An Introduction to Legal, Regulatory and Intellectual Property Rights Issues in Biotechnology

The chapter explores the historical development of a legal framework for biotechnology regulation. It aims to provide an overview of the history of biotechnological practices and the development of modern concepts. It describes how people had used biotechnology processes for millennia, noting that the rise of modern medicine can only be traced back to the 19th century, when the progress of science and the advances in laboratory techniques contributed to the creation of a medical market. The chapter ends by analyzing the origins of the U.S. Food and Drugs Administration and the Food and Drugs Act of 1906. 

This chapter draws upon the role and responsibilities of federal agencies in regulating biotechnology products. It distinguishes the role of the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA) through statutory definitions. Special emphasis is placed on defining the role of the Animal and Plant Health Inspection Service (APHIS), the Agricultural Research Service (ARS), the Agricultural Marketing Service (AMS), the Food Safety Inspection Service (FSIS), and the Foreign Agricultural Service (FAS). 

With the progress of DNA sequencing technology and its falling costs, the number of gene patents is dramatically growing. This chapter aims to shed light on the regulation of human genome editing and its impact on health research. By analyzing legal provisions and cases, this paper assesses whether genetically modified forms of life meet the statutory requirements of utility, novelty, and non-obviousness under patent law. The nature of the patentable subject matter of living organisms and genes in the U.S. is also examined in detail.

It is strange that only extraordinary men make the discoveries, which later appear so easy and simple. This chapter outlines the historical development of genetic manipulation, assesses the aspects that define genome editing technologies as breakthrough technologies and examines the recent trends in patent litigation. It investigates the ownership and licensing issues surrounding the revolutionary and highly lucrative CRISPR patents by focusing on the recent development in patent battles.

The main objective of this chapter is to describe the development of legal principles which are used to protect property rights in the human body and allow the efficient use of human tissue, organs, DNA, and cell lines in medical research.

The recent advances in genetic engineering have enabled the development of new approaches to animal husbandry and agricultural production. Researchers have developed genetically modified laboratory animals to enhance specific characteristics and increase the efficiency of food production. At the same time, new and distinct varieties of plants have been produced with biotechnology. This chapter aims to investigate the legal issues that arise from the use of genetic engineering techniques in plants and animals.