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Supplementary Table 1 Survey results on standards and practices to patent biological patent sequences from patent offices in 2011 compared to WIPO
conducted survey in 2001
Country
2001 WIPO survey: 6. Is it possible to obtain a patent in your
territory
d) on chemical structures
e) on chemical structures
comprising nucleotide
comprising amino acid
sequences corresponding in
sequences corresponding to
whole or in part to nucleotide
peptides or proteins produced
sequences found in organisms
by a naturally occurring
(e.g. coding or non-coding)?
organism,
including plant, animals or a
human being?
2011 Cambia's survey: A. In your jurisdiction, is it possible to
obtain a patent on
1) Nucleotide sequences
2) Amino acid sequences
(coding or non-coding)? If no,
(peptides or proteins from a
please explain
naturally occurring organism,
plant, animals, or a human
being? If no, please explain
Australia
Patent protection is available for
nucleotide sequences provided
the sequences meet all the
normal standards of patentability.
In particular, the invention must
be a “manner of manufacture”
(see question 6(b) above) and the
invention must have an industrial
application.
It is possible to obtain a patent for
oligonucleotides, polynucleotides,
peptides, proteins and similar
molecules. If the molecules come
from a naturally occurring
organism or there is a possibility
that they may exist in a naturally
occurring organism, it must be
clear from the patent claims that
the molecule is only being claimed
in a form in which there is some
form of technical intervention
involved, such as being in an
isolated or purified form or being
recombinant.
Answer to question 6(b):
The Australian Patents Act
requires an invention to be a
“manner of manufacture.” This
means a patentable invention
must reflect some technical
intervention by man, and a claim
cannot define a product in such a
Patent protection is available for
peptides and proteins that meet
all the standard criteria for
patentability. As discussed above
in response to 6(b) and (c) the
invention must reflect technical
intervention and show some
discernable industrial application.
Answer to question 6(b):
The Australian Patents Act
requires an invention to be a
“manner of manufacture.” This
means a patentable invention
must reflect some technical
intervention by man, and a claim
cannot define a product in such a
way that it encompasses the
It is possible to obtain a patent for
oligonucleotides, polynucleotides,
peptides, proteins and similar
molecules. If the molecules come
from a naturally occurring
organism or there is a possibility
that they may exist in a naturally
occurring organism, it must be
clear from the patent claims that
the molecule is only being claimed
in a form in which there is some
form of technical intervention
involved, such as being in an
isolated or purified form or being
recombinant.
way that it encompasses the
product as it exists in nature. For
example, if a claim defines protein
X, bacteria X or gene X, where
protein X, bacteria X or gene X
are naturally occuring, then the
claim would be considered to
define unpatentable subject
matter. However, if there has
been some technical intervention
to change the form of the product
from that which exists in nature;
for example the claim defines a
purified or isolated bacteria X,
protein X or gene X, the claim
would be acceptable – provided it
met all standard criteria for
patentability.
product as it exists in nature. For
example, if a claim defines protein
X, bacteria X or gene X, where
protein X, bacteria X or gene X
are naturally occuring, then the
claim would be considered to
define unpatentable subject
matter. However, if there has
been some technical intervention
to change the form of the product
from that which exists in nature;
for example the claim defines a
purified or isolated bacteria X,
protein X or gene X, the claim
would be acceptable – provided it
met all standard criteria for
patentability.
Answer to question 6(c):
Patent protection is available for
new uses of known material. If an
applicant has discovered a new
and previously unsuspected
property of a known compound
which involves an inventive step,
the applicant is entited to claim
use of the compound provided the
claims are limited to this new use
Austria
Only if sufficient technical steps or
a special industrial applicability is
disclosed.
Only if a sufficient technical step
or a special industrial applicability
is disclosed.
N/A
N/A
Belgium
Yes, if it is isolated or otherwise
produced and on the condition
that is has an industrial
application. (law of March 28,
1984, art. 2, directive 98/44, art.
5).
Yes, if it is isolated or otherwise
produced and on the condition
that is has an industrial
application. (law of March 28,
1984, art. 2, directive 98/44, art.
5).
Yes
Yes
..please find hereafter the
provision of art. 4 of the Belgian
Patent law in French: We
unfortunately do not have an
English translation.
..please find hereafter the
provision of art. 4 of the Belgian
Patent law in French: We
unfortunately do not have an
English translation.
Art. 4. § 1er. (Ne sont pas
brevetables :
Art. 4. § 1er. (Ne sont pas
brevetables :
1) les variétés végétales et les
races animales;
1) les variétés végétales et les
races animales;
2) les procédés essentiellement
biologiques pour l'obtention de
végétaux ou d'animaux.)
2) les procédés essentiellement
biologiques pour l'obtention de
végétaux ou d'animaux.)
(§ 1erbis. Les inventions portant
sur des végétaux ou des animaux
sont brevetables si la faisabilité
technique de l'invention n'est pas
limitée à une variété végétale ou à
une race animale déterminée.)
(§ 1erbis. Les inventions portant
sur des végétaux ou des animaux
sont brevetables si la faisabilité
technique de l'invention n'est pas
limitée à une variété végétale ou à
une race animale déterminée.)
(§ 1erter. Le § 1er, 2), n'affecte
(§ 1erter. Le § 1er, 2), n'affecte
pas la brevetabilité d'inventions
ayant pour objet un procédé
microbiologique, ou d'autres
procédés techniques, ou un
produit obtenu par ces procédés.)
pas la brevetabilité d'inventions
ayant pour objet un procédé
microbiologique, ou d'autres
procédés techniques, ou un
produit obtenu par ces procédés.)
§ 2. (Ne sont pas brevetables les
inventions dont l'exploitation
commerciale) serait contraire à
l'ordre public ou aux bonnes
moeurs (, y compris pour protéger
la santé et la vie des personnes et
des animaux ou préserver les
végétaux, ou pour éviter de
graves atteintes à
l'environnement), la mise en
oeuvre d'une invention ne pouvant
être considérée comme telle du
seul fait qu'elle est interdite par
une disposition légale ou
réglementaire.
§ 2. (Ne sont pas brevetables les
inventions dont l'exploitation
commerciale) serait contraire à
l'ordre public ou aux bonnes
moeurs (, y compris pour protéger
la santé et la vie des personnes et
des animaux ou préserver les
végétaux, ou pour éviter de
graves atteintes à
l'environnement), la mise en
oeuvre d'une invention ne pouvant
être considérée comme telle du
seul fait qu'elle est interdite par
une disposition légale ou
réglementaire.
(§ 3. Au titre du § 2, ne sont
notamment pas brevetables :
1° les procédés de clonage des
êtres humains, c'est-à-dire tout
procédé, y compris les techniques
de scission des embryons, ayant
pour but de créer un être humain
qui aurait la même information
génétique nucléaire qu'un autre
être humain vivant ou décédé;
2° les procédés de modification
de l'identité génétique germinale
(§ 3. Au titre du § 2, ne sont
notamment pas brevetables :
1° les procédés de clonage des
êtres humains, c'est-à-dire tout
procédé, y compris les techniques
de scission des embryons, ayant
pour but de créer un être humain
qui aurait la même information
génétique nucléaire qu'un autre
être humain vivant ou décédé;
2° les procédés de modification
de l'identité génétique germinale
de l'être humain;
3° les utilisations d'embryons
humains à des fins industrielles
ou commerciales;
4° les procédés de modification
de l'identité génétique des
animaux de nature à provoquer
chez eux des souffrances sans
utilité médicale substantielle pour
l'homme ou l'animal, ainsi que les
animaux issus de tels procédés.)
de l'être humain;
3° les utilisations d'embryons
humains à des fins industrielles
ou commerciales;
4° les procédés de modification
de l'identité génétique des
animaux de nature à provoquer
chez eux des souffrances sans
utilité médicale substantielle pour
l'homme ou l'animal, ainsi que les
animaux issus de tels procédés.)
(§ 4. Le corps humain, aux
différents stades de sa
constitution et de son
développement, ainsi que la
simple découverte d'un de ses
éléments, y compris la séquence
ou la séquence partielle d'un
gène, ne peuvent constituer des
inventions
brevetables.
(§ 4. Le corps humain, aux
différents stades de sa
constitution et de son
développement, ainsi que la
simple découverte d'un de ses
éléments, y compris la séquence
ou la séquence partielle d'un
gène, ne peuvent constituer des
inventions
brevetables.
Un élément isolé du corps
humain ou autrement produit par
un procédé technique, y compris
la séquence ou la séquence
partielle d'un gène, peut constituer
une invention brevetable, même si
la structure de cet élément est
identique à celle d'un élément
naturel.
Un élément isolé du corps
humain ou autrement produit par
un procédé technique, y compris
la séquence ou la séquence
partielle d'un gène, peut constituer
une invention brevetable, même si
la structure de cet élément est
identique à celle d'un élément
naturel.
L'application industrielle d'une
L'application industrielle d'une
Bulgaria
Chemical structures comprising
nucleotide sequences
corresponding in whole or in part
to nucleotide sequences found in
an organism are protected, where
they meet the patentability criteria
for products of the invention
category.
It is possible to obtain a patent on
chemical structures comprising
amino acid sequences
corresponding to peptides or
proteins produced by a naturally
occurring organism, including
plants, animals or a human being.
séquence ou d'une séquence
partielle d'un gène qui sert de
base à une invention doit être
concrètement exposée dans la
demande de brevet.)
séquence ou d'une séquence
partielle d'un gène qui sert de
base à une invention doit être
concrètement exposée dans la
demande de brevet.)
Republic of Bulgaria has been a
member state of European union
since 1 January 2007 and as such
we should observe all union
regulations, including Directive
98/44 on the legal protection of
biotechnological inventions In
addition it should be noted that we
are member-state of Patent
cooperation treaty and of
European Patent Convention. In
the light of the our national law of
Republic of Bulgaria has been a
member state of European union
since 1 January 2007 and as such
we should observe all union
regulations, including Directive
98/44 on the legal protection of
biotechnological inventions In
addition it should be noted that we
are member-state of Patent
cooperation treaty and of
European Patent Convention. In
the light of the our national law of
protection of the inventions and
registration of utility models, it is
possible [to obtain] a patent on
nucleotide sequences and amino
acid sequences (peptides or
proteins from naturally occurring
organism, plant, animals or
human being) if it does not fall
under the following proviso of the
National Law:
art. 6. (4) The human body at the
various stages of its formation
and development, and the simple
discovery of one of its elements,
including the sequence or partial
sequence of a gene, cannot
constitute patentable invention.
An element isolated from the
human body or otherwise
produced by means of a technical
process, including the sequence
or partial sequence of a gene,
may constitute a patentable
invention, even if the structure of
that element is identical to that of
a natural element.
protection of the inventions and
registration of utility models, it is
possible [to obtain] a patent on
nucleotide sequences and amino
acid sequences (peptides or
proteins from naturally occurring
organism, plant, animals or
human being) if it does not fall
under the following proviso of the
National Law:
art. 6. (4) The human body at the
various stages of its formation
and development, and the simple
discovery of one of its elements,
including the sequence or partial
sequence of a gene, cannot
constitute patentable invention.
An element isolated from the
human body or otherwise
produced by means of a technical
process, including the sequence
or partial sequence of a gene,
may constitute a patentable
invention, even if the structure of
that element is identical to that of
a natural element.
In addition to the abovementioned, we notice that
according to our Law, the
Biotechnological inventions shall
also be patentable if they concern:
biological material which is
isolated from its natural
In addition to the abovementioned, we notice that
according to our Law, the
Biotechnological inventions shall
also be patentable if they concern:
biological material which is
isolated from its natural
environment or produced by
means of a technical process
even if it previously occurred in
nature;
a microbiological or other
technical process, or a product
obtained by means of such a
process other than a plant or
animal variety.
For Your information, we stress
on the fact that the Law does not
allow to be granted patens in
respect of biotechnological
inventions which, in particular,
concern the following:
processes for cloning human
beings;
processes for modifying the germ
line genetic identity of human
beings;
uses of human embryos for
industrial or commercial purposes;
processes for modifying the
genetic identity of animals which
are likely to cause them suffering
without any substantial medical
benefit to man or animal, and also
animals resulting from such
processes.
environment or produced by
means of a technical process
even if it previously occurred in
nature;
a microbiological or other
technical process, or a product
obtained by means of such a
process other than a plant or
animal variety.
For Your information, we stress
on the fact that the Law does not
allow to be granted patens in
respect of biotechnological
inventions which, in particular,
concern the following:
processes for cloning human
beings;
processes for modifying the germ
line genetic identity of human
beings;
uses of human embryos for
industrial or commercial purposes;
processes for modifying the
genetic identity of animals which
are likely to cause them suffering
without any substantial medical
benefit to man or animal, and also
animals resulting from such
processes.
Canada
Yes, chemical structures
composed of a sequence of
nucleic acids and corresponding
to genetic information found in a
living organism are patentable.
Yes, chemical structures
composed of a sequence of
amino acids and corresponding to
an amino acid sequence found in
a living organism are patentable.
yes, isolated and characterized
and claimed as a "molecule", not
as a sequence per se
yes, isolated and characterized
and claimed as a "molecule", not
as a sequence per se
Chile
N/A
N/A
Yes, it is possible to obtain
protection for nucleotides or
amino acids sequences, provided
they meet the patentability
requirements, its structure is
adequately described and it is not
affected by an exclusion of
patentability. According to article
37 letter f) of our industrial
Property Law the following are
excluded from patentability: "F)
Part of living beings as found in
nature, natural biological
processes, biological material
existing in the wild or that might
be isolated, including genome or
germplasm. However, it will be
possible to protect procedures
that use one or more of the
biological materials set out above
and products directly obtained by
them, provided they meet the
requirements of Article 32 of this
law, the biological material being
properly described and that the
industrial application of the same
being sufficiently disclosed in the
patent application."
Yes, it is possible to obtain
protection for nucleotides or
amino acids sequences, provided
they meet the patentability
requirements, its structure is
adequately described and it is not
affected by an exclusion of
patentability. According to article
37 letter f) of our industrial
Property Law the following are
excluded from patentability: "F)
Part of living beings as found in
nature, natural biological
processes, biological material
existing in the wild or that might
be isolated, including genome or
germplasm. However, it will be
possible to protect procedures
that use one or more of the
biological materials set out above
and products directly obtained by
them, provided they meet the
requirements of Article 32 of this
law, the biological material being
properly described and that the
industrial application of the same
being sufficiently disclosed in the
patent application."
China
Yes, they are protected as
chemical products.
N/A
N/A
N/A
Colombia
No. Protection is granted solely to
the sequences of nucleotides that
do not occur in nature or are a
replica of those occurring in
nature. (Paragraph B) of Article 6
of Decision 344, Common Regime
of Industrial Property.
No. Protection is granted solely to
the sequences of amino acids that
do not occur in nature or are a
replica of those occurring in
nature. (Paragraph b) of Article 6
of Decision 344, Common Regime
of Industrial Property.
N/A
N/A
Cuba
No, it is not possible to patent
chemical structures comprising of
nucleotide sequences
corresponding in whole or in part
to that found in an organism.
N/A
N/A
N/A
Czech Republic
N/A
N/A
Yes, patent can be granted on
any of the subjects mentioned
provided it meets other
requirements.
Yes, patent can be granted on
any of the subjects mentioned
provided it meets other
requirements.
Democratic People's Republic
of Korea
Yes, provided that nucleotide
sequences are capable of
industrial application.
Yes, provided that amino acid
sequences are capable of
industrial application.
N/A
N/A
Denmark
Yes, it is possible to obtain a
patent on chemical structures
comprising nucleotide sequences.
Human and animal genes in their
natural state in the body are not
patentable. However, isolated
genes in the shape of a welldefined nucleotide sequence as
well as a synthetic nucleotide
sequence are eligible to be
patented. Examples of allowable
types of claims are nucleotide
sequences, DNA or RNA
sequence, vector, plasmid or
recombinant DNA. Distinctions
are not made as to the source of
the genetic information.
Yes, it is possible to obtain a
patent on chemical structures
comprising amino acid
sequences, even if it exists in
nature provided that it has been
isolated from its natural source.
No distinctions are made to the
source of the amino acid
sequence.
It is possible to obtain a patent on
nucleotide and amino acid
sequences as long as the claims
comprise subject matter that is
patentable under Danish Patent
law, e.g. not directed at methods
of treatment of the human or
animal body, diagnostic methods
or other un-patentable matter.
We adhere to the following
guidelines on sequences: Danish
Patent Guidelines, Part C,
Chapter IV, 5.4. See the
corresponding Guidelines for
Examination in the European
Patent Office, EPC, Part C,
Chapter IV-16, 5.4:“… The
invention claimed must have such
a sound and concrete technical
basis that the skilled person can
recognise that its contribution to
the art could lead to practical
exploitation in industry (T 898/05).
In relation to sequences and
partial sequences of genes, this
general requirement is given
specific form in that the industrial
application of a sequence or a
partial sequence of a gene must
be disclosed in the patent
application. A mere nucleic acid
sequence without indication of a
function is not a patentable
invention (EU Dir. 98/44/EC, rec.
It is possible to obtain a patent on
nucleotide and amino acid
sequences as long as the claims
comprise subject matter that is
patentable under Danish Patent
law, e.g. not directed at methods
of treatment of the human or
animal body, diagnostic methods
or other un-patentable matter.
We adhere to the following
guidelines on sequences: Danish
Patent Guidelines, Part C,
Chapter IV, 5.4. See the
corresponding Guidelines for
Examination in the European
Patent Office, EPC, Part C,
Chapter IV-16, 5.4:“… The
invention claimed must have such
a sound and concrete technical
basis that the skilled person can
recognise that its contribution to
the art could lead to practical
exploitation in industry (T 898/05).
In relation to sequences and
partial sequences of genes, this
general requirement is given
specific form in that the industrial
application of a sequence or a
partial sequence of a gene must
be disclosed in the patent
application. A mere nucleic acid
sequence without indication of a
function is not a patentable
invention (EU Dir. 98/44/EC, rec.
23). In cases where a sequence
or partial sequence of a gene is
used to produce a protein or part
of a protein, it is necessary to
specify which protein or part of a
protein is produced and what
function this protein or part of a
protein performs. Alternative,
when a nucleotide sequence is
not used to produce a protein or
part of a protein, the function to be
indicated could e.g. be the
sequence exhibits a certain
transcription promoter activity”.
23). In cases where a sequence
or partial sequence of a gene is
used to produce a protein or part
of a protein, it is necessary to
specify which protein or part of a
protein is produced and what
function this protein or part of a
protein performs. Alternative,
when a nucleotide sequence is
not used to produce a protein or
part of a protein, the function to be
indicated could e.g. be the
sequence exhibits a certain
transcription promoter activity”.
Ecuador
Yes, with the exception of material
composing the human body and
its genetic identity.
Yes, with the exception of material
composing the human body and
its genetic identity.
N/A
N/A
Estonia
N/A
N/A
It is possible to apply protection
for the sequence of nucleotides
and amino acids.
It is possible to apply protection
for the sequence of nucleotides
and amino acids.
Ethiopia
There is no explicit provision to
that effect. But, it is a matter of
whether such chemical structures
do constitute essentially biological
processes or not.
Basically, there is no patent
system for biotechnology in
general, and modern
biotechnology (genetic
engineering) in particular in our
country.
N/A
N/A
European Union
Article 5(b) of the directive
provides that an element isolated
from the human body or otherwise
produced by means of a technical
process, including the sequence
or partial sequence of a gene,
may constitute a patentable
invention, even if the structure of
that element is identical to that of
a natural element.
Article 5(b) of the directive
provides that an element isolated
from the human body or otherwise
produced by means of a technical
process, including the sequence
or partial sequence of a gene,
may constitute a patentable
invention, even if the structure of
that element is identical to that of
a natural element.
N/A
N/A
Finland
Yes, the industrial application of
the sequence must be disclosed
in the patent application.
Yes, the industrial application of
the amino acid sequence must be
disclosed in the patent
application.
YES (if they are novel, involve an
inventive step and are industrially
applicable)
YES (if they are novel, involve an
inventive step and are industrially
applicable)
France
N/A
N/A
For a French patent application,
listings of nucleotide and/or amino
acid sequences can be joined to
the description. For more details,
see
http://www.inpi.fr/fr/brevets/boitea-outils-brevet/directives-examendemande-de-brevet.html
For a French patent application,
listings of nucleotide and/or amino
acid sequences can be joined to
the description.
Germany
By way of supplementation of the
remarks that follow it has to be
noted that in any case the general
requirements for the grant of a
patent have to be fulfilled, i.e. the
invention is susceptible of
industrial application, is new and
involves an inventive step.
Yes, under the conditions in
Article 3, paragraph 2,
Biotechnology Directive (see
above).
By way of supplementation of the
remarks that follow it has to be
noted that in any case the general
requirements for the grant of a
patent have to be fulfilled, i.e. the
invention is susceptible of
industrial application, is new and
involves an inventive step.
Yes, under the conditions in
Article 3, paragraph 2,
Biotechnology Directive (see
above).
Under German law, it is in general
possible to obtain a patent on
coding and non-coding nucleotide
sequences and on amino acid
sequences, including peptides or
proteins from naturally occurring
organisms, plants, animals, or
human beings.
Under German law, it is in general
possible to obtain a patent on
coding and non-coding nucleotide
sequences and on amino acid
sequences, including peptides or
proteins from naturally occurring
organisms, plants, animals, or
human beings.
Great Britain
N/A
N/A
Yes, as long as certain
requirements are met (e.g. see
http://www.ipo.gov.uk/biotech.pdf
regarding environment or proceed
by means of a technical process,
and the requirements relating to
novelty inventive step and
industrial application).
Yes, as long as certain
requirements are met (see
above).
Greece
N/A
N/A
In principal yes. However,
industrial applicability has to be
disclosed for the patented
sequences.
Our law is similar to the
provisions included in the
European Patent Convention for
biotechnological inventions.
The Greek Patent Office has
similar practices with The
European Patent Office.
In principal yes. However,
industrial applicability has to be
disclosed for the patented
sequences.
Our law is similar to the
provisions included in the
European Patent Convention for
biotechnological inventions.
The Greek Patent Office has
similar practices with The
European Patent Office.
Hong Kong
N/A
N/A
For provisions regarding
patentable inventions, please
refer to section 93-97 of the
Patents Ordinance (Cap. 514).
Full texts of the Patents
Ordinance are available at
http://www.ipd.gov.hk/eng/intellect
ual_property/ip_laws/patents.htm.
In particular, we would like to
draw your attention to section 93
of the Patents Ordinance.
For provisions regarding
patentable inventions, please
refer to section 93-97 of the
Patents Ordinance (Cap. 514).
Full texts of the Patents
Ordinance are available at
http://www.ipd.gov.hk/eng/intellect
ual_property/ip_laws/patents.htm.
In particular, we would like to
draw your attention to section 93
of the Patents Ordinance.
Section 93 of the Patents
Ordinance – Patentable
inventions
Section 93 of the Patents
Ordinance – Patentable
inventions
(1) An invention is patentable if it
is susceptible of industrial
application, is new and involves
an inventive step.
(2) The following in particular shall
not be regarded as inventions
within the meaning of subsection
(1)(a) a discovery, scientific
theory or mathematical method;
(b) an aesthetic creation;
(c) a scheme, rule or method
for performing a mental act,
playing a game or doing business,
or a program for a computer;
(d) the presentation of
information.
(3) Subsection (2) shall exclude
(1) An invention is patentable if it
is susceptible of industrial
application, is new and involves
an inventive step.
(2) The following in particular shall
not be regarded as inventions
within the meaning of subsection
(1)(a) a discovery, scientific
theory or mathematical method;
(b) an aesthetic creation;
(c) a scheme, rule or method
for performing a mental act,
playing a game or doing business,
or a program for a computer;
(d) the presentation of
information.
(3) Subsection (2) shall exclude
patentability of subject-matter or
activities referred to in that
subsection only to the extent to
which a patent or patent
application relates to such
subject-matter or activities as
such.
(4) A method for treatment of the
human or animal body by surgery
or therapy and a diagnostic
method practised on the human or
animal body shall not be regarded
as an invention which is
susceptible of industrial
application for the purposes of
subsection (1), but this subsection
shall not apply to a product, and in
particular a substance or
composition, for use in any such
method.
(5) An invention the publication or
working of which would be
contrary to public order ("order
public") or morality shall not be a
patentable invention; however, the
working of an invention shall not
be deemed to be so contrary
merely because it is prohibited by
any law in force in Hong Kong.
(6) A plant or animal variety or an
essentially biological process for
the production of plants or
animals, other than a
microbiological process or the
patentability of subject-matter or
activities referred to in that
subsection only to the extent to
which a patent or patent
application relates to such
subject-matter or activities as
such.
(4) A method for treatment of the
human or animal body by surgery
or therapy and a diagnostic
method practised on the human or
animal body shall not be regarded
as an invention which is
susceptible of industrial
application for the purposes of
subsection (1), but this subsection
shall not apply to a product, and in
particular a substance or
composition, for use in any such
method.
(5) An invention the publication or
working of which would be
contrary to public order ("order
public") or morality shall not be a
patentable invention; however, the
working of an invention shall not
be deemed to be so contrary
merely because it is prohibited by
any law in force in Hong Kong.
(6) A plant or animal variety or an
essentially biological process for
the production of plants or
animals, other than a
microbiological process or the
Hungary
N/A
N/A
products of such a process, shall
not be patentable.
products of such a process, shall
not be patentable.
The answer to points "A 1) and A
2)" is yes. For more details,
please, check article 5/A
(patentable biotechnological
inventions) and article 6
(exclusions from patentability) at:
http://www.hipo.gov.hu/English/jo
gforras/Patent_Act_XXXIII_1995_
EN.pdf " (2) Biological material
which is isolated from its natural
environment or produced by
means of a technical process may
be the subject of an invention
even if it previously occurred in
nature."
The answer to points "A 1) and A
2)" is yes. For more details,
please, check article 5/A
(patentable biotechnological
inventions) and article 6
(exclusions from patentability) at:
http://www.hipo.gov.hu/English/jo
gforras/Patent_Act_XXXIII_1995_
EN.pdf
You will see, that the Hungarian
patent legislation is harmonised
with that of the European Patent
Convention (EPC). Hungary is a
member state of the EPC.
You will see, that the Hungarian
patent legislation is harmonised
with that of the European Patent
Convention (EPC). Hungary is a
member state of the EPC.
Iceland
Yes, if the invention is novel,
involves an inventive step and is
susceptible of industrial
application.
Yes, if the invention is novel,
involves an inventive step and is
susceptible of industrial
application.
In Iceland it is possible to obtain a
patent that contains nucleotide
sequences and amino acid
sequences.
In Iceland it is possible to obtain a
patent that contains nucleotide
sequences and amino acid
sequences.
Ireland
N/A
N/A
It is possible to obtain such
patents, as long as a use for the
sequences disclosed has been
given in the patent specification.
Otherwise, such patent
applications would be considered
as mere discoveries, which are
not entitled to a patent.
It is possible to obtain such
patents, as long as a use for the
sequences disclosed has been
given in the patent specification.
Otherwise, such patent
applications would be considered
as mere discoveries, which are
not entitled to a patent.
Israel
N/A
N/A
In our jurisdiction it is possible to
obtain a patent on nucleotide
sequences (coding or non-coding
),as well as amino acid sequences
(peptides and proteins from a
naturally occurring organism
,plant, animals and human being
).
In our jurisdiction it is possible to
obtain a patent on nucleotide
sequences (coding or non-coding
),as well as amino acid sequences
(peptides and proteins from a
naturally occurring organism
,plant, animals and human being
).
Italy
Yes. Under certain conditions
(See Article 5, 2-3 of Directive
98/44).
N/A
N/A
N/A
Japan
Yes, however, a mere DNA
without indication of a function or
specific asserted utility is not a
patentable invention.
Yes, however, a mere peptide or
a mere protein without indication
of a function or specific asserted
utility is not a patentable
invention.
Yes, it is possible to obtain in both
cases. In Japanese patent
system, it is available to obtain a
patent even if an application
includes only either Nucleotide
sequences or Amino acid
sequences themselves.
Yes, it is possible to obtain in both
cases. In Japanese patent
system, it is available to obtain a
patent even if an application
includes only either Nucleotide
sequences or Amino acid
sequences themselves.
Lithuania
The patent shall be granted if
chemical structures claimed has
been obtained from organism by
isolation, purification or other
technical intervention.
The patent shall be granted if
amino acid sequences claimed
have been obtained from naturally
occurring organism by means of
technical intervention.
Yes; nucleotide sequences are
patentable.
Yes; it is obligatory to disclose a
function of an amino acid
sequence.
Malaysia
It is possible to get a patent in
Malaysia for subject-matter that is
identical to that found in nature,
chemical structures comprising
amino acid sequences and
nucleotide sequences whole part
or in part found in organism
including plants, animal or human
being. However, the protection of
the above mentioned only given if
human intervention is introduced
in producing such material, not
merely from a known lab analysis.
The plant and animal itself do not
fall in this category.
It is possible to get a patent in
Malaysia for subject-matter that is
identical to that found in nature,
chemical structures comprising
amino acid sequences and
nucleotide sequences whole part
or in part found in organism
including plants, animal or human
being. However, the protection of
the above mentioned only given if
human intervention is introduced
in producing such material, not
merely from a known lab analysis.
The plant and animal itself do not
fall in this category.
N/A
N/A
Mexico
Genetic material, in as much as it
is found in nature, is excluded
from patentability by Article 16,
paragraph II; however, when it
has been isolated and
characterized, it is susceptible to
patenting, since it is then different
from that found in nature
(example: contained in any
vector).
Nucleotide sequences are
patentable under the Industrial
Property Law as long as the
sequence in question is attributed
to a function or activity, and is
sufficiently demonstrated as such
in the description (in examples).
We consider open reading
frameworks, where the protein
they codify is unknown, do not
comply with the industrial
application nor the sufficiency in
description requisites.
Peptides or proteins are
patentable in the moment that
they have been isolated and
characterized from their natural
state, and once a function has
been sufficiently ascribed to them
in the patent request.
N/A
N/A
Netherlands
N/A
N/A
yes
yes
New Zealand
Yes, provided the scope of the
claims does not encompass the
sequences in their natural state or
as they are normally found in
nature.
Yes, provided the scope of the
claims does not encompass the
sequences in their natural state or
as they are normally found in
nature.
Norway
Patents are granted for nucleotide
sequences corresponding in
whole, or in parts, to nucleotide
sequences found in an organism.
Peru
N/A
Patents are granted for amino
acid sequences corresponding to
peptides or proteins produced by
naturally occurring organism,
including plants, animals and
human beings.
N/A
http://www.otago.ac.nz/law/oylr/
2011/Tom%20Cleary%20%20LLB%20Honours%20Diss%
202011.pdf
New Zealand
position: "According to the
High Court of Australia there
were three general principles.72
First, there must be an
artificially created state of
affairs. Secondly, the process
must be commercially useful.
Finally, the process must
belong to the "useful arts" in
that it is a technological
innovation. This approach was
subsequently adopted in New
Zealand by the Supreme Court
(now the High Court)73 and
affirmed by the Court of
Appeal.74 page 12 ofthe thesis.
N/A
N/A
Yes, but not naturally occurring,
with the exception on primers,
siRNA.
No, if they are naturally occurring
sequences from any source
(plant, animal, microorganism or
human being).
N/A
Philippines
N/A
No. (Note: If no alterations done
on the amino acid sequence to
produce significant difference to
differentiate it from the naturally
occurring.)
N/A
N/A
Poland
Yes. In a description a protein
with a defined biological function
should be determined.
Yes, in a general way, if there is
any related technical application
(if the nucleotide sequences are
not EST) and if these chemical
structures have to be obtained by
a technical process (e.g.
purification and/or isolation).
Yes, but only if they have been
obtained by means of a chemical
or biological process.
Yes, in a general way, if there is
any related technical application
(if the sequences are not EST).
However genetic code of a natural
living being per se is not eligible.
Yes
Yes
Yes, it is possible to obtain a
patent on nucleotide sequences,
but only if the invention complies
with the patentability requirements
(novelty, inventive step and
industrial application), if the
complete sequence is presented
in the description and if the
industrial application of the
nucleotide sequence is concretely
specified in the patent application.
Yes, it is the same as for the
nucleotide sequences. It is
possible to obtain a patent on
amino acid sequences, but only if
the invention complies with the
patentability requirements
(novelty, inventive step and
industrial application), if the
complete sequence is presented
in the description and if the
industrial application of the amino
acid sequence is concretely
specified in the patent application.
N/A
N/A
Yes
see Art. 7 and 18 of the Law
64/1991
http://www.wipo.int/wipolex/en/text
.jsp?file_id=207512#LinkTarget_2
74
Portugal
Romania
Russian Federation
Yes (when in conformity with the
established conditions of
patentability).
Yes (when in conformity with the
established conditions of
patentability).
In compliance with Article 1350 of
Part IV of the Civil Code of the
Russian
Federation a technical solution in
any area related to a product
(including a device,
substance, microorganism strain,
cell culture of plants or animals) or
method
(process of affecting a material
object using material means) shall
be protected as
an invention.
In compliance with Article 1350 of
Part IV of the Civil Code of the
Russian
Federation a technical solution in
any area related to a product
(including a device,
substance, microorganism strain,
cell culture of plants or animals) or
method
(process of affecting a material
object using material means) shall
be protected as
an invention.
Accordingly, a patent can be
granted on nucleic acids,
peptides, polypeptides,
protein, etc. characterized by
nucleotide and amino acid
sequences.
Accordingly, a patent can be
granted on nucleic acids,
peptides, polypeptides,
protein, etc. characterized by
nucleotide and amino acid
sequences.
In order to obtain patent
protection on biological material
exuded from a
naturally occurring organism,
plant, animals or human being,
certain
characteristics as biological
lìinction, sequence identifier and
other valuable
information should be included in
claim.
In order to obtain patent
protection on biological material
exuded from a
naturally occurring organism,
plant, animals or human being,
certain
characteristics as biological
lìinction, sequence identifier and
other valuable
information should be included in
claim.
Singapore
N/A
N/A
For an invention to be patentable
it must satisfy 3 key criteria's in
accordance with section 13 of the
patents act.
1), New - The invention should not
have been made known to the
public in any way, anywhere in the
world.
2) Inventive Step - The invention
must be something that
represents an improvement over
any existing product or process
that is already available. The
improvement must be nonobvious to a person who is skilled
in the art in that technological field
of the invention. 3) The invention
must be useful and have some
form of practical application.
However, an invention of a
method of treatment of the human
or animal body by surgery or
therapy or of diagnosis practised
on the human or animal body
shall not be taken to be capable of
industrial application, and hence,
is not patentable.
Further, An invention that is
generally expected to encourage
offensive, immoral, or anti social
behaviour will not be published or
patentable even if it satisfied the
above three key criteria page 64
at
It must satisfy 3 key criteria's in
accordance with section 13 of the
patents act. 1), New - The
invention should not have been
made known to the public in any
way, anywhere in the world. 2)
Inventive Step - The invention
must be something that
represents an improvement over
any existing product or process
that is already available. The
improvement must be nonobvious to a person who is skilled
in the art in that technological field
of the invention. 3) The invention
must be useful and have some
form of practical application.
However, an invention of a
method of treatment of the human
or animal body by surgery or
therapy or of diagnosis practised
on the human or animal body
shall not be taken to be capable of
industrial application, and hence,
is not patentable. Further, An
invention that is generally
expected to encourage offensive,
immoral, or anti social behaviour
will not be published or patentable
even if t satisfied the above three
key criteria
http://www.ipos.gov.sg/Portals/0/
Guide%20on%20Patentability%20
Issues%20arising%20during%20
Search%20and%20Exam%20(20
%20Sept%202010)_website.pdf
Slovakia
If the basic conditions of
patentability (novelty,
inventiveness, industrial
application) are met, it is possible
to obtain a patent. The importance
is put on existence of technical
step, isolation from natural source
and characteristics that are
applicable in industry.
If the basic conditions of
patentability (novelty,
inventiveness, industrial
application) are met, it is possible
to obtain a patent. The importance
is put on the existence of
technical step, isolation from
natural source and characteristics
that are applicable in industry.
Yes
yes, but amino acid sequences
must be isolated from a living
organism and their function must
be known;
Slovenia
N/A
N/A
yes
yes
Spain
N/A
N/A
Sweden
It would be possible to obtain,
under the usual conditions, a
patent on chemical structures as
mentioned in the question;
however, the novelty requirement
may sometimes be problematic in
this context.
Also in this case, it would be
possible to obtain a patent; what
is said under d) would apply also
here.
Yes, but the industrial application
of a sequence or a partial
sequence of a gene must be
disclosed in the patent
application ( Article 5.3
DIRECTIVE 98/44/EC OF THE
EUROPEAN PARLIAMENT AND
OF THE COUNCIL of 6 July 1998
on the legal protection of
biotechnological inventions)
N/A
Yes. (According to Article 5.2
Directive 98/44/EC, an element
isolated from the human body or
otherwise produced by means of
a technical process, including the
sequence or partial sequence of a
gene, may constitute a patentable
invention, even if the structure of
that element is identical to that of
a natural element).
N/A
Switzerland
Chemical structures comprising
“nucleotide” sequences which
correspond in whole or in part to
those found in an organism can
be patented only if the general
patenting conditions are met: that
it is an invention (not a discovery),
that it is novel, that it is the result
of inventive activity and is
industrially applicable.
Chemical structures comprising
“nucleotide” sequences which
correspond in whole or in part to
those found in an organism can
be patented only if the general
patenting conditions are met: that
it is an invention (not a discovery),
that it is novel, that it is the result
of inventive activity and is
industrially applicable.
Yes, but only if made available in
a technical way and if a function
(technically useful result) is given.
Yes, but only if made available in
a technical way and if a function
(technically useful result) is given.
A simple DNA sequence with no
function indication does not
contain any technical teaching
and therefore, would not
constitute a patentable invention.
In order to comply with the criteria
of industrial applicability, it is
necessary, if a sequence or a
partial sequence of a gene is used
to produce a protein or a partial
protein, to specify which protein or
partial protein is being produced
and what is its function.
A simple DNA sequence with no
function indication does not
contain any technical teaching
and therefore, would not
constitute a patentable invention.
In order to comply with the criteria
of industrial applicability, it is
necessary, if a sequence or a
partial sequence of a gene is used
to produce a protein or a partial
protein, to specify which protein or
partial protein is being produced
and what is its function.
Taiwan
N/A
Turkey
N/A
N/A
Yes
Yes
N/A
Yes
Yes
Uruguay
The new Law does not set defined
criteria regarding these structures,
but the case could fall within the
patentability exclusionary norms
previously mentioned.
Additionally, questions could exist
about the novelty and inventive
step of the product.
Idem, with greater reservations.
[Note by Secretariat: This
response refers to the response of
Uruguay to question 6(d): "The
new Law does not set defined
criteria regarding these structures,
but the case could fall within the
patentability exclusionary norms
previously mentioned.
Additionally, questions could exist
about the novelty and inventive
step of the product."]
N/A
N/A
N/A
N/A
answer to question 6(d):
The new Law does not set defined
criteria regarding these structures,
but the case could fall within the
patentability exclusionary norms
previously mentioned.
Additionally, questions could exist
about the novelty and inventive
step of the product.
Uzbekistan
According to the standard
documentation for chemical
structures comprising nucleotide
sequences corresponding in
whole or in part to nucleotide
sequences found in an organism
(e.g. coding or non-coding) a
patent or a provisional patent is
not granted.
According to the standard
documentation for chemical
structures comprising amino acid
sequences corresponding to
peptides or proteins produced by
a naturally occurring organism,
including plants, animals or a
human being a patent or a
provisional patent is not granted.
Venezuela
Yes, they are patentable as long
as the nucleotide sequence is
codified.
Yes, it is possible to protect them;
excluding those coming from
human beings (Article 7,
Paragraph d, ejusdem), and as
long as the inventor intervenes in
order to obtain the result or
technical solution. That is to say
that a substance found in nature
that must first be isolated from its
medium and characterized by the
development of a process may be
patented if it has not been
previously identified.
N/A
N/A