Importance of being registered
and patented for biologicals
Arysta LifeScience Corporation,
St. Luke’s Tower, 8-1, Akashi-cho, Chuo-ku, Tokyo 104-6591, Japan
Abstract: Registration of predators and parasitoids
has been controversial for the past few years.
How registration system of macrobials worked in Japan although
there was lot of criticism such as
cause of delay in realization of biocontrol, absurd registration
After 10 years of enforcement of registration system, the system
basically contributed for better
biological control implementation in Japan. Patentability of biocontrol
is also discussed.
Key words: biological control, registration,
Registration of beneficial organisms by government, especially
arthropods, is still not the common practice even in developed
countries except several countries such as Japan, Switzerland,
France and so forth, although the definition of registration is
still nebulous. Just submitting minimal requirements could satisfy
registration guideline known as notification or import permission.
As Japanese registration system derived from chemical pesticide
guideline, there are more
data necessary to satisfy all the requirement by the guideline.
In early 90’s, the Japanese registration was criticized as absurd
over-regulation as most of
the countries where natural enemies were used had no registration
system, except Morocco and
Hungary which were later revealed as more or less notification
method. Nowadays more countries have been considering enforcement
of such registration because there are more concerns on non-regulated
alien species introduction, introduction of less efficacious species,
low quality natural enemies, false species introduction without
right taxonomy and so on.
In fact the Japanese natural enemy registration system gave several
positive results contrary to
Patent application of natural enemies have also been regarded
as non-practical exercise by early 90’s but since the human DNA
sequences and their role were found to be patentable, there are
more necessity to consider patent strategy to enhance sound growth
of biological control activities. Moreover improvement and innovation
are not stipulated without reasonable reward.
◆History and Current Japanese Registration
In recent years in Japan, due to the concern on importation
of alien species such as Black Bass, Rhinoceros beetle and pet
animals, natural enemies and bumblebees have been picked up for
scrutiny on their ecological impact to the local fauna and flora.
Fortunately natural enemies in Japan have already been evaluated
on such ecological impact
through laboratory studies and by field studies in some species.
They have been checked by the registration system on overwintering
capability, competition with local species, intraguild predation
and so on, in addition to normal requirement data such as history
of research and development of registering species, taxonomy,
life cycle, production method, counting method, continual quality
control, susceptibility to chemical pesticides, at least 6 valid
and effective field efficacy data in local climate conditions
over 2 years, label requirement where crop and pest insects combination
is clearly mentioned to avoid misuses. In case of microbials,
normal battery of pathogenecity studies with total clearance plus
environment behavior study are required as set by the US-EPA tier
It usually takes full 3 years to obtain registration of a species
as the efficacy study has to be
done in two consecutive years.
At first the criticizing voice commonly focused on this lengthy
trial time which must
delay the implementation of biological control using an insect
species newly found.
In fact such negative impact made the Japanese biological control
situation not synchronized
with European/northern American ones. But as time laps the difference
has been gradually
minimized in 2004 when only unavailable important insect is Eretmocerus
will be registered in 2005-2006 and E.californicus is already
Swirski mites could be usable from 2006-7 after more accumulated
data will be available
for its real scientific field capability.
What influenced most by the registration system, however, is more
was attained because of this registration system.
In Europe and northern America or elsewhere, natural enemies has
been produced and distributed without much consideration for sound
growth of biological control. In other words, each company or
family business copies other company’s products or institute findings
for the past over 20 years because there were no regulation or
patent available in the
domain of insect rearing and distribution.
This led to endless price competition and in worst cases, low
quality product and/or unstable production and/or wasteful discarding
of live insects including bumblebees which ironically
and eventually increased the cost of insect rearing .
This is proved from the financial situation of several major insectaries,
and this situation hinders healthy research and development efforts
in these companies.
Registration may not be the answer for the above mentioned problems
but at least
more orderly production, distribution, research and development
could be possible
with some kind of regulation, namely, one of regulation is registration.
Protection by patent is lacking in the biological control domain
and this hinders timely improvement of application method and
intensive search for new species by industry.
In most industry the search for new technology including new species
or new molecules
is normally done by research institute and industry.
In biological control, the role of industry is too small in serendipity
except for price competition.
◆Patent of biologicals as reward to discoverer
Nowadays everybody knows new findings could be patented if they
are not disclosed to public
in such ways as scientific paper, symposium, science society publication,
A trait of living animal is patentable as long as the discovery
on such trait of animal is without precedent.
In Japan, Hemiptarsenus varicornis, a leafminer parasite, was
patented in 1999 by the Japan Patent office submitted by Shizuoka
Agricultural Experiment station and Tomen Corp( presently Arysta
LifeScience) . The insect was unfortunately not commercialized
but this is the first natural enemy related patent.
Researchers should be aware of submitting patent of their findings
and discoveries even
they seem of low value. Value could be added later with other
improvement and ideas.
Without protection of intellectual property, the progress in biological
control area should be
very insignificant one.
Patent could be on rearing method, fermentation method, application
method, new host elucidation, and even for new predatory and parasite
species by itself.
If a very effective insect is found, insectary should pay royalty
or purchase the right to
use the patent to discoverer.
In this way, most of business such as IT/Pharmaceuticals/Bio industry
have been prosperous and researchers have enough fund to do further
development of their research.
Some entomologists in insectaries usually treat their rearing
method as very secretive
but without patent, such secrecy is always void. This is self
evidently apparent when
we see most of insectaries rear same insects.
I thank Dr.Tsutomu Saito of Shizuoka experiment station for
the idea on Hemiptarsenus varicornis patent.
Saito T. et tal.1996: Effect of pesticides on parasitoid complex
of serpentine leafminer Liriomyza trifolii (Burgess) in Shizuoka
Prefecture. Jpn.J.Appl.Ent.Zool..40(2), p.127-133.
Saito T. et tal. 1997: Developmental time of ectoparasitoid,
Hemiptarsenus varicornis, on Liriomyza trifolii and L. Bryoniae Jpn.J.Appl.Ent.Zool..41(3),
Wada T. 2004: Integrated control of protected crops in Japan,
Farming Japan, vol.38-6, p.38-43