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2.52.5
GLAS2.5 UPDATE
glas.co.kr
우선판매품목허가�예측시스템
상표�및�디자인�분쟁�모니터링�서비스
Green List
Alert Ser vice
허가-특허연계제도란? 복잡한�분쟁상황을�한�눈에�알아볼�수�있는
특화된�소송관계도(LPD)
허가특허연계제도에�대한
제약산업의�대응전략!
1
2
3
2012년�한국과�미국사이에�체결된 FTA에�따라서 2015년 3월
15일부터�허가-특허�연계제도에�따른�제네릭�우선판매품목허가
및�판매금지�조치가�미국의 Hatch-Waxman Act와 Orange-
Book 제도와�유사하게�시행되었습니다.허가-특허�연계제도에
따른�전략을�세우고�준비를�하지�않을�경우�제약업체들의
경쟁력이�뒤쳐지게�될�것으로�예측되고, 이에�따라�허가-특허
연계제도하에서�제네릭�우선판매품목허가를�취득하기�위해�품목
선정과�품목별�맞춤형�특허전략�및�개발전략이�요구되고
있습니다.
예) Dapoxetine
1
허가특허연계제도의�내용을�정확히�이해하고
관련정보를�적극적으로�취득하려는�노력이�필요
우선판매품목허가�취득전략
+
타사의�우선판매품목허가�회피전략
경쟁관계에�있는�제약사가�어떤�특허전략을
수립하여�실행하고�있는지에�대한
모니터링이�필요!
우선판매품목허가�취득요건
판매제한�조치와�통지의무의�상관관계
2
특허소송
청구요건
특허소송
승소요건
완제품
허가요건
최초�허가신청자 승소한�허가신청자
제2호의�요건을
만족하는자�중�최초청구자
또는 14일�이내�청구자
※ 허가�즉시�우선판매품목허가을�취득할�수�있는�경우는�특허관계④의�이미“특허승소“한�경우�뿐
▶ 사전에�소송을�진행해서�승소�해야만�우선판매품목허가의�대상이�되기가�용이하다.
제50조의 4에�따라�통지
하여야�하는�의약품의
품목허가�또는�변경허가를
신청한�자�중�가장�이른�날에
품목�허가�또는�변경허가를
신청한�자일�것
제50조의 7 제2항에�따라
심판을�청구한�자�중�등재
특허권에�관하여�특허의
무효, 존속기간�연장등록의
무효�또는�해당�의약품이
특허권리�범위에�속하지
아니�한다는�취지의�심결
또는�판결을�받은�자일�것
다만, 통지받은�날부터 12
개월이�경과하는�날�이후에
심결�또는�판결을�받은�자는
제외한다.
제2호에�따른�심결�또는
판결을�받은�자�중�다음�각
목의�요건�중�어느�하나의
요건을�만족하는�자일�것
가. 최초로�제50조의 7 제2
각�호의�심판(이하
이호에서“최초심판”이라
한다)을�청구한�자
일�것
나. 최초�심판이�청구된
날부터 14일�이내에�심판을
청구한�자일�것
다. 가목�또는�나목의�요건을
만족하는�자보다�먼저�제2
호에�따른�심결�또는�판결을
받은�자일�것
우선판매
품목허가
특허관계 통지의무 판매제한 우선판매품목허가
① 존속기간만료 면제 없음 없음
③ 상호협의 면제 없음 없음
② 만료 후 판매조건 면제 없음 없음
④ 특허소송 승소 통지의무 없음 우선판매품목허가 개월
⑤ 무효 또는 비침해 주장 통지의무 판매금지 개월 우선판매품목허가 개월
& &
3
Green List Alert Service
허가-특허�연계제도와�관련된�특허등재목록
및�의약품�특허소송정보�서비스로써�제네릭
우선판매품목허가�취득을�위한�정보를�제공
해주는�국내�유일의�서비스입니다.
GLAS® 란?
GLAS® Coverage
특허등재목록�비대상인�제약분야의�특허/소송정보�수시발생!
제약분야의�상표�및�디자인�소송정보�수시발생!
3,000여건의�특허, 상표, 디자인�분쟁정보�상시모니터링�시스템!
현재 1,700건이�넘는�특허등재목록과�약 800여건의�특허, 2,000여건이�넘는�소송현황을�매일�일일이�모니터링하는�것은
제약사에�상당한�부담이�되고�있습니다. 이에, 이러한�제약사의�니즈에�맞도록�주기적인�모니터링�보고서를�제공하는
서비스인 GLAS®(Green List Alert Service)를�제공하고�있습니다.
GLAS®는�특허정보�및�특허의�소송정보를�주기적으로�모니터링하여�매주�보고서를 eBook형식으로 iPad에서�사용할�수
있도록�발간하며, 해당�내용을�인터넷에서도�확인�할�수�있도록�일일�업데이트�되는 Web Service도�제공하고�있습니다.
또한, 독자적인�특허소송�분석기법인 LPD(Lawsuit Perspective Diagram) method를�이용하여�복잡한�소송정보를�한�눈에
알아볼�수�있도록�시각화�하였는데, 이러한�시도는�특허�관련�업계에서도�최초라고�평가받고�있습니다.
특허등재목록
수시등재
특허정보
수시등재
특허소송정보
수시발생
우선판매품목
허가�대상
4
우선판매품목�허가예측시스템
신제품�발굴을�위해�특허,소송,각종�인허가�정보를�통합
제공하여�우선판매품목허가�대상여부를�한눈에�알아볼�수�있는
새로운�시스템입니다.
상표, 디자인분야�소송까지 DB확장
최근�증가되고�있는�제약분야의�상표ㆍ디자인�분야의�소송을
상시�모니터링하여�제공.
GLAS® 2.5 업그레이드
GLAS® Weekly Mailing Service GLAS® IA Service (Instant Alert)
e-mail e-mail SMS
매년�가을마다�개최되는 GLAS
및�허가특허연계제도�관련
컨퍼런스
2014년 10월 31일 (제1회)
GLASCON
매년�봄마다�개최되는 GLAS
사용자�초청�교육
(회원사의�신규교육�및�재교육)
2015년 4월 30일 (제1회)
GLASEDU
일일업데이트(Web)
신청자를�대상으로�매주�특허등재목록�변경사항과
소송변경건수를�통지
(발송대상�제한�없음)
등재목록특허에�대해서�심판이�청구되거나�심결이�내려
졌을때�실시간으로 e-mail과 SMS로�지정통보
(GLAS® Premium 회원사에게만�제공되는�서비스�입니다)
5
GLAS® 웹서비스�이용방법
① 일일�업데이트
② 우선판매품목�허가예측시스템
③ 특허별�소송관계도
④ 등재특허관련�소송�모니터링
⑤ 미등재특허관련�소송�모니터링
⑥ 제약분야�상표�및�디자인�소송�모니터링
⑦ 즐겨찾기�기능
⑧ 상세검색�기능�강화
⑨ 특화된�통계/챠트
검색기능 / 즐겨찾기�기능
① 검색기능�강화로�찾고싶은�품목의�성분명, 제품명, 특허번호,
투여경로, 등재일�등 1개�이상의�검색조건�별로�검색�가능합니다.
② 즐겨찾기�기능으로써�평소�관심있게�보시는�품목을
추가하시면�바로�확인이�가능합니다.
② 즐겨찾기�기능으로써�평소
관심있게�보시는�품목을�추가하시면
바로�확인이�가능합니다.
glas.co.kr
GLAS® Web Service
특화된�소송관계도(LPD)
기간별�소송현황을�도표로�보여줌으로써�누구나�알기쉽게
특화된�서비스를�제공합니다.
원하는�품목을�클릭�시, 팝업창으로�소송관계도(LPD)를
확인�하실�수�있습니다.
본�소송관계도는�저작권보호를�받습니다.
미등재�특허의�특허/소송�정보서비스
특허등록원문�다운로드 심결문�다운로드
Download Download
6
메인메뉴
즐겨찾는�특허�및�소송관리
GLAS Mailing Service 관리
공지사항
제약분야의�모든�특허소송을�모니터링
선택한�품목의�특허등록원문을�다운로드�하실�수�있습니다. 심결이�내려진�품목의�심결문을�다운로드�하실�수�있습니다.
7
최근변동사항
최근 1개월간의�변동내역을�날짜별로�한번에
확인하실�수�있습니다.
캘린더의�해당�일자를�클릭�시,
일별�신규�및�변경사항을�확인할�수�있습니다.
(발생일�기준�또는�업데이트일�기준�선택가능)
우선판매품목허가�예측시스템
신제품�발굴을�위해�특허,소송,각종�인허가�정보를�통합
제공하여�우선판매품목허가�대상여부를�한눈에�알아볼�수�있는
새로운�시스템입니다.
8
상표�및�디자인
GLAS® e-book
① 매주�금요일�발행
② 매달�새로운�디자인
③ 다운로드�후에는�인터넷�없이도�이용가능!
GLAS® e-book의�장점
세부�메뉴의�다양화 이번주�변동사항손쉬운�사용법
GLAS® e-Book
최근�증가되고�있는�제약분야의
상표ㆍ디자인�분야의�소송을
상시�모니터링하여�제공.
9
GLAS® Roadmap
특화된�소송관계도(LPD)
기간별�소송현황을�도표로�보여줌으로써�누구나�알기쉽게
특화된�서비스를�제공합니다.
2013.Q3
GLAS®1.0 오픈 최초서비스�시작
소송범위�확장.
(그린리스트외�품목�특허/소송)
UI대폭�개선
GLAS IA Service 시작
GLASCON2014 개최
허가특허연계제도�시행
허가특허연계제도�시행을�반영하여
서비스�개선!
우선판매품목허가�예측시스템
소송DB 2차�확장
(제약분야상표/디자인소송)
GLASEDU 2015 개최
소송DB 3차�확장!
(국내�특허의�외국대응�특허의�소송
현황�추가!)
2014.10
GLAS®2.0 오픈
2015.03.15
2015.Q2
GLAS®2.5
2015.Q3
GLAS®3.0
10
GLAS® 방문세미나(무료) 실시!
방문세미나�신청!
02) 482-5505
GLAS® 방문세미나�실시(무료)
가입신청서�작성
www.glas.co.kr
가입신청서, 사업자등록증�사본�제출
glas@b2pharm.com
ID/PW 발급 ipad 발송
신제품�개발�전략, 최근�분쟁현황�등에�대한�세미나
(1~2시간)
GLAS® 가입절차
문의사항
(주)비투팜 경기도�성남시�수정구�복정로 103(복정동, 서진빌딩 3층)
Tel : 02-482-5505 ㅣ FAX : 031-753-5506 ㅣ Email : glas@b2pharm.com
※ 위�연락처로�문의�주시면�친절하게�상담해�드립니다.
1
2
3
(주)비투팜 경기도�성남시�수정구�복정로 103(복정동, 서진빌딩 3층) TEL.02-482-5505 FAX.031-753-5506
Ver1.0

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