Supplementary Table 1 Survey Results on Standards and Practices to Patent Biological Patent
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 / 2011 Cambia's survey: A. In your jurisdiction, is it possible to obtain a patent ond) on chemical structures comprising nucleotide
sequences corresponding in whole or in part to nucleotide sequences found in organisms
(e.g. coding or non-coding)? / e) on chemical structures comprising amino acid
sequences corresponding to peptides or proteins produced by a naturally occurring organism,
including plant, animals or a human being? / 1) Nucleotide sequences (coding or non-coding)? If no, please explain / 2) Amino acid sequences (peptides or proteins from a 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.
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 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. / 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 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 / 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. / 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.
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
..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 :
1) les variétés végétales et les races animales;
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.)
(§ 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.)
§ 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 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.
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 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.) / Yes
..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 :
1) les variétés végétales et les races animales;
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.)
(§ 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.)
§ 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 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.
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 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.)
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. / 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.
In addition to the above-mentioned, 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. / 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.
In addition to the above-mentioned, 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.
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 well-defined 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. 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”. / 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”.