Building and Owning Biotechnology Databases

A Workshop organised by The Biotechnology Information Strategic Forum, with support from DGXII of the Commission of the European Communities, and held at Purmerend, The Netherlands, 22-23 September 1998

The workshop - Building and Owning Biotechnology Databases was held at the Golden Tulip Hotel, Purmerend, The Netherlands on 22-23 September 1998. It was organised by The Biotechnology Information Strategic Forum, with support from DGXII of the Commission of the European Communities.

Directive 96/9/EC of the European Parliament and of the Council of 11 March on legal protection of databases. Official Journal L 077, 27/03/1996 p. 0020 - 0028 -- Liz Coleman, DGXV, European Commission

The views expressed are purely those of the writer and may not in any circumstances be regarded as stating an official position of the European Commission.

DG XV is the Directorate-General within the European Commission overseeing policy on the Internal Market - the free movement of goods, services, people and capital. As differences in national intellectual property rights (IPRs) can be used to hinder this free movement, DGXV has the responsibility to monitor, examine and propose legislation.

In the context of today's meeting, one first needs to define a database. Intuitively, this can be a collection or compilation of items, such as data, writings, pictures, sound recordings, films, computer programs, or even a stamp collection. To qualify for inclusion under this definition however, the database has to make these items more easily accessible. Databases are increasingly important for the economic well being of the Community. This alone means they deserve some protection from being altered or copied or "stolen", but they also cost money and intellectual effort and this too has to be protected if investors are to be persuaded to risk investing in new products. IPRs protect this investment in creativity and innovation, and a harmonised environment allowing for equal treatment and protection is obviously advantageous.

As with many areas within the European Community, the original national copyright and database protection environments differed between Member States. Thus there were "unfair competition remedies" in Belgium, France and Germany; in The Netherlands, there was protection for "unoriginal writings" (geschriftenbescherming) and in the UK and Ireland there was (strong) copyright protection for compilations. In the Nordic countries there has been a strong catalogue rule which has covered collections containing a lot of items since 1961. The aim of the Database Protection Directive was to overcome the variation and produce a general environment which protected databases. The directive was of course developed from these national standpoints and so had to encompass many different "attitudes and aims". It came about after 8 years of analysis and consultation which led to the adoption of the Directive in 1996. It was due to be implemented in Member State legislation by 1 Jan 1998 (9 of the 15 countries involved have so far done this - October, 1998) but the Directive will also directly affect countries with legal links to the EC, such as Norway, Iceland and, by virtue of decision number 59/96 of the EEA Joint Committee, Liechtenstein, the Central and Eastern European Countries (CEECs) and the Commonwealth of Independent States (Russian Federation and others), who will all have to implement the directive at some time in the future.

While copyright protection can be traced back many years, the protection for databases was actually not strict nor rigid: one could copyright the structure but it was possible to take and re-arrange the content. The directive was therefore also designed to bring the legal framework more up-to-date as well as producing a harmonising (subsidiarity) framework which, like all IP legislation, will say what is covered i.e. the object of protection, the rights which are granted, to whom, for how long, and exceptions and limitations.

In the case of databases, two separate types of protection have been developed: copyright and sui generis. A database is defined (this applies to both types of protection) as:

Article 1: collection of independent works, data or other materials arranged in a systematic or methodical way and individually accessible by electronic or other means.

As indicated above, it is important to note that an accumulation of material with no way of retrieving specific items (e.g. some types of data file) is not a database (furthermore, a film or literary or musical work as such does not constitute a database either and, even if a music CD is a database, as a rule it will not qualify for either copyright or sui generis).

Copyright protection has been designed to provide a harmonised threshold for protection: thus databases which by reason of selection or arrangement of contents constitute the author's own intellectual creation shall be protected as such by copyright. (NB this protection does not extend to individual contents, which may or may not themselves be protected). Thus, in respect of the expression of the database which is protectable by

(a) temporary or permanent reproduction by any means and in any form, in whole or in part;

(b) translation, adaptation, arrangement and any other alteration;

(c) any form of distribution to the public of the database or of copies thereof. The first sale in the Community of a copy of the database by the rightholder or with his consent shall exhaust the right to control resale of that copy within the Community;

(d) any communication, display or performance to the public;

(e) any reproduction, distribution, communication, display or performance to the public of the results of the acts referred to in (b).

These rights are provided to the natural person(s) who created the database, or a legal person if provided for under national copyright law (including employers), for a period of 70 years pma (as a result of Directive 93/98/EEC). However, there are naturally some exceptions; thus the normal use by an authorised user cannot be prevented, and, at the choice of the Member States, the reproduction for private purposes of non-electronic databases, for teaching or scientific research, quoting source and to an extent justified by non-commercial purpose, may be allowed. All of the 9 Member States which have implemented the directive so far have made provisions on scientific research. Thus certain limitations and exceptions to the restricted acts have been provided, usually along the lines that the national governments followed prior to the harmonising action. However these exceptions should not unreasonably prejudice the rightholder's legitimate interest or conflict with the normal exploitation of the database in question.

The sui generis protection (Chapter III) is in respect of databases involving a substantial investment in obtaining, verification or presentation of contents (finance, time, effort or energy). This stems from the Nordic catalogue protection and one can have these rights with or without copyright protection; and they do not affect any rights subsisting in individual contents. In these cases, the holder has the right to prevent (i) extraction (ii) re-utilisation of whole or substantial part of contents of database (substantial will probably have to be defined through case-law). It should be noted that these rights do not prevent public lending. They are conferred on the maker of the database (or the "investor") for 15 years but this can be prolonged into a new term when substantial new investment has taken place. Again, lawful users cannot be prevented from extraction/re-utilisation of insubstantial parts, except if done repeatedly and systematically so as to conflict with normal exploitation or unreasonably prejudice legitimate interest of maker. They must not cause prejudice to other right holders in respect of database content items.

There are also optional exceptions regarding the extraction of substantial parts for private purposes of contents of non-electronic databases, and for the extraction for illustration for teaching or scientific research (obligation to indicate source, and non-commercial use only).

The directive obviously has international repercussions beyond the EU and its legal partners. Copyright protection is thus available to natural or legal persons of third countries, parties to Berne Convention or WTO TRIPs Agreement, except for shorter term of protection (50 years pma under TRIPs). The sui generis protection is available only to makers who are nationals of European Union Member States, or have their habitual residence in the Community, or companies formed in accordance with law of a Member State and having their registered office (plus operations with ongoing link to economy of Member States) central administration or principal place of business within the Community. So many third country nationals will not be eligible. However, under Article 11(3) reciprocal agreements may be concluded with third countries that offer comparable protection to EU nationals/residents.

The Directive has naturally been the basis for the EC position in the WIPO talks and deliberations. Some critics of database protection claim that the new laws actually prevent access to some information, and this has led to a series of discussions with, in particular, the USA. The EC put their proposal in treaty language to WIPO in Spring 1996, and the US made a counter-proposal but there was no time at the 1996 Diplomatic Conference to handle this. The American text ran into domestic opposition which is still being debated. For constitutional reasons the US cannot take the "property right" approach; instead they prefer "misappropriation" (like unfair competition).

The difference was already considered in the EU during the passage of the Database Protection directive - the original "unfair extraction right" was changed into a full IPR on basis of arguments put forward by the various parties involved. The American situation is that bills are before Senate and the House of Representatives and will be debated in October (HR 2281 was modified in this regard and will have to be re-handled in 1999 - see Paul Uhlir).

The directive aims to protect investment and thus stimulate the production of databases; it also aims to stimulate third parties into releasing data that hitherto has been kept in private files for fear of it being copied and reused. Access should therefore be improved and provisions have been made to allow exceptions according to national perspectives and habit/history. The directive is of course also subject to other legislation providing for availability of information (e.g. Government information or the sharing of information between certain public interest organisations) but this does not mean that all information should be offered for no charge (in certain cases, public information may be charged for).

Finally, in short, if you have a right, you can authorise who you like. The aim is to also be able to prevent free- riders. However, do not forget competition law - one must not try to use IPR legislation as the basis for restrictive agreements, or to abuse a dominant position.

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