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Biotechnology and law are inextricable. Patent, regulatory, and contract law profoundly shape the biotech industry, and each of these practice areas is deeply intertwined with the science it governs. Yet many in this industry lack even a basic grasp of these laws, jeopardizing their business success as a result.This book is an essential introduction to biotechnology law for scientists, startup founders, regulatory specialists, patent liaisons, investors, academics, students, and other nonattorneys with biotech backgrounds. It covers core topics such as patentability, patent prosecution and infringement, patent opinions, the development and FDA approval of small-molecule and biologic drugs, regulatory exclusivity, generic drugs and ANDA litigation, biosimilars and the patent dance, patent licenses, and collaboration agreements. Written with scientists in mind, Biotechnology Law is a clear, concise, and entirely practical primer on the topic, replete with straightforward, real-world examples to illustrate each key concept. Understanding the legal machinery through which science becomes business is not a luxury—it is a crucial part of a scientist’s training. Alan J. Morrison’s expert treatment embraces this new reality.

Biotechnology industries --- Law and legislation

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Chronic Disease. --- Epidemiologic Methods. --- Evaluation Studies as Topic. --- Preventive Health Services. --- Chronic diseases --- -Chronic diseases --- -Medical screening --- -Mass medical screening --- Mass screening, Medical --- Medical examinations --- Screening, Medical --- Diagnostic services --- Health risk assessment --- Diseases, Chronic --- NCDs (Noncommunicable diseases) --- Non-communicable diseases --- Non-infectious diseases --- Noncommunicable diseases --- Diseases --- Health Services, Preventive --- Services, Preventive Health --- Health Service, Preventive --- Preventive Health Service --- Service, Preventive Health --- Preventive Medicine --- Preventive Psychiatry --- Primary Prevention --- Critique --- Evaluation --- Evaluation Indexes --- Evaluation Methodology --- Evaluation Report --- Evaluation Research --- Methodology, Evaluation --- Pre-Post Tests --- Qualitative Evaluation --- Quantitative Evaluation --- Theoretical Effectiveness --- Use-Effectiveness --- Critiques --- Effectiveness, Theoretical --- Evaluation Methodologies --- Evaluation Reports --- Evaluation, Qualitative --- Evaluation, Quantitative --- Evaluations --- Evaluations, Qualitative --- Evaluations, Quantitative --- Indexes, Evaluation --- Methodologies, Evaluation --- Pre Post Tests --- Pre-Post Test --- Qualitative Evaluations --- Quantitative Evaluations --- Report, Evaluation --- Reports, Evaluation --- Research, Evaluation --- Test, Pre-Post --- Tests, Pre-Post --- Use Effectiveness --- Epidemiologic Method --- Epidemiological Methods --- Methods, Epidemiologic --- Epidemiological Method --- Method, Epidemiologic --- Method, Epidemiological --- Methods, Epidemiological --- Epidemiology --- Chronically Ill --- Chronic Illness --- Chronic Diseases --- Chronic Illnesses --- Disease, Chronic --- Illness, Chronic --- Illnesses, Chronic --- Pain Management --- Diagnosis --- Methodology --- methods --- Medical screening --- Evaluation Studies. --- Diagnosis. --- Epidemiology. --- Methodology. --- Preventive Health --- Preventive Health Care --- Preventive Health Programs --- Preventive Programs --- Care, Preventive Health --- Health Care, Preventive --- Health Program, Preventive --- Health Programs, Preventive --- Health, Preventive --- Preventive Health Program --- Preventive Program --- Program, Preventive --- Program, Preventive Health --- Programs, Preventive --- Programs, Preventive Health --- -Diagnosis --- Chronic Disease --- Epidemiologic Methods --- Evaluation Studies as Topic --- Preventive Health Services --- Mass medical screening

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