FAQ Legal protection of biotechnological inventions
Context: A number of questions have been raised 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.
Q. 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, for advanced
therapies or genetic engineering, adequate patent protection is
even more essential to encourage the investment required in
turn 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.
Q. 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 derived 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.
Q. 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.
Q. 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 in 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.
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 resulting product,the isolated gene, can be patented.
In terms of patent law it is "new", involves an inventive step and has industrial
applications. By taking out a patent, Company A has protected the
considerable investment made in its invention.
Q. 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.
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.
Q. 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,
such as that 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 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 licenses, are provided 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 which might otherwise have been kept secret.
Q. 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.
Q. Does the Directive override
national laws governing for example research activities?
No. The biotech patents Directive
can only determine what 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 it follows that the patent holder still cannot grow that crop
in that Member State.
Q. When
was the deadline for the Member States to implement the Directive?
The Directive
had to 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.
To date, all
Member States have implemented the Directive, however, there are
interpretations of Articles that vary from Member State to
Member State.
Q. As the Netherlands has
already challenged the legality of this Directive, what incentive
is there for Member States to implement it?
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, all Member States are bound by the existing law.
Q. 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
Opinion
No. 8 of the Group of Advisors on the Ethical Implications of biotechnology
to the European Commission (pdf)
Further
information on the Directive
(Source : E.U)
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