Article 53(c) EPC - therapy in biotech 5... · Article 53(c) EPC – therapy personlised medicine-...

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


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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



• 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


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


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)



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



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




§ 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)



§ 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


• 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


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


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


Sco

pe

Claim drafting

Examination phaseInvention

patentability

novelty

inventive step

sufficiency

clarity

amendments


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!


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