Patent Act Article 90
Compulsory licensing of pharmaceuticals: grounds and proceduresFor purposes of assisting countries with insufficient or no manufacturing capacities in pharmaceutical sector to obtain pharmaceutical product(s) needed for treating HIV/AIDS, tuberculosis, malaria and other epidemics, the Specific Patent Agency may, upon request, grant a compulsory license to the requestor to exploit a patent concerned for the purpose of producing and importing pharmaceutical product(s) to these countries.Request for a compulsory license made pursuant to the preceding paragraph may only be granted if the requestor has made efforts to obtain authorization from the right holder on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time; however, the above shall not apply if compulsory licensing of the required pharmaceutical product(s) has been granted in the importing country.If the importing country concerned is a WTO member, the requestor shall, when filing a request pursuant to Paragraph 1, provide document(s) proving that the importing country has fulfilled the following:1. the Council for Trade-related Aspects of Intellectual Property Rights has been notified of the name(s) and expected quantities of the pharmaceutical product(s) needed;2. the Council for Trade-related Aspects of Intellectual Property Rights has been notified of its intention as an importer and has established that it has insufficient or no manufacturing capacities in the pharmaceutical sector. However, such document(s) of proof is not required if the importing country is a least-developed country; and3. where the required pharmaceutical product(s) is not patented in the importing country, or where the pharmaceutical product(s) is patented in its territory, the importing country has granted or is about to grant a compulsory license.The so called "least-developed countries" mentioned in the preceding paragraph refers to countries announced by the United Nations (UN) as being least-developed countries.Where the importing country is not a WTO member, but a least-developed country or a country with insufficient or no manufacturing capacities in the pharmaceutical sector, the requestor shall, when filing a request for compulsory licensing pursuant to Paragraph 1, provide document(s) proving that the importing country has fulfilled the following conditions:1. the name(s) and expected quantities of the pharmaceutical product(s) needed have been filed in writing with the foreign affairs authorities of the ROC; and2. stating that it agrees to prevent re-exportation of the pharmaceutical product(s) needed.
中文原文 專利法第90條
為協助無製藥能力或製藥能力不足之國家，取得治療愛滋病、肺結核、瘧疾或其他傳染病所需醫藥品，專利專責機關得依申請，強制授權申請人實施專利權，以供應該國家進口所需醫藥品。
依前項規定申請強制授權者，以申請人曾以合理之商業條件在相當期間內仍不能協議授權者為限。
但所需醫藥品在進口國已核准強制授權者，不在此限。
進口國如為世界貿易組織會員，申請人於依第一項申請時，應檢附進口國已履行下列事項之證明文件：
一、已通知與貿易有關之智慧財產權理事會該國所需醫藥品之名稱及數量。
二、已通知與貿易有關之智慧財產權理事會該國無製藥能力或製藥能力不足，而有作為進口國之意願。
但為低度開發國家者，申請人毋庸檢附證明文件。
三、所需醫藥品在該國無專利權，或有專利權但已核准強制授權或即將核准強制授權。
前項所稱低度開發國家，為聯合國所發布之低度開發國家。
進口國如非世界貿易組織會員，而為低度開發國家或無製藥能力或製藥能力不足之國家，申請人於依第一項申請時，應檢附進口國已履行下列事項之證明文件：
一、以書面向中華民國外交機關提出所需醫藥品之名稱及數量。
二、同意防止所需醫藥品轉出口。
依前項規定申請強制授權者，以申請人曾以合理之商業條件在相當期間內仍不能協議授權者為限。
但所需醫藥品在進口國已核准強制授權者，不在此限。
進口國如為世界貿易組織會員，申請人於依第一項申請時，應檢附進口國已履行下列事項之證明文件：
一、已通知與貿易有關之智慧財產權理事會該國所需醫藥品之名稱及數量。
二、已通知與貿易有關之智慧財產權理事會該國無製藥能力或製藥能力不足，而有作為進口國之意願。
但為低度開發國家者，申請人毋庸檢附證明文件。
三、所需醫藥品在該國無專利權，或有專利權但已核准強制授權或即將核准強制授權。
前項所稱低度開發國家，為聯合國所發布之低度開發國家。
進口國如非世界貿易組織會員，而為低度開發國家或無製藥能力或製藥能力不足之國家，申請人於依第一項申請時，應檢附進口國已履行下列事項之證明文件：
一、以書面向中華民國外交機關提出所需醫藥品之名稱及數量。
二、同意防止所需醫藥品轉出口。