and property, in order for the public to fully benefit from scientific development. The study also examines this aspect in selecting foreign jurisdictions and providing a comparative analysis that may provide global guidance around intellectual property and health in this regard.