WORLD TRADE  
ORGANIZATION  IP/C/W/472 
13 June 2006 
 
 (06-2839) 
Council for Trade-Related Aspects 
of Intellectual Property Rights Original:  English/ 
                 French/                  Spanish 
 
  
THE PATENT SYSTEM AND GENETIC RESOURCES 
 
Communication from Japan  
 
 
 The following communication, dated 9 June 2006, is being circulated at the request of the 
Delegation of Japan.  
_______________ 
 
 
 The present communication from Japan contains in its annex the document
1 submitted to the 
ninth session of the Intergovernmental Committee on Intellectual Property and Genetic Resources, 
Traditional Knowledge and Folklore (IGC) of WIPO held in April 2006.  Japan thinks that the work 
of the TRIPS Council should take into account the rele vant work being carried out by WIPO to avoid 
the duplication of efforts and, in this sense, belie ves that submitting and introducing the document to 
the TRIPS Council is useful.  
                                                     
 
1 See WIPO document WIPO/GRTKF/IC/9/13. IP/C/W/472 
Page 2  
 
  ANNEX 
 
THE PATENT SYSTEM AND GENETIC RESOURCES 
 
I. THE RELATIONSHIP BETWEEN THE CONVENTION ON BIOLOGICAL 
DIVERSITY (CBD) AND THE PATENT SYSTEM AS FOR THE PREMISE OF 
EXAMINATION 
1. The consistency of the Convention on Biological Diversity (CBD) with the patent system has 
been one of the major points at issue in the recen t discussions relating to in tellectual property rights, 
and it is the premise for the examination of various  issues concerning the rela tionship between genetic 
resources, associated traditional knowledge, and intell ectual property rights.  However, as a matter of 
legal rights and obligations, it is apparent that th e CBD and the patent system do not conflict with 
each other and that they are mutually supportive. 
A. THE RELATIONSHIP BETWEEN THE CBD  AND THE PATENT SYSTEM  
2. Article 22.1 stipulates the following:   
The provisions of this Convention shall not affect the rights and obligations of any 
Contracting Party deriving from any existi ng international agreement, except where 
the exercise of those rights and obligations would cause a serious damage or threat to 
biological diversity. 
3. Article 16.5 stipulates the following: 
The Contracting Parties, recognizing that pa tents and other intellectual property rights 
may have an influence on the implementati on of this Convention, shall cooperate in 
this regard subject to national legislation a nd international law in order to ensure that 
such rights are supportive of and do not run counter to its objectives. 
4. First of all, based on Article 22.1 of the CBD, it is clear that the provisions of the CBD do not 
have the direct influence over the current patent system which has been est ablished according to the 
existing international agreement.2 Moreover, although Article 16.5 of the CBD provides the 
cooperation among countries in order for the intellect ual property rights to promote and not to run 
counter to the objectives of the CBD, the Article al so makes clear that such cooperation should take 
place within the framework of "national legislati on and international law", which means within the 
existing international and national patent system.3  Therefore, from the legal perspective, it is apparent 
that the existing patent system would not be change d due to the provisions of the CBD and that it is 
not expected to have such changes.   
                                                      
2  As for the proviso on "serious damage or threat" in this provision, it is difficult to judge in which 
cases "a serious damage or threat to biological diversity" is caused, but it could be considered to be extremely exceptional.  In most national legislation and internationa l law that provides protection of international property 
rights, the possibility of constraints that the intellectual pr operty rights might get in some particular cases as for 
the sake of public interest has been taken into consideration.  
3  At the drafting stage, this provision was changed from "recognizing that…have an influence on…" to 
"recognizing that…may have an influence on… [i.e., 'may ' was added]," and this showed that a consensus on 
whether intellectual property rights has an influence on the CBD or not and, if such rights does have an influence, whether the influence was positive or negative, was not obtained in the process of negotiation among 
the countries.  IP/C/W/472 
 Page 3 
 
 
  5. Regarding the impact of the patent system on th e CBD, it is necessary to keep in mind that the 
patent system grants patents that are only for inve ntions that meet certain requirements such as the 
requirements of novelty,  inventive steps, and industrial applicability, but it does not grant rights for prior art.  In other words, what has existed as pub lic domain will remain as it is, and if countries 
providing/providers of genetic resources and associ ated traditional knowledge can utilize those in the 
same manner as usual, and they will not come under the influence of the patent system. 
6. The objective of treaties relating to the patent system, such as the TRIPS Agreement, is to 
protect intellectual property, namely inventions, while the objective of the CBD is to conserve 
biological diversity;  therefore, the objectives, content, and subject-matter of the CBD as a treaty 
differ from those of treaties relating to the patent system. 
B. M
UTUALLY COMPLEMENTARY EFFECT OF THE CBD  AND THE PATENT SYSTEM  
7. The objectives of the CBD to be pursued in accord ance with its relevant provisions are (1) the 
conservation of biological diversity, (2) the sustai nable use of its components and (3) the fair and 
equitable sharing of benefits arising out of the utilization of  genetic resources, which are 
accomplished, inter alia , by the "appropriate transfer of rele vant technology, taking into account all 
rights over those resources and to technologies" as sti pulated in the CBD.  In this manner, as emphasis 
is placed on technological transfer as the means to accomplish the three objectives of the CBD, the patent system is expected to function as an impor tant factor for the technological transfer.  For 
instance, the publication system and the license syst em under the patent system facilitate the diffusion 
and transfer of technology.  Also, it should be kept  in mind that benefits (m onetary and non-monetary 
benefits, including technologies subject to technology transfer), which are subject to benefit sharing, 
arise from the proper protection of intellectual property rights.  To forbid granting of a patent to any 
living organism will deprive prospective applicants  of opportunities to obtain benefits arising from 
inventions utilizing genetic resour ces and take away incentives for the technology development which 
might be subject to transfer, and, consequently, the opportunities for benefit sharing to the countries 
providing the genetic resources will also be lost. 
8. In this way, it is presumable that the patent  system may complement the CBD in facilitating 
the benefit sharing or technology transfer specified in the CBD.   
II. EFFORTS MADE BASED ON THE CBD 
A. O
BLIGATIONS UNDER THE CBD 
9. The CBD aims at (i) the conservation of biological diversity, (ii) the sustainable use of its 
components, and (iii) the fair and equitable sharing of  benefits arising out of the utilization of genetic 
resources.  
10. Article 16 of the CBD, which is related to "paten ts" or "intellectual property rights", does not 
require disclosing the source/country of origin  of genetic resources and associated traditional 
knowledge.  Therefore, the CBD does not oblige Contracting Parties to disclose the country of origin, etc., of genetic resources and associated trad itional knowledge in pa tent applications. 
11. The CBD leaves the decision to the Contracting Parties' discretion regarding the measures to 
be taken to accomplish said objectives;  therefore, it is permissible for Contracting Parties to implement the Convention by taking other measures th an requiring disclosure of the source/country of 
the origin of genetic resources and associated  traditional knowledge in patent applications. IP/C/W/472 
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  B. A
CTIVITIES IN JAPAN  
12. Japan has been a contracting party since the effec tive date of the CBD;  therefore, we think it 
is very important to accomplish the objectives of the CBD and to realize the sustainable use of genetic 
resources.  Genetic resources are the basic mate rials for various research activities, including 
biotechnology, and for industrial applications of the results of such research activities;  consequently, 
such genetic resources are considered to be essential to  the sound development of industries in Japan.   
13. Therefore, Japan, in "Biotechnological Strategies, " aims at the "realization of the collection, 
acquisition and offer of genetic resources in ha rmony and cooperation with the countries owning 
those resources based on the spirit of the Convention of Biological Diversity (the CBD)" and has carried out various activities in acco rdance with the discretion given to  the Parties by the CBD.  In 
steadily advancing our activities, we have come to consider it possible to facilitate smooth access to 
genetic resources and the fair and equitable sharing of  benefits arising out of their utilization based on 
the CBD. 
1. Preparation of "Guidelines on Access to Genetic Resources for Users in Japan" 
14. Japan considers it possible for the Contracting Pa rties of the CBD to facilitate smooth access 
to genetic resources and fair and e quitable benefit sharing arising out of their utilization, which is one 
of the objectives of the CBD, by fulfilling their obl igations in accordance with the discretion given to 
the CBD Contracting Parties while considering the Bonn Guidelines.  
15. Therefore, since the Bonn Guid elines were adopted in 2002, Jap an has enlightened Japanese 
users of genetic resources and has disseminated the necessity to comply with the law of the countries 
providing said resources and to share benefits arisi ng out of their utilization based on mutually agreed 
terms with concerned parties when Japanese users have access to genetic resources overseas. 
16. Furthermore, "The Guidelines on Access to Genetic Resources for Users in Japan" was 
prepared in March 2005 based on the opinions of industry representatives and academicians in order 
to publicize the idea of access to genetic reso urces and benefit sharing as stipulated in the 
Bonn Guidelines.  From April 2005, the Japanese G overnment has been disseminating the Guidelines 
throughout Japan.  Japan was the first country to prepare the aforementioned Guidelines for the users 
of genetic resources in companies and research instit utions in Japan.  By explaining the necessity of 
obtaining prior informed consent (PIC) from the governments of the providing countries or parties concerned regarding genetic resources and the necessity  of obtaining mutually agreed terms (MAT) in 
contracts with the parties concerned, the Guidelin es aims at the popularization of the CBD, etc., and 
serves as a practical guide which explains each st ep of the procedure involved in accessing genetic 
resources and benefit sharing. 
17. The objective of the Guidelines is to assist both the countries providing genetic resources and 
the countries utilizing them to enjoy the benefits  and to build a win-win relationship between 
themselves by realizing access to genetic resources and fair and equitable benefit sharing.  
2. Activities of the Japan Bioindustry Association (JBA)  
18. There are developing countries where rain forests rich in biological diversity have been 
diminished as a result of development and envi ronmental degradation due to the increase of 
population or industrial growth, and consequen tly, many biological species have disappeared, 
impairing the ecosystem.  Under these circumstan ces, the necessity to "establish and maintain 
programmes for scientific and technical education a nd training in measures for...the conservation…of 
biological diversity and its components and provide  support for such education and training for the  IP/C/W/472 
 Page 5 
 
 
  specific needs of developing countries" was provided in Article 12(a) of the CBD in consideration of 
the needs of developing countries. 
19. Against this backdrop, Japan has been provi ding various research assistance programmes and 
training programmes to developing nations in the ar ea of the conservation of biological diversity with 
an eye to faithfully complying with the CBD a nd enhancing the CBD's international presence.  As 
regards the research assistance pr ogrammes, Japan accepted a total of 591 researchers from Thailand, 
Indonesia, and Malaysia under the "research partnership program to conserve biological diversity and 
to use biological resources" during the period from 1993 to 1999.  Japan has also dispatched experts 
to these countries and supported them with the inst allation of machines and equipment.  As for 
training programmes, the JBA has conducted progra mmes for participants from developing countries 
from all over the world, centring on Asia-Pacific nations.  By the end of fiscal 2004, Japan had 
accepted 159 biotechnology researchers and government officials as trainees from 25 countries.  The 
trainees learned Japan's biotechnology-related po licies and an outline of the CBD as well as how 
genetic resources should be evalua ted and applied.  They also ac quired knowledge and learned to use 
technology relating to biotechnol ogy through hands-on training. 
3. Activities of the National Institute of Technology and Evaluation (NITE)  
20. Since the CBD clearly stipulates that the countries providing genetic resources possess 
sovereign rights over the genetic resources, it b ecame significant to secure the stable and smooth 
acquisition of genetic resources which is the key to the development of new bio-related technology.  
21. Due to this situation, NITE, which is the bi ological resource centre in Japan, deemed it 
important to comply with the CBD and to secure genetic resources by obt aining consent from the 
countries producing such resources, and therefore, NITE came to consider it very important, as a 
national strategy, to forge cooperativ e relationships relating to access to genetic resources with Asian 
countries, which have had historically and economically intimate relations with Japan.  
22. Thus, NITE has signed memorandums of understa nding (MOU) with the relevant government 
organs in such Asian countries as Indonesia, Vietna m, Thailand and the People's Republic of China.  
Under these MOUs, NITE has been promoting jo int projects with these countries to acquire 
microbiological resources in these countries and taxonom ically analyze and utilize such resources.  In 
the joint projects, non-monetary benefits have been  shared such as the dispatch of experts and the 
acceptance of trainees.  NITE has also been working to establish an environment which can produce 
benefits for both parties of a project in accordan ce with the stage of progress in areas such as basic 
research and application.  
23. Through those activities, NITE has promoted mutual understanding with partner countries 
and worked to fairly secure genetic resources by intr oducing the fair and equita ble sharing of benefits 
under the CBD.     
III. SO-CALLED "ERRONEOUSLY GRANTED PATENTS" 
24. Several countries see it as a problem that there are some inventions using genetic resources 
and related traditional knowledge that have been gr anted patents erroneously, as the applications have 
not had novelty and inventive steps and not meet the requirements of patentability.  First of all, we 
would like to point out that, under the present patent system, there is a mechanism in which inventions 
that have been granted patents may be revoked if they do not meet the requirements for novelty and 
inventive steps.  Nevertheless, we understand that it imposes a burden on third parties if "an erroneous 
patent" exists even temporarily.  In order to deal with and solve these problems, we think it useful to 
develop a database related to genetic resources and to traditional knowledge accessible by examiners 
worldwide. IP/C/W/472 
Page 6  
 
  A. E
XAMPLES OF SO -CALLED "ERRONEOUSLY GRANTED PATENTS " 
25. The cases of Turmeric and Neem are taken up by  those who support disclosure obligations as 
model cases of inventions that utilize genetic r esources and related traditional knowledge and have 
been granted patents erroneously although they do not have novelty and inventive steps and do not 
meet the requirements of patentability. 
26. In the case of Turmeric (United States Pate nt No. 5401504), the patent which had been 
granted once was later rejected in a re-exami nation procedure.  The opponents insisted while 
presenting several documents as evidence that the said  invention which was granted a patent was an 
art which had been used for centuries in a cer tain country.  The docum ents included no-patent 
documents, literature which had been written more  than 100 years ago and literature in local 
languages.  The said invention was finally rejected  based on the presented documents for the reason 
that there was no novelty in it. 
27. In the case of Neem (European Patent No.4362 57), the patent was once granted but later 
revoked.  First, opposition to the granting of the patent  was made after the granting of the patent.  The 
opponent to the granting of the patent insisted, while presenting several documents as evidence, that 
there was neither novelty nor inventive steps.  In  the opposition procedure, it was judged that there 
was neither novelty nor inventive steps in the invent ion.  The applicant of the invention, who had an 
objection to the decision, demanded a trial, but in the trial, the invention was finally revoked for the 
reason that there was no inventive step, based on the literature other than the patent documents 
presented at the time of the opposition phase. 
B. THE CAUSE FOR "ERRONEOUSLY GRANTED PATENTS " 
28. It is possible to surmise that examiners gran ted the patents because the examiners could not 
access the evidence which verified th at these inventions had a lack of novelty and/or inventive steps 
or recognize that the documents referred to prior art.  
29. The documents, which were presented when the fi nal decisions of rejection were made, were 
the documents presented by a third party, and the examiners had not cited these documents in the list 
of reference data at the time the patents were gran ted or cited these documents in the research report, 
which was produced during the examination process.  
30. We now review whether the examiner could acces s the documents which were referred to at 
the time the examiners made the final decision in the case along the lines of the examination 
procedure in Japan.  
31. During an examination, examiners investigate the prior art relating to the claimed invention.  
It cannot be denied that it is extremely difficult even for an examiner who has expert knowledge of 
the technical field of the claimed invention to i nvestigate all of the available documents, although the 
examiner is able to review patent documents, the database of technical reports available for 
commercial purposes, the authoritative science journals, etc.  It is impossible to examine any and/or 
all documents including technical papers and science journals which exist in the world. 
32. Examining the above two cases in detail, we c ould not admit that the said documents could be 
regarded as (i) patent documents frequently  used or (ii) documents in a database of t echnical papers, 
since in one of the cases, some of the documents were produced more than 100 years ago, and some 
of the documents were non-patent documents written in the local language, and it must have been 
extremely difficult for examiners to examine tho se old documents or the documents written in local 
languages.  In the other case, we could not deny th at it was not an easy task for examiners to find the  IP/C/W/472 
 Page 7 
 
 
  documents referred to, since the docum ents referred to at the final d ecision were not patent documents 
and probably not included in a database of technical papers.  
33. We believe that it is due to many factors such  as language barrier and limitations in database 
facilities, etc, that makes it difficult for the exam iners to find access to adequate prior art documents. 
C. THE SOLUTION FOR THE PROBLEM OF "ERRONEOUSLY GRANTED PATENTS " 
34. An effective solution is, from the viewpoint of Japan, to establish a database related to genetic 
resources and traditional knowledge, which is accessibl e by examiners in any country, in order to 
avoid the erroneous granting of patents for ge netic resources and rela ted traditional knowledge. 
35. As mentioned is in section B above, Japan th inks that the main cause of the erroneous 
granting of patents is the difficulty due to various restrictions which prevent examiners from finding 
documents which verify a lack of novelty and inventiv e steps in inventions;  therefore, we would like 
to point out that an effective and direct solution is to construct a database , which any examiner can 
easily access. 
36. Examiners have currently been conducting prio r art searches with databases.  In order to 
conduct the most efficient prior art search, it is necessary to construct an access-friendly database 
after all.  It is extremely difficult for examiners to  review all of the available documents, since there 
are countless documents referring to the genetic  resources and related traditional knowledge.  
Furthermore, it is even more difficult for examiner s to review various mag azines and old documents.  
In addition, there might exist prior art only passed down by oral tradition.  Therefore, it is highly 
necessary to construct a database of these documents  (and information on the prior art) in order to 
create an environment which enables ex aminers to perform efficient searches. 
Certain consideration has to be paid to the usage of languages in the creation of the database system, 
since the database to be created must be easily utilized by examiners in each country .  
 
37. We cannot expect every examiner to be capable  of understanding every language in the world 
since it is natural that language use varies in a ccordance with each country.  Also, we have to 
recognize that there may be documents described  in indigenous languages which are used by 
indigenous communities.  These language barriers have  to be removed.  One suggestion is that a 
summary, which has been written in a language which every examiner can understand, be attached to 
documents written in indigenous languages.  
The most efficient approach is for each country to  assess and compile the information being integrated 
in the database . 
 
38. There is a countless amount of information and writings related to genetic resources and 
traditional knowledge.  It is impossible for the ne wly created database system to provide all 
information utilized in patent examination or for th e database system to store all genetic resources and 
related traditional knowledge in the world.  Also, there might be several documents concerning the 
same genetic resources and the related traditiona l knowledge, and there might also be information 
passed down only by oral tradition concerning genetic resources and the related traditional 
knowledge.  Under these circumstances, it is the mo st efficient way for each country to assess and 
compile the information concerning genetic resour ces and the related traditional knowledge under its 
own responsibility. IP/C/W/472 
Page 8  
 
  The database system thus created should be one which examiners of all countries in the world can 
utilize on a one-stop-research basis . 
 
39. There are countries which have provided database s of their country's own genetic resources 
and related traditional know ledge.  Needless to say, the data bases thus created should be easily 
accessible to and utilized by examiners in any countr y, as applications for pa tents on genetic resources 
and related traditional knowledge are not only file d domestically but also internationally.   
40. For instance, "camu-camu" is a plant growing no t only in one country but also beyond the 
borders of countries. Therefore, it is not sufficien t for examiners to search  the database in one 
particular country, even if that country has its own database.  It is necessary for examiners to 
investigate the database of each country in whic h "camu-camu" grows.  It really imposes a heavy 
burden on examiners who have to carry out the investigation within a limited time schedule.  
Additionally, the search work imposes a heavy burden on examiners if each database requires a 
different approach or different way of conducting a search, and unde r such conditions, it is almost 
impossible for examiners to investigate all databas es within a limited time schedule. Consequently, a 
new system has to be a one-stop system where ge netic resources and rela ted traditional knowledge 
can be searched once and comprehensively and not a system in which each database created by each 
country has to be searched separately.  The one-s top database system thus proposed could be an 
all-in-one consolidated system or be composed of multiple systems easily searchable with one click.  
Sufficient discussion has to be conducted to determin e how to create the most efficient database in the 
foreseeable future.   
41. The discussion over the creation of such a database has to be done under the initiative of an 
international organization such as WIPO, which is r esponsible for administering intellectual property, 
as the database system should be utilized by examiners of patents in every country. 
IV. DISCLOSURE COUNTRY OF ORIGIN/PROVIDING COUNTRY/SOURCE, 
EVIDENCE OF PRIOR INFORMED CONSENT (PIC), EVIDENCE OF BENEFIT-SHARING IN PATENT APPLICATIONS, AND PREVENTION OF 
ERRONEOUSLY GRANTED PATENTS    
42. Several countries insist that the risk of errone ously granted patents is reduced by disclosing 
the country of origin/providing country/source, evidence of prior inform ed consent (PIC), and 
evidence of benefit-sharing in patent applica tions because such disclosure provides additional 
information which patent examiners can use when th ey conduct prior art search.  However, based on 
the following reasons, we cannot accept this point of view.  
A. I
NFORMATION ABOUT COUNTRY OF ORIGIN /PROVIDING COUNTRY /SOURCE OF THE GENETIC 
RESOURCES AND RELATED TRADITIONAL KNOWLEDGE  IS IRRELEVANT TO JUDGMENT OF 
NOVELTY AND INVENTIVE STEPS BY THE PATENT EXAMINER .  SIMILARLY , EVIDENCE OF PIC  
AND EVIDENCE OF BENEFIT -SHARING RELATED TO GENETI C RESOURCES AND TRADITIONAL 
KNOWLEDGE IS IRRELEVANT IN JUDGM ENT OF NOVELTY AND INVENTIVE STEPS .  
43. "Novelty" and "inventive steps (un-obviousness)" are words that are u sed in the PCT, the 
TRIPS Agreement, etc.  There are no clear defin itions of these words in the TRIPS Agreement.  
However, in the PCT, the following definitions are provided. 
PCT 
Article 33 The International Preliminary Examination  
 (2) For the purposes of the international pr eliminary examination, a claimed invention 
shall be considered novel if it is not anticipated  by the prior art as defined in the Regulations.  IP/C/W/472 
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 (3) For the purposes of the international pr eliminary examination, a claimed invention 
shall be considered to involve an inventive step if, having regard to the prior art as defined in the Regulations, it is not, at the prescribed releva nt date, obvious to a person skilled in the art. 
 
 Regulations under the PCT 
 Rule 64:  Prior Art for International Preliminary Examination 
 64.1:  Prior Art  (a) For the purposes of Article 33(2) and (3 ), everything made available to the public 
anywhere in the world by means of written disclosure (including drawings and other 
illustrations) shall be considered prior art provi ded that such making available occurred prior 
to the relevant date. 
 
44. Whether only information made available to the public by means of written disclosure is 
defined as prior art or whether all information (wri tten or verbal) made available to the public is 
considered to be prior art depends on the IP re gulations of each country.  Another difference among 
countries, depending on the regulations of a country , is whether only the prior art of a country is 
considered or whether the prior art of a country a nd that of other countries is  considered when judging 
novelty and inventive steps. 
45. Let us examine the following hypothetical case , considering all information existing in any 
place in the world as prior art, which is simila r to the definition of prior art in the PCT. 
(Hypothetical case) 
 
Suppose that the claimed invention is a 'synth etic resin in which the juice of genetic 
resource A is mixed with a raw material.'  In the claims of the filed documents, the i nvention is described as a 'synthetic resin in 
which the juice of genetic resources A is mi xed with raw material,' and there is no 
description of the country of origin of the genetic resources, etc. in the claims.  
Suppose that in the filed documents outside of the claims, it is disclosed that the 
country of origin of genetic resources A is X, and evidence of PIC as well as the sharing of benefits is disclosed.   Additionally, suppose that said invention h as the effect that adding the juice of 
genetic resources A increases the strength of the resin considerably. 
 
The relationship between the effect of an invention and genetic resources 
 
46. Generally, the specific characteristic of genetic  resource A will not change regardless of the 
country in which it was obtained.  Therefore, the eff ect of the invention to increase the strength of the 
resin is the same, regardless of the country form  which resource A that is actually used in the 
invention was obtained.  
47. That is to say, the genetic resource A from the country of origin X has been chosen and 
utilized in the invention by chance.  It is not b ecause the genetic resource A from the country of origin 
X is especially effective for increasing the strength of the resin.  This holds true if the country 
providing the resource and the source are considered in stead of the country of origin.  Additionally, it 
is needless to say that the obtaining of PIC or the sharing of benefits makes no difference to the effect 
of invention.  IP/C/W/472 
Page 10  
 
  Prior art search by examiners 
 
48. Let us consider how an examiner conducts a search of prior art in this case. 
49. The examiner will search the prior art related to the utilization of the genetic resource A, 
irrespective of the country of origin.  There are two meanings in "irrespective of the country of 
origin".  
50. The first meaning is that the country in which th e technical information exists is irrelevant.  
The technical information related to the usage of ge netic resource A produced in the country of origin 
X may exist not only in said country X, but it is also possible that the technical information related to the usage of genetic resource A produced in the country of origin X exists in the country of origin Y.  
Therefore, it is necessary to search  worldwide for technical information relating to the usage of 
genetic resource A, even if, in fact, the claimed invention used genetic resource A produced in the 
country of origin X.  
51. The second meaning is that the technical informati on is irrelevant to the country of origin of 
the genetic resource A that is actually used in th e invention.  For example, there may be technical 
information in which only the use of genetic resour ce A is clearly specified, but not the country of 
origin of genetic resource A.  Additionally, ther e may be technical information which describes the 
use of the genetic resource A from the country of origin X or the use of genetic resource A from the 
country of origin Y.  All technical information is  examined as documents of prior art, regardless of 
whether the country of origin has been clearly specifi ed, or, if it has been clea rly specified, regardless 
of the country of origin of the genetic resource, because the specific charac teristics of the genetic 
resource A do not differ in any country from which it has been obtained.  More over, in the case where 
"the juice of genetic resource A," is only described but the country of origin is not defined in the 
claims, the claimed invention cannot be interpreted as referring to "the juice of the genetic resource A 
from the country of origin X," even though the country of origin X is disclosed in documents filed other than the claims.  This is also another reason why the technical information related to the genetic 
resource A has to be searched, regardless of the country of origin of the genetic resource A.  
52. An examiner's search of the prior art related to genetic resource A is irrelevant to the country 
of origin, and, therefore, information about the c ountry is not necessary.  This holds true if the 
countries providing the resource and the source are c onsidered instead of the country of origin.  
Additionally, it is obvious that evidence of PIC a nd sharing benefits is not necessary information for 
examiners to search prior art. 
In case that the scope of prior art is limited to the prior art in one's country 
 
53. Not every country has adopted the definition of prior art specified in the PCT.  Some 
countries limit the scope of prior art to the prior ar t in their own countries.  Supposing that country Y 
has adopted the definition of prior art mentione d above, then a prior art search is conducted as 
follows.  
54. In countries other than country Y, there is tec hnical information related to the use of genetic 
resource A produced in the country of origin X or te chnical information related to the use of genetic 
resource A produced in the country of origin Y.  Ho wever, in country Y, it is not permitted to include 
technical information that exists in the country of  origin X in searches of prior art, on the grounds 
that, in fact, genetic resource A produced in the countr y of origin X has been u sed in the invention.  
Only the technical information that ex ists in country Y may be searched. 
55. In country Y, the technical information on the use of genetic resource A from country X and 
the technical information on the use of genetic resource A from country Y may possibly exist.  As  IP/C/W/472 
 Page 11 
 
 
  mentioned before, the specific characteristics of th e genetic resource A are identical regardless of the 
country from which the genetic resour ce A is obtained;  therefore, the technical information related to 
the use of genetic resource A is to be searched , regardless of the country from which the genetic 
resource A is obtained.  
56. Therefore, information about the country of or igin of a genetic resource is not necessary in 
prior art search, even though the scope of the prior art is limited to prior art in one's own country. 
Judgment of novelty and inventive steps  
 57. Let us examine how an examiner makes a judgment about novelty and inventive steps. 
58. First, an examiner judges whether a claimed inve ntion is the prior art that was described in 
documents found in the prior art search;  in other wo rds, whether a claimed invention is identical to 
the prior art.  If "a synthetic resin in which the jui ce of the genetic resource A of the country of origin 
Y is mixed with raw material" is found in the prior art, the said prior art and the claimed invention are 
judged to be identical, in this case where the country of origin of the genetic resource A is not recited 
in the claims.  (Supposing there was a description of "the genetic resource A of the country of origin 
X" in the claim, and the specific characteristics of the genetic resource A were identical regardless of 
the country from which the genetic resource A had been collected, the said pr ior art and the claimed 
invention would be judged to be identical, and the in formation about the country of origin would have 
no effect on the judgment of novelty.) 
59. In the case that a claimed invention is different  from the prior art, it is judged whether the 
claimed invention involves an inventive step;  in other words, if, having referred to the prior art, 
whether such a claimed invention is obvious to a person  skilled in the art.  First, an examiner finds the 
prior art most similar to the claimed invention, comp ares the said prior art most similar to the claimed 
invention with the claimed invention, and defines the differences between them.  Then, the examiner 
examines the differences, taking into account not only the said prior art but also other prior art and common general technical knowledge and judges wh ether the different elements the claimed 
invention contains are obvious to a person with ordina ry creativity and skill in the art, as the result of 
having referred to the most similar prior art.  In other words, the examiner examines whether a person 
skilled in the art could have easily made the clai med invention based on the most similar prior art by 
combining other prior art or techniques with the said prior art.  This is a technical judgment.  If the specific characteristics of the genetic resource A do not differ according to the country from which the 
genetic resource A was collected, the information about  the country of origin does not have an effect 
on this judgment.  (Supposing there were a descripti on of "the genetic resource A of the country of 
origin X" in the claim, the information about the co untry of origin would not have an effect on this 
judgment, and the information about the country of origin would have no effect on the judgment of inventive steps, if the specific characteristics of the genetic resource A did not differ according to the 
country from which the genetic resource A had been collected.) 
60. In this way, examiners do not utilize information on countries of origin of genetic resources in 
judging novelty and inventive steps.  This holds tr ue if the country providing the genetic resource and 
the source are considered instead of the country of  origin.  There are no technical implications in 
evidence of PIC and evidence of the sharing of benefits;  consequently, it goes without saying that examiners do not utilize such information when th ey make judgments about novelty and inventive 
steps. 
61. In this manner, the judgments of novelty a nd inventive steps are not associated with 
information about the country of origin, the country  providing the resource, and the sources of genetic 
resources and related traditional knowledge.  Moreover, the judgments  of novelty and inventive steps 
are not associated with evidence based on prior in formed consent relating to genetic resources and IP/C/W/472 
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  traditional knowledge or evidence of the sharing of benefits.  The erroneous granting of a patent for 
an invention, which does not meet the requirements for novelty and inventive steps, cannot be prevented if information which is not useful for making judgments about novelty and inventive steps 
is provided.  
B. E
VEN IF A GENETIC RESOURCE COLLECTED IN  A SPECIFIC PLACE HAS ITS OWN SPECIFIC 
CHARACTERISTICS , THIS DOES NOT SUFFICIENTLY EXPLAIN THE NECESSITY OF IMPOSING THE 
NEW OBLIGATIONS OF DISCLOSURE .   
62. Thus far, we have explained on the premise that the specific characteristics of the genetic 
resource A are identical, regardless of the country in which the genetic resource A is produced, as long as the generally identical genetic resource A is used.  However, there is a counterargument that a 
genetic resource collected in a specific place might have characteristics different from those collected 
in other places.  
63. Even if a genetic resource collected in a sp ecific place has its own specific characteristics, 
which differ from the characteristics of a resource collected in another place, and an invention was made by utilizing such specific characteristics, th is does not sufficiently explain the necessity of 
imposing a new, additional obligation of disclosure on an applicant. 
64. Suppose, for instance, that the genetic resource A of the country of origin X has a specific 
feature Z.  In such a case, the claimed invention might be found to encompass the genetic resource of 
the country of origin Y, if the claim does not describe the country of origin but only mentions "using the genetic resource A."  Even if the words of "the country of origin X" are written in a part of the 
filed documents other than the claims, the claimed invention will be found as described in the claims;  
therefore, it will be found as if the country of or igin of the genetic resource were any country.  
Consequently, if there is a prior art technology usi ng the genetic resource A of the country of origin 
Y, the novelty and inventive steps of the claimed invention will be judged based on the technology, and as a result, the claimed invention will be rejected .  In other words, even if a genetic resource 
collected in "the country of origin X" has specif ic characteristics, inform ation which were to be 
disclosed in accordance with the new obligations of disclosure would not have any effect on the 
novelty and inventive steps if the country of origin  were to be described in a part of the filed 
documents other than the claims. 
65. If the invention focuses its attention on the charact eristic Z, which is specific to the genetic 
resource A of the country of origin X, and uses the genetic resource A of the country of origin X, the 
applicant needs to describe the technical matters in the claims in order to clarify the features of the 
invention which cannot be obtained by using the gene tic resource of the country of origin Y and to 
define the superiority of the invention or to reveal the technical significance of the invention in the filed application.  In this instance, it is necessary to describe in the claims, not that "the country of 
origin is X," but technical matters which directly define the characteristic Z (for example, the specific 
components, the specific genetic structure, etc.) be cause it is difficult to say that the phrase, "the 
country of origin X," distinguishes the characteristic Z from the technical point of view.  Even if most 
genetic resources A of the country of origin X have the specific characteristic Z, there is no guarantee 
that all of the individual genetic resources A equally  have the specific characteristic Z.  It is not 
possible to justify the obligation of disclosing the c ountry of origin within the claims even if the 
invention focuses its attention on the characteristic Z and uses the genetic resource A of the country of 
origin X. 
66. In addition, we would like to note the enablement requirement in this area.  When describing 
the technical matters which directly distinguish the characteristic Z in the cl aims, the applicant needs 
to explain in the filed documents the technical significance of using the genetic resource of the 
country of origin X or the specific characteristic Z in the genetic resource A of the country of origin X  IP/C/W/472 
 Page 13 
 
 
  and the technical matters which directly distinguish the characteristic Z so as to make a person skilled 
in the art understand the invention and make a thir d party understand and carry out the invention.  The 
applicant also needs to describe how to obtai n the genetic resource A which has the specific 
characteristic Z.  It may be required to include in  the filed documents descriptive information, namely 
"the country of origin X," as such information makes it possible to obtain the genetic resource A 
which has the specific characteristic Z.  Although it may be possible to obtain the genetic resource A 
which has the specific charact eristic Z easily if we find the country of origin, it is not always possible. 
In the case that it is difficult to sufficiently discl ose the genetic resource A which has the specific 
characteristic Z in the specifications in order for a th ird party to easily obtain the genetic resource, it is 
necessary to commit the genetic resource A to the care of a deposit organization based on the patent 
law of each country or the Budapest Treaty on the International Recognition of the Deposit of 
Microorganisms for the Purposes of Patent Procedure.  Thus disclosing "the country of origin X" does 
not always fulfil the enablement requirement. 
67. Therefore, it is concluded that even in th e case that only a genetic resource from a specific 
place has a specific characteristic, this does not su fficiently justify the necessity to impose the new 
disclosure obligation. 
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