Patents in the field of biotechnologyiprhelpdesk.eu/sites/default/files/events/patents in...European Patent Office Patentability of Biotech Inventions Patentability requirements Novelty

Dr. Maria Giuseppina Covone Palermo, 8 May 2015Examiner - Biotechnology

Patents in the field of biotechnology

European Patent Office 2

Professional background

contact : [email protected]

• 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


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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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


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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IS THE MATTER PATENTABLE?

YESNO

PATENTABILITYCRITERIA

•Novelty•Inventive step•Industrial applicability •Sufficient disclosure•ClarityExclusions - Art. 52(2) EPC


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PATENTABLE •• NON-PATENTABLE








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


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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• 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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• 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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Presentations of Information - Art. 52(2)(d) EPC

a formula:a molecule

characterized by the formula:

azithromycin


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 ...








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


A patchwork quilt…

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(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


• 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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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)


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


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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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)



• 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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• 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


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


(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








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.


natural isolated

Discovery Vs Invention


Rule 29 (1) (2) sequences or partial sequences of a gene


• 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 ?


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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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Sequences whose function is sufficiently characterised by experimental data patentable, provided all other requirements of the EPC are fulfilled


• 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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ESTs or full-length cDNAs where only the source is indicated (tissue, organism - Human Genome project), orphan receptors

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Sequences with no (plausible) function indicated in the application not patentable


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


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Patentability of gene sequenceswith no plausible function indicated in the application

Documents

Patents in the field of biotechnologyiprhelpdesk.eu/sites/default/files/events/patents in...European Patent Office Patentability of Biotech Inventions Patentability requirements Novelty