리서치툴(research tool) 특허와 특허발명의 이용에 관한 연구 - 연구 또는 시험의 예외 및 강제실시권의 적용 여부에 대한 논의를 중심으로 -
A Study on the Access to Research Tool Patents - A Comparative Analysis of the Applicability of Research Exemptions and Compulsory Licenses -
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참고문헌
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초록
리서치툴 특허란 과학자들이 실험실에서 연구를 수행하는데 도구 또는 수단으로 사용하는 특허를 지칭하는 신조어이다. 리서치툴은 이른바 ‘업스트림 발명’으로 특허의 대상이 되는 하나의 완성된 발명임과 동시에 ‘다운스트림 제품’을 개발하는데 반드시 필요한도구가 됨으로써 특허제도에 독특한 정책상의 문제를 제기하고 있으며, 최근 후발 연구의 수행에 있어서 리서치툴 특허의 이용 제한 문제로 인해 특히 생명공학 분야의 과학과기술 발전의 저해에 대한 우려의 목소리가 높아져 가고 있다. 본 논문은 공공의 이익을위해 특허권자의 의사와 관계없이 후발 연구자가 특허발명이 이용할 수 있도록 허용하는제도로서 각국의 특허법에 규정되어 있는 연구 또는 시험의 예외와 강제실시권의 적용을통해 특허권자에 의한 리서치툴 특허의 이용 제한 문제가 해결될 수 있는지를 비교법적으로 고찰하여 리서치툴 특허가 특허제도에 던지는 특허정책상의 문제를 보다 구체적으로 살펴보고, 리서치툴 특허 문제에 대한 대처에 있어서의 정책상의 어려움에 대해 검토하고 있다.
Abstract
inventions, a research tool is a patentable invention itself, and at the same time, it is an important means used to carry out downstream researches. Since patented research tools are indispensable for downstream biomedical research, the access to research tool patents is critical for downstream biomedical innovation. Accordingly, problems in accessing research tool patents may impede the progress of science and technology in the field. Prior to the enactment of the Bayh-Dole Act in 1980, patented research tools were considered to be shared resources among scientists and researchers, and therefore they could freely use the patented tools in their research. However, the Bayh-Dole Act has changed this atmosphere in the scientific community. The Bayh-Dole Act made research universities and institutes sponsored by the government start to patent their research outcomes and to strictly claim their patent rights against an unauthorized use of the patented inventions. This eventually led downstream inventors to first sign a contract with the patentee in order to use a patented research tool in downstream research. Many patent law scholars and experts have expressed the concerns that allowing patents on research tools might hinder the progress of science and technology and have sought to find solutions for the research tool patent access. This paper mainly reviews patent policy issues caused by the negative impact of research tool patents on downstream biomedical research. To better understand the issues, it comparatively analyzes the applicability of research exemptions and compulsory licenses to the unauthorized use of research tool patents in downstream research. Through the comparative analysis, this paper identifies the patent policy issues against which the patent system is currently facing.
참고문헌 (35)
- 김형건, "유방암 유전자 특허를 둘러싼 특허분쟁에 대한 고찰", 한양법학, (28), pp.185~208 (2009), 한양법학회
- 박영규, "연구 또는 시험을 하기 위한 특허발명 실시의 의미와 한계", 산업재산권, (31), pp.1~42 (2010), 한국산업재산권법학회
- 신재호, "송영식 지적소유권법(상)" (2008), 육법사
- 신혜은, "특허발명의 원활한 이용과 시험ㆍ연구의 자유를 담보하기 위한 리서치툴 특허에 관한 연구", 정보법학, 13(1), pp.1~33 (2009), 한국정보법학회
- 원세환, "특허제도의 부작용 해소를 위한 법적 고찰 -연구·시험의 예외를 중심으로-", 석사, pp.2010
- 육소영, "리서치툴 특허와 그 보호의 정당성", 산업재산권, (28), pp.1~30 (2009), 한국산업재산권법학회
- 조명선, "Research tool 특허에 관한 생명과학분야의 최근 이슈", 지식재산21, 통권 : 101 (2007)
- 지식재산권이 연구개발 활동에 미치는 영향에 대한 연구: 리서치툴이 연구개발 활동에 미치는 영향에 대한 실태조사, "특허청", ~ (2008)
- 한국지식재산연구원 IP연구기반팀, "재정실시권에 의한 리서치툴 특허문제의 대응가능성", 상세정보, (17) (2008)
- Arti K. Rai, "Bayh-Dole Reform and the Progress of Biomedicine", LAW & COMTEMP. PROBS, 66, pp.289~ (2003)
- Arti K. Rai, "Regulating Scientific Research: Intellectual Property Rights and the Norms of Science", NW. U. L. REV, 94, pp.77~ (1999)
- Christophe German, "The Swiss Approach to Compulsory Licensing for Diagnostic Products and Processes, In GENE PATENTS AND PUBLIC HEALTH" (2007), Bruylant
- Filip De Corte, "Licensing in the Medical Sector, In GENE PATENTS AND PUBLIC HEALTH" (2007), Bruylant
- Esther van Zimmeren, "Ex-Officio Licensing in the Medical Sector: The French Model, In GENE PATENTS AND PUBLIC HEALTH" (2007), Bruylant
- Heather Hamme Ramirez, "Defending the Privatization of Research Tools: An Examination of the “Tragedy of the Anticommons” in Biotechnology Research and Development", EMORY L.J, 53, pp.359~ (2004)
- Henrik Holzapfel, "A Cross-Atlantic Dialog on Experimental Use and Research Tools", IDEA, 48, pp.123~ (2008)
- IRINA HARACOGLOU, "COMPETITION LAW AND PATENTS: A FOLLOW-ON INNOVATION PERSPECTIVE IN THE BIOPHARMACEUTICAL INDUSTRY", ~ (2008)
- Janice M. Mueller, "No “Dilettante Affair”: Rethinking the Experimental Use Exception to Patent Infringement for Biomedical Research Tools", WASH. L. REV, 76, pp.1~ (2001)
- Jennifer Miller, "Sealing on the Coffin on Experimental Use", DUKE L. & TECH. REV, 2003, pp.12~ (2003)
- Jérôme Debrulle, "La license obligatoire belge pour raisons de santé publique, translated and summarized in Geertrui van Overwalle, The Belgian Compulsory License for Public Health, In GENE PATENTS AND PUBLIC HEALTH" (2007), Bruylant
- Joshua D. Sarnoff, "Recent Developments Affecting the Enforcement, Procurement, and Licensing of Research Tool Patents", BERKELEY TECH. L.J, 23, pp.1299~ (2008)
- Katherine J. Strandburg, "What Does the Public Get? Experimental Use and the Patent Bargain", WIS. L. REV, 2004, pp.81~ (2004)
- Lori Pressman, "The Licensing of DNA Patents by US Academic Institutions: An Empirical Survey", NATURE BIOTECHNOLOGY, 24, pp.31~ (2006)
- Michael A. Heller, "Can Patents Deter Innovation? The Anticommons in Biomedical Research", SCIENCE, 280, pp.698~ (1998)
- Michelle Cai, "Madey v. Duke University: Shattering the Myth of Universities’ Experimental Use Defense", BERKELEY TECH. L.J, 19, pp.175~ (2004)
- Mildred Cho, "Effects of Patents and Licenses on the Provision of Clinical Genetic Testing Services", JOURNAL OF MOLECULAR DIAGNOSTICS, 5, pp.3~ (2003)
- "Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources: Final Notice", Fed. Reg, 64 (1999)
- Rebecca Eisenberg, "Patenting Research Tools and the Law, in INTELLECTUAL PROPERTY RIGHTS AND THE DISSEMINATION OF RESEARCH TOOLS IN MOLECULAR BIOLOGY 1" (1997), National Research Council, National Academy Press
- SVEN J. R. BOSTYN, "PATENTING DAN SEQUENCES (POLYNUCLEOTIDES) AND SCOPE OF PROTECTION IN THE EUROPEAN UNION: AN EVALUATION", ~ (2004)
- "Advisory Council on Intellectual Property, Patents and Experimental Use 1"[URL]
- "Scientific Research and the Experimental Use Privilege in Patent Law CRS-1"[URL]
- "Recent Developments Affecting the Enforcement, Procurement, and Licensing of Research Tool Patents, 1"[URL]
- "Patenting and the Research Exemption 1"[URL]
- "The Bolar Provision: A Safe Harbour in Europe for Biosimilars"[URL]