- 國際法規基準比較與實務問題探討 張仁平 摘要 Abstract Based one ethical consideration, inventions directing to diagnostic,therapeutic and surgical methods for the treatment of humans or animals are excluded from patent protection in most countries. However, the scope of medical treatment is expanding and the nature of medical treatment is undergoing changes due to the progress of medical technology, the patentability of such methods becomes a developing issue worldwide. At present, the boundary of medical treatment is not always clear-cut, it is necessary to make a concrete and detailed criterion Comparing the 93.07 智慧財產權月刊 67 期 5
patent laws, examination guidelines and case laws relating to methods of medical treatment between EPO, China, Japan and Taiwan, some basic principles and general judgment standards as to what should be considered for the examination of such patent applications may be established 關鍵詞,,, Keywords diagnostic, therapeutic and surgical method, medical treatment, cosmetic method, kit, combination 壹 前言 1 2 3 ( ) 4 5 TRIPs WTO 1 2 3 4 5, (USPTO), 1954 Ex parte Scherer, 1990 18(2),,1994 Anaesthetic Supplies PTY Ltd. v. Rescare Ltd. (EPC) EPC 52(4),, 29 1, EXAMINATION GUIDELINES FOR PATENT AND UTILITY MODEL IN JAPAN,PART II,Chapter 1,P.5(2000) 25 1 4,, 6 智慧財產權月刊 67 期 93.07
6 7 8 貳 我國專利法對於醫療處理方法相關條文之修正 2004 7 1 6 27.3(a) Members may also exclude from patentability:(a)diagnostic,therapeutic 7 8,, EXAMINATION GUIDELINES FOR PATENT AND UTILITY MODEL IN JAPAN,PART II,Chapter 1,P.5(2000) 産, 産,,p.2-63(2001) 93.07 智慧財產權月刊 67 期 7
21 2 24 2 surgical method 25 1 4 1986 12 24 9 1994 11 25 10 2000 2003 11 2004 (2004 7 1 ) 12 9 10 11 12.,p.1-1-5(1994) EXAMINATION GUIDELINES FOR PATENT AND UTILITY MODEL IN JAPAN,PART II,Chapter 1,P.6(2000) Methods for surgical operations and drawing blood are included in method for treatment of the human body by surgery practiced on the human body,p.2(2003),.,p.2-2-14,, http://www.tipo.gov.tw 8 智慧財產權月刊 67 期 93.07
參 醫療處理方法的範疇與規範 一 醫療處理方法的範疇 (methods of therapeutic treatment) (methods of elective treatment) (diagnostic methods) 13 14 15 13 14 15 Todd Martin, Patentability of Methods of Medical Treatment:A Comparative Study, JPTOS,p.382,June 2000,,61,p.55(2004.1) T 182/90(OJ EPO 1994,641) (SEE-SHELL/Blood flow)( medical treatment ) 93.07 智慧財產權月刊 67 期 9
二 國際上規範之差異 16 EPC 52(4) 17 TRIPs 27.3(a) 18 24 2 16 17 18 25 1 4 4 27.3(a) Members may also exclude from patentability: 10 智慧財產權月刊 67 期 93.07
肆 國際上有關 診斷方法 的規範比較 一 基本規定 1. ( ) EPC 52(4) 19 X NMR (1) (2) (3) ( ) (4) ( ) 20 19 20 EPO GUIDELINES, PART C, CHAPTER IV,4. 2.1,p.53(2003) EPO T 964/99 of 11 02 1997 T 385/86(OJ EPO 1988,398)(BRUKER 93.07 智慧財產權月刊 67 期 11
21 22 2. 爲 (1) 爲 (2) 爲 (3) 21 22,EPO,, T 385/86(OJ EPO 1988,398)(BRUKER/Non-invasive measurement) EPC 52(4),,,, T 964/99 of 11 02 1997,,,,EPO T 964/99,, Derk Visser, The Annotated European Patent Convention p.47,10 th ed.(2002) EPO T 964/99 of 11 02 1997, (iron dextran), (NMR), (in vivo) NMR,, EPO, ( ),, 12 智慧財產權月刊 67 期 93.07
23 3. (1) 24 (2) 25 26 4. ( ) ( ) 23 24 25 26 X 3.3.1,p.2-6(2001) X, EXAMINATION GUIDELINES FOR PATENT AND UTILITY MODEL IN JAPAN,PART II,Chapter 1, P.7(2000),p.3(2003), EXAMINATION GUIDELINES FOR PATENT AND UTILITY MODEL IN JAPAN,PART II,Chapter 1,P.7(2000),p.3(2003) ( ), EXAMINATION GUIDELINES FOR PATENT AND UTILITY MODEL IN JAPAN,PART II,Chapter 1,P.7-8(2000),p.3(2003) 93.07 智慧財產權月刊 67 期 13
( ) (1) (2) (3) 27 28 二 審查判斷要點 1. (nature) 29 2. ( ) 30 ( ) ( ) ( ph ) 27 28 29 30 2004 (2004 7 1 ),p.2-2-12, http://www.tipo.gov.tw EPO T 655/92(OJ EPO 1998,17)(NYCOMED/Contrast agent for NMR imaging),t 385/86(OJ EPO 1988,398)(BRUKER/Non-invasive measurement) EPC,,, EPO T 385/86(OJ EPO 1988,398) (BRUKER/ 14 智慧財產權月刊 67 期 93.07
( ) (NMR) 31 32 X 33 X 34 3. 35 爲 36 / ( ) 31 32 EPO,,,,, EPO T 385/86(OJ EPO 1988,398)(BRUKER/Non-invasive measurement),t 400/87,T 964/99 of 11 02 1997 33 EPO T 775/92 34 35 36 23 EPO T 61/83,T 208/83, 爲 93.07 智慧財產權月刊 67 期 15
37 ( ) ( ) 38 4. 39 ( ) 40 37 38 39 40 3.3.2.2,p.2-6(2001) EPO T 61/83,T 208/83,T 18/84,T 45/84 X NMR, 3.3.1.2,p.2-6 2-7(2001) EPO GUIDELINES,PART C,CHAPTER IV,4.2.1, p.53(2003) 1988 1991,,, EPO T 385/86(OJ EPO 1988,398)(BRUKER/Non-invasive measurement), ( ph ),,, X NMR, 3.3.1.2,p.2-6 2-7(2001) EPO GUIDELINES,PART C,CHAPTER IV,4.2.1, p.53(2003) 1988 1991, EPO T 385/86(OJ EPO 1988,398)(BRUKER /Non-invasive measurement), ( ph ),,, 16 智慧財產權月刊 67 期 93.07
X X 41 (NMR) 5. ( ) 42 41 EPO T 775/92, X,,EPO,,, EPC 52(4) 42,p.1-1-6(1994) 93.07 智慧財產權月刊 67 期 17
6. ( ) 43 (NMR) 44 伍 國際上有關 治療方法 的規範比較 一 基本規定 1. 45 46 47 48 49 43 44 45 46 47 48 49 EPO T 329/94(OJ EPO 1998,241)(BAXTER/Blood extracting method),t 964/99 of 11 02 1997 EPOT 655/92(OJ EPO 1998,17)(NYCOMED/Contrast agent for NMR imaging) EPO T 19/86(OJ EPO 1989,24)(DUPHAR/PIGS II) EPO T 290/86(OJ EPO 1992,414)(ICI/ Cleaning plaque) EPO T 245/87(OJ EPO 1989,171)(SIEMENS/FLOW MEASUREMENT) EPO GUIDELINES,PART C,CHAPTER IV,4.2.1,p.53(2003) EPO EPO T 144/83(OJ EPO 1986,301)(DU PONT/Appetite suppressant) 18 智慧財產權月刊 67 期 93.07
50 51 52 2. 爲 爲 爲 爲 爲 爲 53 3. (1) (2) ( ) (3) ( ) ( ) (4) ( ) ( 50 51 52 53 EPO T 24/91(OJ EPO 1995,512)(THOMPSON/Cornea) Derk Visser, The Annotated European Patent Convention p.44,45,10 th ed.(2002) 3.3.2,p.2-8(2001) 93.07 智慧財產權月刊 67 期 19
( ) 54 4. 55 二 審查判斷要點 1. 56 ( 57 ) EPC 52(4) (Munich Diplomatic Conference) 54 55 56 57 EXAMINATION GUIDELINES FOR PATENT AND UTILITY MODEL IN JAPAN,PART II,Chapter 1,P.6-7(2000),p.2(2003) 2004 (2004 7 1 ),p.2-2-13, http://www.tipo.gov.tw ( ) ( ),, 20 智慧財產權月刊 67 期 93.07
58 ( ) ( ) EPC 52(4) 59 ( ) ( ) 2. ( ) ( ) 60 61 ( 58 59 60 61 EPO T 19/86(OJ EPO 1989,24)(DUPHAR/PIGS II),T 290/86(OJ EPO 1992,414)(ICI/ Cleaning plaque),t 820/92(OJ EPO 1995,113)(THE GENERAL HOSPITAL/Contraceptive method) T 19/86 Both prophylactic and curative treatments of disease should be regarded as falling within the meaning of the word therapy in the sense that that word is used in Article 52(4) EPC, since both are directed to the same objective, i.e. the maintenance or restoration of health.,t 438/91, EPC 52(4), EPO G 5/83(OJ EPO 1985,64)(EISAI/Second medical indication),t 144/83(OJ EPO 1986,301)(DU PONT/Appetite suppressant),t 385/86(OJ EPO 1988,398) (BRUKER/ Noninvasive measurement) EPO GUIDELINES, PART C, CHAPTER IV, 4.2,P.51(2003) EPO T 1005/98, not published in OJ, EPO GUIDELINES, PART C, CHAPTER IV, 4.2, P.51 (2003) (2001) 93.07 智慧財產權月刊 67 期 21
) (functional link)( ) 62 3. ( ) 63 ( ) ( ) ( ) 64 62 63 64 EPO T 245/87(OJ EPO 1989,171)(SIEMENS/FLOW MEASUREMENT) ( ) EPC 52(4),EPO,,, EPC 52(4) EPO T 24/91(OJ EPO 1995,512)(THOMPSON/Cornea) The meaning of the term therapy is not restricted to curing a disease and removing its causes. Rather, the term covers any treatment which is designed to cure, alleviate, remove or lessen the symptoms of, or prevent or reduce the possibility of contracting any disorder or malfunction of the human and animal body. EPO T 81/84(OJ EPO 1988,207)(RORER/DYSMENORRHEA) 22 智慧財產權月刊 67 期 93.07
4. (essentially biological) 65 66 67 ( EPC 52(4) ) ( EPC 53 ) ( EPC 57 ) 68 69 70 65 66 67 68 69 70,, 93 7 1 24 1 24 1 EPC 53 (b) TRIPs 27.3(b),2004 (SPLT) (Tenth Session) 12 (5), EPO T 774/89,EPO, (disclaimer), 3.3.2.2,p.2-8(2001) EPO GUIDELINES,PART C,CHAPTER IV,4.2.1,p.52(2003) 3.3.2.2,p.2-8(2001) 3.3.2.2,p.2-8(2001),, EPO T 144/83(OJ EPO 1986,301)(DU PONT/Appetite suppressant) 93.07 智慧財產權月刊 67 期 23
71 72 EPC 52(4) EPC 52(4) 73 74 EPC EPC 57 75 5. 76 71 72 73 74 75 76 EPO GUIDELINES,PART C,CHAPTER IV,4.2.1,p.52(2003) EPO T 820/92(OJ EPO 1995,113)(THE GENERAL HOSPITAL/Contraceptive method),t 74/93(OJ EPO 1995,712)(BRITISH TECHNOLOGY GROUP/Contraceptive method) 3.3.2.1,p.2-8(2001) EXAMINATION GUIDELINES FOR PATENT AND UTILITY MODEL IN JAPAN,PART II,Chapter 1,P.6(2000) EPO GUIDELINES,PART C,CHAPTER IV,4.2.1,p.52(2003) EPO T 74/93(OJ EPO 1995,712)(BRITISH TECHNOLOGY GROUP/Contraceptive method), (alicyclic),, ( ),,, EPC 57 EPO T 774/89,T 469/94 of 01 07 1997 24 智慧財產權月刊 67 期 93.07
( ) ( ) seldinafil( Viagra) (acetylcholine) 77 6. ( ) 77 EPO T 469/94 of 01 07 1997: It is the board s view that the two effects of choline are not inseparably linked or correlated but,on the contrary, are readily distinguishable because they involve two groups of persons(or patients) undoubtedly distinct. The one consists of patients known to have a muscular disease, muscular injury or epilepsy, whereas the second comprises healthy persons who will receive no therapeutic benefit from the treatment. Moreover, the times necessary for appreciating the different effect(days for the therapeutic effect and minutes or hours for the non-therapeutic effect[reducing fatigue])would appear to be so different that no unwanted overlap of the treatment could occur. 93.07 智慧財產權月刊 67 期 25
78 79 80 81 ( ) ( ) 78 79 80 81 EPO T 820/92(OJ EPO 1995,113)(THE GENERAL HOSPITAL/Contraceptive method),t 290/86(OJ EPO 1992,414)(ICI/Cleaning plaque),t 780/89(OJ EPO 1993,440)(BAYER/ Immunostimulant),T 1077/93 of 30 05 1996 T 1077/93, 3,5- (3,5-Diisopropyl salicylic acid) (CuDIPs),,, EPC 52(4),, EPO,EPC 52(4), CuDIPs,, ( ), EPO T 820/92(OJ EPO 1995,113)(THE GENERAL HOSPITAL/Contraceptive method) In the case of a method involving administration of two or more substances, the question for the purpose of Article 52(4) EPC is not whether the main or even the only reason for carrying out the whole of the claimed method is non-therapeutic. Rather a method claim falls under the prohibition of Article 52(4) EPC already if the administration of one of the substances is a treatment by therapy, and the administration of the substance is a feature of the claim. EPO T 290/86(OJ EPO 1992,414)(ICI/Cleaning plaque) EPO T 116/85(OJ EPO 1989,13)(WELLCOME/Pigs I) 26 智慧財產權月刊 67 期 93.07
( 82 ) 83 84 7. 85 ( ) ( 82 83 84 85 EPO T 438/91 EPO T 780/89(OJ EPO 1993,440)(BAYER/Immunostimulant), 1 (I), EPC 52(4),, EPO, 1.,, 2., (secondary effect) EPC 52(4) EPO T 36/83(OJ EPO 1986,295)(ROUSSEL-UCLAF/Thenoyl peroxide) EPO T 144/83(OJ EPO 1986,301)(DU PONT/Appetite suppressant), EPO ( ) ( ),,,, 93.07 智慧財產權月刊 67 期 27
) 86 87 陸 國際上有關 手術方法 的規範比較 一 基本規定 1. 88 86 87 88 EPO T 780/89(OJ EPO 1993,440)(BAYER/Immunostimulant) EPO T 584/88 EPO GUIDELINES,PART C,CHAPTER IV,4.2.1,p.53(2003) 28 智慧財產權月刊 67 期 93.07
89 90 2. 91 爲 ( 92 ) 93 爲 産 爲 ( 94 ) ) 爲 95 89 90 91 92 93 94 95 EPO T 182/90(OJ EPO 1994,641)(SEE-SHELL/Blood flow) EPO T 35/99(OJ EPO 2000,447)(GEORGETOWN UNIVERSITY/Pericordial access),t 182/90(OJ EPO 1994,641)(SEE-SHELL/Blood flow),, 3.3.2.2,p.2-8(2001), 1.3.3,p.208,, (2002) 3.3.2.3,p.2-9(2001) 92 3.2.4,p.2-65(2001) 93.07 智慧財產權月刊 67 期 29
( ) ( ) 3. ( ) 96 4. ( ) 97 二 審查判斷要點 1. 98 96 97 98 EXAMINATION GUIDELINES FOR PATENT AND UTILITY MODEL IN JAPAN,PART II,Chapter 1,P.6(2000),p.2(2003) 2004 (2004 7 1 ),p.2-2-14, http://www.tipo.gov.tw 3.3.2.2,p.2-8(2001) 30 智慧財產權月刊 67 期 93.07
99 ( ) 100 2. 101 99 EPO T 182/90(OJ EPO 1994,641)(SEE-SHELL/Blood flow),, EPO,,, 100 EPO T 35/99(OJ EPO 2000,447)(GEORGETOWN UNIVERSITY/Pericordial access),t 329/94(OJ EPO 1998,241)(BAXTER/Blood extracting method) 101 EPO T 35/99(OJ EPO 2000,447)(GEORGETOWN UNIVERSITY/Pericordial access) 93.07 智慧財產權月刊 67 期 31
102 103 EPC ( ) 3. 10 1994 102 EPO GUIDELINES,PART C,CHAPTER IV,4.2.1,p.52(2003) A cosmetic treatment involving surgery or therapy would, however, not be patentable.,t 290/86(OJ EPO 1992,414) (ICI/Cleaning plaque) 103,,1994 1,p.39 32 智慧財產權月刊 67 期 93.07
2004 爲 産 柒 醫療處理方法不予專利的基本前提 一 必須以活體為直接實施對象 104 (1) 105 (2) ( 104, EPC (Intergovernmental Conference), Gerald Paterson, THE EUROPEAN SYSTEM-The Law and Practice of the European Patent Convention, 2 nd.ed. p.423(2001) 105 ( ), 3.3.1.2 3.3.2.2,p.2-7,2-8(2001) EPO GUIDELINES,PART C,CHAPTER IV,4.2.1,p.52(2003) EXAMINATION GUIDELINES FOR PATENT AND UTILITY MODEL IN JAPAN,PART II,Chapter 1,P.6(2000),p.1-1-5(1994) 93.07 智慧財產權月刊 67 期 33
) 106 ( ) 107 108 (1) (2) 109 106, 107 3.3.2.1,p.2-7(2001) EPO GUIDELINES,PART C,CHAPTER IV,4.2.1,p.52(2003) EXAMINATION GUIDELINES FOR PATENT AND UTILITY MODEL IN JAPAN,PART II,Chapter 1,P.6(2000), p.1-1-5(1994) 1975,,, 108 2003 7 ( ),, 109 87 399,82107448, (a),(b),(c), ( ),, 34 智慧財產權月刊 67 期 93.07
(in vitro) 110 ( ) 111 二 必須以 方法 為申請標的 1. (treating method) ( ) (operating procedure) 112 2002 110 2003 10 1 86119711, 1., (A), 1999 1 27 EP 554441 B1 claim 1 A method for determining, in vitro, the effectiveness of a therapeutic agent for treatment of a cancer, wherein malignant cells of the cancer express or overexpress an oncogene product on the extracellular domain of the cells, the method comprising the step of.. 111,,p.44, (2002) 112, 1.3.3,p.208,, (2002), EXAMINATION GUIDELINES FOR PATENT AND UTILITY MODEL IN JAPAN,PART II,Chapter 1,P.5-6(2000) 93.07 智慧財產權月刊 67 期 35
113 2. 114 (functional feature) 115 3. 113,,, V.S.,p.31, (2003 5 ) 114 EPC 52(4) This provision shall not apply to products, in particular substances or compositions, for use in any of these methods., EXAMINATION GUIDELINES FOR PATENT AND UTILITY MODEL IN JAPAN,PART II,Chapter 1,P.5(2000) 3.3,p.2-5 (2001),p.1-1-6(1994) EPC 167 (2000 EPC ), 115 EPO T 712/93, EPO EPC 52(4),,, EPO,, EPC,,, EPC 52(4) 36 智慧財產權月刊 67 期 93.07
116 4. 117 ( ) 118 119 捌 醫療處理方法不予專利的共通原則 一 包含任一醫療處理特徵的方法即屬醫療處理方法 (technical character) 116 EPO T 789/96 117 EPO T 426/89 118 (new matter) 119 EPO T 82/93(OJ EPO 1996,274)(TELECTRONICS/Cardiac pacing) 93.07 智慧財產權月刊 67 期 37
120 121 122 123 二 具有產業利用性的醫療處理方法仍被排除專利 ( ) ( 120 T 438/91,EPO T 820/92(OJ EPO 1995,113)(THE GENERAL HOSPITAL/Contraceptive method), T 82/93(OJ EPO 1996,274)(TELECTRONICS/Cardiac pacing) T 820/92,, EPC 57 ( ) EPO EPC 52(4),, EPC 52(4), (LHRH), (progestational steroids), LHRH, EPC 52(4),,EPC 52(4),, 121,,,,,,, EXAMINATION GUIDELINES FOR PATENT AND UTILITY MODEL IN JAPAN,PART II,Chapter 1,P.8(2000) 122 EPO T 820/92(OJ EPO 1995,113)(THE GENERAL HOSPITAL/Contraceptive method) 123 EPO T 82/93(OJ EPO 1996,274)(TELECTRONICS/Cardiac pacing) 38 智慧財產權月刊 67 期 93.07
( EPC 52(4) ) ( EPC 53 ) ( EPC 57 ) ( ) 124 三 醫療處理未必皆由醫療人員執行, 醫療人員執行者未必皆屬醫療處理 1. 124 EPO T 116/85(OJ EPO 1989,13)(WELLCOME/Pigs I),EPO,,,,,,,,,,,,,,, 93.07 智慧財產權月刊 67 期 39
125 ( ) 126 127 2. 128 129 125 EPO T 116/85(OJ EPO 1989,13)(WELLCOME/Pigs I),T 182/90(OJ EPO 1994,641) (SEE- SHELL/Blood flow),t 329/94(OJ EPO 1998,241)(BAXTER/Blood extracting method),t 964/99 of 11 02 1997 126 EPO T 116/85(OJ EPO 1989,13)(WELLCOME/Pigs I) 127 EPO T 182/90(OJ EPO 1994,641)(SEE-SHELL/Blood flow),t 329/94(OJ EPO 1998,241) (BAXTER/Blood extracting method) 128 EPO T 24/91(OJ EPO 1995,512)(THOMPSON/Cornea) Such medical treatments need not necessarily be carried out by physicians However, where, in view of the health risks connected with such a treatment, a claimed method for treatment has to be performed by a physician or under his supervision, it will normally fall within the exclusion of the first sentence of article 52(4) EPC., ( ), 129 EPO T 385/86(OJ EPO 1988,398)(BRUKER/NON-invasive measurement),t 24/91(OJ EPO 1995,512)(THOMPSON/Cornea),T 655/92(OJ EPO 1998,17)(NYCOMED/Contrast agent for NMR imaging) 40 智慧財產權月刊 67 期 93.07
130 ( ) 3. 131 ( ) 130 EPO T 385/86(OJ EPO 1988,398)(BRUKER/Non-invasive measurement) T 400/87,, 131 EPO T 1165/97,EPO,,, 93.07 智慧財產權月刊 67 期 41
132 玖 醫療處理方法不予專利的基本歧異問題 是否限於 疾病 之處理? TRIPs 27.3(b) EPC 52(4) EPC 52(4) ( ) ( 132 EPO T 329/94(OJ EPO 1998,241)(BAXTER/Blood extracting method) EPO, EPO,,,,,, 12, 1, 1, 12,,, 42 智慧財產權月刊 67 期 93.07
) ( ) ( ) 拾 我國醫療處理方法專利審查實務之爭議問題 一 申請標的為 醫藥組合物, 而實質內容為治療方法者, 是否以其涉及 疾病之治療方法 而不予專利? ( X Y ) ( ) ( X Y ) 93.07 智慧財產權月刊 67 期 43
133 ( X Y ) ( ) 二 申請標的為 醫藥組合物, 卻附帶敘述其施用方式, 是否涉及 疾病之治療方法? ( ) ( ) ( ) 133,2004 7 1 44 智慧財產權月刊 67 期 93.07
三 合併非同時服用的兩種以上成分藥物之標的 ( 套組(kit) 與 組合(combination) ) 是否涉及 疾病之治療方法? (compound) (pharmaceutical composition) (pharmaceutical formulation ) (pharmaceutical preparation) (medicament) (method process) (use) 頴 93.07 智慧財產權月刊 67 期 45
134 頴 (optionally with instructions for use) 135 (method) 134 2002 2 1 87112465, 1, -1,.. 135 2002 6 23 85101447 HIV AIDS 1 HIV AIDS,,.., 2..,, 3.., EPO EP 0806957 B1 46 智慧財產權月刊 67 期 93.07
136 (kit of parts ) ( (combination) 137 頴 138 139 136 US 5120713 claim 1 A method of inducing growth hormone secretion in an obese patient which comprises administering.alpha-2-adrenergic agonist and a growth hormone releasing peptide., EP 0500847 B1 claim 1 A pharmaceutical kit containing alpha-2-adrenergic agonist and a growth hormone releasing peptide.. claim 10 The use of an alpha-2-adrenergic agonist in the manufacture of a medicament for the treatment of obesity by administration of the alpha-2-adrenergic agonist to an obese patient, simultaneously, separately or sequentially with a growth hormone releasing peptide.. JP 2509185 claim 1 137 T 9/81(OJ EPO1983,372)(ASTA/Cytostatic combination) A B (combined preparation) (cytostatic therapy), A, B, (composition), (functional unity), (kit-ofparts), EPC 54(5) (formulation),,, (combination),, 138 Franz Zimmer & Thomas Friede, Method of Treatment Inventions under the EPC: What kind of Protection can you get,http://www.grunecker.de/download/publications /treat.pdf(2001) 139 Derk Visser, The Annotated European Patent Convention p.63,10 th ed.(2002) 93.07 智慧財產權月刊 67 期 47
140 拾壹 結語 140 EP 10149895 B1(2003 5 21 ) claim 1 combination, claim 9 use, claim 11 pharmaceutical formulation, claim 15 process,claim 17 kit, US 6159971(2000 12 12 ) use method, 48 智慧財產權月刊 67 期 93.07
X X ( ) X (NMR ) X X X X ( ( ( ( ) X ) ) ( ) 爲 ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) 93.07 智慧財產權月刊 67 期 49
( ) ( ) ( ( X ) ) ( ) X ) ( ( ) ( ( ) ) 50 智慧財產權月刊 67 期 93.07
( ) ) ( ) ( ( ) ( ) ( ) ( ) X 93.07 智慧財產權月刊 67 期 51