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MEMO/00/39
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.
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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.
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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:
Processes for cloning human beings;
Processes for modifying the germ line genetic identity of human beings;
Uses of human embryos for industrial and commercial purposes;
Processes for modifying the genetic identity of animals which are likely to cause
them suffering without any substantial medical benefit to man or animal, and
also animals resulting from such processes.
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.
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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
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the 30 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
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the Directive by 30 July.
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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.
Useful Links
Text of Directive EC 98/44 on the legal protection of biotechnological inventions
http://europa.eu.int/eur-lex/en/lif/dat/1998/en_398L0044.html
Opinion No. 8 of the Group of Advisors on the Ethical Implications of biotechnology
to the European Commission
http://europa.eu.int/comm/secretariat_general/sgc/ethics/oldversion/en/opinion8.pdf
Further information on the Directive
http://www.ipr-helpdesk.org/t_en/i/i_410_en.asp?adt_id=817&ads=0
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