제약사업자 시장진입지연 담합에서 경쟁정책과 특허정책의 조화 방안
Competition Policy and Patent Policy in Pay-to-delay Settlement
0
조회
0
다운로드
3
인용
0
참고문헌
키워드
초록
The term “pay-to-delay settlement” or “reverse payment settlement” has been used as shorthand to characterize a variety of diverse agreements between patent owners and alleged infringers that involve a transfer of consideration from the patent owner to the alleged infringer. Pay-to-delay settlements are particularly associated with drug patent challenges mounted by generic drug companies under the Hatch-Waxman Act in USA. Many, including the Federal Trade Commission, would characterize these agreements as antitrust violations. However, U.S. courts have generally declined to find these agreements in violation of the antitrust laws based solely on the presence of a reverse payment. [Key words：reverse payment settlement, pay-to-delay settlement, new drug developer, generic drug]This article begins in Section II with an overview of the diverse array of patent settlement agreements that have been classified within the general taxonomy of “reverse payment settlements.” Section III discusses the development of the FTC's position, which would find most reverse payment settlements presumptively illegal, and reviews the courts' response to antitrust challenges against reverse payment settlements, and identifies an emerging consensus position that will find a violation of the antitrust laws only in cases where the challenged agreement contains restrictions on competition that exceed the exclusionary potential of the patent. The article concludes in Sections Ⅳ with a discussion of the future prospects for the antitrust treatment of reverse payments settlements in Korea, including a suggestion that in evaluating the anti-competitive implications of these agreements more explicit consideration be paid to barriers to market entry facing potential third party generic competitors and consumer protection.
Abstract
The term “pay-to-delay settlement” or “reverse payment settlement” has been used as shorthand to characterize a variety of diverse agreements between patent owners and alleged infringers that involve a transfer of consideration from the patent owner to the alleged infringer. Pay-to-delay settlements are particularly associated with drug patent challenges mounted by generic drug companies under the Hatch-Waxman Act in USA. Many, including the Federal Trade Commission, would characterize these agreements as antitrust violations. However, U.S. courts have generally declined to find these agreements in violation of the antitrust laws based solely on the presence of a reverse payment. [Key words：reverse payment settlement, pay-to-delay settlement, new drug developer, generic drug]This article begins in Section II with an overview of the diverse array of patent settlement agreements that have been classified within the general taxonomy of “reverse payment settlements.” Section III discusses the development of the FTC's position, which would find most reverse payment settlements presumptively illegal, and reviews the courts' response to antitrust challenges against reverse payment settlements, and identifies an emerging consensus position that will find a violation of the antitrust laws only in cases where the challenged agreement contains restrictions on competition that exceed the exclusionary potential of the patent. The article concludes in Sections Ⅳ with a discussion of the future prospects for the antitrust treatment of reverse payments settlements in Korea, including a suggestion that in evaluating the anti-competitive implications of these agreements more explicit consideration be paid to barriers to market entry facing potential third party generic competitors and consumer protection.
참고문헌 (13)
- 권오승, "｢경제법｣(제6판)" (2008), 법문사
- 정윤택, "한미FTA 이후 제네릭 의약품 개발 및 대응전략", BT 스페셜Zine, (9) (2009), ,
- 홍춘택, "약가거품, 어떻게 제거할 것인가?" (2002), 복지동향
- BBC News, "Drug firms ‘block cheap medicine’", ~ (2008)
- Christopher M. Holman, "Do Reverse Payment Settlements Violate The Antitrust Laws?", Santa Clara Computer & High Tech. L. J., 23 (2007)
- FTC, "Antitrust Guidelines for Collaborations Among Competitors" (2000)
- FTC, "Agreements Filed with the FTC under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003: Summary of Agreements Filed in FY 2006" (2006)
- FTC, "Generic Drug Entry Prior to Patent Expiration: An FTC Study" (2002)
- FTC, "In the Matter of Schering-Plough Corporation", Opinion of the Commission
- Herbert Hovenkamp, "Anticompetitive Settlement of Intellectual Property Disputes" (2003), Minn. L. Rev
- Michael A. Carrier, "Innovation for the 21st Century" (2009)
- Richard D. Chaves Mosier, "IN RE CARDIZEM AND VALLEY DRUG: A VIEW FROM THE FAULTLINE BETWEEN PATENT AND ANTITRUST IN PHARMACEUTICAL SETTLEMENTS" (2004), SANTA CLARA COMPUTER & HIGH TECH. L. J.
- The New York Times, "European Regulators Widen Inquiry Into Drug Makers" (2008)