Danish
reservations
The adoption
of a EU directive on protection of biotechnological
inventions has not been easy. From a Danish point
of view, we have had a number of reservations, before
the Danish Parliament and the Danish Government finally
agreed upon the text, as it is today.
The Danish
Government was very interested in joining the Council’s
common position, because it found that the directive
was important for innovation and the Danish biotechnological
industry. Accordingly, the Minister of Business and
Industry worked very hard to get the acceptance from
Parliament. This resulted in a lot of discussions
and debates in relation to the Danish reservations
up to the Council meeting in November 1997, and I
have been working closely together with the Minister
in this process. The Minister of Business and Industry
was very much involved in this matter and did participate
in the drafting of the final adjustments to the Danish
proposal at the final discussions at the Council meeting.
The discussions
that have taken place in Denmark are very much similar
to the discussions in the other EC countries. I will
not go through all the Danish reservations, but only
concentrate on a few, just to give you an idea of
the broadness of these reservations.
Patents
for animals
First
of all, we had a reservation concerning the possibility
of obtaining patents for animals. As the Danish Patents
Act is today, like the patent’s acts in most
of the other EC countries and the EPC, it is not possible
to obtain patents for animal varieties, but the Danish
interpretation of this exemption is that this also
covers animals as such. After many discussions and
after some amendments of the directive, we finally
accepted - with certain restrictions - that it is
now possible to obtain patents for animals. I here
mainly have Observation 45 and Article 6 d in mind.
Further, it is also expressly stated in Article 4
1 (a), that animal varieties are not patentable. One
of the reasons for accepting the wording as it is
today being that the use of such animals in research
can reduce the number of animals used in tests, and
the outcome of such research can contribute to the
cure of diseases, which cannot be cured today.
Patents
for human beings
Another
Danish reservation was about patents for human beings.
This issue is now covered by the text of the directive.
Farmer’s
privilege
Thirdly,
we wanted the directive to cover "farmer’s
privilege". The directive now includes provisions
regarding this issue, both in respect of plants and
animals.
Biodiversity
Finally,
the Danish reservation regarding preserving the biological
diversity caused a lot of debate, both internationally
and nationally. After intense negotiations at the
Council meeting in October 1997, we succeeded in having
an observation included. The observation states that
information about biological material should be included
in the patent application if this information is known.
However, this is not a condition for obtaining a patent.
The reason for adding such an observation to the directive
is that this will keep the focus on the obligations,
which the member states have in relation to the Convention
on Biological Diversity. Like the European Parliament,
Denmark’s prior aim was to add an Article to
the directive, but this was not possible, among other
things because this would mean new requirements to
fulfil in order to obtain a patent. This will not
be feasible due to the obligations in respect of other
international agreements (TRIPS).
All in
all, the reservations made by Denmark were all met
in such a way that Denmark did join the common position
as agreed upon in November 1997, and which was formally
adopted by the Council in February this year.
Measures-
amendments
Just
to give you a brief view of what needs to be done
nationally to implement the directive to national
law, I can inform you that the directive has to be
implemented within two years from the date of publication
in the Official Journal of the European Communities.
This seems to be a long time, but bearing in mind
that all national legislation in each member state
has to be reviewed and amended, it is in most cases
the time it takes before the implementation has fully
taken place. Amending the Danish Patents Act, associated
orders, directives guidelines etc. is not something
that is done overnight, but is a time-consuming process.
First it has to be determined which provisions in
the Act, the orders etc. that have to be amended.
Secondly, the "users" of the patent system
have to be heard and their proposals have to be evaluated.
Then the new Act has to be adopted by the Danish Parliament,
which, at the earliest, can take place at the assembly
of the Parliament in 1999. Once the Act has been amended,
the orders, directions, guidelines etc. have to be
amended, too. So a heavy work load is lying ahead
of us.
Essential
aspects to be evaluated in connection with the implementation
of the directive to Danish law
Now some
preliminary considerations from a legal point of view
of what needs to be considered when implementing the
directive to Danish law. I must emphasise that these
considerations are only preliminary, because at this
time we have not fully determined what needs to be
done to make the Danish Patents Act in accordance
with the provisions in the directive. This will, as
I will come back to, also be something that has to
be discussed with our Nordic colleagues.
However,
I will say a few words about some main issues:
Patents
for animals
First
the issue about patents for animals. As in the directive,
the Danish Patents Act contains a provision stating
that species of animals cannot be patented. As mentioned
earlier, this provision is in Denmark interpreted
as also covering animals "as such" meaning
that no patent can be obtained for animals or parts
hereof, irrespective of the process in which the animal
is made (biological or microbiological). However,
the non-biological process itself is, under certain
circumstances patentable. And, it is under certain
circumstances possible to obtain a patent for microbiological
processes and the products thereof, eg. isolated somatic
cells as long as the product is not regarded as an
animal. However, the directive goes further than the
interpretation of the Danish Patent Act. In article
6.2.d. it is stated, that no patent shall be granted
for processes for modifying the genetic identity of
animals which is likely to cause them suffering without
any substantial medical benefit to man or animal,
and also animals resulting from such processes.
Accordingly, it is possible to obtain a patent for
genetic modified animals which not suffer, and for
genetic modified animals which suffer under the conditions
mentioned earlier. Since we interpret the Danish Patents
Act as prohibiting patents for animals as such, including
animals resulting from microbiological processes,
we probably have to amend the Act to be in accordance
with the directive. Otherwise, we have to adopt a
new interpretation of the provisions as they are now.
But most likely, the Act will have to be amended.
Patents
for human beings
Secondly,
I will focus a little bit on the issue regarding patents
for human beings. It is not under any circumstances
possible to obtain a patent for the human body, parts
thereof etc. However, it is possible to obtain patents
for specific types of isolated human cells. This is
not expressly stated in the Danish Patents Act, but
is due to an interpretation of the provision regarding
"ordre public", order and morality.
Contrary
hereto, the directive contains provisions regarding
the exclusion of patents for human beings, parts of
the human body, embryos etc. In order to comply with
these provisions, it has to be considered whether
the Danish Patents Act should contain specific provisions
regarding the exclusion of patents for human beings.
It has to be determined, whether the provisions as
they are today can be interpreted in accordance with
the provisions in the directive.
Farmer’s
privilege
Thirdly,
I will focus on the issue relating to "farmer’s
privilege". The Danish Patents Act has no provisions
dealing with farmer’s privilege, neither in relation
to plants, nor in relation to animals. However, provisions
about farmer’s privilege covering plant varieties
(which are non patentable) are found in the act on
plant varieties and associated orders. These provisions
only cover plant varieties, and accordingly amendments
should be considered in order to extend farmer’s
privilege also to cover patents for plants and plant
propagating material. The extent and condition of
farmer’s privilege on such inventions shall according
to the directive correspond to those mentioned in
EU Regulation 2100/94.
As regards
farmer’s privilege in relation to animals, no
provisions exist as also mentioned before, neither
in the Danish Patents Act, nor in any other act. Consequently,
it is essential that specific provisions in this field
is included in the Danish Patents Act. As described
in relation to plants, the extend and conditions of
farmer’s privilege have already been determined
in EU regulations. However, these EU regulations do
not cover animals. So in this area, we are left with
no guidance from other legislation apart from the
provisions in the plant area. It is also expressly
stated in Article 11.3 that the extend and the conditions
shall be determined by national laws.
The precise
wording of the provisions relating to farmer’s
privilege within the field of animals have of course
not yet been determined. Further, such wording has
to be discussed with the Ministry of Agriculture and
the relevant organisations.
Biodiversity
Finally,
as mentioned in relation to the Danish reservations,
we wanted to maintain the focus on the obligations
of the member states in relation to the Convention
on Biological Diversity. Article 1.2 expressly states
that the directive is without prejudice to these obligations.
Further, as also mentioned earlier, the Danish delegation
succeeded in having an observation added to the directive
which also deals with the obligations in the Convention
(information about the origin of biological material).
We
now have to determine how to deal with this in national
law.
In addition
to this, it should be noted that the parties of the
Convention have just concluded a Conference regarding
the implementation of the intentions of the Convention
on Biological Diversity, at which the issue relating
to import/export of biological material and benefit-sharing
was subject to discussion. From a Danish point of
view, the existence of sufficient legislation in each
contracting state is of importance in order to secure
that the intentions in the Convention will become
effective.
Other
aspects in relation to the directive
As mentioned
in the summary, other aspects exist, which have to
be dealt with when implementing the directive to Danish
law. It should be noted that what I have mentioned
in the summary is not an exhaustive list of aspects.
Biological
process
The definition
of biological process appears from Article
1.2, and the definition of "microbiological process"
is found in Article 1 b of the directive.
In the
Danish Patents Act, as it is today, Article 1.4.2
contains the following wording regarding biological
processes (non-patentable inventions) "ºessential
biological processes for the production of plants
or animals. As regards "microbiological processes,
the wording of the Act is: " Patents may, however,
be granted for microbiological processes and the products
thereof". It has not yet been determined whether
it is necessary to change the wording of the Act,
or if the definitions will be amended to national
orders, guidelines etc. However, it is very important
that initiatives are made at national level to ensure
a uniform interpretation.
Research
exemption
As regards
research exemptions, the directive does not
require amendments of Danish law on this point. According
to Danish law, the proprietor of the patent cannot
prevent acts done for noncommercial purposes, acts
concerning products put on the market in Denmark by
the proprietor of the patent or with his consent (consumption),
acts done for experimental purposes relating to the
subject matter of the patented invention and preparation
in a pharmacy of a medicinal product according to
a prescription in individual cases or acts concerning
the medicinal product so prepared.
This
principle is also in accordance with the principal
provision of the patent legislation of patent protection
that information about patents shall be made available
to the public.
Compulsory
licensing
Compulsory
licensing is also an aspect that needs to be dealt
with in relation to the amendment of the Act. The
Danish Patents Act contains provisions regarding compulsory
licensing in the field of patents, and the act concerning
plant varieties and the EU regulation contains provisions
in the plant field. However, the directive introduces
a new possibility of obtaining a compulsory license,
namely what is called compulsory cross-licensing.
This opens up for a holder of a plant variety - under
specific circumstances such as interdependence between
the plant variety and the invention - to get a license
on an invention which is protected by a patent and
conversely. No such provisions exist today in either
the Danish Patents Act or the act concerning plant
varieties, and accordingly such provisions must be
added to the acts. I will also mention that the EU
Commission is presently considering possible amendments
of the EU Regulation No 2100/94 in order to comply
with the directive in relation to the requirements
that have to be fulfilled when applying for compulsory
licensing.
Any further
changes and/or amendments to national legislation
as a result of the implementation of the directive
and so-called "grey areas" will be assessed
in the final work. At this stage it is not possible
to comment further on this aspect.
Conclusions
To conclude
my speech, I will briefly mention that any amendments
to the Danish Patents Act will most probably be made
in cooperation with our Nordic colleagues, as the
patent’s acts of the Nordic countries are very
much alike. Working groups, also in the field of patents
on biotechnological inventions already exists today,
and would be an obvious forum to discuss any amendment
that needs to be made as a result of the directive.
And speaking
of amendments, it is also very likely that the EPC
and the EPO practise to some extent will be amended
as a result of the directive. However, it is also
worth mentioning that the directive to a certain point
can be regarded as a codification of the EPO practise.
Further,
the Danish Patents Act, as I have just described,
is at several points probably already in accordance
with the provisions in the directive and can be interpreted
in such a way that there will be compliance with the
directive. However, amendments have to be considered
more thoroughly, especially in the field of patents
for animals, farmers privilege and compulsory licensing.
Finally,
let me just say, that the Danish Minister of Business
and Industry is very pleased that the directive finally
seems to become a reality, and that Denmark joined
the common position in November 1997. As you all may
very well be aware, Denmark has a large biotechnological
industry, and the directive is one way to harmonise
the legislation within the EU, creating a basis for
equal competition between the Danish industry and
the industry in EU. Further, the directive will be
a means to preserve the Danish biotechnological industry
in Denmark. The directive will also strengthen the
European biotechnological industry in relation to
the United States of America and Japan. Finally, the
directive may contribute to the invention of methods/medicine
to cure diseases, which are non-curable today.
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