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Article 53(c) EPC - therapy - IPR-Helpdesk in... · European Patent Office Article 53(c) EPC -...
Transcript of Article 53(c) EPC - therapy - IPR-Helpdesk in... · European Patent Office Article 53(c) EPC -...
European Patent Office 58
Compound X is not new, but no medical use
(a) compound X for use as a medicament (b) compound X for use in treating disease Y (c) composition A containing X for use in treating disease Y(d) medicament containing the compound X (e) use of X in a composition A for the treatment of disease
Y (f) use of X as a medicament for the treatment of disease Y (g) use of X for the treatment of disease Y (h) use of X for preparing a medicament (i) use of X for the manufacture of a medicament for
treating disease Y (j) process for the preparation of a medicament for treating
disease Y using compound X as an active ingredient (k) method of treatment of disease Y using X
Article 53(c) EPC - therapy
European Patent Office
Article 53(c) EPC - therapy
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Compound X is not new and known as medicament
(a) compound X for use as a medicament (b) compound X for use in treating disease Y (c) composition A containing X for use in treating disease Y(d) medicament containing the compound X (e) use of X in a composition A for the treatment of disease
Y (f) use of X as a medicament for the treatment of disease Y (g) use of X for the treatment of disease Y (h) use of X for preparing a medicament (i) use of X for the manufacture of a medicament for
treating disease Y (j) process for the preparation of a medicament for treating
disease Y using compound X as an active ingredient (k) method of treatment of disease Y using X
European Patent Office
Article 53(c) EPC - therapy
• dosage regimen
2nd medical use
• mechanism of action
• dosage• route of
administration
1st medical use
• patient group
• disease
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compound X for use in treating disease Y characterised in that:
• the compound is given 3 times a day
• the compound is given orally
• treat diseases Y by increasing receptor A
• the compound is administered to patients who do not
respond to compound Z
• personalised medicines (effect in a subpopulation
having a certain genotype)
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Article 53(c) EPC – therapy2nd medical use
European Patent Office
Article 53(c) EPC – therapy2nd medical use
Novelty based on a new technical effect of a known composition
Further definition of a known therapeutic indication by a novel mechanism of action is not in itself distinctive, but only if it results in a novel (and inventive) clinical situation that can be clearly distinguished from the known clinical situation (patient group, dose, etc.). The mere explanation of a known effect, the discovery of the mechanisms how a certain effect is achieved, cannot confer novelty to a second-medical use claim directed to therapy of the same disease (T 0254/93; T 0486/01)
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Biological concepts
• Determination of predisposition
• Diagnosis, disease staging
• Prognosis
• Drug response
markers phenotypes
association
§ SNPs / haplotypes
§ del/ins/inv/dup
§ Expression profiles
§ CpG methylation
Article 53(c) EPC – therapypersonlised medicine
European Patent Office
Method to diagnose / detect predisposition / determine prognosis of disease Z
Method to predict response to drug Y
genotyping a SNP
measuring expression of gene X
A nucleic acid probe suitable to detect SNP-1
A microarray comprising a probe specific for gene X
Drug Y for use in a method of treatment of disease Z
wherein the patient has genotype C/C at SNP-1
method
product
purpose-limited product
(2nd med. use)
Article 53(c) EPC – therapypersonlised medicine
European Patent Office
Novelty: methods
1. Method to predict response of a cancer patient to doxorubicin comprising genotyping the SNP defined by SEQ ID NO: 1
• Diagnostic methods are new as soon as the association is new
Article 53(c) EPC – therapypersonlised medicine
European Patent Office
Novelty: products
1. A nucleic acid probe specific for SEQ ID NO: 1
2. A microarray comprising probes for each one of the genes of Table 1
3. A microarray consisting of probes for each one of the genes of Table 1
• SNP is known
• gene sequence is known
• "instructions" are the only distinguishing feature
• specific oligonucleotides
• closed set of probes
most likely, not new could be new
Article 53(c) EPC – therapypersonlised medicine
European Patent Office
Article 53(c) EPC – therapypersonlised medicine
§ two different scenarios...
• product has never been used for such therapeutic purpose:
Antisense oligonucleotide directed to the SURV mRNA
for use in a method of treatment of cancer
• product is a known medicament for said disease:
Doxorubicin for use in a method of treatment of cancer
wherein the patient has genotype C/C at SNP defined by
SEQ ID NO: 1
Novelty: therapeutic purpose-limited products (I)
European Patent Office
Article 53(c) EPC – therapypersonlised medicine
§ Method to predict response of a cancer patient to compound X comprising
genotyping the SNP defined by SEQ ID NO: 1
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• Association needs to be demonstrated with experimental data (problem solved across whole scope):
• predisposition • diagnosis (point in time)
• prognosis • subtyping (point in time)
• mRNA • protein
• individual marker • set of markers
• colorectal cancer mRNA • any cancer
• Choice of the marker cannot be obvious: no clear pointers; prejudice
• Additional features may confer inventive step: sample type, disease subtype, sub-population
European Patent Office
• the application must disclose compounds with the technical effect - you cannot patent “anything that works” against a new target (T0852/09)
• the technical clinical effect has to be plausible from the application in vitro data may be enough (T609/02) clinical data can be provided later, to back up what was made credible in the application
• Example: pharmaceutical composition having a certain specific activity. At first sight, not inventive in the light of the relevant prior art
• Evidence provided later that this composition is less toxic (unexpected advantage)
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Article 53(c) EPC – therapypersonlised medicine- experimenal support
European Patent Office
Article 53(c) EPC - surgery
Surgery defines the nature of the treatment rather than its purpose; any breaking of the body entirety (needle injection) means surgery (GL:C-IV 4.8.1)
Whether a claimed method is to be considered "surgical"
treatment excluded from patentability under Article 53(c)
EPC should be assessed on a case-by-case basis, taking
into account the individual merits of each.
(G1/07)
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Article 53(c) EPC – diagnosis
• Use of substance X or composition comprising X in the "in vitro"/"ex vivo" diagnosis of disease Y
• A method for "in vitro"/"ex vivo" diagnosing disease Y using substance X ...
• Use of substance X or composition comprising X as contrast agent for imaging blood flow
• A method of imaging blood flow using substance X....
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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
Conclusions (1)
Most biotechnological inventions are patentable
• Polypeptides: Enzymes, Hormones, antibodies
• Isolated DNA and RNA molecules, Genes
• Elements isolated from the human / animal body (cells,
tissues, organs)
• Plasmids and Vectors
• Microorganisms (e.g. bacteria, viruses, phages, etc.)
• Plants and non-human Animals
• As well as methods related to these products, and their use
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Conclusions (2)
Some inventions are patentable only with specific wordingor after a specific date
• medical, surgical and diagnostic methods
• stem cells: instruction pending
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Conclusions (3)
Few inventions are not patentable
• human embryonal cells, methods to modify human germline
• animal and plant varieties
• transgenic animals with no medical benefit
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Inherent to all patent systems is the frustration that
"You can't always get what you want"
why is that?and what has it got to do with this animal?
Now over to something completely different...
The Brontosaurus theory of patenting!Thin - Thick – Thin
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Sco
pe
Claim drafting
Examination phaseInvention
patentability
novelty
inventive step
sufficiency
clarity
amendments
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The examiners will use all available tools to make sure that a strong defendable patent is granted.
Dr. Maria Giuseppina Covone Palermo, 8 May 2015Examiner - Biotechnology
Thank you!
European Patent Office
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