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논문 기본 정보
- 자료유형
- 학술저널
- 저자정보
- 발행연도
- 2011.9
- 수록면
- 915 - 948 (34page)
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초록· 키워드
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Reverse payment is a payment by original pharmaceutical firms to generic firms on conditions that the generic firms would delay their entry into market. Reverse payment has been a hot topic in antitrust because of the Hatch-Waxman Act. Because of the Korea-U.S. FTA, Korean government would adopt a similar approval-patent linkage system.
It is unprecedented that there are many supporting opinions on applying the perse illegality or the standard of exclusiveness on patents on reverse payment, even though the anti-competitiveness of reverse payment is not clear.
For applying rule of reason, we consider several market structure elements, by assessing the market power and the possibility of other generic medicine manufacturer entering. After the competition authority can prove that the anti-competitiveness is remarkable by assessing the objective elements such as the size of reverse payment, agreed entering time, and collateral transaction, firms can counter-argue by justifying their agreement based on legal costs and uncertainty in legal process.
Finally, in legislating Korean approval-patent linkage system, in order to limit the anti-competitive effects of reverse payment, we could consider the followings: we give the exclusive right to a generic firm which first proves invalidity of a patent in the court, we deprive a firm of the exclusive right when the firm makes a reverse payment, we allow multiple firms share the right, or we might not adopt the 180-day exclusivity clause.
It is unprecedented that there are many supporting opinions on applying the perse illegality or the standard of exclusiveness on patents on reverse payment, even though the anti-competitiveness of reverse payment is not clear.
For applying rule of reason, we consider several market structure elements, by assessing the market power and the possibility of other generic medicine manufacturer entering. After the competition authority can prove that the anti-competitiveness is remarkable by assessing the objective elements such as the size of reverse payment, agreed entering time, and collateral transaction, firms can counter-argue by justifying their agreement based on legal costs and uncertainty in legal process.
Finally, in legislating Korean approval-patent linkage system, in order to limit the anti-competitive effects of reverse payment, we could consider the followings: we give the exclusive right to a generic firm which first proves invalidity of a patent in the court, we deprive a firm of the exclusive right when the firm makes a reverse payment, we allow multiple firms share the right, or we might not adopt the 180-day exclusivity clause.
목차
Ⅰ. 서
Ⅱ. 역지급 합의 논의의 전제
Ⅲ. 역지급 합의의 위법성 판단기준
Ⅳ. 경쟁제한적 역지급 합의의 억지방안
Ⅴ. 결론
〈참고문헌〉
〈Abstract〉
참고문헌 (32)
참고문헌 신청
1. [단행본] - 남재현 / 2011 / 지적재산권과 경쟁정책, In 한국의 경쟁정책 / 형설출판사
2. [보고서] - 정차호 / 2009 / 신약 특허권자와 복제약 개발자간 역지불 합의에 대처하는 한국식 허가-특허연계제도 운용방안, In 의약품 분야 지식재산권 관련 경쟁제한행위에 대한 외국사례분석 및 효과적인 법집행 방안 연구
4. [학술지(정기간행물)] - 최승재 / 2009 / 제약시장에서의 역지급합의에 대한 경쟁법 적용에 관한 연구 / 경쟁법연구 19 : 118 ~ 158
5. [학술지(정기간행물)] - Allison, John R. / 1998 / Empirical Evidence on the Validity of Litigated Patents / American Intellectual Property Law Association Quarterly Journal 26 : 185 ~
6. [학술지(정기간행물)] - Butler, Henry N. / 2010 / Policy Reversal on Reverse Payments: Why Courts Should Not Follow the New DOJ Position on Reverse-Payment Settlements of Pharmaceutical Patent Litigation / Iowa Law Review 96 : 57 ~
2. [보고서] - 정차호 / 2009 / 신약 특허권자와 복제약 개발자간 역지불 합의에 대처하는 한국식 허가-특허연계제도 운용방안, In 의약품 분야 지식재산권 관련 경쟁제한행위에 대한 외국사례분석 및 효과적인 법집행 방안 연구
4. [학술지(정기간행물)] - 최승재 / 2009 / 제약시장에서의 역지급합의에 대한 경쟁법 적용에 관한 연구 / 경쟁법연구 19 : 118 ~ 158
5. [학술지(정기간행물)] - Allison, John R. / 1998 / Empirical Evidence on the Validity of Litigated Patents / American Intellectual Property Law Association Quarterly Journal 26 : 185 ~
6. [학술지(정기간행물)] - Butler, Henry N. / 2010 / Policy Reversal on Reverse Payments: Why Courts Should Not Follow the New DOJ Position on Reverse-Payment Settlements of Pharmaceutical Patent Litigation / Iowa Law Review 96 : 57 ~
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