Biotechnology Law encompasses various areas of law applied to biological sciences combined with technology and engineering. It involves contract, corporations, taxation, real estate, intellectual property, and international law. Biotech launches require typical corporate law and specialized aspects such as joint ventures, financing, and investment structures. Ongoing practice includes government approvals, regulations, and protection of intellectual property rights, as well as domestic and international investment and taxation.
Biotechnology Law is the collection of multiple areas of the law as applied to people, products, and companies that combine biological sciences with technology and engineering. It includes aspects of contract, corporations, taxation, real estate, intellectual property and international law. Lawyers practicing in this area tend to have a pervasive involvement in a biotechnology project from inception, through development, to market, and finally to bringing the project to fruition.
The legal corpus of biotechnology law is made up of statutes governing matters relating to applied biology, judicial decisions in disputes relating to biotechnology and the regulatory framework governing specific scientific applications. This field as a legal practice has only been around since the 1970s, so its establishment as its own area of law is still somewhat nascent. As the scientific field expands, the law coalesce around it, particularizing the application of the core areas of law, such as contracts and corporations, which constitute the specialty.
Biotechnology is the application of technology and engineering to biological systems in order to create a commercial product. The process begins with a scientist and a theory and proceeds over an extended development cycle that can last ten years or more until an actual approved product can be sold to the public. While the scientist is uncovering the science behind the product, the lawyers typically handle the business of preparing the landscape for the product’s eventual debut. Biotechnology law involves much of the same type of legal work that would be involved in any complex company startup, while also addressing the particular needs of the biotechnology industry.
A biotech launch can raise $250 to $300 million US dollars (USD). The legal practice underpinning this at startup is typical corporate law, including business organization, capitalization, financing, securitization, and corporate alliances. Special aspects include the design of alliances and agreements to allow for joint venture between the scientist, pharmaceutical companies and teaching hospitals, as well as the financing and investment structures to reflect the long incubation period with no guarantee of success in the end.
Ongoing practice of Biotechnology Law after inception includes domestic and international mitigation of government approvals and regulations, as well as protection of intellectual property rights. Most biotech products will have a worldwide distribution plan that requires complex, interjurisdictional, multinational legal work that relies heavily on the economic, labor, and human rights conventions of international law. The project financing structure over time is also specialized, with legal aspects covering domestic and international investment and taxation.
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