Importance of being registered and patented for biologicals
Tetsuo Wada
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 requirement.
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, predator, parasitoid

◆Introduction

　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
earlier expectation.
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 System

　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 system guideline.
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 mundus which
will be registered in 2005-2006 and E.californicus is already registered.
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 organized implementation
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, any 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.

◆Acknowledgements

　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), p.161-163.

Wada T.　2004: Integrated control of protected crops in Japan, Farming Japan, vol.38-6, p.38-43