Statement of the EGLS¹ regarding the patenting of genes

based on a discussion with experts from research, industry, law and the European Patent Office and members of the EGLS on 5^th of July 2001²

1. Patenting of biotechnological inventions, including the application of genes, is important to support research and innovation in biotechnology.
2. Universities, academic institutions and small-and-medium-sized enterprises, in particular start-ups, are the major drivers of innovation in biotechnology. They have become important, and increasingly experienced, users of the patent system.
3. In view of the increase in international research collaborations, a grace period is needed in Europe, in particular for academic researchers, to put them on the same level as their counterparts in the US and Japan. In view of the harmonisation of international patent law, this should be in the context of the "first to file" principle and in a manner that minimises legal uncertainty, which is a concern of large industry.
4. The European Commission should be supported in its efforts to simplify patenting procedures and to improve the overall cost-effectiveness of the system. All possible ways to expedite this process should be investigated. In this respect, the group welcomes the aim of the European Patent Office [EPO] to reduce translation requirements for the EPC³ procedure.
5. According to the directive 98/44/EC, the mere discovery of one element of the Human body including the sequence or a partial sequence of a gene cannot constitute patentable inventions. However, an element isolated from the Human body or otherwise produced by means of a technical process including the sequence or partial sequence of a gene may constitute a patentable invention in so far as criteria of patentability are fulfilled.
6. Patents on genes do not apply to elements in their natural environment, but only to molecules isolated from the human body or produced by means of a technical process. In this context, the phrase "patenting of life" is misleading and should therefore be avoided.
7. The Commission should step up efforts to inform the public about the role and the functioning of the patent system, to counteract certain misconceptions, e.g. that gene patents provide ownership to those genes and provide patent protection over elements of the human body. Patents do not provide ownership, but merely allow the patentee to forbid others to use the patented product or process for a limited amount of time.
8. Collective learning and sharing of experience between the different stakeholders responsible for innovation in biotechnology (academics, educators, media, industry, investors, policy makers, etc.) is a priority. There is an educational gap that invites greater awareness for patent law, its objectives and its potential benefits to society.
9. Patenting of biotechnological inventions touches upon other national and international agreements and laws, which need to be respected by researchers, such as the use of patient data ("informed consent") and the use of genetic resources of other countries. Researchers need to be made aware of and respect these agreements and laws in order to perform their research in full compliance with these regulations.
10. The members of the LSHLG have identified a need for stakeholders to explore issues of scientific and legal nature in the context of directive 98/44/EC, taking into account all possibilities provided for by the reporting articles 16 a, b and c. Potential "dependency" problems related to overly broad patent claims are important in this respect and should therefore be followed closely:
11. Genes or gene sequences are likely to be used for different applications (diagnostics, protein coding, etc.) and may code for different proteins which are likely to have different functions (molecular function, cellular component, biological pathways and processes). The application of the product patent and "first medical use" principles may therefore not be reasonable with respect to genetic inventions and could have an undesirable impact on investments into research related to further applications or medical uses.
12. Case law related to recital 25 of the directive, which will further clarify the notion of independence of inventions in cases of partly overlapping sequences.
13. In collaboration with the EPO, dissemination and communication efforts should be envisaged, in particular to rapidly document any changes in examination practices following the establishment of new case law, and in particular as a result of scientific progress and the advancement of the state of the art. The loop should be closed between advances in scientific knowledge, development of case law, and guidelines used by examiners of patent applications. Relevant information stemming from all three critical points of this loop should be disclosed proactively and discussed in a wide audience. The research programmes of the Commission could be an amplifier of this communication process.
14. The opportunities and limits associated with the patenting of biotechnological inventions should be made more understandable to a wider audience, in particular regarding the substantial issues associated with this in the context of fierce competition and with the view to serving mankind in a responsible way. This will be the responsibility of all stakeholders and the Commission could support this process through the design and dissemination of an attractive pamphlet and through other communication channels.

1. European Group on Life Sciences (formerly LSHLG)
2. Adopted November 2001
3. European Patent Convention