RESTRICTEDWORLD TRADE
ORGANIZATIONIP/C/W/251/Add.1
11 July 2001
(01-3449)
Council for Trade-Related Aspects
of Intellectual Property RightsOriginal:  Spanish
REVIEW OF LEGISLATION
Replies by Bolivia to Follow-up Questions Posed by Japan
Addendum
By means of a communication from the Permanent Mission of Bolivia, dated 22 June 2001,
the Secretariat has received the following replies to  follow-up questions posed by Japan, circulated in
document IP/C/W/238/Add.1.
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A. PATENTS
3. (i) Please describe how Decision 486 of the Commission of the
Cartagena Agreement and, if applicable, its national legislation define the notion
of "invention", in the light of Articl e 27.1 of the TRIPS Agreement stipulating
that patents shall be available for any "inventions" in all fields of technology,
provided that they are new, involve an inventive step and are capable of
industrial application.  What is the reasoning that  the subject-matters
prescribed in Article 15(b) of Decision 486 are deemed non-inventions;  is itbecause they exist in nature or because they are related to living things or
biological material?
Decision 486 does not include any definition of the notion of invention;  however, patents are
granted "for inventions, whether products or processes, in all fields of technology, provided they are
new, involve an inventive step and are capable of industrial application".
The items described in Article 15(b) of Decision 486 are not considered to be inventions
because they do not comply with the patentability requirements laid down in Article 14 of the
Decision, being products of nature and not man-made inventions.  For there to be an invention, what
already exists in nature must be transformed by man.
(ii) If a living thing, its part or biological material that has no previously recognized
existence has been first isolated or purified artificially from its surroundings in
nature (i.e., if it involves "human intervention"), is it deemed an invention under
Article 15 of Decision 486?  Otherwise, is it automatically deemed anon-invention regardless of the extent of human intervention involved?
Biological material that has not previously been identified in nature and has been isolated or
purified artificially from its surroundings in nature is not deemed to be an invention within the context
of Article 15 of Decision 486.  However, under Arti cle 14 of Decision 486 the technological processIP/C/W/251/Add.1
Page 2
whereby the material has been isolated is deemed to be a patentable invention.  Thus, any separation,
isolation or purification process that complies with the patentability requirements can be the subject of
a process patent.
(iii) Where a particular type of chemical substance exists in nature but is neither a
part or whole of a living thing nor a biological material (such as carbon beads
isolated from the oil residue which is produced through the oil refinement
process when lamp oil and light oil are removed from crude oil), is it deemed an
invention under Article 15 of Decision 486 if it is first isolated or purified
artificially from its surroundings?
We can only confirm the provisions of Article 14 of Decision 486 and the Government of
Bolivia's reply to Question 3(ii), and repeat that any separation, isolation or purification process that isnot intrinsic and complies with the patentability requirements may be the subject of a process patent.
Follow-up question
Please indicate whether or not a chemical substance (not a living thing or a procedure)
described in Japan's earlier Questi on 3(iii) is deemed an invention.
A chemical substance that exists in nature is not  deemed to be an invention.  Such a substance
would be a product of nature or a discovery but not a man-made invention.  The mere separation,
isolation or purification of substances existing in nature does not make separated, isolated or purifiedsubstances patentable, except where these have been intrinsically transformed.  A product existing in
nature must be transformed by man in order to be deemed an invention.
Without prejudice to the foregoing, any separation, isolation or purification process may be
the subject of a process patent where it fulfils the patentability requirements.
4. Please explain whether or not the below-listed subject-matters are deemed an invention
under Article 15 of Decision 486 and, if applicable, its national legislation.  If any of those
subject-matters is deemed a non-invention, please specify the reason. Please suppose that (a),
(h), (i), (l), (m), (n), and (o) have been no previously recognized existences and have been first
isolated or purified artificially from their surr oundings in nature, and that all of those listed
meet other requirements for patenting, such as novelty (in the sense that they have not beenknown to the public), an inventive step, and industrial applicability.
(a) Human insulin isolated or purified from beta cells of a human pancreas
Not deemed to be an invention.  See replies to Questions 3(ii) and 3(iii).
(b) A gene which encodes  the said human insulin
If it is a question of a gene already existing in the human body, that is to say,
discovered in and isolated from the human body, it is not deemed to be an invention.
If it is a question of a gene created by man (for example, by genetic engineering) and
when introduced into the human body, or an appropriate medium, encodes and is
expressed in the production of human insulin, it is deemed to be an invention.IP/C/W/251/Add.1
Page 3
(c) An expression vector which carries the said gene
If it is a question of an expression vector already existing in the human body or in
nature, it is not deemed to be an invention.  An expression vector created by man
would be deemed to be an invention.
(d) Escherichia coli  transformed by the said expression vector
In the cases mentioned in subparagraphs (d), (h), (i) and (j) relating to
micro-organisms, Bolivia applies the provisions of Article 27.3(b) of the
TRIPS Agreement, via Decision 486 of the Andean Community.  Since the
discussion of this topic is to be taken up again at WTO level, the Andean Decision in
question states this commitment in a transitional provision.
(e) A process for producing human insulin by culturing the said Escherichia coli
Deemed to be an invention.
(f) Recombinant human insulin obta ined by the said process
Deemed to be an invention.
(g) A mutant obtained by genetically modifying the said recombinant human insulin
Deemed to be an invention.
(h) Baker's yeast isolated or purified artificially from its surroundings in nature
See the reply under subparagraph (d).
(i) A micro-organism which is isolated or purified artificially from its surroundings
in nature and produces an antibiotic mycin X
See the reply under subparagraph (d).
(j) An antibiotic mycin X produced by the said micro-organism
See the reply under subparagraph (d).
(k) A mutant obtained by artificially muta ting the said micro-organism with UV ray
Deemed to be an invention.
(l) A hybridoma which produces an antibody recognizing antigen A
(m) Human hepatocyte Y
If it is a question of an hepatocyte already existing in the human body (or in nature), it
is not deemed to be an invention.  An hepatocyte created by man would be deemed to
be an invention.
(n) Human liver tissue Z
Not deemed to be an invention.  See replies to Questions 3(ii) and 3(iii).IP/C/W/251/Add.1
Page 4
(o) Carbon beads isolated from the oil resi due which is produced through the oil
refinement process when lamp oil and light oil are removed from crude oil
Follow-up question
Please indicate whether or not the subject-matters of items (d), (h), (i), and (j) of Japan’s
earlier Question 4 are deemed inventions.  Please  also provide replies as to items (l) and (o),
indicating whether or not the subject-matters of such items are deemed inventions (please note
your answer as to item (n) is likely the answer as  to item (o) and provide, if needed, a revised
answer as to item (n)).
The following criteria apply in establishing whether the subject-matters listed in
subparagraphs (d), (h), (i), (j), (l), (n) and (o) of Question 4 above are deemed to be inventions:
(d) Escherichia coli  transformed by the said expression vector
A micro-organism modified by man is deemed  to be an invention.  If transformed by
means of the expression vector in question (or by any other method), it is considered
an invention, because it is not Escherichia coli  existing in nature.
(h) Baker's yeast isolated or purified artificially from its surroundings in nature
Baker's yeast isolated or purified from its surroundings in nature is not deemed to be
an invention.  It is a product of nature, not a man-made invention.  The mere isolation
or purification of a substance already existing in nature does not make this substancepatentable, even if its existence was not known previously.  A product of nature must
be transformed by man to be considered an invention.
(i) A micro-organism which is isolated or purified artificially from its surroundings 
in nature and produces an antibiotic mycin X
A micro-organism which is isolated or purified from its surroundings in nature is not
deemed to be an invention.  It is a product of nature, not a man-made invention.  The
mere isolation or purification of a substance already existing in nature does not make
this substance patentable, even if its existence was not known previously.  The
method whereby isolation is achieved is irrelevant in this regard, so that even if the
method of isolation were novel, the substan ce thus isolated would not be patentable.
A micro-organism, which is a product of nature, must be transformed by man to be
deemed to be an invention.  A micro-or ganism not modified by man would be a
product of nature and would not be considered an invention.
(j) An antibiotic mycin X produced by the said micro-organism
The patentability of the antibiotic produced by the micro-organism in question
depends on whether the antibiotic constitutes an invention.  If the antibiotic was being
produced naturally by the micro-organism prior to the latter's isolation and
purification, the antibiotic would be regarded as a product of nature and would not
deemed to be an invention.
On the other hand, if the micro-organism, as a result of its isolation and purification
through human intervention, produces a substance (an antibiotic) that it was not
producing in its natural state, the antibiotic in question could be considered to be theIP/C/W/251/Add.1
Page 5
result of human intervention.  In such a case, the antibiotic (but not the micro-
organism) could be deemed to be an invention, as it would stem from human impact
on nature.
(l) A hybridoma which produces an antibody recognizing antigen A
Deemed to be an invention.
(n) Human liver tissue Z
As regards human liver tissue, if it is a qu estion of liver tissue already existing in the
human body (that is, in nature), this is not considered an invention.  Artificial liver
tissue, created by man, could in principle be deemed to be an invention.
(o) Carbon beads isolated from the oil resi due which is produced through the oil 
refinement process when lamp oil and light oil are removed from crude oil
Not deemed to be an invention.  A substance existing in nature is not considered an
invention.  Such a substance would be a product of nature or a discovery but not a
man-made invention.  The mere separation, isolation or purification of substances
existing in nature does not make separated, isolated or purified substances patentable,
except where these have been intrinsically transformed.
5. Please explain the relationship between  Article 29.1 of the TRIPS Agreement and
Articles 26(h) and (i) of Decision 486 which oblige patent applicants to submit a copy of the
contract for access to genetic resources and a copy of the documents certifying the authorization
to use of traditional knowledge.  Does your country consider the above-mentioned applicant's
obligation as an enablement requirement which is clearly stipulated in Article 29.1 of the
TRIPS Agreement, or as an additional requireme nt which is not stipulated in that Article?
According to the third complementary provis ion of Decision 391 of the Andean Community
establishing a Common Regime on Access to Genetic Resources:  "The competent national offices on
intellectual property shall require the applicant to give the registration number of the access contract
and supply a copy of it as a prerequisite for granting the respective right, when they are certain orthere are reasonable indications that the products or processes whose protection is being requested
have been obtained or developed on the basis of genetic resources or their by-products which
originated in one of the Member countries".  Article 26(h) of Decision 486 implements the third
complementary provision of Decision 391.  This requirement for additional information also makes it
possible to verify the country of origin of the genetic material, on the basis of which the products or
processes forming the subject-matter of the patent application have been obtained or developed.
Article 29.2 of the TRIPS Agreement states that:  "Members may require an applicant for a
patent to provide information concerning the applicant's corresponding foreign applications and
grants".  Article 26(h) of Decision 486 and the th ird complementary provision of Decision 391 fit
within this context.
Thus, the applicant is required to ensure that he provides information that discloses the
invention sufficiently clearly and completely.
Likewise, Article 35 of Decision 391 states that "when access is requested to genetic
resources or their by-products with an intangible component (associated traditional knowledge), theaccess contract shall incorporate, as an integral part of that contract, an annex stipulating the fair and
equitable distribution of the profits from use of that component and reflecting the consent of theIP/C/W/251/Add.1
Page 6
possessors of the traditional knowledge.  The annex shall be signed by the supplier of the intangible
component and the applicant for or user of the genetic resource".  Thus, Article 26(i) of Decision 486
ensures compliance with Article 35 of Decision 391 and Article 29.2 of the TRIPS Agreement as an
additional information requirement.
Follow-up question
As to Japan’s earlier Question 5, please explai n how you relate a copy of the contract for
access to genetic resources and a copy of the documents certifying the authorization to use of
traditional knowledge to "information concerning the applicant’s corresponding foreign
applications and grants" stipulated in Article 29.2 of the TRIPS Agreement though such copies
are rarely required in foreign applications and grants.
There is no relationship between Article 29.2 of the TRIPS Agreement and Article 26(h)
and (i) of Decision 486 of the Andean Community.  The two Articles cover different subject matter.
Article 29.2 of the TRIPS Agreement stipulates that Members may require an applicant for a
patent to furnish information concerning corresponding foreign applications or grants.  Its purpose isto facilitate verification of requirements for the patentability of the invention.  This is provided for in
Articles 46 and 47 of Decision 486.
The provisions of Article 26(h) and (i) of Decision 486 do not deal with the verification of
patentability requirements.  They simply require verification of the lawful access to genetic resourcesor traditional knowledge serving as a basis for developing an invention.  Their purpose is to help
ensure respect for and compliance with domesti c, Andean Community and international legal
provisions (e.g., the Convention on Biological Diversity) governing access to genetic resources and
traditional knowledge.  Access to genetic resources and traditional knowledge falls within the purview
of intellectual property where the genetic resource or traditional knowledge gives rise to a patentabletechnological development.
In order to deal with such cases, the provisio ns of Decision 486, which are consistent with the
relevant provisions of Decision 391 on access to genetic resources, seek to prevent a patent from
being granted for an invention created on the basis of an unlawfully obtained genetic resource or item
of traditional knowledge.  Patents for inventions are granted by the State as an incentive orinducement for a lawful activity, namely the development of new technologies.  Should such anactivity be conducted on the basis of unlawfully obtained material or information (illegal access to a
genetic resource or traditional knowledge), the State is empowered not to grant a patent.  This is
consistent with the State policy on the protection of genetic resources and traditional knowledge,
which is implemented at several different levels.
Subparagraphs (h) and (i) of Article 26 of Decision 486 lay down requirements concerning
the lawful granting of patents.  As in the case of other requirements for granting patents, these are not
dealt with in the TRIPS Agreement but fall within the scope of the domestic legislation of the WTO
Members.
6. Please explain the rationale of Article 21 of Decision 486 stipulating that a product
which has been already patented and included in the state of the art may not be the subject of a
new patent solely because the product is put to a use different from that originally contemplated
by the initial patent.
Please also explain how Article 21 of Decision 486 complies with Article 27.1 of the
TRIPS Agreement stipulating that patents shall be available for any inventions in all fields of
technology, provided that they are new, involve an inventive step and are capable of industrialIP/C/W/251/Add.1
Page 7
application.  Is the rationale of Article 21 based on the lack of novelty?  If so, can a patent claim
directed to a new "use" (not a "product" as such) be deemed a new invention?  What other
types of patent claims for a new use can be patentable?
Article 21 of Decision 486 stipulates that a product or process already patented and included
in the state of the art may not be the subject of a new patent on the sole ground of having been put to a
use different from that originally contemplated.
Follow-up question
As to Japan’s earlier Question 6, please explain how a known chemical compound whose
therapeutic use was not known can be patented under Section 21 of the Decision 486.  Howabout a known chemical compound whose insecticidal use was not known?
Article 21 of Decision 486 stipulates that a product or process already patented and included
in the state of the art may not be the subject of a new patent on the sole ground of having been put to a
use different from that originally contemplated.  This provision makes it clear that an invention(whether a product or a process) may not be patented anew unless it meets the requirement of novelty
under patent law.  The requirement of novelty may not be circumvented on the ground that theproduct or process is being put to a new use.
Where a known product or process is capable of being used - or applied - in a manner
different from that already known and such use fulfils the requirements for patentability (i.e., that it be
new, involve an inventive step and be capable of industrial application), the new use would constitute
a patentable technical solution.  Such a patent can claim only the new use, not the product itself, as the
latter does not meet the requirement of novelty.
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