Patent laws for the biotech and genetic engineering industry are due to come under scrutiny from 15 experts appointed by the European Commission (EC).
The EC said the group, which consists of specialists in such areas as intellectual property law and R&D, will examine the existing laws regarding biotech patients and advise on where updates to the Biotech Patent Directive are necessary.
The Directive was initially adopted in 1998, but advances in science and technology, especially in the field of genetic engineering, have raised questions related to the relevance of current patent laws.
According to the EC, patents are necessary to drive biotech innovation, but problems arise when the ethical aspects of invention are taken into account.
These issues are particularly relevant in the sequencing of a genome, which is seen as an advancement of human knowledge rather than an advance in human ability, and is therefore not patentable.
However, the EC said it takes the position that such a conclusion 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 EC concluded.
The current Directive accounts for this to an extent, stating that inventions that make use of gene sequences or partial gene sequences can be patented provided they satisfy the normal criteria for any invention and the patent application, includes a specific reference to the industrial application of the gene sequence.
The isolation and manufacture of genes is now better understood than it was in 1998, leading to such projects as the UK’s plans to map the genomes of up to 100,000 patients suffering from cancer and rare diseases, driving the need for further clarity on what constitutes an inventive step.
“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,” said the EC.