Taiwan’s intellectual strategy in response to the amendment of Article 31 of the TRIPS Agreement came into effect
The Roberto Azevedo, Secretary General of the World Trade Organization (WTO), convened an interim meeting of the Council on Trade-Related Aspects of Intellectual Property Rights (TRIPS) on 30 January this year, announcing that the amendment to Article 31 (Article 31bis) of the TRIPS Agreement WTO two-thirds members to accept the proposal reached the threshold, then in January 23 this year, entered into force.
The reason for Article 31 of the TRIPS Agreement amendment is because of the insufficient capacity of some developed and low-level developing countries (LDCs) to be able to effectively address the public security crisis caused by AIDS, malaria and tuberculosis in the country. Therefore, WTO published the TRIPS Agreement and Public Health Declaration in November 2001 to try to resolve this grim situation.
After years of efforts, the WTO finally adopted the TRIPS Agreement Amendment on December 6, 2005 to update Article 31 of the TRIPS Agreement, allowing members of compulsory licensing to export to pharmaceuticals with insufficient pharmaceutical capacity, import and export, etc. To ensure that the system is used for public health purposes and to take measures to avoid re-export of the medicine, not in accordance with the provisions of import and resale. In order to overcome this public health problem, WTO members should focus on the technology transfer and capacity building of the pharmaceutical industry, and strengthen the capacity of some developing and low development countries (LDCs) to obtain medicines.
In line with the WTO Public Health Declaration, Taiwan has revised the relevant supporting measures in accordance with Article 90 and Article 91 of the Patent Law in 2011, and completed the acceptance of the WTO on July 31, 2012. In order to help solving the public health problems in developing countries and low development countries, Taiwan has the ability to manufacture medicines related to pharmaceutical companies that should have applied for compulsory licensing of manufactured medicines and exported to the demand for human life safety, health and public health.
In response to this amendment, Taiwan needs to be friends with developing countries or low-level development countries, free of charge to provide the medicines needed by these countries, that is the right strategy. At the same time, after the entry into force of the amendment, it is the real challenge for Taiwan to have any policy to implement the concept of the system.
The corresponding Articles of Taiwan Patent Law listed as follows.
Article 90 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.
Article 91 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.