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    공법 : TRIPs협정상 개발도상국의 의약품 접근권에 관한 연구 -인도 개정특허법 소송을 중심으로- = A Study on Accessibility to Medicines by the Developing Countries in the TRIPs Agreement -Focused on the Case of India`s Patent(Amendment) Act of 2005-

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    https://www.riss.kr/link?id=A87026553

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    다국어 초록 (Multilingual Abstract) kakao i 다국어 번역

    The development of the intellectual property rights begun when the World Trade Organization drew up the Agreement on Trade--Related Aspects of Intellectual Property Rights in 1995. As the Agreement entered into force, the developed countries, where transnational pharmaceutical companies that produce and sell innumerable types of drugs are situated, have strengthened their drugs` patents based on the TRIPs Agreement. Such situation resulted in the increase of price and monopolization of the industry by these transnational pharmaceutical companies; the nationals of developing countries are experiencing difficulty in gaining access to some of these essential medicines. This has pushed the society into the critical state of threatening the public health. A classic dispute surrounding such patent rights and the accessibility to medicines is the case concerning Novartis, the multi-national pharmaceutical company, requesting the amendment of India`s Patent Act. Novartis asserted that India`s Patent Act is inconsistent with the TRIPs Agreement - as India has refused its patent application for Gleevec (Glivec - EU), a type of drug used for treating leukemia. About 20% of all generic drugs produced in the world and especially since 90% of lifesaving drugs for AIDS distributed to the third world countries are manufactured in India, thus relevant organizations and patients who need the treatment are keen to follow the result of this India`s case. There is no doubt that the transnational pharmaceutical company put enormous amounts of time, effort and costs to develop a new drug; it would only be natural for the "owner" to profit fully with its new discovery. Therefore, the end-product must be protected by a patent. Patent right is a private property and the enforcement and disposal of the patent is rightfully the patentee`s. However, as general property rights have limitations to the exercise of such rights for the public - patent rights should also have certain limitations of its use for the interest of the public. The original purpose of investing the patent for a medicine was to create an incentive to the research and development of a new drug and also for encouraging such procedure. This permits the access of the new medicine to the patients around the world to maintain a better physical condition. When a person`s life and an intellectual right collide, the intellectual right should be limited as a way of practicing the promotion of right to life. An economic profit should give away to a person`s life because the latter cannot be replaced by another. A State invests intellectual rights for a certain period of time but an individual is impossible to be deprived of one`s human rights. This is specifically why an intellectual right should not authorize economical privileges to an individual or a group for the sake of everyone`s well-being. To achieve this goal, developed countries should and must, along with the transnational pharmaceutical companies, as members of the international community, realize the changing social attitudes and support the developing countries` access to affordable medicines.
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    The development of the intellectual property rights begun when the World Trade Organization drew up the Agreement on Trade--Related Aspects of Intellectual Property Rights in 1995. As the Agreement entered into force, the developed countries, where tr...

    The development of the intellectual property rights begun when the World Trade Organization drew up the Agreement on Trade--Related Aspects of Intellectual Property Rights in 1995. As the Agreement entered into force, the developed countries, where transnational pharmaceutical companies that produce and sell innumerable types of drugs are situated, have strengthened their drugs` patents based on the TRIPs Agreement. Such situation resulted in the increase of price and monopolization of the industry by these transnational pharmaceutical companies; the nationals of developing countries are experiencing difficulty in gaining access to some of these essential medicines. This has pushed the society into the critical state of threatening the public health. A classic dispute surrounding such patent rights and the accessibility to medicines is the case concerning Novartis, the multi-national pharmaceutical company, requesting the amendment of India`s Patent Act. Novartis asserted that India`s Patent Act is inconsistent with the TRIPs Agreement - as India has refused its patent application for Gleevec (Glivec - EU), a type of drug used for treating leukemia. About 20% of all generic drugs produced in the world and especially since 90% of lifesaving drugs for AIDS distributed to the third world countries are manufactured in India, thus relevant organizations and patients who need the treatment are keen to follow the result of this India`s case. There is no doubt that the transnational pharmaceutical company put enormous amounts of time, effort and costs to develop a new drug; it would only be natural for the "owner" to profit fully with its new discovery. Therefore, the end-product must be protected by a patent. Patent right is a private property and the enforcement and disposal of the patent is rightfully the patentee`s. However, as general property rights have limitations to the exercise of such rights for the public - patent rights should also have certain limitations of its use for the interest of the public. The original purpose of investing the patent for a medicine was to create an incentive to the research and development of a new drug and also for encouraging such procedure. This permits the access of the new medicine to the patients around the world to maintain a better physical condition. When a person`s life and an intellectual right collide, the intellectual right should be limited as a way of practicing the promotion of right to life. An economic profit should give away to a person`s life because the latter cannot be replaced by another. A State invests intellectual rights for a certain period of time but an individual is impossible to be deprived of one`s human rights. This is specifically why an intellectual right should not authorize economical privileges to an individual or a group for the sake of everyone`s well-being. To achieve this goal, developed countries should and must, along with the transnational pharmaceutical companies, as members of the international community, realize the changing social attitudes and support the developing countries` access to affordable medicines.

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    참고문헌 (Reference)

    1 오병일, "특허에 의한 살인-제3세계 민중의 건강권과 특허권의 대립: 사회비평" 나남 2002

    2 김남규, "특허발명의 강제실시제도 -의약품 접근권 향상을 위한 제도개선을 중심으로" 한국법정책학회 (2(6)) : 805-824, 2006

    3 이윤주, "특허권과 개발도상국에서의 의약품에 대한 접근과의 조화를 위한 모색" 한국산업재산권법학회 (24) : 189-234, 2007

    4 윤선희, "지적재산권법" 세창출판사 2010

    5 신혜은, "자료독점권(Data Exclusivity), 사실상 특허권 존속기간의 연장인가" 안암법학회 (35) : 333-369, 2011

    6 김희상, "인도의 의약품 특허제도와 TRIPS 규범" 법무부 (74) : 142-173, 2007

    7 박영규, "에버그린 전략의 산업적, 특허법적 그리고 경쟁법적 문제" 세창출판사 (58) : 122-160, 2010

    8 이수연, "다국적 제약자본의 지적재산권 보호 對 국민 건강권 보장간의 갈등" 한국사회복지연구회 (23) : 139-167, 2004

    9 조영정, "국제통상론" 法文社 2003

    10 임호, "공중보건과 국제지적재산권법" 한국학술정보 2006

    1 오병일, "특허에 의한 살인-제3세계 민중의 건강권과 특허권의 대립: 사회비평" 나남 2002

    2 김남규, "특허발명의 강제실시제도 -의약품 접근권 향상을 위한 제도개선을 중심으로" 한국법정책학회 (2(6)) : 805-824, 2006

    3 이윤주, "특허권과 개발도상국에서의 의약품에 대한 접근과의 조화를 위한 모색" 한국산업재산권법학회 (24) : 189-234, 2007

    4 윤선희, "지적재산권법" 세창출판사 2010

    5 신혜은, "자료독점권(Data Exclusivity), 사실상 특허권 존속기간의 연장인가" 안암법학회 (35) : 333-369, 2011

    6 김희상, "인도의 의약품 특허제도와 TRIPS 규범" 법무부 (74) : 142-173, 2007

    7 박영규, "에버그린 전략의 산업적, 특허법적 그리고 경쟁법적 문제" 세창출판사 (58) : 122-160, 2010

    8 이수연, "다국적 제약자본의 지적재산권 보호 對 국민 건강권 보장간의 갈등" 한국사회복지연구회 (23) : 139-167, 2004

    9 조영정, "국제통상론" 法文社 2003

    10 임호, "공중보건과 국제지적재산권법" 한국학술정보 2006

    11 WHO, "World Health Statistics 2011"

    12 특허청, "WTO TRIPs협정 조문별 해설"

    13 World Health Organization, "WTO Agreements & Public Health - A Joint Study by the WHO and the WTO Secretariat"

    14 UNITAID, "UNITAID CONCERNED OVER FUTURE OF MEDICINES ACCESS AFTER EU-INDIA FTA"

    15 박기갑, "UN 인권조약 감시기구의 일반논평 및 일반권고 1"

    16 MSF, "The crisis in research and development for drugs for neglected diseases"

    17 WHO, "The TRIPs Agreement and Pharmaceuticals" Report of an ASEAN Workshop on the TRIPs Agreement and its Impact on Pharmaceuticals 2000

    18 Brigit Toebes, "The Right to health: Economic, Social and cultural rights" Martinus Nijhoff Publishers 2001

    19 Scherer.F.M, "The Pharmaceutical Industry and World intellectual Property Standard" 53 : 2245-, 2000

    20 U.N, "The Millennium Development Goals Report 2010" U.N 2010

    21 Frederick M.Abbott, "The Doha Declaration on the TRIPs Agreement and Public Health : Lighting a dark at the WTO" 5 : 469-, 2002

    22 Janice M. Mueller, "Taking TRIPs to India - Novartis, Patent Law, and Access to Medicines" 356 : 541-, 2007

    23 Ellen F.M. ’t Hoen, "Public Health and international Law: TRIPs, Pharmaceutical Patents, and access to Essencial Medicine: a Long Way From Seattle to Doha" 36 : 27-, 2002

    24 Shamnad Basheer, "Popping Patented Pills: Europe and a Decade’s Dose of TRIPs" 25 : 202-, 2006

    25 WIPO, "PATENT PROTECTION AND ACCESS TO HIV/AIDS PHARMACEUTICALS IN SUB-SAHARAN AFRICA"

    26 Maxwell R.Morgan, "Medicines for the Developing World: Promoting Access and Innovation in the Post-TRIPs Environment" 64 : 45-, 2006

    27 World Health Organization, "Medicine Prices: a new approach to measurement"

    28 Judy Rein, "International Governance through Trade Agreements: Patent Protection for Essential Medicines" 21 : 379-, 2001

    29 Prabhu Ram, "India’s New TRIPs-Compliant Patent Regime Between Drug Patents and The Right to Health" 5 : 195-, 2005

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