Biotechnology law requires specialized expertise in the laws, regulations, business, and transactions applicable to biotechnology and pharmaceutical companies, and the institutions that finance and support them, such as venture capital and investment banking firms and medical research institutes. Biotechnology and pharmaceuticals are heavily regulated industries with exceptionally long and expensive product development cycles.
The commercial success of these companies often depends on their ability to protect their intellectual property rights, to develop and commercialize their products in conformity with FDA and other regulatory requirements, to successfully raise financing from all available sources in both good and bad economic conditions, and to partner with larger companies in the industry to help bring their innovative products to the market. As a result, life sciences companies require significant legal expertise in the fields of intellectual property, FDA regulations, marketing compliance, licensing and collaborations, venture capital financings, public offerings, mergers and acquisitions, and commercial agreements unique to the industry, such as biologic and pharmaceutical manufacturing, supply, distribution, and co-promotion agreements. Biotechnology lawyers must be experts in one or more of these fields and be able to work collaboratively with legal experts in related fields.
Marc Rubenstein, Partner