|Patent Act Article 91May 1, 2019|
Compulsory licensing of pharmaceuticals: export and remuneration
Pharmaceutical product(s) produced under compulsory licensing pursuant to the preceding Article shall be exported to the importing country entirely, and the quantity of the product authorized to be produced shall not be more than the quantity required by the importing country in its notice sent to the Council for Trade-related Aspects of Intellectual Property Rights or the foreign affairs authorities of the ROC.
Pharmaceutical product(s) produced under compulsory licensing granted pursuant to the preceding Article and the external packaging thereof shall be marked with the licensing basis specified by the Specific Patent Agency; the packaging, coloring or shaping of the pharmaceutical product(s) produced under compulsory licensing shall be sufficiently distinguishable from pharmaceutical product(s) produced by the patentee or his/her licensee(s).
The licensee of a compulsory license shall pay appropriate remuneration to the patentee. The amount of remuneration shall be decided by the Specific Patent Agency, taking into account the economic value of the patent of the required pharmaceutical product(s) to the importing country with reference to the human development index issued by the United Nations.
Before exporting the pharmaceutical product(s) produced under a compulsory license, the licensee shall post on a website the quantities, name(s) and destination(s) of such pharmaceutical product(s), as well as distinctive features thereof.
Inspection and registration of the pharmaceutical product(s) produced and exported under compulsory licensing pursuant to the preceding Article shall not be bound by Paragraph 2, Article 40ter of the Pharmaceutical Affairs Act.
|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:
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:
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