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초록

영어

We will require a further thorough preparation for the United States’ dominant role play to maximize the profits of its own domestic pharmaceutical companies by strong patent protection for the new drug through the FTA and TPP. Especially our domestic generic pharmaceutical companies suffer from severe revenues decline by the introduction of the patent linkage system with a permission of medical and the market power of the blockbuster companies is likely to be further strengthened owing to blockbuster pharmaceutical companies’ effort trying to seek the strategy to extend the patent term of their blockbuster drugs. Most importantly, we should strive to build pharmaceutical companies's robust business base that can compete with multinational pharmaceutical capital through patents and R&D capacity building and awareness of the importance of IP. In particular, many generic pharmaceutical manufacturers must establish a patent invalidation strategy of the global drug developer's pioneer patents, or develop improved drugs about to patent expire by joint research with the global manufacturer for new drugs and it is necessary to seek strategic alliances with the global manufacturer for entering the foreign market. Our data exclusivity requires a higher level of protection compared to the US data exclusivity and relevant regulations of the FTA. By equalizing data exclusivity period for new drugs and improved drugs, does not obtain the original purpose of the system of recognition of the value of research and development and vice versa, it is necessary to modify the system because a possibility of adverse willing to lower the innovative drug development. In future the implementation of patent linkage system with a permission of medical will strengthen patentee’s rights protection and patent dispute and litigation for generic manufacturers are to increase significantly. Conversely, our domestic pharmaceutical manufacturers’ patent challenge for patent acquisition seems to be accelerating. Only if the patent holder submit patent information list to upload by patent linkage system with permission, she is able to prevent latecomer from entering the medicine market. Accordingly, the patent holder is going to create a lot of secondary patents or to stop the approval process of generics, or to induce a reverse payment settlement to delay the entering to market. Because it affects to delay release of a relatively less expensive generic and is more likely to have an adverse effect on the finances of the national health insurance, the Pharmaceutical Affairs Law revision is to be required along with government measures to eliminate these habitual evils.

목차

I. 서론
II. 제약사들의 특허분쟁과 에버그리닝(evergreening) 전략
1. 국내 제약사의 특허분쟁 현황 및 대책
2. 특허분쟁 판결과 에버그리닝 및 그에 대한 대책
III. 자료독점권(Data Exclusivity)
1. 특허권과 유사한 자료독점권 장벽
2. 우리나라의 자료독점권 운용 현황
3. 자료독점권과 특허권의 관계 및 산업에 미치는 영향
IV. 역지불 합의(reverse payment settlement)
1. 역지불 합의 정의 및 집행법 개정
2. 각국의 역지불 합의에 대한 법집행 현황
3. GSK와 동아제약 건으로 살펴본 공정위의 최초 역지불합의 사례와 그 의의
V. 의약품 허가-특허연계제도
1. 해치-왁스만법과 허가-특허연계제도 비교 및 그 준거법
2. 의약품 허가-특허연계제도 정부 확정 개정안
3. 각국의 제네릭 시판방지제도 비교
4. 바이오 의약품에 대한 허가-특허연계제도 적용 여부
VI. TPP 압력에 의한 제약산업 제도 변화
1. TPP에 의한 미국의 새로운 압력
2. TPP 미국안에 의한 특허대상 및 특허기간연장제도
3. TPP 미국안에 의한 자료독점권제도
4. TPP 미국안에 의한 허가-특허 연계제도와 그 영향
VII. 결론
참고문헌

키워드

한미 FTA TPP 자료독점제도 의약품 허가-특허연계제도 제네릭 특허권 존속기간연장 에버그리닝 역지불 합의. KORUS FTA TPP Data exclusivity Evergreening Patent linkage system with a permission of medical Patent term extension Reverse payment settlement.

저자

• 김병남 [ Kim, Byung-Nam | 단국대학교 교수 ] 주저자.
• 조재신 [ Jo, Jae-Shin | 전남대학교 교수 ] 교신저자

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