Patent Act Article 90

Patent Act Article 90May 1, 2019
Compulsory licensing of pharmaceuticals: grounds and procedures For 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; and 3. 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; and 2. stating that it agrees to prevent re-exportation of the pharmaceutical product(s) needed.

Patent Act Article 90May 1, 2019

Compulsory licensing of pharmaceuticals: grounds and procedures

For 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; and
3. 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; and
2. stating that it agrees to prevent re-exportation of the pharmaceutical product(s) needed.

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