Intellectual Property Challenges for the Modern Biotechnology Enterprise: An Overview

Abstract

The paper investigates the IP protection in the field of biotechnology among new innovators. Incompatibilities of the development process in modern biotechnology and the current IP systems are highlighted. Development process in biotechnology is notoriously slow, characterized by long delays in obtaining experimental data and marketing approvals. Initial development stages have been accelerated by the development in silico, by the global competition and accessibility of information. Thus, the most valuable part of the innovation (e.g., genetic sequence, protein structure) may be known years before the full experimental data. This significantly increases the risks of losing IP protection due to competing development, espionage, accidental disclosure, urging the premature patenting despite lack of resources to maintain global patents. Moreover, in biotechnology enterprise prohibitive costs of international patenting deplete the limited development resources and adversely affect both patenting and development. Costs are compounded by the increasing complexity of obtaining IP protection. Some of the complexities are recognized and underline multiple legislative interventions in establishing special regulations for biotechnology. The market also adjusted through practices such as evergreening. Unfortunately, legislative and market responses are not serving new innovators and may be contributing to the biotechnology patenting conundrums. The paper suggests that new legal innovation is needed in order to sustain healthy innovation in biotechnology and address the needs of new innovators. Several general and specific features for advancement of the legal protection of biotechnology are proposed for further research and discussion.