Courses 2009 - 2010

Rapid advances in biotechnology bring new benefits and controversies on an almost daily basis. At the same time, the commercialization of these innovations is increasingly reliant on venture capital, start-up companies, and strategic alliances with large corporations and universities. This course focuses on what the general counsel of a small to mid-sized biotech company needs to know to navigate this new business terrain. We follow the life of a fictitious biotech company from its pre-organizational planning to "exit strategies" such as an acquisition or initial public offering. Along the way, we focus on three areas of concern: (i) business and securities laws issues faced by technology companies as they seek crucial funding from private and public sources; (ii) issues related to the development, protection, use, and licensing of intellectual property as a key business asset; and (iii) FDA and other regulatory issues which the company’s products must satisfy before they can be brought to market.

A background in Intellectual Property and Business Organizations law is helpful but not required. Students will draft legal documents for the various stages of an emerging biotechnology company. Grading will be based on these drafting exercises and a final examination.