Download or read book The Impact of Human Gene Patents on Innovation and Access written by Christopher M. Holman and published by . This book was released on 2013 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: In 2005, an article in the highly influential journal Science reported that roughly 20% of human genes are patented. This figure has been widely cited and at times over-interpreted. For example, a popular science fiction author warns the public that their bodies are "owned" by someone else. A bill was introduced in Congress in 2007 that would essentially seek to ban the patenting of DNA. The bill appears motivated in part by a perception that one-fifth of our genes are owned by somebody else, that these owners can do whatever they want with these genes, and that there is "nothing that we can do to stop them" (presumably short of banning the patenting of DNA). While clearly many US patents have issued that reference human genetic sequences, the actual scope of exclusivity varies dramatically from claim-to-claim as dictated by the actual claim language. Many patents restrict only some very narrow use of the genetic sequence, others are much broader - none cover actual human genes as they exist in their native state. And it should go without saying that none confer actual ownership of human beings, or allow a patent owner to do "whatever it wants" with another person's genes. In light of the hyperbole and high interest currently surrounding human gene patents, and in an attempt to assess the true impact of these patents, I conducted a search to identify and analyze all instances where a patent relating to a human gene was asserted in a lawsuit. The results suggest that the impact of human gene patents has been felt primarily in the context of biotechnology-derived protein therapeutics, i.e., biologics, the most important fruit of the biotechnology revolution. The impact on genetic testing and assess to research tools has been relatively modest, with some notable exceptions. Furthermore, lawsuits are being filed at a decreasing frequency over time, and it appears that only three human gene patent litigations are currently pending. Two involve patents relating to the production of recombinant erythropoietin, an important biologic drug; these patents claim priority to applications filed in the early 1980s. The third is best characterized as a contract dispute, wherein the licensor of a research tool patent alleges that a licensee has exceeded the scope of its license; this case has been stayed pending the outcome of a court-ordered arbitration of the underlying contractual dispute. The article concludes with a discussion of some policy implications to be drawn from the results of this survey.
Download or read book Seeing the Forest Through the Trees written by Tina Renee Saladino and published by . This book was released on 2012 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Patents prevent anyone but the patent-holder from manufacturing, using, or distributing discoveries and inventions for twenty years from the date of filing. In order to be patentable, an invention needs to be useful, non-obvious, and represent an original design or process rather than an abstract concept or item commonly found in nature. Patents related to genetics received their first legal test in 1980, when the U.S. Patent and Trademark Office (USPTO) granted protection to a genetically engineered bacterium that consumed oil and was useful in cleaning oil spills. The legality of this patent was affirmed in Diamond v. Chakrabarty, where the Supreme Court observed that although “[t]he laws of nature, physical phenomena, and abstract ideas” were not patentable subject matter under § 101, the claimed invention in the case was distinguished from nature as “a product of human ingenuity having a distinctive name, character and use.” The Court held that although the invention comprised a living thing, the patentee had produced a new bacterium with “markedly different characteristics” from the original. The bacterium was, therefore, “not nature's handiwork but [the patentee's] own.” Although Chakrabarty settled the question of whether manufactured genes can receive patent protection, it did not address the patentability of naturally occurring genes. In the absence of such definitive legal guidance, the USPTO routinely issues patents on human deoxyribonucleic acid (DNA) sequences, reasoning that the material has been purified from its natural form through human intervention and is thus sufficiently “touched by man” to be beyond the scope of nature. From 1980 to 2009, the USPTO issued between 3,000 and 5,000 patents on human genes, encompassing nearly 20% of the human genome. In addition, the USPTO has issued nearly 50,000 patents involving human genetic material, yet the fundamental validity of such patents has never been reviewed until now. In March 2010, a district court decision in New York brought attention to the role of gene patents in the advancement of biomedical research. In Association for Molecular Pathology v. United States Patent and Trademark Office (“AMP”), the Southern District of New York enforced a strict standard for subject matter patentability by invalidating seven patents relating to the human breast cancer genes BRCA1 and BRCA2 (collectively “BRCA”). The court reasoned that not only were the coding sequences and mutations of BRCA results of natural phenomena but that, the purified forms of BRCA maintain essentially the same structures and functions as their natural forms and therefore fall outside the scope of patent law protection. Although the decision primarily addressed the patent's subject matter, the court also noted the possible social implications resulting from how patents affect access and innovation in biomedical research. Contrary to concerns raised by the plaintiffs in AMP, empirical studies indicate that gene patents do not impede access to biomedical research data or play a significant role in influencing the topics of research that scientists choose to pursue. These results suggest that while gene patents do not impede innovation, they may not be necessary for it either, at least at the foundational level. Some scholars still maintain, however, that patent protection is necessary to ensure adequate funding for further research, development, and marketing of their innovations. This Note focuses on the role of patent law in encouraging or discouraging innovation in the field of biomedical research. Specifically, this Note analyzes the policy justifications underlying gene patents and explores whether these justifications validly apply to the patenting of the BRCA gene. Part I establishes a basic understanding of patents, genes, and gene patents. Part II provides greater detail regarding the arguments and holding in the AMP case. Part III introduces the traditional rationales for patent protection and applies them to gene patents. Part IV considers the concerns surrounding gene patents and whether these concerns are realistic given the results of empirical studies on the relationship between patents and biomedical research. Part IV also examines whether the district court's holding in AMP is consistent with the policy goals behind intellectual property rights and the reality of the industry. Finally, this Note concludes that, in general, patents do not impede upon innovation. However, the broad issuance of composition claims, such as those held by Myriad in AMP, may block research in areas of study that the patent holder is not pursuing (such as therapeutics). This Note suggests that this issue could be resolved by narrowing the focus of the patent claim to the application of the gene composition, rather than the composition on its own.
Download or read book Genes and Ingenuity written by Australia. Law Reform Commission and published by Virago Press. This book was released on 2004 with total page 690 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Who Owns You written by David Koepsell and published by John Wiley & Sons. This book was released on 2015-06-15 with total page 245 pages. Available in PDF, EPUB and Kindle. Book excerpt: The 2nd Edition of Who Owns You, David Koepsell’s widely acclaimed exploration of the philosophical and legal problems of patenting human genes, is updated to reflect the most recent changes to the cultural and legal climate relating to the practice of gene patenting. Lays bare the theoretical assumptions that underpin the injustice of patents on unmodified genes Makes a unique argument for a commons-by-necessity, explaining how parts of the universe are simply not susceptible to monopoly claims Represents the only work that attempts to first define the nature of the genetic objects involved before any ethical conclusions are reached Provides the most comprehensive accounting of the various lawsuits, legislative changes, and the public debate surrounding AMP v. Myriad, the most significant case regarding gene patents
Download or read book Reaping the Benefits of Genomic and Proteomic Research written by National Research Council and published by National Academies Press. This book was released on 2006-03-09 with total page 188 pages. Available in PDF, EPUB and Kindle. Book excerpt: The patenting and licensing of human genetic material and proteins represents an extension of intellectual property (IP) rights to naturally occurring biological material and scientific information, much of it well upstream of drugs and other disease therapies. This report concludes that IP restrictions rarely impose significant burdens on biomedical research, but there are reasons to be apprehensive about their future impact on scientific advances in this area. The report recommends 13 actions that policy-makers, courts, universities, and health and patent officials should take to prevent the increasingly complex web of IP protections from getting in the way of potential breakthroughs in genomic and proteomic research. It endorses the National Institutes of Health guidelines for technology licensing, data sharing, and research material exchanges and says that oversight of compliance should be strengthened. It recommends enactment of a statutory exception from infringement liability for research on a patented invention and raising the bar somewhat to qualify for a patent on upstream research discoveries in biotechnology. With respect to genetic diagnostic tests to detect patient mutations associated with certain diseases, the report urges patent holders to allow others to perform the tests for purposes of verifying the results.
Download or read book Who Owns You written by David Koepsell and published by John Wiley & Sons. This book was released on 2011-09-23 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt: Who Owns You? is a comprehensive exploration of the numerous philosophical and legal problems of gene patenting. Provides the first comprehensive book-length treatment of this subject Develops arguments regarding moral realism, and provides a method of judgment that attempts to be ideologically neutral Calls for public attention and policy changes to end the practice of gene patenting
Download or read book Gene Patents and Collaborative Licensing Models written by Geertrui van Overwalle and published by Cambridge University Press. This book was released on 2009-06-11 with total page 517 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Patents in the Knowledge Based Economy written by National Research Council and published by National Academies Press. This book was released on 2003-08-11 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume assembles papers commissioned by the National Research Council's Board on Science, Technology, and Economic Policy (STEP) to inform judgments about the significant institutional and policy changes in the patent system made over the past two decades. The chapters fall into three areas. The first four chapters consider the determinants and effects of changes in patent "quality." Quality refers to whether patents issued by the U.S. Patent and Trademark Office (USPTO) meet the statutory standards of patentability, including novelty, nonobviousness, and utility. The fifth and sixth chapters consider the growth in patent litigation, which may itself be a function of changes in the quality of contested patents. The final three chapters explore controversies associated with the extension of patents into new domains of technology, including biomedicine, software, and business methods.
Download or read book How Do Patents Affect Follow on Innovation written by Bhaven N. Sampat and published by . This book was released on 2015 with total page 48 pages. Available in PDF, EPUB and Kindle. Book excerpt: We investigate whether patents on human genes have affected follow-on scientific research and product development. Using administrative data on successful and unsuccessful patent applications submitted to the US Patent and Trademark Office, we link the exact gene sequences claimed in each application with data measuring follow-on scientific research and commercial investments. Using this data, we document novel evidence of selection into patenting: patented genes appear more valuable -- prior to being patented -- than non-patented genes. This evidence of selection motivates two quasi-experimental approaches, both of which suggest that on average gene patents have had no effect on follow-on innovation.
Download or read book Patenting Life written by and published by . This book was released on 1989 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Intellectual Property and Health Technologies written by Joanna T. Brougher and published by Springer Science & Business Media. This book was released on 2013-11-08 with total page 223 pages. Available in PDF, EPUB and Kindle. Book excerpt: Intellectual Property and Health Technologies Balancing Innovation and the Public's Health Joanna T. Brougher, Esq., MPH At first glance, ownership of intellectual property seems straightforward: the control over an invention or idea. But with the recent explosion of new scientific discoveries poised to transform public health and healthcare systems, costly and lengthy patent disputes threaten both to undermine the attempts to develop new medical technologies and to keep potentially life-saving treatments from patients who need them. Intellectual Property and Health Technologies grounds readers in patent law and explores how scientific research and enterprise are evolving in response. Geared specifically to the medical disciplines, it differentiates among forms of legal protection for inventors such as copyrights and patents, explains their limits, and argues for balance between competing forces of exclusivity and availability. Chapters delve into the major legal controversies concerning medical and biotechnologies in terms of pricing, markets, and especially the tension between innovation and access, including: The patent-eligibility of genes The patent-eligibility of medical process patents The rights and roles of universities and inventors The balancing of access, innovation, and profit in drug development The tension between biologics, small-molecule drugs, and their generic counterparts International patent law and access to medicine in the developing world As these issues continue to shape and define the debate, Intellectual Property and Health Technologies enables professionals and graduate students in public health, health policy, healthcare administration, and medicine to understand patent law and how it affects the development of medical technology and the delivery of medicine.
Download or read book Biotechnology Patents and Human Rights in Europe written by Helena Żakowska-Henzler and published by Edward Elgar Publishing. This book was released on 2023-07-01 with total page 267 pages. Available in PDF, EPUB and Kindle. Book excerpt: This innovative book explores the complex interplay between intellectual property for biotechnological innovations and human rights. Examining the clash between the drive to incentivise innovations that can fulfil human needs and the desire to grant global access to healthcare technologies, it presents thoughtful solutions to the challenges of protecting the human rights of all parties impacted by biotechnological patents and other relevant IP rights.
Download or read book The Ethics of Patenting DNA written by Nuffield Council on Bioethics and published by . This book was released on 2002 with total page 132 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Promoting Access to Medical Technologies and Innovation Intersections between Public Health Intellectual Property and Trade written by World Intellectual Property Organization and published by WIPO. This book was released on 2013 with total page 259 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Research Handbook on Intellectual Property and the Life Sciences written by Duncan Matthews and published by Edward Elgar Publishing. This book was released on 2017-06-30 with total page 529 pages. Available in PDF, EPUB and Kindle. Book excerpt: Intellectual property (IP) is a key component of the life sciences, one of the most dynamic and innovative fields of technology today. At the same time, the relationship between IP and the life sciences raises new public policy dilemmas. The Research Handbook on Intellectual Property and the Life Sciences comprises contributions by leading experts from academia and industry to provide in-depth analyses of key topics including pharmaceuticals, diagnostics and genes, plant innovations, stem cells, the role of competition law and access to medicines. The Research Handbook focuses on the relationship between IP and the life sciences in Europe and the United States, complemented by country-specific case studies on Australia, Brazil, China, India, Japan, Kenya, South Africa and Thailand to provide a truly international perspective.
Download or read book Gene Patenting and Human Health written by Australia. Law Reform Commission and published by . This book was released on 2004 with total page 816 pages. Available in PDF, EPUB and Kindle. Book excerpt: On 4 December 2002 the Australian Government announced that it would ask the Australian Law Reform Commission (ALRC) to conduct an Inquiry into intellectual property issues raised by genetic information. The Terms of Reference required the ALRC to examine the impact of patent laws and practices as they relate to 'genes and genetic and related technologies.' This was to be done in three contexts: the conduct of research and its subsequent application and commercialisation; the Australian biotechnology sector; and the cost-effective provision of healthcare. The ALRC was also asked to report on what changes may be required to address any problems that were identified in current laws and practices 'with the aim of encouraging the creation and use of intellectual property to further the health and economic benefits of genetic research and genetic and related technologies.' In making its Inquiry, the ALRC was also to have regard to a number of considerations including: the role of intellectual property rights in promoting technological innovation; the potential for human genetics to improve the quality of life of all Australians; the ethical, legal and social issues arising from intellectual property in genes and genetic technologies; the national interest in using genetic technologies in agriculture and industry; trade and investment issues affecting intellecutal property; and international obligations and practices, both existing and proposed.
Download or read book Will Gene Patents Derail the Next Generation of Genetic Technologies written by Christopher M. Holman and published by . This book was released on 2013 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
