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Care required to draft pharma patents and prosecution of pharma patents

Care required to draft pharma patents and prosecution of pharma patents. Ahmedabad, November 26, 2006 Kiyoshi Kuzuwa Patent Attorney KUZUWA & PARTNERS Tokyo, Japan. Care required to draft pharma patents and prosecution of pharma patents. I. Patentability on pharmaceutical/medical

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Care required to draft pharma patents and prosecution of pharma patents

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  1. Care required to draft pharma patents and prosecution of pharma patents Ahmedabad, November 26, 2006 Kiyoshi Kuzuwa Patent Attorney KUZUWA & PARTNERS Tokyo, Japan Nov. 26, 2006 Kuzuwa & Partners

  2. Care required to draft pharma patents and prosecution of pharma patents I. Patentability on pharmaceutical/medical inventions II. Historical background of pharmaceutical/ medical patent practice in JPO, EPO and USPTO III. How to draft pharmaceutical/medical patent specification • Special attention to experimental data for pharmaceutical patent applications Nov. 26, 2006 Kuzuwa & Partners

  3. Patentability on pharmaceutical/medical inventions 1. Categories of medical inventions (1) Novel chemical compounds (2) “Pharmaceutical” agent comprising chemical compounds (3) “Anti-cancer” agent comprising chemical compounds (4) Use of chemical compounds for manufacturing anti-cancer agent (Swiss-type) (5) Therapeutic or diagnostic method (6) Medical devices Nov. 26, 2006 Kuzuwa & Partners

  4. Patentability on pharmaceutical/medical inventions 2. Criterion on patentability of pharmaceutical/medical inventions (1) Novelty (2) Inventiveness (3) Industrial applicability (4) Reproducibility/Enablement Nov. 26, 2006 Kuzuwa & Partners

  5. Patentability on pharmaceutical/medicalinventions 2. Criterion on patentability of pharmaceutical/ medical inventions (1) Novelty Novelty of chemical compounds, novelty of use, novelty of medical devices Nov. 26, 2006 Kuzuwa & Partners

  6. Patentability on pharmaceutical/medical inventions 2. Criterion on patentability of pharmaceutical/medical inventions (2) Inventiveness Unexpectedly remarkable effects : most critical proven by experimental data -in the original disclosure -later submission Nov. 26, 2006 Kuzuwa & Partners

  7. Patentability on pharmaceutical/medical inventions 2. Criterion on patentability of pharmaceutical/medical inventions (3) Industrial applicability depends on political, ethical, humanitarian reasons in each country. Nov. 26, 2006 Kuzuwa & Partners

  8. Patentability on pharmaceutical/medical inventions 2. Criterion on patentability of pharmaceutical/medical inventions (4) Reproducibility/Enablement Experimental data on ● chemical entity per se, i.e. identification data (m.p. IR etc.) ● medical use, i.e. pharmacological data (in vivo, in vitro) -in the original disclosure -later submission Nov. 26, 2006 Kuzuwa & Partners

  9. II. Historical background of pharmaceutical/ medical patent practice in JPO, EPO and USPTO 1. JPO (1) General principle on pharmaceutical/medical inventions -Medical devices, pharmaceutical products per se: patentable since 1975, where substance patent was introduced -Method for surgery, therapy or diagnosis: unpatentable due to lack of industrial applicability Nov. 26, 2006 Kuzuwa & Partners

  10. II. Historical background of pharmaceutical/medical patent practice in JPO, EPO and USPTO 1. JPO (2) History in patent practice (Examination Standard) 1960s Inventions having features involving human bodies e.g. method for permanent wave to hairs: unpatentable 1970s Only method for surgery, therapy or diagnosis out of inventions having features involving human bodies: unpatentable Nov. 26, 2006 Kuzuwa & Partners

  11. II. Historical background of pharmaceutical/medical patent practice in JPO, EPO and USPTO 1. JPO (2) History in patent practice (Examination Standard) 1993 Method for surgery, therapy or diagnosis: unpatentable irrespective of whether inventions have features involving human bodies Note inventions involving a process to return extracts to the same human body (e.g. artificial dialysis): unpatentable Nov. 26, 2006 Kuzuwa & Partners

  12. II. Historical background of pharmaceutical/medical patent practice in JPO, EPO and USPTO 1. JPO (2) History in patent practice (Examination Standard) 2003 •A part of regenerative medicine and/or gene therapy related technology: patentable -inventions involving a process to return extracts to the same human body for therapeutic purpose (e.g. dialytic treatment): unpatentable, but -method for producing medical products by using extracts, even if inventions involve a process to return said extracts to the same human body for therapeutic purpose (e.g. dialytic treatment): patentable • Method for operating medical devices not involving the process applying to the human body: patentable Nov. 26, 2006 Kuzuwa & Partners

  13. II. Historical background of pharmaceutical/medical patent practice in JPO, EPO and USPTO 1. JPO (2) History in patent practice (Examination Standard) 2003 A part of regenerative medicine and gene therapy related technology: patentable Example (patentable) “Process for producing a therapeutic cell for treating cancer characterized by introducing the gene by vector Z comprising DNA encoding protein X into tissue W extracted from a human body” Nov. 26, 2006 Kuzuwa & Partners

  14. II. Historical background of pharmaceutical/medical patent practice in JPO, EPO and USPTO 1. JPO (2) History in patent practice (Examination Standard) 2003 A part of regenerative medicine and gene therapy related technology: patentable Example (patentable) Extract Tissue W Vector Z Gene: DNA encoding protein X Therapeutic cell Nov. 26, 2006 Kuzuwa & Partners

  15. II. Historical background of pharmaceutical/medical patent practice in JPO, EPO and USPTO 1. JPO (2) History in patent practice (Examination Standard) 2005 -Broader protection on method for operating medical devices, e.g. driving and moving incision means, transmitting and detecting radiation etc.: patentable unless the claim sets forth a work of medical doctor directly applied to human bodies. Nov. 26, 2006 Kuzuwa & Partners

  16. II. Historical background of pharmaceutical/medical patent practice in JPO, EPO and USPTO 1. JPO (2) History in patent practice (Examination Standard) 2005-Protection on method for generating a new efficacy and/or new indication for producing and/or selling medicaments, e.g. “therapeutic agent forHepatitis C for treating patient having α-type gene, characterized by administering compound A in a dosage of 5.0 - 10.0 mg at the first time and 0.3 – 0.5 mg every two days” Nov. 26, 2006 Kuzuwa & Partners

  17. II. Historical background of pharmaceutical/medical patent practice in JPO, EPO and USPTO 1. JPO (2) History in patent practice (Examination Standard) • 5.0-10.0 mg/ first time • 0.3-0.5 mg/ every two days administer Compound A α-type gene Nov. 26, 2006 Kuzuwa & Partners

  18. II. Historical background of pharmaceutical/medical patent practice in JPO, EPO and USPTO 2. EPO (1) General principle on pharmaceutical/medical inventions under current EPC Article 52 (patentable inventions) (1) European patents shall be granted for any inventions which are susceptible of industrial application, which are new and which involve an inventive step. …………. (4) Methods for treatment of human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body shall not be regarded as inventions which are susceptible of industrial application within the meaning of paragraph 1. This provision shall not apply to products, in particular substances or compositions, for use in any of these methods. Nov. 26, 2006 Kuzuwa & Partners

  19. II. Historical background of pharmaceutical/medical patent practice in JPO, EPO and USPTO 2. EPO (2) Current practice under EPC -Method for surgery, therapy or diagnosis: unpatentable due to lack of industrial applicability (Art. 52(4)) Exceptions, e.g. Out of 3 steps, i.e. data collecting step, comparison step and medical determination step, invention related to only 1st and 2nd steps: patentable -Medical devices, pharmaceutical products: patentable -2nd medical use: patentable only in Swiss type claim Nov. 26, 2006 Kuzuwa & Partners

  20. II. Historical background of pharmaceutical/medical patent practice in JPO, EPO and USPTO 2. EPO (3) EPC2000 will come into effect on December 13, 2007. Article 53 (Exceptions to patentability) in place of Article 52 European patents shall not be granted in respect of: …………. (c) methods for treatment of 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. Nov. 26, 2006 Kuzuwa & Partners

  21. II. Historical background of pharmaceutical/medical patent practice in JPO, EPO and USPTO 2. EPO (3) EPC2000 -Methods for treatment of human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body have been excluded from patentablity by the fiction of their lack of industrial applicability. -This fiction is not appropriate, because those methods are excluded in the interests of public health rather than lack of industrial applicability. 　　　　　　　　　　　　　　　　　　　　 ↓ Article 52 (industrial applicability)→Article 53 (Exceptions to patentability) Nov. 26, 2006 Kuzuwa & Partners

  22. II. Historical background of pharmaceutical/medical patent practice in JPO, EPO and USPTO 2. EPO (4) Possible practice under EPC2000 2nd medical use: -Swiss type claim no longer necessary -Product claim patentable “Use of compound A and/or its physiologically acceptable salts for manufacturing a therapeutic agent treating diabetes” (Swiss type claim) 　↓ “A therapeutic agent treating diabetes comprising compound A and/or its physiologically acceptable salts” (product claim) Nov. 26, 2006 Kuzuwa & Partners

  23. II. Historical background of pharmaceutical/medical patent practice in JPO, EPO and USPTO 2. USPTO (1) General principle on pharmaceutical/medical inventions -Any inventions are patentable -exceptions for infringements against practitioner’s performance of medical activity Art. 287, Art. 271 Nov. 26, 2006 Kuzuwa & Partners

  24. II. Historical background of pharmaceutical/medical patent practice in JPO, EPO and USPTO 2. USPTO US patent law §287 ………… (c) (1) with respect to a medical practitioner’s performance of a medical activity that constitutes an infringement under section 271(a) or (b) of this title, the provisions of sections 281, 283, 284, and 285 of this title shall not apply against the medical practitioner or against a related health care entity with respect to such medical activity. Nov. 26, 2006 Kuzuwa & Partners

  25. II. Historical background of pharmaceutical/medical patent practice in JPO, EPO and USPTO 2. USPTO (2) History of practice on pharmaceutical/medical inventions - 1950 medical methods: unpatentable 1950 - medical methods: patentable 1993 Pallin vs Singer (both practitioners) 1996 current US patent law §287(c) Nov. 26, 2006 Kuzuwa & Partners

  26. III. How to draft pharmaceutical/medical patent specification Novelty, Inventiveness, Industrial applicability, Reproducibility (enablement) must be met. How to draft - Claims - Specification How to amend specification How and when to submit - Working examples, comparative examples - Pharmacological data Nov. 26, 2006 Kuzuwa & Partners

  27. 1. Comparison on patentability of pharmaceutical/medical inventions among JPO, EPO and USPTO (1) III. How to draft pharmaceutical/medical patent specification EN:enablement NV:novelty IA:industrial applicability Nov. 26, 2006 Kuzuwa & Partners

  28. III. How to draft pharmaceutical/medical patent specification 2. Chemical compounds “Chemical compounds of chemical formula X” (JP,EP,US patentable) -Novelty and inventiveness are met, when compounds are new and inventive. -Industrial applicability are met, when disclosed how to make, how to use (medical use) in the original specification. -Reproducibility (enablement) is met, when data on identification of compounds, e.g., IR, m.p., etc. are disclosed in the original specification (at least for JP). (pharmacological data not necessarily needed) Nov. 26, 2006 Kuzuwa & Partners

  29. III. How to draft pharmaceutical/medical patent specification 3. First medical use of novel (inventive) compounds “ Pharmaceutical agent comprising novel chemical compounds of chemical formula X” (JP,EP,US patentable) Industrial applicability is met, when identification data on at least one chemical compound. Reproducibility is met, when pharmacological data (in vivo or in vitro) on at least one disease, e.g., diabetes, are disclosed in the original specification (at least for JP). Nov. 26, 2006 Kuzuwa & Partners

  30. III. How to draft pharmaceutical/medical patent specification 4. First medical use of known compounds “ Pharmaceutical agent comprising known chemical compounds of chemical formula X“ (only EP patentable) Industrial applicability are met in JP,EP,US. Novelty are met in JP,EP, but not in US due to known compounds. Reproducibility is met, when pharmacological data on at least one disease (e.g. diabetes) in EP, but not in JP due to insufficient disclosure. Nov. 26, 2006 Kuzuwa & Partners

  31. III. How to draft pharmaceutical/medical patent specification 5. Second medical use of known compounds For novelty/inventiveness and industrial applicability Product: Anticancer agent comprising chemical compounds of chemical formula X (JP, EPC2000) Swiss type: Use of chemical compounds of chemical formula X for producing therapeutic agents for treating cancer (Swiss-type, current EPO) Method: Therapeutic method for treating cancer using chemical compounds of chemical formula X (US) For reproducibility/enablement At least one pharmacological data (in vivo or in vitro) on the second indication, e.g., anticancer in the original specification (at least for JP) Nov. 26, 2006 Kuzuwa & Partners

  32. III. How to draft pharmaceutical/medical patent specification 6. Comparison on patentability of pharmaceutical/medical inventions among JPO, EPO and USPTO (2) EN:enablement NV:novelty IA:industrial applicability, EX:exception to patentability Nov. 26, 2006 Kuzuwa & Partners

  33. III. How to draft pharmaceutical/medical patent specification 7. Therapeutic or diagnostic method using pharmaceutical products JP: unpatentable, due to lack of industrial applicability EP: unpatentable, due to lack of industrial applicability EPC2000: unpatentable, due to unpatentable invention US: patentable Nov. 26, 2006 Kuzuwa & Partners

  34. III. How to draft pharmaceutical/medical patent specification 8. Regenerative medical method JP: patentable if extracts used for producing medical products EP: unpatentable, due to lack of industrial applicability EPC2000: patentable? US: patentable Nov. 26, 2006 Kuzuwa & Partners

  35. III. How to draft pharmaceutical/medical patent specification 9. Dosage form characterized by administering method JP: patentable EP: unpatentable, due to lack of industrial applicability EPC2000: patentable? US: unpatentable due to lack of novelty, but patentable as administering method Nov. 26, 2006 Kuzuwa & Partners

  36. III. How to draft pharmaceutical/medical patent specification 10. Operating method for medical devices JP: patentable, if not involving human body EP(EPC2000): patentable, if not involving diagnostic determination → depends on how to draft the claim US: patentable Nov. 26, 2006 Kuzuwa & Partners

  37. III. How to draft pharmaceutical/medical patent specification 11. How to draft original specification and how to amend claims in the prosecution -Practice on amendments, so strict … so called new matter practice: EP (§123)> JP (§ 17bis)> US (§ 132) Nov. 26, 2006 Kuzuwa & Partners

  38. III. How to draft pharmaceutical/medical patent specification 11. How to draft original specification and how to amend claims in the prosecution In the original specification, - more working examples, - more specific compounds listing, - more stepwise numerical ranges, e.g. “5-50°C, preferably 10-30°C, more preferably 15-20°C”, - less negative expression, e.g. “if higher than 50°C, adverse effect appears” ↓ more possibilities for amending claims during prosecution Nov. 26, 2006 Kuzuwa & Partners

  39. IV. Special attention to experimental data for pharmaceutical patent applications How important Identification data, Pharmacological data etc. are? • Critical for fulfilling enablement requirements • Must be present in the original specification. • Late submission of data is not acceptable when none of data was given in the original specification (at least for Japan). Nov. 26, 2006 Kuzuwa & Partners

  40. IV. Special attention to experimental data for pharmaceutical patent applications Recent Court decisions (JP) Nov. 26, 2006 Kuzuwa & Partners

  41. IV. Special attention to experimental data for pharmaceutical patent applications How to cope with the strict practice (at least for Japan) on pharmaceutical/ medical patent application? Nov. 26, 2006 Kuzuwa & Partners

  42. 1. New chemical compounds represented by following formula I A-R (A: novel chemical structure) 2. Anticancer agent comprising chemical compounds represented by formula I IV. Special attention to experimental data for pharmaceutical patent applications N Hypothetical example 1 A- A- A- H A- Nov. 26, 2006 Kuzuwa & Partners

  43. Substance invention No chance Pharmaceutical invention No chance IV. Special attention to experimental data for pharmaceutical patent applications Hypothetical example 1 Nov. 26, 2006 Kuzuwa & Partners

  44. 1. New chemical compounds represented by following formula I A-R (A: novel chemical structure) 2. Anticancer agent comprising chemical compounds represented by formula I IV. Special attention to experimental data for pharmaceutical patent applications N Hypothetical example 2 A- A- H A- Nov. 26, 2006 Kuzuwa & Partners

  45. Substance invention A-H: Likely patentable A- A- A- Pharmaceutical invention No chance IV. Special attention to experimental data for pharmaceutical patent applications N Hypothetical example 2 Patentable if pharmacologically equivalent to A-H H Nov. 26, 2006 Kuzuwa & Partners

  46. 1. New chemical compounds represented by following formula I A-R (A: novel chemical structure) 2. Anticancer agent comprising chemical compounds represented by formula I IV. Special attention to experimental data for pharmaceutical patent applications N Hypothetical example 3 A- A- H A- Nov. 26, 2006 Kuzuwa & Partners

  47. Substance invention A-H: Likely patentable A- A- A- Pharmaceutical invention A-H: Likely patentable A- A- A- IV. Special attention to experimental data for pharmaceutical patent applications N N Hypothetical example 3 Patentable if pharmacologically equivalent to A-H H Patentable if pharmacologically equivalent to A-H H Nov. 26, 2006 Kuzuwa & Partners

  48. IV. Special attention to experimental data for pharmaceutical patent applications Suggestion 1. General • The more experimental data, the more chance. • Experimental data for at least one embodiment, which support the utility of said embodiment, are absolutely necessary for chemical/pharmaceutical inventions. Nov. 26, 2006 Kuzuwa & Partners

  49. IV. Special attention to experimental data for pharmaceutical patent applications Suggestion 2.Substance invention • Identification data on at least one chemical compound selected from a reasonably categorized group should be given in the specification. Otherwise, almost no chance as a whole. • The reasonably categorized group has more chance to be granted, whereas the other groups are likely rejected. • Pharmacological data are not necessarily needed for enablement requirements for substance invention, but would be useful for asserting inventiveness. Nov. 26, 2006 Kuzuwa & Partners

  50. IV. Special attention to experimental data for pharmaceutical patent applications Suggestion 3.Pharmaceutical (use) invention • Pharmacological data on at least one chemical compound selected from a reasonably categorized group should be given in the specification. • The reasonably categorized group may well be patentable. • The other groups falling within the claim are theoretically also patentable, only if -a reasonable explanation on why compounds falling within the other groups are pharmacologically equivalent to the above compound and -additional pharmacological data on the other group’s compounds are submitted. Nov. 26, 2006 Kuzuwa & Partners

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