Biotechnology Law Definition
Biotechnology Law is a rapidly growing area of law, stemming from the field of science and technology. The modern definition of “biotechnology” refers to the industrial or commercial use of recombinant DNA (e.g. genetic engineering), cell fusion, and novel bioprocessing techniques to make or modify products, improve plants or animals, or to develop useful micro-organisms, with application to pharmaceuticals and health care products, food and agriculture, and industrial processes. The legal and business environments in which biotechnology companies operate are very complex, involving various regulatory regimes, long development times, and hundreds of millions of dollars in investment. Lawyers practicing in Biotechnology Law work with their clients in a myriad of ways throughout the evolution of their business.
Biotechnology Law encompasses areas of corporate and commercial law common to other commercial enterprises, operating within the unique context of the biotechnology fields, including the legal areas of corporate, securities, financing, employment, regulatory, intellectual property, international trade, product liability, commercial litigation, competition, and mergers and acquisitions. The unique demands of the biotechnology business put a particular importance on regulatory law, intellectual property law, and commercial agreements specific to pharmaceutical or other biotechnology fields. The regulatory aspect of Biotechnology Law involves navigating the regulatory approval processes and ongoing compliance for pharmaceutical, health care, and agricultural products. Biotechnology also relies heavily on collaboration, which involves drafting comprehensive agreements for research, development, testing, and manufacturing of product candidates, along with licensing, outsourcing, and commercialization. Finally, as intellectual property is developed, it becomes integral to the success of a biotechnology company to establish and maintain ownership of it, through patent protection and trade secrets as well as robust confidentiality and contractual ownership provisions.
Regardless of whether your company is a biotechnology start-up in the initial stages of development, or in late-stage development or commercialization, to succeed, you need a legal partner with a working knowledge of all major areas of corporate and commercial law, along with firsthand experience representing clients in the biotechnology fields. Whether it is helping you with establishing the corporation, raising money in public and private markets, effectively structuring the transactions, navigating the regulatory web, or protecting your intellectual property, your legal counsel should provide you with the cross-disciplinary insight and practical legal advice you need to realize your business objectives.