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Brussels, 3 July 2000
Legal protection of biotechnological inventions Frequently Asked Questions on scope and objectives of the EU Directive (98/44)
A number of questions have been raised recently 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 patents Directive'. For example, there have been questions raised as to 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 following set of answers to a number of Frequently Asked Questions (FAQ) is intended to clarify and explain the provisions of the Directive and to allay any concerns.
Why are patents necessary in the area of biotechnology?
Patents provide an incentive to innovation. Without the safeguard provided by patents, industry and other inventors would be unwilling to invest their time and money in research and development. This applies to biotechnology as well as any other area of technology. Indeed given the considerable amount of high risk investment that is often required in the area of biotechnology, particularly in the field of genetic engineering, adequate patent protection is even more essential to encourage the investment required to create jobs and maintain the European Union's competitiveness in this crucial field. Indeed, the key role of adequate patent protection in the creation of a dynamic; knowledge based economy was explicitly underlined by the March 2000 Lisbon Summit conclusions.
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, adopted.
Much consideration was given during those discussions to the ethical aspects of biotechnological inventions. The resulting Directive both addresses these ethical aspects and provides the necessary incentives to encourage the research and development.
Can the discovery of DNA or the human genome be patented under the Biotech Patents Directive?
No. Neither DNA nor the human genome can be patented under the Biotech Patents Directive because they are not inventions but discoveries i.e. they existed already, they extend knowledge but that knowledge has thereafter to be applied to be technically useful.
The Directive states explicitly that discoveries cannot be patented. Yet, it also states that the patentability of an industrial process or a product received as a result of such a process is not prevented by the mere fact that during this industrial application DNA is used. In fact, in this case it is not the DNA as such that is patented but the industrial application or isolation process using DNA.
Surely all biotechnological inventions which deal with human, vegetable, or animal genes involve materials which already occur in nature and can therefore under no circumstances be invented, but only discovered?
Discoveries, which do not extend human ability, but only human knowledge, are by their very nature not patentable. This is certainly the case with the mere sequencing of a genome which belongs to the area of discovery and for that reason alone cannot be the subject of patent protection. The Directive confirms and reinforces this position.
It is different however 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. Here there is a step taken from knowing to being able. Such a gene is new in the patent sense and therefore patentable, if it was not previously accessible to the public as such, and thus technically was 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 comprising of, or based on, gene sequences should be allowed. This position took account of the Opinion of the Group of Advisers on the Ethical Implications of Biotechnology to the European Commission. Indeed the Group of Advisers fully recognised the stimulus provided by patents for medical research.
The Directive therefore provides that inventions based, on or comprising of, gene sequences or partial gene sequences can be patented provided that they satisfy the normal criteria for any invention namely that they are novel, involve an inventive step and are capable of industrial application. In this last respect, the Directive took account of some of the controversy surrounding some of the earlier patent applications for gene sequences that were filed and indeed granted before the Directive was agreed. In particular the Directive makes clear that patents should not be granted where the application does not include specific reference to the industrial application of the gene sequence.
But isn't the Directive unclear on whether gene-based inventions can be patented?
The relevant provision in the Directive relating to this issue is Article 5. Concerns have been expressed is that there is a contradiction between the first two paragraphs of this article. The first paragraph provides that the human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene cannot constitute patentable inventions (emphasis added). This paragraph is clearly in line with the basic principle that discoveries are not patentable.
The second paragraph of Article 5 states however that 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, even if the structure of that element is identical to that of a natural element. As noted above, the invention arises from the isolation of a particular gene from its natural surroundings by means of a technical process. Of course to be patentable, that invention would still need to satisfy the criteria of novelty, inventiveness and industrial applicability.
Paragraphs 1 and 2 are therefore consistent with each other.
Let us take a hypothetical example. Since the human genome provides information related to growth and repair, it may be possible to take a DNA sequence and to isolate from it a particular gene that relates to hair loss. Company A wants to develop a shampoo for baldness. It successfully develops a way to isolate the gene responsible for baldness from the DNA sequence. The underlying genetic material remains free - other researchers can do work on growth and repair. But the technique developed to isolate the gene is hugely complex, involving identification, purification and classification techniques which are costly to develop. Without human intervention, it would have been impossible to isolate the gene. The isolation process cannot therefore be said to occur in nature and the product the isolated gene - can be patented. It is a "new" in terms of patent law, involves an inventive step and has industrial applications. By taking out a patent, Company A has protected the considerable investment made in its invention.
But aren't the techniques for isolating and even determining the function of particular genes now becoming more routine?
The rapid advancement of the technology and our understanding in this area has indeed made the isolation and manufacture of genes more straightforward. It may also be possible now to deduce the function of a gene from a computer based comparison with other genes. These advances in technology are taken into account when a patent is examined in particular in respect of 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.
But patents for gene based inventions will surely inhibit research in the area of gene technology and restrict access and use of the data on the human genome?
The raw fundamental data on the human genome that has been, and is still being, produced by the Human Genome Project (HUGO) and private sector companies is not patentable. Therefore access to that data will not be restricted or encumbered by patents. Intellectual property protection for gene based inventions will however play an important role in stimulating investment into using this raw data on the human genome to develop important new products, for example in the area of health care.
Moreover all patent systems in Europe include exceptions to the rights provided by a patent so as to allow for research and experimentation on the subject matter covered by a patent. In addition, safeguards such as compulsory licences are provide to ensure that patent holders do not abuse their rights for example by charging unreasonable fees for the use of their inventions.
Finally, the requirement to fully disclose the invention in the patent application brings into the public domain for use by other researchers information that might otherwise be kept secret.
Does the Directive allow for methods of cloning human beings to be patented?
No. Article 6 of the Directive clearly states that the following are not patentable on the basis that their commercial exploitation would be contrary to the public order or morality:
This is precisely why European Patent EP 69 53 51 on transgenic stem cells granted by the European Patent Office to the University of Edinburgh in December 1999 would have been illegal under the terms of Article 6 of the Directive.
Does the Directive override national laws governing for example research activities?
No. The biotech patents Directive determines only what, in terms of patent law, can and cannot be patented. A patent does not give any positive right to use an invention. The use of any invention, and indeed the research and development leading up to that invention, are still governed by general national and European laws.
For example, take the case of genetically-modified organisms (GMOs). The biotech patents Directive makes it possible to patent both the process for genetically modifying plants and also the resulting plants, although not a particular variety of plant. However, if a Member State legislates against the planting of GMO crops, then the patent holder still cannot grow that crop in that Member State.
When must the Directive be implemented by the Member States?
The Directive must be implemented by the 30th July 2000. The Commission is working with the Member States to help them to implement the Directive correctly and on time and has already started to receive notifications of implementing regulations from the Member States.
As the Netherlands has already challenged the legality of this Directive, what incentive is there for Member States to implement it by the 30th July deadline?
The Biotech Patents Directive was approved by a majority of Member States and by the European Parliament in 1998 after lengthy discussions. It is hence existing Community law. EU rules provide that any Member State may challenge EU legislation, for example regarding the underlying legal base. However, until such time that the European Court of Justice has ruled on the issue (and the timing of that is up to the Court), all Member States are bound by the existing law. In this case the ECJ has not yet set a date for a hearing and so all Member States must implement the Directive by 30th July.
Does the Commission plan any further initiatives in the area of patents and biotechnology?
No. That said, as with all legislation, the Commission will monitor the Directive to ensure that its scope of protection remains relevant to the rapid technological developments that are likely in this field and also that it remains in line with the public's attitude to this area of technology. As required by the Directive, the Commission will make reports to the European Parliament and to the Council on a regular basis on the development and implications of patent law in the field of biotechnology and genetic engineering.
Text of Directive EC 98/44 on the legal protection of biotechnological inventions
Opinion No. 8 of the Group of Advisors on the Ethical Implications of biotechnology to the European Commission
Further information on the Directive