Description
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.
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Legal experts specializing in biotechnology law, intellectual property, patent licensing, and related areas present a clearly written review of multiple aspects of the latest wave of better living through science and its legal ramifications. Following a primer defining biotechnology and the life cycle and regulation of biotech companies, contributors treat issues in obtaining patents, innovation financing and management, technology creation and transfer, Federal regulation regarding research, product approval, and post- approval marketing; international regulation; patient privacy; medical reimbursement; and last but not least, litigation. The final chapter lists biotechnology resources worldwide; key U.S. Federal acts, cases, and agencies; and state laws. The volume also includes a glossary, highlighted legal practice points, and sample agreements. Annotation ©2007 Book News, Inc., Portland, OR (booknews.com)
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