HUMAN STEM CELL RESEARCH IN EUROPE AND THE U.S.A.: POST BRÜSTLE AND SHERLEY, ETHICS ISSUES AND PATENT QUAGMIRE

Patent protection of human stem cell inventions (HSCI) has substantial challenges ahead in Europe. Regarding human embryonic stem cell (hESC) research recent European Court’s decision narrows down the scope of the research and patent. This paper addresses the existing areas of lack of uniformity for the intellectual property right (IPR) protection of HSCI. A comparative picture between Europe and the U.S.A. regarding the recent legal and policy environment of human stem cell research (HSCR) and patent scope is drawn and the future complications which may arise is focused. One repercussion of present move of the European Court will be denial of patent protection in hESC inventions and rejection of patents obtained from other continents. However, in the national level, European States have perceived and implemented the patent laws relating to HSCI in a diverse manner. National patent remains in the hands of the countries. Recent ‘Unitary Patent’ is an added layer over the European Patent which would create lack of coordination and more divergence. One effect of diversity in protection tool of HSCI between the countries could be enforcement failure. The U.S.A. does not have uniform State level laws and policies for HSCR and patent, but there are fewer complexities than in Europe. The paper measures the appropriateness of patenting HSCI and encounters many ethical debates. This article calls for a balanced IPR protection framework unique to invention that uses human biological material while finding that patent as a protection tool is not the most appropriate one for the HSCI.