Jusletter IT

ACGT's aim is to develop a European Knowledge Grid infrastructure offering methods and systems for ameliorated medical knowledge discovery.  This can only be done through a complex integration of biomedical data and information which includes not only the modeling, visualization, data mining and Grid technology of clinical information relating to tissues, organs or personal health-related information, but also information at molecular and cellular levels.  By collecting, storing, sharing, analyzing and collating all these cellular and intracellular data particularly from cohorts of cancer patients we enter into a bundle of Intellectual Property Rights (IPRs).

Therefore, the access to data and the ability to extract and re-utilize the data will play an important part in ACGT's scientific investigation and exploitation.  As always in intellectual property law it is a question of achieving a balance between a sufficient incentive and adequate protection of investment to encourage the creation and use of information.

In the realm of Trans-European Genetic Research Projects a Grid computing infrastructure has been identified as a key to support and facilitate the cooperation of scientists and resources through scalable computation and the management of data systems. It has been proposed to be the next generation infrastructure.¹

A Grid infrastructure is generally described with three different layers. The lowest layer is usually called «platform», consisting of the hardware resources such as computers, networks and interface devices which are geographically distributed, presenting their data in a variety of formats. The second layer, also called the «middleware», is defined as the software layer that lies between the operating system and the applications on each site of the system. The last layer provides the user with application services including workflow engines, data visualization tools, semantic web and web portals.²

The ACGT platform consists of multiple interconnected IT resources networks allowing users to execute a variety of scientific applications requiring a trustworthy, steady and prevalent access to computational capabilities. This complex collection of servers and communication protocols poses legal intellectual property questions: should copyrights or patents protect the grid? What about software licenses in a Grid environment?

Intellectual property rights can be applicable to different aspects of the Grid infrastructure:

First of all, the law of copyrights must protect the originality of the authors. Therefore, as soon as there is an expression of creativity in an original way, it implies an automatic protection. This is the case in the ACGT Grid infrastructure that must then be protected accordingly by a two-fold protection. On the one hand, the fact that different project partners are creating a new infrastructure tailored to ACGT’s needs, by selecting and arranging the Grid layers. On the other hand, copyright protection for the computer programs arises since their development. According to Art. 1 (3) of Directive 2009/24/EC³ , a computer program shall be protected if it is original in the sense that it is the author’s own intellectual creation. The object of copyright protection is the source code and the machine code in order to protect against mere copying, but not to protect against the exploitation of the (technical) idea as such.

Second, as far as the patentability of Grid-based computer programs is concerned, Art. 52 (1) and 52 (2) lit c of the European Patent Convention (EPC)⁴ may be applied when the deployment on Grid of the program produces an additional technical effect subject to industrial application. The solution of computer program-related problems does not give rise to patent protection, as Art. 52 (2) lit c of the EPC is applicable in those cases. Nevertheless, it is conceivable that when a computer program is developed and constitutes a new way of using a Grid infrastructure or makes Grids more efficient, it becomes a solution to a technical problem. It therefore becomes generally patentable.

Careful assessment is therefore to be made on whether a problem is technical or computer-program related as Grids are based on implementation of computer programs. Therefore, if within the project, a new and innovative way of distributing resources on Grid infrastructure is developed by using a computer program, this may be patentable according to Art. 52 (1) EPC.

The European Database Directive⁵ provides a two-fold way of protection. The first scheme of protection is as intellectual creation by copyrights while the second scheme is the so calledsui generis right. In accordance to the former, databases which, by reason of the selection or arrangement of their contents, constitute the author’s own intellectual creation shall be protected as such by copyright. The latter focuses its attention on the protection of the investment spent on the making of databases as a compilation of data.

Therefore, the novel database right protects the investment of the databases as such i.e. as a compilation of factual data regardless their copyright protection provided there is a substantial investment not only in terms of money but time, effort, human resources and technical equipments.

The project partners need to develop an intellectual property rights strategy regarding the exploitation of rights, especially regarding the use of licenses. The management of licenses should be centralized. Thus a central mechanisms validation authority, such as the Center for Data Protection (CDP) in ACGT, may act as a central institution empowered to manage the license agreements. That is, the central authority for data protection, which is present in almost every trans-European research project, due to compliance with data protection issues, could be the institution to take care of the licenses used. This is a twofold task: on the one hand the central authority is responsible for licensing the works that were created within the project, on the other hand, it is responsible for ensuring that works that are used within the project are used according to the licenses that govern them.

Taking into consideration that ACGT owes its existence to the participation of patients through clinical trials, a fundamental question is ‘Who owns the patient’s data?’ This question has to be answered not only legally but also ethically. Regarding the donation of biological material and data, the so called ‘gift model’ has been revised and slightly supplemented by other models and ideas submitted very recently. In this respect, patients taking part of ACGT’s clinical trials are asked to sign an informed consent form concerning the processing of their data for further research within ACGT. The Center for Data Protection (CDP) is empowered to conclude legally binding contracts providing security and trust to the framework. For this reason, the CDP could also act as a «Trusted Party» and could define property rights on the biological material and the data coming out of this material as a «common». In order to find a balance between the interests of patients, doctors and researchers, the CDP as the «Trust» could hold a percentage of the net profits and re-distribute the revenues to the community of patients.

In the realm of trans-European research projects there are many intellectual property rights that have to be taken into account. Despite any potential copyrights and patent issues in either the grid infrastructure, or the software or biological data as such, information seems to be present in raw form and ownership of such information – i.e. biological data – seems to represent a current legal problem. In order to palliate this problematic situation it is important to establish a central authority entrusted to take into account a number of legal issues such as the management of licenses agreements and the ownership of data. In order to strike a balance between the main stakeholders, the «Trust» model has been put forward.

Lister, A., Williams A.L., Kersey P.J., Pruess M. and Apweiler R. Biological Databases: Infrastructure, Content and Integration, p. 16 in: Data Analysis and Visualization in Genomics and Proteomics, ed. by Azuaje, F., and Dopazo J., UK, John Wiley & Sons, Ltd. (2005).
World Information Technology and Service Alliance (WITSA), Background paper on grid computing,www.witsa.org/papers/WITSAGridCompFinal.pdf last retrieved 2 February 2010, pp. 1-9 (2004).
Directive 96/9/EC of the European Parliament and the Council of 11 March 1996 on the legal protection of databases (1996).
Directive 2009/24/EC of the European Parliament and of the Council of 23 April 2009 on the legal protection of computer programs (2009).
European Patent Convention (EPC).

Marcelo Corrales, Research Associate, Leibniz Hannover Universität, Institut für Rechtsinformatik (IRI)
Königsworther Platz 1, 30167, Hannover, Germany, DE
corrales@iri.uni-hannover.de;http://www.iri.uni-hannover.de