A legal analysis of the recent developments in human gene patenting

Abstract

We are all witnesses of the ground breaking scientific research and major biotechnological innovations that have developed and come to fruition over the past century. The gene is the very core of human life and is one scientific field of study where development has been outstanding. It was never going to be possible for science to keep developing without updating the requisite legal framework. This thesis therefore begins by exploring the relationship between the patent system and genes, discussing the way in which human gene patents have challenged the traditional boundaries of the patent system. With rapid evolvement comes obvious controversy; gene patenting is now one of the most controversial and hotly debated fields of intellectual property law. The US is a pioneer in biotechnology and a leading country in the field of patent law; it therefore comes as no surprise that the main focus of this study is an analysis of the recent developments in gene patent legislation and litigation in the US. The recent landmark judgment Myriad Genetics has raised the bar on gene patenting by challenging the doctrines and requirements that are crucial to this area of study, such as the product of nature doctrine and the isolation principle. Albeit different in various aspects, the European experience of gene patenting also faces challenges of its own that have led to the imposition of limitations on the scope of gene patents via the Monsanto judgment. The European dimension will also be given due regard in this study. The discussion takes on a gripping dimension, as the analysis must be carried out against a backdrop of a multitude of subjective ethical arguments. The human dignity argument, common heritage of mankind argument are analysed with the ultimate aim of shedding light onto the most frequently asked question: should human genes be patented at all? At the heart of this study is the constant struggle between balancing on the one hand a patent system that encourages innovation by offering the possibility of having one’s creation protected, while on the other hand making sure to avoid monopolies and protecting the interests of humanity as a whole. These arguments together with the ethical debates and the active role the courts have been playing in this field will show how the controversial nature of gene patents will surely live on.