In the new millennium, biotechnology is enabling genetic engineering to yield very important breakthroughs, with immense possibilities for novel organisms to be developed. The myriad biotechnological applications released into the environment for pharmaceutical, agricultural, and medicinal purposes generate transnational concerns that pose an enormous challenge to national and international communities. The means of protection sought for these types of inventions is the patent. Although opinions about how much patent systems contribute to long-term economic growth vary, there can be no dispute that patents are vital to the business models of many companies and are playing an increasing role in society. As human technological prowess has expanded throughout the natural and human worlds, the patent has followed, not far behind. Questions about the proper place of patents in society, some old and some new, have found increasing urgency and importance, especially as patent law extends to societies not accustomed to its peculiarities.

Peoples in developing countries (DCs) denounce the patentability of genes, which reduces the world's genetic resources (GRs) down to mere property rights, resulting in corporate control over access to food, medicinal technology, and other resources essential to mankind's health and welfare. Additionally, potential transnational harm caused by genetic engineering may also arise through the destabilization of regional ecologies via genetic pollution and through an accelerated decline of biological diversity on a global scale. Thus, legal control over biodiversity is an issue of serious international consequence.