Biotechnology and the Law
by Wellons, Hugh B.; Ewing, Eileen SmithFormat: Paperback
Pub. Date: 2007-02-14
Publisher(s): American Bar Association
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Summary
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.
Table of Contents
| Introduction to biotechnology and the law | p. 1 |
| Managing innovation : patent basics for biotechnology counsel | p. 25 |
| Company formation | p. 69 |
| Acquisition of biotechnology - technology transfer | p. 139 |
| Financing a biotech company | p. 203 |
| Employment issues for biotechnology companies | p. 265 |
| Federal regulation of research through funding | p. 325 |
| Regulation of preclinical research | p. 407 |
| Research and development collaborations | p. 445 |
| FDA regulation of biomedical research | p. 479 |
| Privacy issues for biotechnology companies | p. 509 |
| Medical reimbursement | p. 563 |
| Approval of products for human use | p. 591 |
| The regulation of biomedical products for animal use | p. 623 |
| Approval process for biotechnology products in agricultural use | p. 661 |
| Legal requirements after approval | p. 677 |
| Development and commercialization alliances | p. 707 |
| Expansion : European and international considerations for biotechnology companies | p. 735 |
| Biotechnology patent litigation for the non-patent attorney | p. 813 |
| Litigation issues | p. 857 |
| Biotechnology resources | p. 893 |
| Table of Contents provided by Blackwell. All Rights Reserved. |
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