Article 53(c) EPC - therapy

Transcription

1 Article 53(c) EPC - therapy Compound X is not new, but no medical use (a) (b) (c) (d) (e) (f) (g) (h) (i) (j) (k) compound X for use as a medicament compound X for use in treating disease Y composition A containing X for use in treating disease Y medicament containing the compound X use of X in a composition A for the treatment of disease Y use of X as a medicament for the treatment of disease Y use of X for the treatment of disease Y use of X for preparing a medicament use of X for the manufacture of a medicament for treating disease Y process for the preparation of a medicament for treating disease Y using compound X as an active ingredient method of treatment of disease Y using X 58

2 Article 53(c) EPC - therapy Compound X is not new and known as medicament (a) (b) (c) (d) (e) (f) (g) (h) (i) (j) (k) compound X for use as a medicament compound X for use in treating disease Y composition A containing X for use in treating disease Y medicament containing the compound X use of X in a composition A for the treatment of disease Y use of X as a medicament for the treatment of disease Y use of X for the treatment of disease Y use of X for preparing a medicament use of X for the manufacture of a medicament for treating disease Y process for the preparation of a medicament for treating disease Y using compound X as an active ingredient method of treatment of disease Y using X 59

3 Article 53(c) EPC - therapy mechanism of action dosage route of administration patient group disease 2nd medical use 1st medical use dosage regimen 60

4 Article 53(c) EPC therapy 2nd medical use 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) 61

5 Article 53(c) EPC therapy 2nd 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) 62

6 Article 53(c) EPC therapy personlised medicine Biological concepts SNPs / haplotypes del/ins/inv/dup Expression profiles CpG methylation markers association Determination of predisposition Diagnosis, disease staging Prognosis Drug response phenotypes

7 Article 53(c) EPC therapy personlised 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 method A nucleic acid probe suitable to detect SNP-1 A microarray comprising a probe specific for gene X product Drug Y for use in a method of treatment of disease Z wherein the patient has genotype C/C at SNP-1 purpose-limited product (2nd med. use)

8 Article 53(c) EPC therapy personlised medicine 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

9 Article 53(c) EPC therapy personlised medicine 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 most likely, not new specific oligonucleotides closed set of probes could be new

10 Article 53(c) EPC therapy personlised medicine Novelty: therapeutic purpose-limited products (I) 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

11 Article 53(c) EPC therapy personlised medicine Method to predict response of a cancer patient to compound X comprising genotyping the SNP defined by SEQ ID NO: 1 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 68

12 Article 53(c) EPC therapy personlised medicine- experimenal support 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) 69

13 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) 70

14 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... 71

15 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 72

16 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 73

17 Conclusions (2) Some inventions are patentable only with specific wording or after a specific date medical, surgical and diagnostic methods stem cells: instruction pending 74

18 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 75

19 Now over to something completely different... 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? The Brontosaurus theory of patenting! Thin - Thick Thin 79

20 Scope Invention Claim drafting patentability novelty inventive step sufficiency clarity amendments Examination phase 77

21 The examiners will use all available tools to make sure that a strong defendable patent is granted. 78

22 Thank you! Dr. Maria Giuseppina Covone Examiner - Biotechnology Palermo, 8 May 2015

23 All patent documents are accessible free of charge on Espacenet over 90 million patent documents, easily searchable Patent Translate Automatic translation between English and 31 other languages, including Chinese, Japanese, Korean and Russian. 80

24 Useful links to Legal Texts - BoA Decisions 81