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originality). The copyright protection does not extend to the data contained in the database (which may however be subject to copyright in its own right) but rather to the manner in which the data are organized and presented. The author of the database is the natural person(s) who created the database or (where national legislation permits it) the legal person designated as the rightholder by that legislation (e.g. the employer of the database creator). In addition, or alternatively, there may be a “sui generis database right” protecting the content of the database (irrespective whether there has been creativity in its arrangement), provided that there has been a substantial (qualitative and/or quantitative) investment in obtaining, verifying or presenting the material. The sui generis database right should protect the maker of the database against the unauthorised extraction and/or re-utilisation of the whole or a substantial part of the database. In essence, the sui generis right aims to protect the investment of time, money and effort incurred by database producers in relation to non-original (in terms of intellectual creativity) databases. The sui generis right applies irrespective of the eligibility of the database (or of its contents) for protection by (ordinary) copyright or other rights. In terms of copyright/database rights there are generally two types of rights under copyright: (i) economic rights (which allow the author to derive financial benefits from the use of his works by others); and (ii) moral rights (which allow the author to take certain actions in order to preserve the personal link between himself and the work). Databases containing genomic or metagenomic data may therefore be protected by both copyright (if they are intellectual creations in terms of their arrangement or selection of the data) and/or by the sui generis database right (if they are the product of a substantial investment in obtaining, verifying or presenting the data). International harmonisation of copyright law has been achieved to a certain extent through, inter alia, the minimum standards set out by the Berne Convention282, TRIPS, the WIPO Copyright Treaty of 20 December 1996 and, within the EU, through a number of copyright-related Directives, including the Directive 96/9/EC of 11 March 1996 on the legal protection of databases (the ‘Database Directive’283), Directive 2009/24/EC of 23 April 2009 on the legal protection of computer programs284 and Directive 2001/29/EC of 22 May 2001 on the harmonisation of certain aspects of copyright and related rights in the information society (the ‘Copyright Harmonisation Directive’)285. It should nevertheless be noted that, although subject to both international and EC law, the subsistence and enforcement of copyright will mainly occur at the national level. Patents Patents protect the rights of inventors. Simply put, a patent is the right granted to an inventor by a national or regional patent office (e.g. the European Patent Office in Munich), which allows the inventor to exclude anyone else from commercially exploiting the invention for a limited period (generally 20 years). As already noted, patents are usually created at the level of national law which will therefore determine the extent to which biotechnology inventions may receive patent protection although as with copyright, there are harmonising legal instruments at: (i) international level, namely the Paris 282 Berne Convention for the Protection of Literary and Artistic Works of 9 September 1886, as revised. 283 OJ L 77/20 of 27 March 1996. 284 OJ L 111/16 of 5 May 2009. 285 OJ L 167/10 of 22 June 2001. 204 Study in support of Impact Assessment work on Blue Biotechnology

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