The European Directive on the legal protection of biotechnological inventions

The European Biotechnology Directive, which finally came into force on 30 July 1998, will clarify a number of issues in connection with patents for biotechnological inventions and has generally been welcomed by the pharmaceutical and biotechnology industries. The Directive generally confirms that, in principle, patent protection should be available in all European Union (EU) countries for most biotechnological inventions, including human and non-human-derived gene sequences and cell-lines and transgenic plants and animals. It should bring the laws of EU member states substantially in line with the practice which has already been adopted at the European Patent Office (EPO), although some confusion remains over the patentability of transgenic plants. Certain inventions will not be patentable on moral grounds, including processes for human cloning or germ line gene therapy, certain uses of human embryos, certain transgenic animals and human/animal chimeras. In many cases, the Directive will extend the scope of protection available for biotechnology patents so that the patentee can prevent unauthorised replication of patented biological material, although farmers will have the right to propagate transgenic crops and breed transgenic animals in certain circumstances. Finally, the Directive also addresses issues arising from the interaction of patent and plant variety rights, the deposit of biological material in recognised institutions in connection with filing for a patent, and the provision of further information on the impact of the Directive and developments in biotechnology patent law by the European Commission to the European Parliament.