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About the Book
Biotechnology and the Law 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.
This book contains over 20 chapters by more than 20 leading experts in specialties such as patents, company formation, finance, federal regulation of research through funding, FDA regulation of biomedical research, approval of products for human use, privacy issues, litigation issues and more.
Additional Resources
The editors and authors of Biotechnology and the Law have distilled the book's 950 pages and 21 chapters into a fast- paced overview of key legal issues that affect a biotech company through its complex life cycle.
Biotechnology and the Law: A Primer, Part One (Audio CD Package) In the first session, the panel will start with the fundamentals of corporate structure and other issues in starting up a biotech company. They will cover dos and don'ts of acquiring the key ingredients namely, intellectual property, staff, and financing. The first session concludes with a discussion of research, development and commercial collaborations.
Biotechnology and the Law: A Primer, Part Two (Audio CD Package) In the second session, the panel provides an overview of the regulatory approval process, explaining how a scientific discovery becomes an approved pharmaceutical or biologic product. Patent counsel sketch out how patent prosecution and litigation unfold and impact the success or failure of a biotech company. Finally, the panel discusses which missteps can lead to litigation and strategies to help minimize and manage these risks. Although primarily focused on U.S. legal issues, the panelists will touch on select aspects of E.U. and other foreign laws that can dramatically affect a biotech company's prospects for success.
