POSTER NO: 679

EU database rights and Genomic databases

Jason Bovenberg
Prof. E.M.Meijers Institute of the Law School of the University of Leiden, Leiden, Netherlands

The EU directive on the legal protection of databases gives database builders specific protection-'database rights'-recognizing the blood, sweat and tears entailed in compiling, validating and presenting data. The 'database right' arises by operation of law and allows its holder to prevent extraction or reutilization of substantial parts of the database for 15 years after completion of a database. The question is whether database rights also extend to genomic databases.

To trigger the protection of the directive a database must be a 'collection of works, data or other independent material, arranged in a systematic way and individually accessible.' Clearly, there are elements of 'collection', 'systematic arrangement', and 'individual accessibility'. DNA sequences or in any event cDNA sequences seem to simply qualify as 'data'. Though it has been argued that 'data discovered in nature' cannot be the subject of a 'database right', the directive does not limit the nature of the data. It is however, still necessary that DNA sequences are shown to be 'independent material'. When DNA sequences are partial and their functions unknown, they may be considered independent. However, sequences with a known function could be considered 'chapters' of an entire genome. Thus, a DNA sequence database may be less readily protected the more complete it becomes.

A database right will only attach to a maker of a database who can demonstrate a substantial investment. It has been argued that no database right would arise if a database was a mere spin off of the actual object of the investment. That can hardly be said of the DNA sequence databases currently being built. The same might not apply as readily to, for instance, databases of human genetic variation that emerged as part of broad health surveys. A major complication is the fact that DNA databases are usually built up from the contributions of numerous compilations of partial sequences. How can one decide who built a DNA database and who, consequently, owns the database rights?