CIOPORA Chronicle 2015

Zooming in on IP
Only for EU plant
breeding
Next, a “user” is defined as “a
natural or legal person that utilizes
genetic resource...”. In turn, the
term “utilization” is defined as “to
conduct research and development
on the genetic and/or biochemical
composition of genetic resources,
including through the application
of biotechnology...”. According
to an informal clarification from
the European Commission, the
NPC Regulation will only apply to
utilisation of genetic resources in the
EU. In other words, if the research
and/or development take place
outside the EU, the Regulation’s due
diligence obligations will not apply.
However, “genetic resources” are
broadly defined as “genetic material
of actual or potential value”,
whereas the term “genetic material”
means “any material of plant,
animal, microbial or other origin
containing functional units of heredity”.
It is immediately clear from
these definitions that plant breeders
are users within the meaning of the
Regulation and that plant breeding
is a form of utilisation of genetic
resources.
A lot of information
Unless this “user” manages to obtain
an “internationally-recognised
certificate of compliance”, which is a
type of permit that may be provided
by the country of origin in case PIC
and MAT have been concluded, the
NPC Regulation imposes upon “users
of genetic resources” a number of
cumulative obligations to be met for
the user to be considered as having
exercised due diligence.
The “user”, amongst other things,
has the obligation to seek, keep and
“transfer to subsequent users”, information
and relevant documents
on (i) the date and place of access of
genetic resources, (ii) the description
of the genetic resources utilized, (iii)
the “source” from which the genetic
resources were directly obtained “as
well as subsequent users of genetic
resources”, (iv) the presence or absence
of rights and obligations relating
to ABS, (v) access permits, and
(vi) MAT. Users have to keep all of
this information “for 20 years after
the end of the period of utilization”.
Breeders´ exemption
Taking into account that, according
to the European Commission, the
term “genetic resources” also covers
commercially available material of
protected varieties for further breeding
purposes, it is immediately clear
that, with respect to varieties protected
by a plant variety certificate,
the European due diligence rules
create a conflict with the breeders'
exemption under the Plant Variety
Rights regime. This is because the
due diligence obligation effectively
abolishes the principle of free access
to germplasm. On the one hand, it
forces the breeder of the new variety
to seek all the required information
and documents listed in the NPC
Regulation from the breeder who
put the variety on the market and
thereby to disclose his intention to
use material of the initial variety to
the owner of that variety. On the
other hand, it forces the owner of
the protected variety to disclose his
pedigree to the new breeder (which
is normally confidential and which,
after a few years of application of
the Nagoya Protocol, may include
hundreds of different genetic
resources). The NPC Regulation
thus creates a legal and commercial
relationship between plant breeders
that previously did not exist.
Ironically, without this relationship,
neither breeder can comply with
the NPC Regulation’s due diligence
requirements…
Severe sanctions
To make things worse, according
to European law-makers, whenever
“the information in their possession
is insufficient or uncertainties
about the legality of access and
utilization persist”, plant breeders
should still try to obtain an access
permit and/or establish MAT. If
this is not possible, which will
hardly ever be the case, they should
simply “discontinue utilization”!
If the user continues, the genetic
resource in question (and, in view of
the “knock-on” effect created by the
NPC Regulation, all plant material
building on that genetic resource)
will be considered as having been
illegally accessed. In that case, the
competent national authorities will
have recourse to a wide variety of
remedies against the non-complying
user.
What the future
will bring
In this context, it is clear that plant
breeders should keep as detailed
records as possible on the origin of
the resources they use in their plant
breeding activities after 12 October,
2014. The implementing rules
that will be adopted later this year,
as well as the promised guidance
document should provide some
further clarification for breeders on
how they can align themselves with
the NPC Regulation.
However, it is clear that many
uncertainties will remain. This is
why on 28 July, 2014, two consortia
of German and Dutch plant breeders
launched an annulment action
against the NPC Regulation. The
cases 1 are currently pending before
the EU General Court. A date for a
decision has not yet been set. |||
1 Cases T-559/14 and T-560/14.
CIOPORA Chronicle June 2015 | www.FloraCulture.eu 41