The European Commission will be building a new team with 15 experts, to examine the development and implications of patent law in the field of biotechnology and genetic engineering. The group will consist of experts in the areas of intellectual property law (in particular patent law and the law on plant variety rights), public and industrial research and development, life sciences (including plant and animal breeding) and biotechnology. Their role will be to examine the implications of patent law and provide high quality legal and technical expertise, which will help the Commission with its reporting obligations.
The team of experts will be crucial in advising the Commission on a number of questions concerning the Directive (98/44) of the EU's Council of Ministers and the European Parliament on the legal protection of biotechnological inventions, the so-called 'Biotech Patent Directive'.
One particular area that has raised many questions is on how the Directive affects access to the human genome data and possible restrictions on the research and applications for which this data could be used. The role of the experts will be to assist and advise the European Commission in its reporting requirements and on the legal protection of biotechnological inventions (referred to as 'Directive 98/44/EC').
Patents are necessary in biotechnology as they provide an incentive to innovation. Without the safeguards provided by patents, industry and other inventors would be unwilling to invest their time and money in research and development. However, biotechnology carries a considerable amount of high risk investment, particularly in the field of genetic engineering. So adequate patent protection needs to be in place to encourage the investment required to create jobs and maintain the European Union's competitiveness in this important area of research. This is why Directive 98/44 on the legal protection of biotechnological inventions was proposed and, after lengthy and thorough discussions within the European Parliament and among Member States, it was adopted.
But still, the patent laws surrounding biotechnology remain a complex issue, particularly the ethical aspects of inventions. For example, discoveries, which do not extend human ability, but only human knowledge, are by their very nature not patentable. Sequencing of a genome belongs to the area of discovery, which means it cannot be the subject of patent protection. However, it is different if a DNA sequence is released from its natural surroundings by means of a technical procedure and is made available for the first time to a commercial application. This makes such a gene 'new' in the patent sense and therefore patentable, if it was not previously accessible to the public and was previously not available.
The position that was agreed by both the European Parliament and the Council of Ministers after much discussion was that patents for inventions comprised of, or based on, gene sequences should be allowed. The Directive therefore provides that inventions based on, or comprised of, gene sequences or partial gene sequences can be patented provided that they satisfy the normal criteria for any invention as well as making clear that patents should not be granted where the application does not include specific reference to the industrial application of the gene sequence.
However, advances in technology have made understanding the isolation and manufacture of genes easier to understand, and are taken into account when a patent is examined, in particular whether the invention in the patent application possesses an inventive step. If it is decided by either the patent offices or the national courts that there is no inventive step then the patent will either be refused or revoked.
It is expected that the addition of a new team of experts will ensure a greater understanding of patentable biotechnology and help to unravel the complexities that surround this area.