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BLOG@IP::JURPatent Attorney Axel H Horns' Blog on Intellectual Property Law.
Wednesday, September 10, 2003German Draft Bill on national implementation of EC biotechnology directive.The Directive 98/44/EC of the European Parliament and of the Council of 06 July 1998 on the legal protection of biotechnological inventions has up to now not been implemented in German national law. Only recently the European Commission had decided to refer, amongst other Member States, Germany to the European Court of Justice as she has still not implemented said Directive 98/44/EC. The Directive should have been written into national law by 30 July 2000.
Now, the German Government has submitted a  draft bill [In German] concerning the implementation of the said Directive to the Upper House ("Bundesrat") of the German Parliament.
The Draft Bill closely follows the wording of the Directive. In particular, inventions are deemed to be patentable even if they concern a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used. Furthermore, biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature. The Bill confirms that the human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions. However, an element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. And, perhaps most important, the industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application. In order to reflect ethical concerns raised by the public, and in accordance with the Directive, inventions will be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality; however, exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation. And, in particular, the following list of inventions is deemed to be unpatentable: (a) processes for cloning human beings; (b) processes for modifying the germ line genetic identity of human beings; (c) uses of human embryos for industrial or commercial purposes; and (d) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes. About two years ago, in the case C-377/98, the European Court of Justice had to decide on a request made by the Kingdom of the Netherlands for annulment of Directive 98/44/EC. On October 09, 2001 this request had been rejected by the ECJ.
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