Should Companies Set up Databases in Europe?

COMMENTARY

DATABASES Should companies set up databases in Europe?

Jasper A. Bovenberg

Companies that are in the biological data To trigger the protection of the directive, is the fact that they are built up from the con- business should think about establishing a DNA database must fit within its definition tributions of numerous compilations of par- databases in the European Union (EU). of “database”; that is, it must be “a collection tial sequences. How can one decide who built Many EU countries have implemented laws of works, data or other independent material, a DNA database and who, consequently, owns following the 1996 directive (96/9/EC) on the arranged in a systematic way and individually the database rights? Even databases created by legal protection of databases (“Database accessible.” At first glance, DNA sequence commercial genomics companies are combi- Directive”). These give database builders spe- databases seem to qualify. Clearly, there are nations and extensions of a mix of commer- cific protection—“database rights”—recog- elements of “collection,” “systematic cial and nonprofit databases. Each of the nizing the work and costs entailed in compil- arrangement,” and “individual accessibility.” researchers who have submitted new data to ing, verifying, and presenting data. From a legal point of view, it can be argued GenBank, for example, could claim to have Legislation also affords protection to the that sequence data or at least the annotations invested in the collection of the database, as structure of databases. Database producers rely in a sequence record, do qualify as “works,” could others who keep the database compre- on both technical means and on legal devices, even though the term generally means copy- hensive, current, and accurate, or annotate it4. including patents, trade secrecy law, unfair rightable works, in the sense of literary, artis- Legally speaking, the directive covers this

.com competition and contractual arrangements, to tic, or other creations. Such argument may, issue. It says that the maker of a database secure conditional access to their databases. however, be superfluous since DNA sequences (and thus the holder of the database right) is However, the EU directive gives another level of qualify simply as “data.” Though it has been the person who takes the initiative to make protection based on the premise that databases argued that "data discovered in nature" cannot the investments and bears the risks. It explic- h.nature are expensive to create, but cheap to copy. be the subject of a Database Right2, the direc- itly excludes subcontractors, a status that There is no comparable legal protection for tive describes “data” as “figures,” “facts,” and might apply inter alia to annotation staff. But databases in the United States yet. Copyright “data,” and does not limit the nature of the external publicly funded research teams sub- protection in the United States has to involve data. Thus DNA sequences or in any event mitting multiple sequences or even genomes

http://biotec 1 ¥ “creative originality” and, as US law stands , cDNA sequences should qualify. might not consider themselves subcontrac-

building databases is not creative enough. It is, however, still necessary that DNA tors and might, therefore, wish to retain a The “database right” in a DNA database sequences are shown to be “independent mate- database right with respect to their submis- would almost undoubtedly represent valuable rial.” The purpose of the requirement for inde- sion. Jointly held database rights are certainly intellectual property, especially with the pendence is to exclude from database protec- a legal possibility2. uncertainty that still surrounds DNA tion works such as books; the constituent The commercial reality, however, is more sequence patenting. A database builder does chapters of a book are not independent. When complicated. Some contributors may waive not have to address issues such as discovery- DNA sequences are partial and their “mean- the joint rights they could enjoy in DNA data- versus-invention, novelty, inventive step, ings” or functions unknown, they may be con- bases, but they are under no obligation to do industrial application, or “ordre public”. Also, sidered independent. However, given that so. Indeed, they may be required under the 2000 Nature America Inc.

© since the “database right” arises by operation genomes have been described as “books of terms of their grant or tenure to exercise those of law, there is no need to register a database or life,” might it not be argued that sequences rights. And if they did, database makers would to discuss its accrual or scope with a patent with a known function are “chapters” or “para- have to negotiate numerous contracts licens- office. The “database right” allows its holder to graphs” of an entire genome? The issue of ing or swapping data5. Licensing is unlikely to prevent extraction or reutilizaton of substan- independence of the data is largely unresolved. be straightforward because it is not compulso- tial parts of the database for 15 years after It is at least an interesting possibility that a ry and would be complicated further by the completion of a database. In fact, the right DNA sequence database is less readily protect- fact that the Database Right will be denied to may pertain in perpetuity given that it can be ed the more complete it becomes. contributors outside the EU. rolled over following any substantial modifi- Another interesting nuance of the Database Both public and private contributors to cation to the database that requires a substan- Directive is that a database right will only attach DNA databases could enjoy a Database Right. tial investment. Such modifications include to a maker of a database who can demonstrate, Given the number of biological databases the routine business for builders of DNA data- quantitatively or qualitatively, a substantial and their architecture, a proliferation of frag- bases: extensions, deletions, and amendments. investment1. It has been argued that no data- mented and overlapping rights could Although the value of database rights is base right would arise if a database was a mere emerge. The detailed arrangements for shar- clear, it is less certain that databases of DNA spinoff of the actual object of the investment3. ing the rights could be prohibitive to further sequences qualify for them. The first thing to That can hardly be said of the DNA sequence research and development, unless we can be said is that the directive was not designed databases currently being built: both the pub- devise a Database Right pool with an accom- with this type of database in mind. Nothing in licly funded bodies and the genomics compa- panying clearance system. the directive says, explicitly, that DNA data- nies have been “building up DNA sequence bases are covered. Equally, nothing explicitly databases” as their stated missions and apply 1. Anon. Nat. Genet. 23, 1–2 (1999). excludes them either. most of their resources to that end. The same 2. Gaster, J-L. Der Rechtsschutz von Datenbanken, might not apply as readily to, for instance, data- Kommentar zur Richtlinie 96/9/EG mit Erlauterungen zur Umsetzung in das deutsche und ostereichische bases of human genetic variation that emerged Recht. (Carl Heymanns Verlag KG, Köln, 1996). Jasper A. Bovenberg is an attorney with as part of broad health surveys. 3. See the legislative history of the act implementing Nauta Dutilh, Amsterdam, The Netherlands A major complication in considering the Directive into the laws of the Netherlands 4. Maurer, S.M. & Scotchmer, S. Science 284, 1129 (1999). ([email protected]). database rights for DNA sequence databases 5. Anon. Nature 405, 719 (2000).

NATURE BIOTECHNOLOGY VOL 18 SEPTEMBER 2000 http://biotech.nature.com 907