제약사업자 시장진입지연 담합에서 경쟁정책과 특허정책의 조화 방안
Competition Policy and Patent Policy in Pay-to-delay Settlement
차성민(한남대학교)
10권 3호, 1099~1116쪽
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.
- 발행기관:
- 한국법정책학회
- 분류:
- 법학