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.
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.
As technological developments multiply around the globeâ€"even as the patenting of human genes comes under serious discussionâ€"nations, companies, and researchers find themselves in conflict over intellectual property rights (IPRs). Now, an international group of experts presents the first multidisciplinary look at IPRs in an age of explosive growth in science and technology. This thought-provoking volume offers an update on current international IPR negotiations and includes case studies on software, computer chips, optoelectronics, and biotechnologyâ€"areas characterized by high development cost and easy reproducibility. The volume covers these and other issues: Modern economic theory as a basis for approaching international IPRs. U.S. intellectual property practices versus those in Japan, India, the European Community, and the developing and newly industrializing countries. Trends in science and technology and how they affect IPRs. Pros and cons of a uniform international IPRs regime versus a system reflecting national differences.
Raising hopes for disease treatment and prevention, but also the specter of discrimination and "designer genes," genetic testing is potentially one of the most socially explosive developments of our time. This book presents a current assessment of this rapidly evolving field, offering principles for actions and research and recommendations on key issues in genetic testing and screening. Advantages of early genetic knowledge are balanced with issues associated with such knowledge: availability of treatment, privacy and discrimination, personal decision-making, public health objectives, cost, and more. Among the important issues covered: Quality control in genetic testing. Appropriate roles for public agencies, private health practitioners, and laboratories. Value-neutral education and counseling for persons considering testing. Use of test results in insurance, employment, and other settings.
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.
'Daniel Cahoy and Lynda Oswald have brought together some of the country's most prominent patent scholars outside the legal discipline. From the LeahySmith America Invents Act to recent court cases from the Supreme Court and the Federal Circuit, this timely, informative and well-edited volume examines the latest changes in US patent law and their impact on business strategy. The book is a must-read for anybody who wants to learn more deeply about the ever-increasing role of patents in the business environment.' Peter K. Yu, Drake University Law School, US Within the complex global economy, patents function as indispensable tools for fostering and protecting innovation. This fascinating volume offers a comprehensive perspective on the US patent system, detailing its many uses and outlining several critical legislative, administrative and judicial reforms that impact business strategy. The expert contributors to this book provide an overview of how the US patent system functions today and describe how recent changes affect firms and individual inventors. Topics discussed include the drivers of intellectual property policy; recent revisions to the patent application process in terms of the new first-to-file regime, inequitable conduct, and allowable subject matter; and changes to patent enforcement and infringement related to the Federal Circuit's special role and post-grant review. Contributors address recent legislation such as the 2011 America Invents Act, which enacted some of the most significant patent reforms in decades. This examination of the US patent system highlights some of the most important issues for business. It will serve as an important tool for both policymakers and business leaders, and will also interest students and professors of business and management studies, innovation studies and business law.
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.
This book offers a valuable contribution to contemporary legal literature, providing deep insights into the interface between law and genetics, highlighting emerging issues and providing meaningful solutions to current problems. It will be of interest to a broad readership, including academics, lawyers, policy makers and scholars engaged in interdisciplinary research. In the context of examining and analyzing the legal and social implications arising from the recent conjunction of biotechnology and intellectual property rights, the book particularly focuses on human genes and gene variations. Emphasis is placed on “patent law,” as a considerable percentage of genetic inventions are covered by patents. The book presents a comparative and critical examination of patent laws and practices related to biotechnology patents in the United States, Canada, European Union and India, in order to gather the common issues and the differences between them. The international patent approach regarding biotechnology is also analyzed in light of the constant conflict between differentiation and harmonization of patent laws. The book highlights the potential gaps and uncertainties as to the scope of numerous terms such as invention, microorganisms, microbiological processes, and essential biological processes under TRIPS. Also analyzed are the social and policy implications of patents relating to genetic research tools and genetic testing. The intricacies involved in providing effective intellectual property protection to bioinformatics and genomic databases are also examined. Bearing in mind the collaborative nature of bioinformatics and genomic databases, the book evaluates the pros and cons of open biotechnology and assesses the implications of extending intellectual property rights to human genetic resources, before explaining the ownership puzzle concerning human genetic material used in genetic research.
Intellectual property law is built on constitutional foundations and is underpinned by the twin freedoms of freedom of expression and freedom of economic enterprise. In this thoughtful evaluation, Gustavo Ghidini offers up a reconstruction of the core features of each intellectual property paradigm, including patents, copyright, and trademarks, suggesting measures for reform to allow intellectual property to become socially beneficial for all.