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What Is Biotechnology Law?

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  • Written By: Terry Masters
  • Edited By: Allegra J. Lingo
  • Last Modified Date: 03 December 2016
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Biotechnology law is the compilation of multiple areas of the law as applied to people, products, and companies that combine the biological sciences with technology and engineering. It includes aspects of contract, corporation, tax, real property, intellectual property, and international law. Lawyers who practice in this area tend to have a pervasive involvement in a biotechnology project from inception, through development, to market, and finally bring the project to fruition.

The statutes that govern issues related to applied biology, the judicial decisions in disputes regarding biotech matters, and the regulatory scheme that governs specific scientific applications comprise the legal corpus of biotechnology law. This field as a legal practice has only been in existence since the 1970s, so its establishment as its own area of jurisprudence is still somewhat nascent. As the scientific field expands the law coalesces around it, particularizing the application of the core areas of the law, such as contracts and corporations, that make up the specialty.

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Biotechnology is the application of technology and engineering to biological systems in order to create a commercial product. The process starts with a scientist and a theory, and proceeds over a protracted development cycle that can be ten years or longer until an actual approved product can be sold to the public. While the scientist is figuring out the science behind the product, lawyers typically handle the business of readying the landscape for the product's eventual debut. Biotechnology law entails much of the same type of legal work as would be involved in any complex corporation start-up, while also addressing the particular needs of the biotech industry.

A biotech launch can involve raising anywhere from $250 to $300 million US Dollars (USD). The legal practice behind this at start-up is typical corporations law, including business organization, capitalization, financing, securitization, and corporate alliances. Specialty aspects include designing the alliances and agreements to enable joint venturing 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 at the end.

The ongoing practice of biotechnology law after start-up includes domestic and international mitigation of governmental approvals and regulations as well as the protection of intellectual property rights. Most biotech products will have a worldwide distribution plan requiring complex, cross-jurisdictional, and multinational legal work that relies heavily on the economic, labor, and human rights conventions of international law. The financing structure of the project over time is also specialized, with legal concerns that address domestic and international investment and taxation.

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