의료행위의 특허대상성: 산업상 이용가능성의 한계를 넘어 = Patent Eligibility of Medical Methods : Beyond the Frame of Industrial Application

다국어 초록 (Multilingual Abstract)

Korea has showed hostility toward patent eligibility of medical related activity from the enactment of Patent Act. Presently, Korea Patent Agency(hereafter ‘KIPO’)’s guideline do not recognize patent eligibility of medical methods by seeing not susceptible to industrial application under the article 29(1) of Patent Act while it recognize the patent eligibility of substance or composition used in medical methods. Court also follow the lead of Agency by denying patent eligibility of claims involving human body when the purpose of claimed methods lies in surgery,diagnostics, therapeutics. Comparatively, U.S., leaded by court opinion, recognize broad patent eligibility of medical methods not distinguishing from other industrial field only negating patent eligibility when the claims is fall within laws of nature, natural phenomena, abstract ideas.
Europe's Convention on the Grant of European Patents excepts patent eligibility of medical methods subdividing as surgery, therapeutic, diagnostic methods in the purpose of social policy, but board of appeals of European Patent Office(hereafter ‘EPO’) in charge of interpretation of the Convention takes different attitude toward each sub categories and recognize patent eligibility partially.
The advent of personalized medicine and related industry which are based on the recently furthered knowledge of Human DNA change the frame of division between medicine and medical methods on which Korea‘s dichotomy was founded. U.S.- where the related industries already spread wings- courts are now issuing a burgeoning set of eligibility decisions regarding a wide range of the human gene information, diagnostic and therapeutic methods based on it. DNA and diagnostics related Association for Molecular Pathology v. U.S.P.T.O and therapeutics related Mayo Collaborative Servs. v. Prometheus Labs., Inc. cases are representatives. Comparatively,Europe is taking narrow view toward eligibility, but Enlarged Board of Appeals of EPO expands eligibility by diagnostics related Diagnostic Method decision, and surgery related Medi-Physic/Treatment by surgery decision.
Contrary to U.S. and Europe, Korea entrust medical method eligibility to the KIPO's discretion on the industrial application and KIPO usually follows steps of settled U.S. and Europe's way to reduce the limit of industrial application on medical methods without further review. This frame of policy has serious problem on both logical theories and policy consideration against public healthcare side. Therefore the improvement of frame is imminent and necessitated.

국문 초록 (Abstract)

특허법의 제정 당시부터 그 특허대상성에 부정적이었던 의료행위에 대하여 한국은 의료행위와 관련된 도구나 약품의 특허대상성은 인정하고 의료행위는 특허의 요건을 정한 특허법 제29조 제1항을 해석하는 특허청의 심사지침에 의해 산업적 이용가능성 없는 발명으로 보고 있으며 법원의 판결도이를 추종해 인체를 필수적 구성요소로 하고 있는 특허청구 중 그 행위가 수술, 치료, 진단행위가 아닌다른 목적 행위로 볼 수 없다면 특허대상성을 부정하는 판단 방식을 취하고 있다. 그에 비해 미국은법원을 중심으로 의료행위의 특허대상성을 다른 특허청구와 구분하지 않고 특허대상성을 인정해 자연법칙, 자연현상, 추상적 사상만을 특허대상성을 부정하는 광범위한 특허대상성 인정의 입장을 취하고있고, 유럽은 사회정책적으로 유럽특허조약을 통하여 이를 수술, 치료, 진단행위로 나누어 그 특허대상성을 명문의 규정으로 부정하고 있으나 그 해석을 책임지는 유럽특허청 내 심판위원회는 각 행위마다해석을 통하여 특허대상성을 부분적으로 인정하고 있다.
최근 인간 유전정보에 대한 진보된 연구결과를 바탕으로 하는 환자에 특화된 의약품과 그 관련산업의 등장은 그동안 한국이 의존해왔던 의료행위와 의약품의 2분법을 무너뜨리고 있다. 이에 따라 상대적으로 위 산업의 발전이 앞선 미국에서는 위 산업의 기초가 되는 인간유전정보 및 이를 이용한 진단,치료행위의 특허대상성의 허용범위를 놓고 최근 다양한 판결이 쏟아지고 있으며 유전정보와 진단방법에 관련된 Association for Molecular Pathology v. U.S.P.T.O 사건 치료행위와 관련된 Mayo Collaborative Servs. v. Prometheus Labs., Inc. 사건을 대표적으로 들 수 있다. 유럽의 경우 미국에 비해 상대적으로 그 범위는 좁은 편이지만 유럽특허청 확장심판위원회의 진단행위와 관련된 Diagnostic Method 결정, 수술행위와 관련된 Medi-Physic/Treatment by surgery 결정 등을 통해 진단행위를 중심으로 의료행위의 특허대상성을 확장하고 있는 추세이다.
그에 비해 한국은 위 문제의 결정이 특허청의 산업상 이용가능성의 틀에 맡겨져 있고, 특허청은 사실상 미국과 유럽의 경향이 결정되면 이를 추종해 산업상 이용가능성에 제한 범위를 줄이는 방식으로 대응하고 있는데 이는 이론적 한계를 가지고 있을 뿐 아니라 의료행위가 상당한 공공성을 가진 행위라는점에서 심각한 문제를 가지므로 이에 대한 개선이 필요하다.

참고문헌 (Reference)

1 "특허법원 2011. 12. 15. 선고 2011허7645 판결"

2 "특허법원 2005. 6. 23 선고 2004허7142 판결(대법원 2005후1936 판결로 상고기각)"

3 "특허법원 2004. 7. 15. 선고 2003허6104 판결"

4 조영선, "특허법" 박영사 96-, 2011

5 김관식, "의료행위관련발명 보호체제의 개선방안에 관한 小考" 과학기술법연구원 12 (12): 57-76, 2006

6 "의료심사기준"

7 "의료심사기준"

8 신원혜, "의료관련행위발명에 대한 국내․외 판단기준 비교연구-진단방법을 중심으로" 특허청 1 : 2007

9 김정완, "유전공학 발명에 대한 특허법적 보호, In 보건의료법의 현대적과제" 130-132, 2006

10 특허청, "심사지침서-특허·실용신안(2011)"

11 "심사지침서"

12 "심사지침서"

13 설민수, "소프트웨어 특허대상성 논의의 역사적 전개와 한국에서의 시사점" 사법발전재단 1 (1): 101-158, 2012

14 "생명공학 심사기준, 1.3.2"

15 "생명공학 심사기준, 1.2"

16 "생명공학 심사기준"

17 장정일, "생명공학 기술과 특허-배아줄기세포 복제기술의 특허를 중심으로-" 6 (6): 405-406, 2005

18 특허청, "산업부분별 심사기준-의료·위생분야"

19 특허청, "산업부분별 심사기준-생명공학분야"

20 "대법원 2006. 8. 25. 선고 2005후1936 판결"

21 "http://www.ncbi.nlm.nih.gov/About/primer/est.html. 2011"

22 Allen K. Yu, "Within Subject Matter Eligibility : A Disease and a Cure" 84 : 387-, 2011

23 "USPTO Utility Examination Guidelines"

24 "U.S. Const. art. I, § 8, cl. 8, 35 U.S.C. § 101"

25 "Thompson/Conear, T 24/91, [1995] O.J.E.P.O. 512, 515～6(TBA 3.2.2 May 5, 1994)"

26 "THERMAGE/Apparatus for skin resurfacing"

27 "TELECTRONICS/Pacer, T 82/93, [1996] O.J.E.P.O 274( TBA 3.4.1. May 15, 1995)"

28 "T 385/86, [1988] O.J.E.P.O 308(TBA 3.4.1 Sep. 25, 1987)"

29 "T 383/03, [2005] O.J.E.P.O. 159(TBA 3.2.2 Oct. 1, 2004)"

30 "T 35/99, [2007] O.J.E.P.O. 447(TBA 3.2.2 Sep. 29, 1999)"

31 "Sec’y’s Advisory Comm. on Genetics, Health & Soc’y, Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests, 20-36"

32 "Second Medical Use, G 5/83 [1985] O.J.E.P.O 64 (EBA, Dec. 5, 1984)"

33 "SIEMENS/Pacemaker"

34 Leisa Talbert Peschel, "Revisiting the Compromise of 35 U.S.C. § 287(C)" 16 : 299-, 2008

35 Michael Risch, "Reinventing Usefulness" 2010 : 1195-1206, 2010

36 "ROKER/Dysmenorrhoea"

37 "REICHART/Anti-snoring means, T 584/88, [1989] E.P.O.R. 449(TBA 3.3.1 Apr. 3, 1989)"

38 "Prometheus Labs., Inc. v. Mayo Collaborative Servs. No. 04-CV-1200 JAH (RBB), 2008 WL 878910(S.D. Cal. Mar. 28, 2008)"

39 "Prometheus Labs., Inc. v. Mayo Collaborative Servs. 628 F.3d 1347 (Fed. Cir. 2010)"

40 "Prometheus Labs., Inc. v. Mayo Collaborative Servs. 581 F.3d 1336(Fed. Cir. 2009)"

41 "Plant Genetic Systems/Glutamine Synthetase Inhibitors"

42 Matthew Herder, "Patents & the Progress of Personalized Medicine: Biomarkers Research as a Lens" 18 : 187-, 2009

43 D. Thomas, "Patentability Problems in Medical Technology" 34 : 847-, 2003

44 Joshua D. Sarnoff, "Patent-Eligible Inventions After Bilski: History and Theory" 63 (63): 63-83, 2011

45 "Pallin v. Singer, No. 2:93-CV-202, 1996 WL 274407 (D. Vt. Mar. 28, 1996)"

46 "Official Opinions of the Judicial Council" 163 : 1156-, 1957

47 "Norton v. New York Eye Infirmary, 17 F. Cas. 879 (C.C.S.D.N.Y. 1862)"

48 "NOGIER/Magnetic therapy"

49 "NEXINS RESEARCH/Apoptotic cells, T 1038/00, Unpublished(TBA 3.2.2 Jun. 11, 1997)"

50 R. MOUFANG, "Methods of Medical Treatment under Patent Law" 18 : 45-47, 1993

51 "Max-Planck/BDP1 Phosphatase, T 870/04, Unpublished(TBA 3.3.8 May 11, 2005)"

52 USTPO, "Manual of Patent Examining Procedure, §2107.03 I"

53 USTPO, "Manual of Patent Examining"

54 "MIT/Perception of fatigue"

55 Robert M. Portman, "Legislative Restriction on Medical and Surgical Procedure Patents Removes Impediment to Medical Progress" 4 (4): 116-117, 1996

56 "LabCorp, 548 U.S. at 137～38"

57 "Kuehmsted v. Farbenfabrikin of Elberfeld Co., 179 F. 701 (7th Cir. 1910) 판결"

58 "KONINKLIJKE PHILIPS ELECTRONICS NV/Determining a dimension from density distribution, T 0009/04, Unpublished(Sep. 8, 2006. TBA 3.2.2)"

59 "Juicy Whip, Inc. v. Orange Bang, Inc., 185 F.3d 1364, 1366 (Fed. Cir. 1999)"

60 "In re Fisher, 421 F.3d 1365 (Fed. Cir. 2005)"

61 "ICI/Cleaning plaque, T 290/86, [1992] O.J.E.P.O 414(TBA 3.3.1 Nov. 13, 1990)"

62 "Howard Florey/Relaxin, [1995] O.J.E.P.O 388(Opposition Div. 1994)"

63 "Harvard/Transgenic Animal, T 315/03, [2006] O.J.E.P.O 15(TBA 3.3.8 Jul 6, 2004)"

64 "Harvard/Onco-Mouse, T 19/90, [1990] O.J.E.P.O 476 (TBA 3.3.2 Oct. 3, 1990)"

65 "Genomics and Personalized Medicine Act of 2007, §2, S. 976, 110th Cong(2007)"

66 "G 2/06, [2009] O.J.E.P.O. 306(EBA Nov. 25, 2008)"

67 "G 1/07, [2011] O.J.E.P.O. 134(Feb. 15, 2010. EBA)"

68 "G 1/07, [2006] O.J.E.P.O. 334(EBA Dec. 16, 2005)"

69 Kara W. Swanson, "Food, and Drug Law as Intellectual Property Law: Historical Reflection" 2011 : 331-, 2011

70 "Ex parte Brinkerhoff, 24 Off. Gaz. Pat. Office 349(1883)"

71 Jordan Paradise, "European Opposition to Exclusive Control Over Predictive Breast Cancer Testing and the Inherent Implications for U.S. Patent Law and Public Policy : A Case Study of the Myriad Genetics’ BRCA Patent Controversy" 59 : 133-144, 2004

72 "EPC art. 99"

73 "EPC Rule 28(c)"

74 "ELA MEDICAL/Therapeutic method"

75 "Duphar/PigsII, T 19/86, [1989] O.J.E.P.O. 24, 27(TBA 3.3.1 Oct. 15, 1987)"

76 "Diamond v. Chakrabarty, 447 U.S. at 309"

77 Asher Hodes, "Diagnosing Patentable Subject Matter" 225 : 252-, 2011

78 "DU PONT/Appetite suppressant"

79 "Council Directive 98/44/EC, 1998 O.J. (L 213)"

80 "Convention on the Grant of European Patents"

81 "Classen Immunotherapies, Inc., 659 F.3d at 1065～9(다수의견), 1076～81(소수의견)"

82 EPO, "Case Law of the Boards of Appeals of the European Patent Office"

83 "CYGNUS/Diagnostic method, T 964/99, [2002] E.P.O.R. 26 (TBA 3.2.2. Jun. 11, 1997)"

84 "Breast and Ovarian Cancer/Univ. of Utah, T 1213/05, Unpublished(TBA 3.4.4. Sep 27, 2007)"

85 "BRITISH TECHNOLOGY GROUP/Contraceptive method, T 74/93, [1995] O.J.E.P.O 712(TBA 3.3.2. Nov. 9, 1994)"

86 "BGH GRUR 430, 432"

87 "BAXTER/Blood extraction method, T 329/94, [1998] E.P.O.R. 363(TBA 3.2.2 Jun. 11, 1997)"

88 "Ass’n for Molecular Pathology v. U.S. P.T.O, 702 F. Supp. 2d 181 (S.D.N.Y. 2010)"

89 김미경, "An Overview of the Regulation and Patentability of Human Cloning and Embryonic Stem Cell Research in the United States and Anti-Cloning Legislation in South Korea" (645) : 681-685, 2005

90 "Am. Cyanamid Co. v. Berk Pharm. Ltd., [1976] R.P.C. 231 (Ch. 1976)"

91 "AMP2, 653 F.3d"

92 "AMP2, 353 F.3d at 1357～8"

93 "AMP2, 353 F.3d at 1356"

94 "AMP2, 353 F.3d at 1336"

95 "98년 집행지침 art. 6(2), EPC Rule 28"

96 "98년 집행지침 art. 5(3), EPC Rule 29(3)"

97 "98년 집행지침 art. 5(2), EPC Rule 27(a), 29(1)(2)"

98 "927 F.2d 1200, 1206 (Fed. Cir. 1991)" 1991

99 "659 F.3d at 1067"

100 "659 F.3d 1057(Fed. Cir. 2011)"

101 "653 F.3d 1329 (Fed. Cir. 2011)(이하 ‘AMP2’)"

102 "560 F.3d 1366 (Fed. Cir. 2009)"

103 "548 U.S. 124"

104 "447 U.S. 303"

105 "409 U.S. 63"

106 "383 U.S. 519"

107 "36 U.S.P.Q.2d 1050 (D. Vt. 1995)"

108 "35 U.S.C. § 287(c)(2)(A),(E)"

109 "35 U.S.C. § 287(c)(2)(A), (c)(3)"

110 "35 U.S.C. § 287(c)(1)"

111 "333 U.S. 127"

112 "1911년 Parke-Davis & Co. v. Fibre Disintegrating Co., 189 F. 95 (C.C.S.D.N.Y. 1911) 판결"

113 "130 S.Ct. 3218"

114 "103 U.S.P.Q. (BNA) 107 (Pat.Off.Bd.App.1954)"