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The
patent directive: what it does and does not cover
- Nick
Scott-Ram
- UK
Bioindustry Association
- 77
Great Clarendon Street
- Oxford
OX2 6AU
- UK
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- Ladies
and Gentlemen, it gives me a great pleasure to have
the opportunity to talk to you about the biotechnology
patent directive. Armin Machmer, who follows me, will
address the political process and what that involves.
It took ten years for this directive from initiation
to final approval a few weeks ago and that is a considerable
amount of time
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- The
biotechnology patent directive
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- The
directive is a balance between the variety of different
interests, including industry, the consumer, legislators
and also, for the first time in such detail, ethics
in biotechnology. The main focus of the directive
is on patentability of biological material:
what can and cannot be patented. Also, important from
a public perception view point, it covers the question
of patentability of human genes. Another important
issue is the infringement on second generation
material, i.e. on material that is capable of
reproducing or being reproduced. The areas on ethical
issues and the question of the plant varieties
is clarified in the directive. In the directive, the
farmer’s privilege and compulsory cross-licensing
represent a derogation from the patent rights.
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- Before
going into detail on the directive, a couple of areas
need to be highlighted:
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- Discovery
and invention
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- There
has been a debate about the difference between discovery
and invention. Many people argued that if you found
or isolated a gene from the human body, or even from
an animal, that was a discovery and not an invention.
However, prior to that, the European Patent Office
(EPO) has said that even if you find something which
is a substance freely occuring in nature, there is
a distinction between whether it is just a discovery
or a whether it is subsequently isolated and then
used for a technical purpose. This would be more akin
to an invention. The EPO guidelines for examination
(Part C, Ch. IV, 2) say on naturally occurring products
(Article 52(3) EPC - Discoveries): "To find a
substance freely occurring in nature is also mere
discovery and therefore unpatentable. However, if
a substance found in nature has first to be isolated
from its surroundings and a process for obtaining
it is developed, that process is patentable. Moreover,
if that substance can be properly characterised either
by its structure, by the process by which it is obtained
or by other parameters and it is ‘new’ in
the absolute sense of having no previously recognised
existence, then the substance per se may be
patentable. An example of such a case is that of a
new substance which is discovered as being produced
by a micro-organism."
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- DNA
is not "life"
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- Another
difficult question at the time when the directive
was debated in European Parliament, concerned the
question of DNA. "DNA is akin to life" was
an often used argument. The European Patent Office,
in a case between the Howard Florey Institute versus
the Green Party of European Parliament, argued on
this, for "Relaxin" (EP-B-0112149), DNA
fragments encoding human H2-preprorelaxin: "it
is worth pointing out that DNA is not ‘life’,
but a chemical substance which carries genetic information
and can be used as an intermediate in the production
of proteins which may be medically useful".
- This
was an important distinction. It was also important
that it came forward ans was clarified.
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- Exceptions
to patentability under the European Patent Convention
(EPC)
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- Article
53 of the EPC is critically important for today’s
discussion. It covers two situations where patents
cannot be patented. It says:
- "European
patents should not be granted in respect of:
- a) inventions
the publication or exploitation of which would be
contrary to ‘ordre public’ or morality,
provided that the exploitation shall not be deemed
to be so contrary merely because it is prohibited
by law or regulation in some or all of the Contracting
States;
- b) plant
or animal varieties or essentially biological
processes for the production of plants or animals;
this provision does not apply to microbiological processes
or the products thereof."
- Prior
to the EU biotechnology patent directive, there was
a lot of debate over the difference between plant
varieties and transgenic plants and transgenic animals,
and how those relate in patent law on plant and animal
varieties. The definition of a plant variety is :
"characterised by at least one single transmissible
characteric distinguishing it from other plant groupings
and which is sufficiently homogeneous and stable in
its relevant characteristics" (Council Regulation
(EC) no 2100/94). However, you can also argue that,
if you insert a new gene through a common DNA technology,
e.g. coding for petal colour using a series of genes,
you end producing a variety as well. It is not clear
how patent legislation should distinguish this.
- Historically,
crossing and selection of plant varieties is not patentable.
However, when you use recombinant DNA technology,
involving the insertion of single genes should be
patentable.
- For
animal varieties, the situation is even more complex.
There is no unanimity about the definition of animal
variety. There are different definitions for animal
varieties in different languages. E.g. in French ‘races
animales’, and in German ‘Tierarten‘
(meaning species). Species are groups of interbreeding
populations which are reproductively isolated from
other such groups. Simply drawing parallels is therefore
not possible.
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- Case
law
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- Recent
European Patent Office Opposition proceedings covering
this issue include the Technical Board of Appeal Decision
T356/93 Re Plant Genetic Systems - "Plant Cells":
the case of Plant Genetic Systems versus Greenpeace
(1995, T356/93) about herbicide resistant transgenic
plants (EP-B-242236). Greenpeace argued that patentability
of transgenic plants is immoral; that it was a plant
variety and that an essentially biologically process
for the production of plants was used. The EPC Technical
Board decided, referring to Article 53b, that "plant
cells as such, which can be cultured like bacteria
and yeast, cannot be considered to fall under the
definition of a plant or a plant variety." They
are "considered to be ‘microbiological products’
in the broad sense". As for the ‘essentially
biological process’, the EPC decided that "a
process for the production of plants comprising at
least one essential step, which cannot be carried
out without human intervention...shall be taken into
account. A process which, taken as a whole, does not
exist in nature and is more than a traditional breeding
process shall be considered patentable".
- Also
in this Technical Board of Appeal Decision it says
that
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claims to plants per se were directed to plant
varieties and therefore invalid, even though the claims
did not appear to define a variety, examples used
in the specification involved recognised plant varieties,
because the transgene was genetically stable, and
because any claim to the transgene would cover varieties
- - products
of microbiological processes have to be micro-organisms
themselves or metabolites of them
- - claims
directed to plant cells per se are allowed
- - the
herbicide resistant transgenic plants are not contrary
to morality
- So you
cannot get claims to transgenic plants and in theory
the same can be applied to transgenic animals.
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- The
new EU patent directive
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- It is
clear that part of the difficulty in defining the
scope of definitions for ‘plant varieties’,
‘microbiological processes’ and the applicability
to transgenic animals and plants involves the overlap
in applicability: traditional crossing of whole genomes
cannot be patented, while transgenic organisms can.
Transgenic organisms can be defined as those organisms
where one or more specific, well determined DNA coding
sequences are introduced by direct gene transfer.
The new directive seeks to address this difficult
area of the dividing line and scope of patentability
of transgenic organisms and how this links to traditional
breeding techniques. It is one of the important features
in the new directive.
- The
directive helps to clarify the position in respect
of these issues. In particular, Articles 2, 4 and
6* provides the basis for clarifying the scope of
patenting transgenic animals and plants in respect
of microbiological processes, plant and animal varieties
and ethical requirements.
- Article
2 starts with defining biological material, and when
a process is essentially biological. Any natural crossing
or selection is an essentially biological process.
The concept of plant variety is also defined; this
refers back to the previous definition (EC 2100/94).
- In Article
3, the directive restates the fundamental principles
of patentability (new inventions, involving an inventive
step, industrial applicability).
- In addition
to the articles, the directive has a number of recitals,
which help to clarify some ot the areas around it.
They help to give a greater interpretation of the
articles, and are meant as a guidance.
- Recital
29, about plant and animal varieties, says that if
you have a patent that covers a transgenic plant and
it is only directed at one variety, than you would
not get that patented. Recital 30 iterates the concept
of plant varieties.
- Article
4 follows the EPC, saying that neither plant and animal
varieties, nor essentially biological processes are
patentable. Article 4.2 and 4.3 say that you cannot
get claims to transgenic plants or animals, provided
that you are not focusing on one particular variety.
That is an important point in the Directive. Recital
31 covers the situations when you are extending this
to new varieties. Recital 32 and 33: a new plant variety
which is derived from a variety which cannot be patented
cannot be covered by a patent. It relates back to
the definitions of essentially biological.
- The
next issue that comes up concerns patentability of
nucleotide sequences derived from human research and
human genetic material. The Parliament was keen to
balance out the ethical considerations in relation
to patentability of human gene sequences (recital
16). Some people had the idea "if you patent
one of my gene sequences, you own part of me".
Nothing is further from the truth, but the perception
people had of it was a matter of concern. Article
5 states, that no parts of the human body are patentable.
However, an isolated element is patentable, and also
the industrial application of a (partial) sequence
of a gene must be given. In patent terms, if you work
with cDNA then that is not naturally occurring. And
if you work with interferon and only put down the
structure and no industrial applicability or technical
input in it, than that will constitute a discovery.
With an application or indication of a function it
is a patent. The EPO takes the approach that if you
have a problem, and you find the solution, then that
is where you have the invention coming in. A number
of recitals clarify issues around this (Recitals 22,
23, 24, 25, 26).
- The
Directive also gives directions on the scope of the
Farmer's privilege in respect of transgenic animals
(Articles 8 and 1, and Recitals 47 and 50*). There
was a lot of debate about the scope and extent of
this pivilege, such as farm saved seed and transgenic
animals. Farm saved seed. Article 11.1 says that farmers
can use the patented material on their farm, but not
for resale. On transgenic animals the way Article
11.2 is drafted is more vague. This will be discussed
this afternoon. This is an area where there could
be ambiguity about what you would define as an agricultural
actitivity and how much overlap there would be with
that within the sale. It also means that if you make
transgenic organisms or transgenic animals, i.e. BSE
resistant cows, and if you take this combined with
Article 6.2.d , one would have to look very closely
whether or not you could get adequate patent coverage
out of that. To me it is not really clear. And it
will take some time before the patent applications
will work their way through the EPO.
- As for
cross-licensing, I would like to refer to the information
pack of today’s meeting.
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- Research
exemption
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- There
is often a lot of concern that a patent can stop fundamental
research going on. Under European law you have exemption
from patent infringement for doing research on a patent
for non-commercial acts and acts done for experimental
purposes. The reason behind it is that patents should
only prohibit economic commercial exploitation of
the invention. The precise interpretation of these
criteria can be difficult. In the pharmaceutical area
in Europe, it is such that, when you take a product
into a clinical trial that would no longer constitute
an experimental purpose. You then are on the development
pathway at a stage where you are looking to commercialise
a product. In your industries there may be different
marking points at which you can say you are definitely
going to commercialise something or not. That is something
you would have to look at on a case to case basis.
- There
is a difference here from the USA where legislation
is more lean. In the USA it are more later stage clinical
trials which would cause an infringement of the patent.
However, in Europe it is still early in the development
and this area is not fully explored yet.
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- Comparison
between Europe and the United States
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- Apart
from the basic patent law differences (i.e. grace
period, transgenic plants and animals, derogation
and cross-licensing) the differences are not too big.
- - Inventions
vs discoveries
- USA
allow patents on discoveries, however
- USA
law prohibits patents on ‘products of nature’
- USA
law permits patents on purified strains of naturally-occurring
plants and
- microbes
- - Human
genetic sequences and ESTs
- USA
requires ‘utility’ for ESTs
- There
are substantially differences on
- - Transgenic
plants
- USA
allows all transgenic plants and plant materials
to be patentable
- - Transgenic
animals
- USA
allows patenting of all transgenic animals
- - Requirements
for derogations and cross-licensing
- USA
have no farmer’s privilege or compulsory
cross-licensing
- Due
to these substantial differences the debate on whether
Europe is setting up trade barriers or not to USA
imported material is probably going on.
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- These
were the main issues in the EU patent directive for
biotechnological inventions. Thank you for your attention.
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* Annex
to these proceedings is a copy of the Directive
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