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Dr. Maria Giuseppina Covone Palermo, 8 May 2015Examiner - Biotechnology
Patents in the field of biotechnology
European Patent Office 2
Professional background
contact : mcovonevanhees@epo.org
• degree in cellular biology (University “La Sapienza”,
Rome)
• PhD in molecular biology (Novartis, Siena)
• Epo examiner in biotechnology since 1998
• antibody
• trainer for newcomers, ex & ex biotechnology
European Patent Office 3
Outline of the presentation
• Introduction• Exclusions (Art.52 EPC)• Exceptions (Art.53 (a) EPC)
• Rule 28 EPC• Rule 29 EPC
• Exceptions (Art.53 (b) EPC)• Exceptions (Art.53 (c) EPC)
• Art.54 (4) (5) EPC• Conclusions
European Patent Office
What information do patent documents contain?
• Title of the invention, name of the
inventor
• Detailed description of the invention: how
it is constructed, how it is used, benefits
compared with what already exists
• Claims providing a precise definition of
what the patent protects
• Drawings
• Abstracts: summary of the invention •
particularly useful for search engines
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European Patent Office
Patentability of Biotechnological Inventions
• Most biotechnological inventions are patentable
• Some inventions are patentable only with specific wording or after a specific date
• Few inventions are not patentable
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Patent
European Patent Office
Patentability of Biotech Inventions
Patentability requirements
Novelty - Art. 54 EPC
Inventive Step - Art. 56 EPC
Industrial Applicability - Art. 57 EPC
Disclosure and Support - Clarity - Art. 83, 84 EPC
Biotech-specific issues
Exclusions - Art. 52(2) EPC
Exceptions - Art. 53 EPC
Therapy/Surgery/Therapy - Art.54(4) and (5) EPC
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European Patent Office
IS THE MATTER PATENTABLE?
YESNO
PATENTABILITYCRITERIA
•Novelty•Inventive step•Industrial applicability •Sufficient disclosure•ClarityExclusions - Art. 52(2) EPC
Exceptions - Art. 53 EPC
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PATENTABLE •• NON-PATENTABLE
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Outline of the presentation
• Introduction• Exclusions (Art.52 EPC)• Exceptions (Art.53 (a) EPC)
• Rule 28 EPC• Rule 29 EPC
• Exceptions (Art.53 (b) EPC)• Exceptions (Art.53 (c) EPC)
• Art.54 (4) (5) EPC• Conclusions
European Patent Office 10
Article 52 EPC - Exclusions
1) European patents shall be granted for any inventions, in all fields of
technology, provided that they are new, involve an inventive step and are
susceptible of industrial application
2) The following, in particular, shall not be regarded as inventions within the meaning of paragraph 1:
(a) discoveries, scientific theories and mathematical methods;
(b) aesthetic creations;(c) schemes, rules and methods for performing mental acts,
playing games or doing business, and programs for computers;
(d) presentations of information
3) only when it is referred to said subject-matter as such
European Patent Office
Discovery or Invention ? Art.52(2) (a) EPC
Plant extracts having appetite suppressing activity
Traditional knowledge: "eating the fibrous, water rich stems ... saved further suffering from the pangs of hunger ..."
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European Patent Office
• A mere finding of something already existing in nature is aDiscovery: contamination with mould kills bacteria
• If a technical character is associated to this finding, then, this finding can be regarded as an Invention: isolated fungus, means for its culturing, isolated antibiotic agent
Discovery or Invention ?
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European Patent Office
• A discovery is cognitive in nature, e.g.finding a plant, finding a mineral ...
• An invention is always technical in nature, consisting of a reproducible technical teaching (isolation, purification, characterization, technical effect suggesting a use)
• An invention has to solve a meaningful technical problem (Article 56 EPC) and it has to be industrially applicable (Article 57 EPC)
Discovery / Invention: conclusions
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European Patent Office 14
Presentations of Information - Art. 52(2)(d) EPC
a formula:a molecule
characterized by the formula:
azithromycin
European Patent Office 15
Presentation of Information - Art. 52(2)(d) EPC
• A DNA sequence ...• An amino acid sequence ...• An expression profile / an expression pattern related to
certain gene(s) / and activity graph ...
• A DNA molecule comprising the nucleotide sequence ...• A polypeptide comprising the amino acid sequence ...
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Outline of the presentation
• Introduction• Exclusions (Art.52 EPC)• Exceptions (Art.53 (a) EPC)
• Rule 28 EPC• Rule 29 EPC
• Exceptions (Art.53 (b) EPC)• Exceptions (Art.53 (c) EPC)
• Art.54 (4) (5) EPC• Conclusions
European Patent Office
Is everything patentable ?Article 53 EPC - Exceptions to patentability
European patents shall not be granted in respect of:(a) inventions the commercial exploitation of which
would be contrary to " ordre public " or morality; such exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States;
(b) plant or animal varieties or essential biological processes for the production of plants or animals; this provision shall not apply to microbiological processes or the products thereof;
(c) methods for the treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods.
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10.03.2015
European Patent Office
A patchwork quilt…
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Outline of the presentation
• Introduction• Exclusions (Art.52 EPC)• Exceptions (Art.53 (a) EPC)
• Rule 28 EPC• Rule 29 EPC
• Exceptions (Art.53 (b) EPC)• Exceptions (Art.53 (c) EPC)
• Art.54 (4) (5) EPC• Conclusions
European Patent Office
(a) processes for cloning human beings;(b) processes for modifying the germ line genetic
identity of human beings;(c) uses of human embryos for industrial or
commercial purposes;(d) 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.
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morality/public order – Article 53(a) Rule 28(a)-(d) EPC
European Patent Office
• A process for cloning animals / mammals / primates / humans
• Human totipotent cells (able to give rise to a human organism)
• A process for duplicating human embryos / fertilized human oocytes
• A process for cloning non-human
• animals• mammals / primates• mice / sheep / horses / cows etc.
• A process for cloning animals / mammals, provided that this process is not a process for cloning humans.
Rule 28(a) EPC - Cloning of human beings
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European Patent Office
Rule 28(b) modification of human germ-line
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Transgenic humans transgenic animals (?)(Rule 28(d))
Transgenic humansVs
Products for Gene-therapy (Art.53c)
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Rule 28(d) modification of germ line which causes suffering
The Harvard Oncomouse -
used as a model for studying cancerThe naked mouse –used to test hair products
European Patent Office
Transgenic animals are patentable provided that:
• non-human (Rule 28(b) EPC)
• their genetic modification does not cause their suffering without any substantial medical benefit to man or animal (Rule 28 (d) EPC)
• the way to obtain it is sufficiently disclosed (Art. 83 EPC)
• the animal is not an animal variety (Art. 53(b) EPC)
• the technical feasibility of the invention is not confined to a particular animal variety (Rule 27(b) EPC)
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European Patent Office
Rule 28(c) uses of human embryos
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"A cell culture comprising primate embryonic stem cells which ........
maintain the potential to differentiate to derivatives of endoderm, mesoderm, and ectoderm tissues throughout the culture, ...............”
forbids the patenting of claims directed to products which - as described in the application – at the filing date could be prepared exclusively by a method which necessarily involved the destruction of the human embryos from which the said products are derived,
even if the said method is not part of the claims. In this context
it is not of relevance that after the filing date the same products could be obtained without having to use a method necessarily involving the destruction of human embryos
(G02/06 - 2008)
European Patent Office
Rule 28(c) uses of human embryos
• embryo means any human ovum after fertilisation, any non-fertilised human ovum into which the cell nucleus from mature human cells has been transplanted
• any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis constitutes a " human embryo “
• the use of human embryos for purposes of scientific research excluded from patentability, only use for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it being patentable
Judgement C-34/10 Court of Justice of the European Union
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Rule 28(c) uses of human embryos
• if the embryo is created through parthenogenesis, is not capable of developing after implantation
• in order to be classified as a “human embryo”, a non-fertilised human ovum must necessarily have the inherent capacity of developing into a human being
• research involving a human egg used to produce embryonic stem cells unable to develop into an embryo can be patented
European court of justice – Dec.2014
European Patent Office 29
destructive
non-destructive
direct indirect
method product product
established hES
NO: R. 28(c) NO: G 2/06 NO: C34/10 and GL 2012, G-II, 5.3(iii)
NO: R. 28(c)
indirect non-destructive
YES: effective on or after 10 January 2008
Rule 28(c) uses of human embryosfour scenarios
European Patent Office
(May 2007)
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Rule 28(c) EPC - Conclusions
• Uses of human embryos for industrial or commercial purposes
• Human embryonic cells isolated by methods involving destruction of human
embryos
• Human embryonic cells isolated by methods not involving destruction of human
embryos
• Uses of human embryos wherein the invention is useful/beneficial to the
embryo itself ...
• Human Foetal cells / non-embryonic stem cells and uses thereof
European Patent Office 32
Outline of the presentation
• Introduction• Exclusions (Art.52 EPC)• Exceptions (Art.53 (a) EPC)
• Rule 28 EPC• Rule 29 EPC
• Exceptions (Art.53 (b) EPC)• Exceptions (Art.53 (c) EPC)
• Art.54 (4) (5) EPC• Conclusions
European Patent Office
morality/public order – Article 53(a) Rule 29
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(1) The human body, at the various stages ofits formation and development, and the simplediscovery of one of its elements, including thesequence or partial sequence of a gene, cannotconstitute patentable inventions.
(2) An element isolated from the human bodyor otherwise produced by means of a technicalprocess, including the sequence or partialsequence of a gene, may constitute a patentableinvention, even if the structure of thatelement is identical to that of a natural element.
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natural isolated
Discovery Vs Invention
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Rule 29 (1) (2) sequences or partial sequences of a gene
European Patent Office
• public objections for patenting human genes:
(1) genes cannot be invented
(2) their patenting is contrary to morality
(3) life should not be monopolized by companies
(4) gene claims are too broad (use restricted ?)
• Should animal (or plant) genes be treated differently ?
• And under which ground ? Plant and animals are living
organisms as well as humans.
• Where do we draw a line between what is patentable and
what is not ?
Rule 29 (1) (2) sequences or partial sequences of a gene
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European Patent Office
A gene coding for a hormone, its function is experimentally demonstrated, this hormone can be used to treat a certain type of disease (efficacy demonstrated in laboratory)
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Rule 29 (1) (2) sequences or partial sequences of a gene
Sequences whose function is sufficiently characterised by experimental data patentable, provided all other requirements of the EPC are fulfilled
European Patent Office
• an enzymatic activity ? Pathway known ? Use / applicability
foreseen ?
• interaction with another polypeptide/subunit ?
• being a receptor ? Is the ligand known ?
• involvement in a certain signal transduction pathway ? is it
related to a specific effect ?
• involvement in a disease ? tissue-specific expression
(pattern) ? cell marker ? probe ?
• general or „throw away“ function enough ?
e.g. secreted protein, polypeptide as food / feed
What do we mean by Function ?
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European Patent Office
ESTs or full-length cDNAs where only the source is indicated (tissue, organism - Human Genome project), orphan receptors
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Rule 29 (1) (2) sequences or partial sequences of a gene
Sequences with no (plausible) function indicated in the application not patentable
European Patent Office
Patentability requirements
Novelty - Art. 54 EPC
Inventive Step - Art. 56 EPC
Industrial Applicability - Art. 57 EPC
Disclosure and Support - Clarity - Art. 83, 84 EPC
Biotech-specific issues
Exclusions - Art. 52(2) EPC
Exceptions - Art. 53 EPC
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Patentability of gene sequenceswith no plausible function indicated in the application
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