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European Biopharmaceutical Review

Patent Protection for Genes and Other Parts of the Human Body under EC Law

After a decade of heated controversies, in 1998 the Council of the European Union and the European Parliament finally adopted the European Community's Directive 98/44/EC on the Legal Protection of Biotechnological Inventions (1). The EC Biotechnology Directive was hailed as a breakthrough in favour of the necessary incentives for research and development, especially in the area of diagnostic and therapeutic tools as well as new pharmaceuticals (2). However, recent controversies have rekindled the legal battle over patents on genes and DNA sequences. In particular, the patent on the BRCA gene (3) (related to breast cancer) raises highly plausible concerns about exclusive rights over the gene's diagnostic functions and the use of all proteins coded for by the patented DNA sequence. Within the scientific community, the call for a cautious approach to patents on DNA sequences has gathered considerable force (4).


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By Professor Matthias Herdegen, Director of the Institute of International Law and the Institute for Public Law, University of Bonn Professor Matthias Herdegen is Director of the Institute of International Law and the Institute for Public Law at the University of Bonn.
He is the editor and author of a loose-leaf collection on international biotechnology law, which includes the legislation of the EU, European countries, the US, Japan, China and other countries and international treaties, as well as commentaries on these legal instruments.

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Professor Matthias Herdegen
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