헬스케어 발명특허와 기술사업화(AI시대 보건의료산업인을 위한)

어릴 적 장래희망은 늘 '발명왕'이었다. 또래 친구들 장래희망을 '과학자'라고 할 때 나는 발명왕을 고집했다. 당시에도 실용화에 관심이 컸던 것일까, 발명가도 아니고 발명왕이면 얼마나 많은 발명을 해야 되는 걸까? 그 시절 과학자는 뭘 하는지, 발명이 어떤 건지 의미를 정확히 몰랐을 테지만 발명왕을 꿈꾸었던 건아마도 윤승운 작가의 〈요철발명왕〉의 영향이 있었던 것 같다.

주인공 요철 군은 집 안에 비밀연구소를 차리고 틈만 나면 새로운 것을 만들어냈다. 쥐 잡는 기계, 고기 잡는 망태 같은 작은 발명품부터 시작해서 잠수함, 타임머신, 우주선 같은 대형 개발 프로젝트도 거침없이 추진했다. 많은 이들이 기억하고 있는 〈요철발명왕〉의 명장면은 주인공이 자신의 비밀 발명연구소로 들어가'오늘은 뭘 만들까' 고민하는 모습일 것이다. 요철이의 발명 이야기는 언제나 이 연구소에서부터 출발한다.

2008년 전공의 3년 차 때 첫 발명특허를 출원해 보았다. 전공의 수준에서 맞닥뜨린 문제를 해결해보고자 제안한 특허로 처음에는 조악한 수준의 발명이었다. 초기 아이디어 스케치 단계에서 동료들의 의견을 반영하고 지도교수님의 조언을 받아 점차 그럴듯한 발명으로서 구색을 갖추어 갔다. 3년에 걸친 후속개발로 시제품 단계까지 개발할 수 있었고, 결국은 생애 첫 기술이전 까지 이룰 수 있었다. 최종 제품화에는 실패하였지만 당시 경험에서 큰 성취감을 맛볼 수 있었다. 2015년 의과대학 조교수 발령을 받자마자, 당시 조직을 재정비하던 '지식재산실'의 호출을 받았다. 본교(울산대학교) 산학협력단에는 기술사업화 조직이 갖추어 있지만 병원에는 담당직원 몇 명 외에는 이렇다 할 전담조직이나 장기적 전략수립은 상대적으로 부족한 상태였다. 김종재 연원장님의 전폭적인 지원으로 영상의학과 이덕희 교수님이 병원내 지식재산과 기술이전을 전문적으로 관리하는 팀을 확충하던 와중에 담당교수의 역할을 제안받은 것이다. 스스로가 햇병아리 교수에 불과했지만 지식재산실이 출범한 이후 팀원들의 업무진행을 돕고 기술가치평가 자문이나 발명심사 등 실무를 경험하면서 지재권의 개념을 이해하고 무한한 가능성에 대해 눈뜨게 되었다. 그 이후로 김재승 교수님, 강동화 교수님 등 기술사업화 경험이 풍부하고 탁월한 역량을 가진 실장님을 연거푸 모시게 되어 각기 다른 업무스타일과 추구하는 주안점을 가까이서 지켜보면서 많이 배우고 성장할 수 있었다. 특히 병원에서 수행되는 모든 연구의 가장 초기 결과물인 특허를 검토하고 최신 연구동향을 살필 수 있는 경험은 무엇과도 바꿀 수 없는 귀중한 시간이었다. 그렇게 새로운 영역에서 고군분투하던 사이에 지식재산실은 특허출원뿐 아니라 기술이전과 제품화를 비롯한 기술사업화 전략의 전반을 담당하는 R&D 사업단으로 성장하였다. 부교수로 승진한이듬해 연구중심병원 육성과제의 총괄책임자를 맡게 되었다. 병원의 진료역량과 연구인프라를 개방하여 실용화를 돕는 보건복지부의 대표적인 사업이다. 연구중심병원 과제를 시작한 직후 그간의 연구성과를 발판으로 스타트업을 창업하였다. 교원 발령 후 10년의 기간 동안 사업단 담당교수로 8년, 연구중심병원 책임자로 4년, 스타트업 대표로 3년을 최일선에서 경험하였다. 병원에 서 일어나는 기술사업화의 한복판에 있으면서 나름대로의 역량과 진지한 문제의식을 갖게 되었다.

병원에서의 발명과 특허는 어떤 모습이어야 할까? 아니, 좀 더 근원적인 질문을 던져보자. 왜 의료인이 특허와 기술이전을 알아야 할까? 대학병원 교수들은 진료와 교육만 수행하기에도 이미 바쁘다. 연구의 성과물로 논문이면 충분하지 특허는 왜 내야 하고 기술이전이나 기술사업화까지 생각해야 하는 것일까? 그동안 의료 현장경험에서 보면 기업들이 우수한 의료 기술력을 바탕으로 시장을 제패할 수 있을 것이라고 믿고 제품개발을 하는 경우가 많이 있다. 그러나 많은 기업들이 기술은 완벽한데 시장에서 필요로 하지 않는 제품을 만들었거나, 건강보험수가 적용을 받을 수 없는 제품, 사용자의 요구를 파악하지 못한 제품으로 처음 원점에서 다시 검토하게 되는 경우가 있다. 기술사업화 과정에서 의료인의 강점과 역할은 무엇일까? 의료인은 의료기기와 의약품의 최종사용자이기 때문에 진료현장에서 미충족 의료수요를 가장 잘 이해하는 당사자이다. 제품개발 초기부터 관심을 갖고 개발자들과 토의해야 결과물이 엉뚱한 곳으로 가지 않을 수 있다. 또한 본인이 진료과정에서 불편지점(pain point)을 발견하고 문제를 재정의하고 해결책을 구체화하는 과정에서 자연스럽게 신의료기술, 혁신의료기술이 도출될 수 있다. 따라서 의료인에게 특허는 더욱 중요하다. 결국 의료인이 적극적으로 참여해야 진료현장의 목소리를 담아낼 수 있고 만들어진 제품을 임상시험으로 검증하고 산업체의 개발방향을 가이드해 줄 수 있다.

제발 사고 좀 치지 말고 '공부나 해'라는 것이 〈요철발명왕〉에 담긴 교훈적 결말인도 모른다. 단념하라는 충고와 호통도, 말도 안 된다는 수군거림 속에서도 요철은 '뭘 만들어야' 할지를 고민했다. 남들은 그것이 또 다른 걱정을 만드는 일이라 했지만 요철은 그것이 지금의 걱정을 해결하는 일이라 믿었다. 그리고 매일매일 뭘 만들었다. 뭘 만들까? 지금은 뭘 만들어야 할까? 병원의 의사들도 때로는 환자만 열심히 보라는 요구를 받는지 모르겠다. 물론 진료는 의사의 본분이며 존재이유다. 그렇지만 산학연병의 가치사슬에서 의료인의 역할도 매우 크고 중요하다. 의료인들이 특허와 기술이전에 더욱 관심을 갖고 기술사업화의 중심에서 맡은 바 역할을 다할수록 그간의 높은 진료성과에서 더불어 더욱 큰부가가치를 창출할 것으로 믿는다.

출판 과정에서 부족한 원고를 꼼꼼하게 검토하고 오류를 바로잡아준 울산대학교 산학협력단 산학자산운영팀 김대겸 파트장님, 병원기반 교수창업의 정책적 방향성을 짚어주고 조사자료를 제공한 과학기술정책연구원 김석관 박사님, 그리고 어려운 와중에 흔쾌히 출판을 결정하고 추진한 도서출판 대한의학에 다시 한번 감사를 드린다.

2024년 11월
김성훈

발명 특허란 무엇인가 ···································································································································································· 16

특허출원 전 준비사항 ···································································································································································· 20
선행기술조사와 특허 데이터베이스 20
특허맵의 활용 23
인용문헌 및 조사보고서 26

특허출원 절차 ······························································································································································································· 29
특허청 제출서류 작성 29
출원 수속 진행 절차 30
특허출원 시 유의사항 31
권리 측면에서 특허제도 살펴보기 ························································································································ 33

[판례로 보는 바이오의료기기 특허소송]
# 1 코비디엔, BIS 모니터링 기기개발 애스펙트사 인수 37

특허 명세서 작성법 ············································································································································································ 40
특허공보 40
특허 명세서 구성 42
'발명의 상세한 설명' 파트의 활용 43
청구항 작성시 유의사항 45

거절통지에 대한 대응전략 ··················································································································································· 47

해외특허······················································································································································································································· 49
출원 기한과 절차 49
해외 출원과 속지주의 52

디자인 특허와 상표권········································································································································································ 54

[판례로 보는 바이오의료기기 특허소송]
#2 박스터, 마취제 용기 특허에 대해 경쟁사 고소 56

의료관련 발명과 보건의료기술 ··································································································································· 58

특허제도 이모저모 ··············································································································································································· 62
출원공개제도란? 62
선사용권 제도란? 63

특허침해의 판단과 대응법 ··················································································································································· 65

[판례로 보는 바이오의료기기 특허소송]
#3 애플워치, 마시모의 특허침해로 수입 금지 조치 68

신산업분야 특허 동향과 전망············································································································································· 71

헬스케어 영역에서 인공지능기술······························································································································ 73
인공지능 특허출원 전략 74
인공지능 특허를 받기 어려운 사례 77

보건의료 신기술 특허출원 전략····································································································································· 81
사물인터넷(Internet of Things, IoT) 81
디지털치료제(DTX) 82
생성형AI 83
SaaS (Software as a Service) 84
비지니스모델(BM, Business Model) 특허 85

바이오 기술개발과 특허································································································································································ 86

[판례로 보는 바이오의료기기 특허소송]
#4 머크의 블록버스터 특허만료일 단축 소송 89

연구개발 단계에서 특허 정보 활용·························································································································· 91
연구성과물로서 특허··········································································································································································· 94
학술논문과 특허의 관계 94
학회에 발표한 기술의 특허보호 98
논문 발표 시 국내우선권 주장출원의 활용 99

직무발명이란?···················································································································································································· 101
직무발명 제도의 이해 101
대학교수 및 겸직 교원의 직무발명 104

외부기관과 공동연구 수행 시 주의사항········································································································· 107
외부기업과의 공동연구과제 107
해외 연구자와의 공동연구과제 108

MZ연구원들과 일하기········································································································································································ 110
'3요'를 아시나요? 110
MZ세대의 특징 #1. 수평적 문화 선호 111
MZ세대의 특징 #2. 가치 있는 일을 하고 싶다 112
MZ세대의 특징 #3. 개인 취향과 사생활을 중요시 114
그렇다면 '3요'에 대한 적절한 대응은? 115

연구기관의 특허경영 및 기술사업화 전략································································································· 117
비밀유지계약이란? 121
기술이전 협상전략 123
기술료 책정 125
성공적인 기술마케팅 전략 127

기술가치평가와 기술성숙도·················································································································································· 130
기술가치평가 절차 130
기술성숙도 TRL 지표 132

[판례로 보는 바이오의료기기 특허소송]
#5 국내중소기업, 글로벌기업 상대로 특허분쟁 승리 135

기술지주회사······································································································································································································ 137

미국과 한국 대학의 기술사업화 방식의 차이······················································································ 140

직접사업화를 위한 스타트업 설립····························································································································· 144
창업 절차 및 관련 법령의 이해 144
개인기업과 법인기업의 차이 145
사업계획서 작성시 유의사항 147
스타트업과 특허출원전략 ························································································································································· 148
스타트업에서 지식재산권 보유 필요성 149
사업계획서와 기술가치평가의 활용 151

기술기반 스타트업의 자금조달과 투자유치 전략········································································ 152
자금조달과정에서 특허의 역할 152
기술기반창업에서 투자유치자료(IR) 155
국내외 헬스케어 투자환경과 병원기반 교수창업········································································ 158
···························································
미국 대학 창업교육 프로그램과 교수창업 지원 정책····························································162

미니 인터뷰 조지아텍 의공학과 여운홍 교수 168
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참고자료 170
별첨1. 산학연협력기술지주회사 설립운영 현황(2021.12.31. 기준) 171
별첨2. 병원기반 교수창업기업 현황(2022년말 기준) 174
별첨3. 미국 주요 대학의 교직원 스타트업 창업 규정183

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