| 篇名 |
藥品市場產品跳躍行為之評析：以美歐案例及競爭法理為中心 |
| 並列篇名 |
Product Hopping in the Pharmaceutical Market: Critical Assessment in Light of US and EU Cases and Competition Law Principles |
| 作者 |
王立達、邱靖芳 |
| 中文摘要 |
產品跳躍行為是專利藥廠近十年間新發展的競爭策略。截至目前為止，美歐至少有四件作成實體裁判的案件，對於是否違反競爭法及其具體判斷標準，法院在不同個案中所表示看法亦有所不同。產品跳躍行為的操作策略多會搭配所處國家相關管制規範而因地制宜，產品跳躍的具體型態與強度在不同案例中亦有所不同，凡此更增添本議題之複雜度。本文將介紹美歐實務案例之事實背景與法院見解，分析法院判斷標準的差異並且評析可能引發的問題，最終回歸競爭法理進行統整分析，試圖尋找出競爭法上適當之違法判斷標準。 |
| 英文摘要 |
Product hopping is one type of competitive strategies developed by brand-name pharmaceutical companies in the past ten years. The hopping conducts varied in terms of their specifics and strength, and were individually adapted to the pharmaceutical regulations in different countries. To date there have been at least four pertinent judicial decisions delivered in Europe or the United States, where the courts substantially diverged on the conclusion and appropriate test for their compatibility with the rules of competition law. This paper investigates the facts and opinions of those judicial cases, analyzes the difference and the whole picture of their rulings, and identifies possible problems. On that basis, the adequate test and key facts for assessing the legitimacy of product hopping will be put forth accordingly.
|
| 起訖頁 |
113-157 |
| 關鍵詞 |
醫藥專利、學名藥上市許可、學名藥替代制度(DPS)、獨占濫用、合理原則、Pharmaceutical Patents、Generic Drug Marketing Approval、Drug Product Selection Laws、Monopolization、Rule of Reason |
| 刊名 |
月旦財經法雜誌 |
| 出版單位 |
元照出版公司
|
| 期數 |
201511 (37期) |
| DOI |
10.3966/1815008X2015110037005 複製DOI DOI申請 |
| QRCode |
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