Patent law plays a crucial role in all three pillars of sustainable development. Economically, patents serve as a highly valuable competitive tool, socially, they promote advancements that benefit public health and nutrition, and environmentally, patents facilitate the development and dissemination of environment-friendly technologies. In recent decades, biotechnology has emerged as one of the most significant patent-intensive industries. This paper examines the evolution of the patentability of biotechnological inventions from the early 1970s to the present day, with a primary focus on the case law of the United States, a predominant actor in this field. The main contributions of this paper are twofold. First, it explores the framework of patentability for biotechnological inventions, particularly focusing on different genomes. Second, the paper considers the potential future of biotechnology, particularly in light of ongoing litigation over CRISPR-Cas9 gene-editing technology. The findings suggest that recent US case law, particularly regarding CRISPR-Cas9, will shape patentability criteria and market access. Over-protection of biotechnology may hinder the fulfillment of sustainable development goals, while the lack of exclusive rights would hold back innovation, which is also harmful to these goals.

The purpose of this study is to carry out an examination of the economic sustainability of product liability, paying particular attention to the development risk that enables exemption from liability, as an exemption case. The product liability regulation that enables or excludes the manufacturer’s reference to development risk is not only a legal and legal policy issue, but also an economic policy issue affecting economic efficiency. In addition, how to install the development risk is also a question closely related to the role of the state in liability. The study pays special attention to the development risk related to the damage caused by medicines, vaccines as special products, maneuvering between state compensation obligation and manufacturer’s liability. In doing so, the study aims to answer such questions as whether product liability regulation is economically sustainable, and in accordance with this, is the currently defined procedure for deploying development risk cost-effective?