LONDON - Many genomics companies, hoping to recoup their investments in high throughput technologies, have created huge databases of gene sequences for which they charge subscription fees.
Bioinformatics companies, meantime, have either developed software that allows users to bundle multiple databases, or focused on developing software that enables great chunks of data to be manipulated to help researchers design better drugs.
In other words, databases lie at the very heart of the bioinformatics universe. But are US companies missing out on opportunities to protect their investments.
In the United States, innovators have traditionally relied on copyright and confidential-information rights to protect their databases. In Europe, however, database owners have a novel weapon in their IP armamentarium: the database right.
But there's a catch: Database innovators must have sufficient nexus with Europe--actually, the European Economic Area, or EEA--in order for their databases to qualify for protection. Perhaps it's time for US database makers to consider how they might create sufficient ties with Europe to benefit from this powerful new IP right.
Database et mon droit
In 1996, a European Directive introduced the database right, and European Union member states, including the UK, France, and Germany, have now introduced domestic legislation implementing it. Importantly, there are geographical restrictions to qualification for database right.
As a point of standard definition, the maker of the database is the person who takes the initiative and the risk of investing in it, so sub-contractors are excluded from the definition of maker. Also, the right does not subsist in a database unless, at the time it was made, its maker was:
(a) a national of an EEA state or habitually resides within the EEA; or
(b) a body that was incorporated under the law of an EEA state and
has its central administration or principal place of business within the EEA, or
has its registered office within the EEA and its operations are linked on an ongoing basis with the economy of an EEA state; or
(c) a partnership or other unincorporated body that was formed under the law of an EEA state and which, at that time, has its central administration or principal place of business within the EEA.
If the database was made over an extended period, these conditions must be satisfied for a substantial part of that period. Furthermore, if a database is made by an employee in the course of his or her employment, the employer is regarded as the maker of the database subject to any agreement to the contrary.
In relation to the second bullet point in paragraph (b) above, it is thought that the generation of revenue and/or the payment of tax would help to show the requisite link between the registered office and the economy of an EEA state.
For database right to exist, there must have been 'investment'--spending financial resources and/or time, effort, and energy--in the creation of the database. In particular, there must have been qualitatively and/or quantitatively a substantial investment directed at obtaining, verifying, or presenting its contents.
The maker of the database has the right to prevent 'extraction' and/or 're-utilisation' of the whole or of a substantial part, evaluated qualitatively and/or quantitatively, of the contents of the database. 'Extraction' is the permanent or temporary transfer of all or a substantial part of the contents of a database to another medium by any means or in any form.
Essentially, this means that for infringement by extraction there has to be copying (provided there is transfer to another medium). 'Re-utilisation,' meanwhile, means making all or a substantial part of the contents of a database available to the public. Repeated or systematic extraction or re-utilisation of insubstantial parts may amount to extraction or re-utilisation of a substantial part.
Database right starts to run from the date the database is completed and lasts for 15 years from the following Jan. 1. Or, if the database is made public, it will live for 15 years beginning on the Jan. 1 that follows the date of first publication.
For databases that are continuously updated, the right may exist indefinitely since the period of protection starts again following any substantial investment. As the onus is on the maker of the database to prove a substantial new investment, it would be prudent to save database contents on a regular basis so as to create a comprehensive audit trail and to keep records of investments (including labor expended).
Owners of databases that contain genetic information can either rely on copyright to protect their work or they can try to keep it secret and hope for the law of confidential information to keep it safe. But European-based genomics, proteomics, and bioinformatics enterprises will benefit from the extra protection afforded by the relatively new database right.
Although the right arises automatically and does not require any registration, careful consideration and planning is needed to ensure that it is preserved for commercial and enforcement purposes. Indeed, recent case law in the UK and the rest of Europe suggests that the new database right will be a potent addition to a company's portfolio of intellectual property rights.
Penny Gilbert is a partner at the law firm of Bristows in London. She has a DPhil in molecular biology and specializes in advising on IP rights in the biotech field. Harjinder Obhi is an Assistant Solicitor at Bristows who has a PhD in Physics and advises on IP rights relating to information technology and electronics.