A.  Introduction

Whether patents should be granted on human genes or gene sequences is highly controversial, both ethically and politically; not only in Germany but throughout Europe and in most parts of the world. Proof of this has been the attention created by US biotechnology company Myriad Genetics, which, in 2001, obtained European patents for human gene sequences indicating an increased risk of certain types of cancer. In Germany the Bundestag has recently addressed the issue: the core of a newly introduced provision of the German Patent Statute (PatG) is Paragraph 1a Sec. 4 PatG, which limits the scope of patent protection available for human gene sequences or parts thereof. If the subject of an invention is a human gene sequence, Paragraph 1a Sec. 4 PatG requires disclosure of not only the sequence but also at least one application. Without such disclosure a human gene sequence is not patentable under German Patent Law. This is remarkable, because under the Directive of the European Parliament and the Council on the Legal Protection of Biotechnological Inventions, the so-called Biotechnology Directive of 1998, a piece of European Union legislation, the situation is different.

The Biotechnology Directive was enacted because the European Council as well as the European Parliament deemed biotechnology and genetic engineering to be technologies of the future. It obligated all EU member states to provide patent protection for biotechnological inventions within a harmonized framework of the member states' respective national patent laws by July 30, 2000.

In Germany the Directive's transposition triggered a lengthy and extremely controversial discussion in the Bundestag as well as among legal scholars. Key issues in this debate were the technology's great opportunities and high hopes for medical breakthroughs as well as its economic significance and a plethora of ethical issues. Many who viewed the human genome as the common heritage of mankind were concerned that the Directive might breed "patents...