ABSTRACT
Biotechnology is opening up new routes to novel products, processes and services in a wide range of industries. Applications in pharmaceuticals, chemicals, agriculture and food are being widely pursued by established large companies and new biotechnology SMEs. These companies need strong intellectual property (IP) protection because, in principle, many biotechnology inventions, once published, are easily copied. IP issues in biotechnology have focused on the legal difficulties of distinguishing molecules and defining categories of organisms as well as the ethics of ownership (Dworkin, 1997; McTaggert, 1996). Although patent law now covers a wide variety of rDNA molecules, processes and organisms in industrialised countries, the immaturity of the biotechnology industry and the complex and sometimes controversial legal decisions taken to protect its inventions, coupled with diverse national patent systems, suggest that this is likely to continue. Within biotechnology, a rapidly expanding range of technologies continues to pose challenges to existing patent systems.
