The Implementation of the Biotechnology Directive in Belgium and its Aftereffects: The Introduction of a New Research Exemption and a Compulsory License for Public Health

Abstract:     
The extension of patent protection to biological material is by no means a recent phenomenon in Belgium. In 1836 the Belgian Patent Office granted the first patent for a micro-organism, viz. a yeast for the production of beer. A century later, in 1949, the Office delivered the first patent for a plant, viz. a succulent. As for animals, the Office granted patents for the culture of animal cells from 1970 onward. And as for human material, the Office first granted patents for human cell lines, viz. human liver cells, in 1970. Given this rather open and lenient granting policy in the field of biological material, it might come as a surprise that the implementation of the EU Biotechnology Directive from 6 July 1998 met with considerable resistance in Belgium. In order to reconcile the many diverging viewpoints and interests at stake, the Belgian patent legislator opted for a mixture of legal measures. On the one hand, a rather literal transposition of the Directive was opted for in order to join the harmonization objective at the European level. On the other hand, some breathtaking novelties, exceeding the strict finality of the Directive, were introduced in order to accommodate the many national aspirations and complaints.

The present contribution first offers an overview of the genesis and objectives of the Belgian implementing Act of 28 April 2005. Next, the paper elaborates in detail the way in which the various stipulations of the Directive have been implemented into Belgian patent law. Finally, the paper examines some measures which do not strictly relate to the Directive, such as the renewed research exemption and the compulsory license for domestic public health use.

Number of Pages in PDF File: 32

Keywords: Patents, Biological material, European Biotechnology Directive, Belgian Patent Act, Compulsory license, Research exemption, Experimental use exemption

JEL Classification: D23, D45, H51, I18, K11, L14, L 65, O31, O32, O34

Accepted Paper Series