Based on a discussion with experts
from research, industry, law and the European Patent Office and
members of the EGLS on 5th of July 2001
- Patenting of biotechnological inventions, including the application of genes, is important to support research and innovation in biotechnology.
- 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
- 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.
- 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
to reduce translation requirements for the EPC procedure.
- 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.
- 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
- 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.
- 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.
- 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.
- The members of the EGLS 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:
- 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.
- 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.
- 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.
- 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.
On Behalf of the EGLS
(former chairman of the EGLS)