This is based on a talk by Enrique Molina Galan, a Director
at the EPO, on 15 November 2013 at the CIPA Life Sciences Conference.
1. The patentability
of plants is not straightforward in Europe.
Plant varieties are excluded protection under the EPC since protection is
available under the UPOV treaty. G1/98
allowed claims which embrace plant varieties as long as the relevant technology
is not restricted to a plant variety. However
it also affirmed that plant varieties were not patentable, even if they were produced
by recombinant technology. Thus the assumption
was made that the method of producing a plant/variety was not relevant to patentability
of the plant/variety.
2. In the EPC the term
‘essentially biological’ was previously interpreted as applying to a process
which consists ‘entirely’ of natural phenomena, e.g. sexual crossing. However G2/07 and G1/08 said sexual crossing
and subsequent selection is not patentable.
This broadened the exclusion as it meant having additional ‘technical’
steps before or after the natural steps did not make the method
patentable. It was still ‘essentially biological’. That seems to mean that having any ‘sexual crossing’
step in a claim makes it unpatentable. Growing
plants from seeds seems to be OK, though that is not entirely certain.
3. Now the question
of whether plants produced by an essentially biological process are patentable
is outstanding in G2/12 and G2/13. Allowing
such claims would circumvent legislators’ intentions as plants breeders could
not be able to commercialise their products. In G2/13 there is the additional
question of whether a disclaimer could solve the problem.
4. The EPO is staying
examination proceedings on relevant plant applications and in oppositions where
the outcome depends entirely on outcome of G2/12 and G2/13. Cases to genetically engineered plants are considered
not affected and are not being stayed. The
EPO granted around 1,500 plant patents in 1995 to 2012, mostly 2003
onwards. The EPO is staying cases to
non-transgenic plants prepared by crossing as well as cases to plant mutants
generated by conventional mutagenesis, and about 100 of such cases granted in 1995
to 2012. Thus the number of cases being
stayed is going to be small.
5. Turning to
disclaimers added to exclude unpatentable subject matter, the EPO decided in G1/03
one could disclaim subject matter for non-technical reasons in the situation
where the disclaimer did not have basis in the application as filed (referred
to as ‘undisclosed disclaimers’ below). In T329/06 the following undisclosed
disclaimer was allowed: ‘provided that the cells are not human embryonic stem
cells’.
6. Looking again at undisclosed
disclaimers, G2/10 decided that what remains after disclaiming must be present
in the application as filed. In this
context T2464/10 decided that the undisclosed
disclaimers ‘non-human’ (for a claim to an animal) and ‘wherein the cell is not
produced using a process which involves modifying the germ line genetic
identity of a human being or involves us of human embryo for industrial or
commercial purposes’ were allowable.
7. On the question of
whether an undisclosed disclaimer could exclude a plant produced by an
essentially biological process, Article 53(b) EPC does not exclude such plants from
patentability and so at the moment Examiners will not allow this, but the
situation may change after G2/12 and G2/13 are decided.
8. The speaker then addressed the question of whether the
EPO listens to applicants and IP practitioners in making policy. Added matter has been a controversial area
with the EPO being seen as too strict.
However the EPO now has the intention to harmonise practice on this at the
IP5 level (IP5 is made up of the five largest Patent Offices).
9. The speaker said
that Rule 36 regarding the deadline for filing divisional applications was
amended in response to pressure from applicants. The recent change to Rule 164 allowing further
searches was also cited as an example of this.
10. The EPO is also setting
up a working group to look at problems associated with biotech cases, in
particular the frequent lack of unity findings and harmonising internal policy on
broad claims and inventive step.
You may also wish to see the related articles Top
10 Biotech Claims You Cannot Have in Europe and Top
10 Points about Gene and Protein Sequences.
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