Pharmaceutical and Biotech Patent Law

Pharmaceutical and Biotech Patent Law
Author: Arnold & Porter Kaye Scholer Llp
Publisher:
Total Pages: 1204
Release: 2019-06-07
Genre: Bioethics
ISBN: 9781402431388

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.

HealthTech

HealthTech
Author: Jelena Madir
Publisher: Edward Elgar Publishing
Total Pages: 394
Release: 2020-10-30
Genre: Law
ISBN: 1839104902

This comprehensive book provides a detailed survey and practical examination of a wide range of legal and regulatory topics in HealthTech. Key features include: • Analysis of the impact of emerging innovations on the accessibility, efficiency and quality of healthcare and its effects on healthcare providers • Examination of artificial intelligence, blockchain and digital identity applications in healthcare, alongside associated regulatory challenges • Guidance on the financial requirements of healthcare start-ups at different stages of growth and various collaboration and partnership models in the HealthTech market • Discussion of the major regulatory questions affecting the HealthTech industry, from data protection, public procurement and product liability, to the regulation of medical devices, intellectual property and advertising.

CRISPR People

CRISPR People
Author: Henry T. Greely
Publisher: MIT Press
Total Pages: 395
Release: 2022-03-01
Genre: Technology & Engineering
ISBN: 0262543885

What does the birth of babies whose embryos had gone through genome editing mean--for science and for all of us? In November 2018, the world was shocked to learn that two babies had been born in China with DNA edited while they were embryos—as dramatic a development in genetics as the 1996 cloning of Dolly the sheep. In this book, Hank Greely, a leading authority on law and genetics, tells the fascinating story of this human experiment and its consequences. Greely explains what Chinese scientist He Jiankui did, how he did it, and how the public and other scientists learned about and reacted to this unprecedented genetic intervention. The two babies, nonidentical twin girls, were the first “CRISPR'd” people ever born (CRISPR, Clustered Regularly Interspaced Short Palindromic Repeats, is a powerful gene-editing method). Greely not only describes He's experiment and its public rollout (aided by a public relations adviser) but also considers, in a balanced and thoughtful way, the lessons to be drawn both from these CRISPR'd babies and, more broadly, from this kind of human DNA editing—“germline editing” that can be passed on from one generation to the next. Greely doesn't mince words, describing He's experiment as grossly reckless, irresponsible, immoral, and illegal. Although he sees no inherent or unmanageable barriers to human germline editing, he also sees very few good uses for it—other, less risky, technologies can achieve the same benefits. We should consider the implications carefully before we proceed.

Biotechnology and the Patent System

Biotechnology and the Patent System
Author: Claude E. Barfield
Publisher: A E I Press
Total Pages: 116
Release: 2007
Genre: Law
ISBN: 9780844742564

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.

Biotechnology Entrepreneurship

Biotechnology Entrepreneurship
Author: Craig Shimasaki
Publisher: Academic Press
Total Pages: 489
Release: 2014-04-08
Genre: Medical
ISBN: 0124047475

As an authoritative guide to biotechnology enterprise and entrepreneurship, Biotechnology Entrepreneurship and Management supports the international community in training the biotechnology leaders of tomorrow. Outlining fundamental concepts vital to graduate students and practitioners entering the biotech industry in management or in any entrepreneurial capacity, Biotechnology Entrepreneurship and Management provides tested strategies and hard-won lessons from a leading board of educators and practitioners. It provides a 'how-to' for individuals training at any level for the biotech industry, from macro to micro. Coverage ranges from the initial challenge of translating a technology idea into a working business case, through securing angel investment, and in managing all aspects of the result: business valuation, business development, partnering, biological manufacturing, FDA approvals and regulatory requirements. An engaging and user-friendly style is complemented by diverse diagrams, graphics and business flow charts with decision trees to support effective management and decision making. - Provides tested strategies and lessons in an engaging and user-friendly style supplemented by tailored pedagogy, training tips and overview sidebars - Case studies are interspersed throughout each chapter to support key concepts and best practices. - Enhanced by use of numerous detailed graphics, tables and flow charts

Medical Apartheid

Medical Apartheid
Author: Harriet A. Washington
Publisher: Vintage
Total Pages: 530
Release: 2008-01-08
Genre: History
ISBN: 076791547X

NATIONAL BOOK CRITICS CIRCLE AWARD WINNER • The first full history of Black America’s shocking mistreatment as unwilling and unwitting experimental subjects at the hands of the medical establishment. No one concerned with issues of public health and racial justice can afford not to read this masterful book. "[Washington] has unearthed a shocking amount of information and shaped it into a riveting, carefully documented book." —New York Times From the era of slavery to the present day, starting with the earliest encounters between Black Americans and Western medical researchers and the racist pseudoscience that resulted, Medical Apartheid details the ways both slaves and freedmen were used in hospitals for experiments conducted without their knowledge—a tradition that continues today within some black populations. It reveals how Blacks have historically been prey to grave-robbing as well as unauthorized autopsies and dissections. Moving into the twentieth century, it shows how the pseudoscience of eugenics and social Darwinism was used to justify experimental exploitation and shoddy medical treatment of Blacks. Shocking new details about the government’s notorious Tuskegee experiment are revealed, as are similar, less-well-known medical atrocities conducted by the government, the armed forces, prisons, and private institutions. The product of years of prodigious research into medical journals and experimental reports long undisturbed, Medical Apartheid reveals the hidden underbelly of scientific research and makes possible, for the first time, an understanding of the roots of the African American health deficit. At last, it provides the fullest possible context for comprehending the behavioral fallout that has caused Black Americans to view researchers—and indeed the whole medical establishment—with such deep distrust.

Biotechnology and the Law

Biotechnology and the Law
Author: Hugh B. Wellons
Publisher: American Bar Association
Total Pages: 1016
Release: 2007
Genre: Law
ISBN: 9781590317617

The book is written to help lawyers faced with the challenge of identifying the legal issues and processes that must be faced by their clients in building, marketing, and protecting a biotech business. The contributors are experts in this specialized area and provide thorough, yet accessible, overviews of biotech subspecialties with an eye to practical application. A biotech legal practice involves specialized subject matter and regulatory schemes that, generally, are not part of the business lawyer's repertoire and which can present many hazards for the uninitiated. Because of the expansion in biotech practice beyond the traditional organizations and their representatives, this guide was written to help lawyers find their way through the biotech maze.

Bioinformatics Law

Bioinformatics Law
Author: Jorge L. Contreras
Publisher: American Bar Association
Total Pages: 0
Release: 2013
Genre: Bioinformatics
ISBN: 9781627220101

"Databases containing the accumulated genomic data of the research community are growing exponentially. This book contains cutting-edge insights from scholars, bioethicists and legal practitioners who work at the ever-changing intersection of law and bioinformatics"--Page 4 of cover.

Preparing for Future Products of Biotechnology

Preparing for Future Products of Biotechnology
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Total Pages: 231
Release: 2017-07-28
Genre: Science
ISBN: 0309452058

Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5â€"10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.

Betting on Biotech

Betting on Biotech
Author: Joseph Wong
Publisher: Cornell University Press
Total Pages: 217
Release: 2011-10-15
Genre: Political Science
ISBN: 0801463386

After World War II, several late-developing countries registered astonishingly high growth rates under strong state direction, making use of smart investment strategies, turnkey factories, and reverse-engineering, and taking advantage of the postwar global economic boom. Among these economic miracles were postwar Japan and, in the 1960s and 1970s, the so-called Asian Tigers—Singapore, South Korea, and Taiwan—whose experiences epitomized the analytic category of the "developmental state." In Betting on Biotech, Joseph Wong examines the emerging biotechnology sector in each of these three industrial dynamos. They have invested billions of dollars in biotech industries since the 1990s, but commercial blockbusters and commensurate profits have not followed. Industrial upgrading at the cutting edge of technological innovation is vastly different from the dynamics of earlier practices in established industries. The profound uncertainties of life-science-based industries such as biotech have forced these nations to confront a new logic of industry development, one in which past strategies of picking and making winners have given way to a new strategy of throwing resources at what remain very long shots. Betting on Biotech illuminates a new political economy of industrial technology innovation in places where one would reasonably expect tremendous potential—yet where billion-dollar bets in biotech continue to teeter on the brink of spectacular failure.