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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.
Softbound - New, softbound print book.
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
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.
"Beginning in the 1970s, several scientific breakthroughs promised to transform the creation of new medicines. As investors sought to capitalize on these Nobel Prize-winning discoveries, the biotech industry grew to thousands of small companies around the world. Each sought to emulate what the major pharmaceutical companies had been doing for a century or more, but without the advantages of scale, scope, experience, and massive resources. How could a large collection of small companies, most with fewer than 50 employees, compete in one of the world's most breathtakingly expensive and highly regulated industries? This book shows how biotech companies have met the challenge by creating nearly 40% more of the most important treatments for unmet medical needs. Moreover, they have done so with much lower overall costs. The book focuses on both the companies themselves and the broader biotech ecosystem that supports them. Its portrait of the crucial roles played by academic research, venture capital, contract research organizations, the capital markets, and pharmaceutical companies shows how a supportive environment enabled the entrepreneurial biotech industry to create novel medicines with unprecedented efficiency. In doing so, it also offers insights for any industry seeking to innovate in uncertain and ambiguous conditions. Looking to the future, it concludes that biomedical research will continue to be most effective in the hands of a large group of small companies as long as national healthcare policies allow the rest of the ecosystem to continue to thrive"--
An essential guide for students in the life sciences, established researchers, and career counselors, this resource features discussions of job security, future trends, and potential career paths. Even those already working in the industry will find helpful information on how to take advantage of opportunities within their own companies and elsewhere.
Antibodies have revolutionized medicine and biotechnology, and have become indispensable tools in therapy, diagnostics, analytics, and research. Therapeutic antibodies, for example, have come to dominate the ranks of blockbuster drugs, currently accounting for 10 out of the top 15 best-selling medicines. At the same time, a body of case law dealing specifically with the patentability of antibody-related inventions and the enforcement of antibody patents has emerged in major jurisdictions. The, at times, significant divergences between different jurisdictions have been compounded by recent decisions in the United States, most notably Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017), which have severely curtailed the possibilities to obtain broad antibody patents. It is therefore essential to understand how antibody inventions are assessed in different jurisdictions in order to secure an optimal patent protection and to successfully enforce such patents. This book provides practitioners with a comprehensive resource elucidating all aspects of the patenting of antibodies from initial drafting and prosecution to enforcement, using a country-by-country format. It covers 23 of the most important IP jurisdictions worldwide – i.e., the European Patent Office, France, Germany, Italy, the Netherlands, Poland, Spain, Switzerland, the United Kingdom, Israel, the United States of America, Argentina, the Andean Community (Bolivia, Colombia, Ecuador, and Peru), Brazil, Canada, Chile, Mexico, China, India, Japan, Singapore, South Korea, and Australia. The 35 contributors to this book, all distinguished experts in this field, provide clear and practice-oriented advice on a range of topics including: – Which types of antibody inventions are patent-eligible? – Which types of functional and structural features are accepted for claiming antibodies? – What needs to be considered when defining antibodies in terms of their antigen, target affinity, binding specificity, epitope, competitive binding and other characteristics in relation to reference antibodies, as well as their effects on the target? – Which pitfalls must be avoided when defining amino acid sequences, chemical modifications or glycosylation patterns, and when relying on cell line deposits? – Which breadth of claims is accepted for antibody inventions, and what experimental support is required? – Which specific medical applications of antibodies can be claimed? – How is inventive step assessed in the specific case of antibody inventions? – What has to be considered when enforcing antibody patents, including in relation to biosimilars as well as the doctrine of equivalence? All chapters follow the same structure, which makes this book easily accessible and allows a direct comparison between different jurisdictions. Practitioners will find the much-needed tools and guidance to secure the best possible patent protection for antibody inventions in 23 of the most important jurisdictions worldwide. This book is the fifth volume in the AIPPI Law Series which has been established together with the International Association for the Protection of Intellectual Property (AIPPI), a non-affiliated, non-profit organization dedicated to improving and promoting the protection of intellectual property at both national and international levels.
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.
FDLI's popular reference book, A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition, provides an introduction to the laws and regulations governing development, marketing, and sale of FDA-regulated products, including topics on food, drugs, medical devices, biologics, dietary supplements, cosmetics, new animal drugs, cannabis, and tobacco and nicotine products. Structured to serve as a reference and as a teaching tool, the book offers practical legal and regulatory fundamentals, and each chapter builds sequentially from the last to provide an accessible overview of the key topics relevant to practitioners of food and drug law and regulation. This book is a standard legal text in law schools and graduate regulatory programs and has been cited as a reference in judicial opinions (including the U.S. Supreme Court). This Seventh Edition includes new sections on controlled substances, compounded drugs, and cannabis and cannabis-derived compounds. It also incorporates the latest amendments to the Federal Food, Drug, and Cosmetic Act, as well as FDA regulations and guidances.