論涉及專利連結之專利侵權訴訟與其訴訟標的價額之計算
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陽明交通大學科技法律學院(原名稱:交通大學科技法律研究所)
NYCU School of Law
NYCU School of Law
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Abstract
2019 年起藥事法實施專利連結制度,於學名藥廠申請學名藥藥品許可證 之過程中,提供原藥廠提早解決專利權侵害爭議之機制。本文意在藉由過去 智財法院涉及藥品專利的民事訴訟裁定,共四件案例,以提出在涉及專利連 結之專利侵權訴訟中訴訟標的價額之計算方法。案例 1 與案例 4 皆屬原藥廠 與學名藥廠間的訴訟,但涉及不同原廠藥。案例 2、案例 3、與案例 4 涉及相 同原廠藥,但三個案件的被告分別為藥局、藥品經銷商、與學名藥廠。最 後,本文建議在涉及專利連結之專利民事訴訟中,原告排除侵害請求權之訴 訟標的價額之計算公式為:「原藥廠就系爭原廠藥之年度營業所得」×「原 藥廠就系爭原廠藥之淨利率」×「起訴時至專利權到期日之期間」;其中, 「年度營業所得」以起訴日為起點回算至前一年之營業所得;「淨利率」則 可參考財政部之《營利事業各業所得額暨同業利潤標準》中之最接近起訴日 之數據。
In 2019, the Pharmaceutical Affairs Act introduced a patent-linkage system in generic drug application. The patent-linkage mechanism allows a potential patent dispute to be resolved early when the generic drug application is under review. This article attempts to resolve an issue of valuation of a cause of action in patentlinkage-related patent infringement litigation. The resolution relies on four previous decisions of the Taiwan Intellectual Property Court which relate to patent infringement by generic drug sales. Case 1 and Case 4 involve a brand-named drug company and a generic drug company, where Case 2, Case 3, and Case 4 involve the same generic drug but different infringers, a pharmacy, two local medicine distributors, and a generic drug company. This article proposes a calculating method: (Annual revenue of the brand-named drug company related to the brand-named drug) × (net profit rate concerning the brand-named drug) × time period starting from the law suit filing date to the expiration date of the disputed patent).
In 2019, the Pharmaceutical Affairs Act introduced a patent-linkage system in generic drug application. The patent-linkage mechanism allows a potential patent dispute to be resolved early when the generic drug application is under review. This article attempts to resolve an issue of valuation of a cause of action in patentlinkage-related patent infringement litigation. The resolution relies on four previous decisions of the Taiwan Intellectual Property Court which relate to patent infringement by generic drug sales. Case 1 and Case 4 involve a brand-named drug company and a generic drug company, where Case 2, Case 3, and Case 4 involve the same generic drug but different infringers, a pharmacy, two local medicine distributors, and a generic drug company. This article proposes a calculating method: (Annual revenue of the brand-named drug company related to the brand-named drug) × (net profit rate concerning the brand-named drug) × time period starting from the law suit filing date to the expiration date of the disputed patent).
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Keywords
專利連結 , 學名藥 , 原廠藥 , 訴訟標的 , 專利侵權 , Patent Linkage , Generic Drug , Brand-Named Drug , Cause of Action , Patent Litigation