陽明交大法學評論第10期
- 發布單位：科技法律研究所
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
Patent-Linkage-Related Patent Infringement Civil Litigation and Valuation of a Cause of Action
作者：陳秉訓
出版年月：202203
關鍵詞：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
中文摘要
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。
英文摘要
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 patent-linkage-related patent infringement litigation. The resolution relies on four previ-ous decisions of the Taiwan Intellectual Property Court which relate to patent in-fringement 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 dis-tributors, 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).
作者：陳秉訓
出版年月：202203
關鍵詞：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
中文摘要
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。
英文摘要
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 patent-linkage-related patent infringement litigation. The resolution relies on four previ-ous decisions of the Taiwan Intellectual Property Court which relate to patent in-fringement 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 dis-tributors, 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).
