篇名

專利連結制度下之公平交易法議題──以美國經驗為借鏡   免費試閱

並列篇名

Issues Concerning the Fair Trade Act after the Implementation of the Patent Linkage System in Taiwan: From the Experiences of the U.S.A.

作者
中文摘要

藥事法新增西藥專利連結制度,並於第48條之19規定關於新藥與學名藥廠商之間所簽訂之和解協議或其他協議,需要通報衛生主管機關;涉及逆向給付之協議,尚需通報公平交易委員會,明確揭示專利連結制度的上路,將可能涉及公平交易法之議題。從美國專利連結制度運作之經驗中,最常見涉及反托拉斯法之情形即為逆向給付協議,此外,尚有不當登錄以及虛假訴訟之態樣。廠商除對於專利連結下之登錄制度、訟方式之熟悉以外,對於因此制度所產生競爭法問題之國外經驗,仍應有所熟悉以預作準備。

英文摘要

Patent linkage of drugs has been amended in the Pharmaceutical Affairs Act, and in Article 48-19, the settlement agreements or other agreements signed between parties related to the new drug and the generic drug shall be notified to the Central Competent Health Authority; and if reverse payment agreements are involved, shall also be notified to the Fair Trade Commission. This clearly reveals that the patent linkage system may involve issues of the Fair Trade Act. From the experiences of the patent linkage system in the U.S.A., the most common cases involving anti-trust law are the reverse payment agreements. Improper registration and sham litigation are also involved. In addition to the familiarity with the registration and litigation processes under the patent linkage system, foreign experiences with issues concerning the competition law arising from this system should still be familiar and prepared.

起訖頁

049-060

出版單位
DOI

10.3966/241553062019120038004  複製DOI  DOI查詢

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