Patent Framework for the Human Stem Cellsin Europe and the USA: Innovation, Ethics andAccess to Therapy

Abstract

Significant differences prevail in human Stem Cell Research (hSCR) policy and patent protection of human Stem Cell based Inventions/Innovations (hSCI) among the countries. This study being an interdisciplinary one combined very different disciplines, i.e., human stem cell research, ethics/bioethics and IPR/patent. The laws and policies of Germany, Italy, Lithuania, Spain, UK and the USA are revisited. For the empirical investigation, thirty-one (31) experts on bioethics, life science and intellectual property law from sixteen (16) countries were inquired. Both the theoretical discussion and the empirical investigation (findings from the survey data analysis) comprised the Monograph. The techniques of derivation of human stem cells examined from the clinical, ethical and legal perspectives include: Human Embryonic Stem Cells (hESC) from the Inner Cell Mass (ICM) of the Blastocyst, Nuclear Transfer Embryonic Stem Cells (NT-ESC) / Somatic Cell Nuclear Transfer (SCNT), Embryonic Stem Cells (ESC) from the blastomere cell of the pre-implantation stage embryo, Induced Pluripotent Stem Cells (iPSC) and Human Parthenogenetic Stem Cells (hpSC). Their “issued and pending” patents have been investigated. The hESC research being the most controvertial form of hSCR, “a definition of human embryo”and “how unethical” its destruction and use was expolored. The iPSC being the cleanest technology from the ethical perspective, was examined throughly. Adequacy of the patent system and patent related concerns for the hSCI are inquired. The study explored how incentive to invention/innovation can be offered, access to therapies can be fostered and the ethical crisis can be handled better.The conclusions put forward certain ideas for the ethical hSCR, better IP protection of hSCI and fostering access to the therapy.