The International Consortium on Agricultural Biotechnology Research (ICABR)
EU database rights and DNA databases
Jasper A. Bovenberg
By now most EU countries have implemented the EU directive on the legal protection of databases. This Directive gives database builders specific protection-"database rights"-recognizing the blood, sweat and tears entailed in compiling, validating and presenting data. On top of technical means and existing legal devices, the database right gives another level of protection to secure conditional access to databases. 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. To trigger the protection of the directive a DNA 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?
Legally speaking, the directive covers this issue. It says that the maker of a database is the person who takes the initiative to make the investments and bears the risks. It explicitly excludes subcontractors. But external publicly funded research teams submitting multiple sequences might not consider themselves subcontractors and might, therefore, whish or be required to retain a database right with respect to their submission, resulting in jointly held database rights. As a result, database makers would have to negotiate numerous contracts licensing or swapping data. Licensing would be complicated because it is not compulsory and because the database right will be denied to contributors outside the EU. The detailed arrangements could be prohibitive to further research and development. A solution might be the establishment of a database right pool with an accompanying clearance system.