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Laws & Regulations Database of The Republic of China (Taiwan)

Print Time:2024/05/21 20:49
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Chapter Law Content

Title: PATENT ACT CH
Category: Ministry of Economic Affairs(經濟部)
Chapter II Invention Patent
Section 5 Compulsory Licensing
Article 87
Grounds for compulsory licensing
In response to national emergency or other circumstances of extreme urgency, the Specific Patent Agency shall, in accordance with an emergency order or upon notice from the central government authorities in charge of the business, grant compulsory licensing of a patent needed, and notify the patentee as soon as reasonably practicable.
The Specific Patent Agency may, upon request, grant compulsory licensing of a patent under any of the following circumstances for which it is deemed necessary:
1. where a patented invention is to be exploited non-commercially for the enhancement of public interest;
2. where a later invention or utility model patent cannot be exploited without infringing upon a prior invention or utility model patent, and where the later invention or utility model patent involves an important technical advancement of considerable economic significance in relation to the prior invention or utility model patent; or
3. where a patentee has committed acts restricting competition or has committed unfair competition acts, for which a judgment has been made by a court of law or a decision has been rendered by the Fair Trade Commission of the Executive Yuan.
Request for compulsory licensing of a patent involving semiconductor technology shall be filed based on the grounds set forth in Subparagraph 1 or 3 of the preceding paragraph.
Request for compulsory licensing of a patent made pursuant to Subparagraph 1 or 2 of Paragraph 2 may only be approved 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 time period.
Where a request for compulsory licensing of a patent is made pursuant to Subparagraph 2 of Paragraph 2, the owner of the prior patent may propose reasonable terms and conditions and seek grant of compulsory licensing of the later patent owned by the requestor.
Article 88
Procedure and decision of compulsory licensing
After receiving a request for compulsory licensing filed pursuant to Paragraph 2 of the preceding Article or Article 90, the Specific Patent Agency shall notify and require the patentee concerned to respond within a specified time period. If no response is made within the specified time period, the Specific Patent Agency may then proceed to the examination of the compulsory licensing request.
Exploitation of a compulsory license shall be predominantly for the supply of domestic market. The above shall not apply to the compulsory license granted pursuant to Subparagraph 3, Paragraph 2 of the preceding Article.
The decision on a request for compulsory license shall be made in writing and shall indicate the reasons, scope, duration, and the required remuneration.
Granting of compulsory licensing shall not affect the exercise of patent right by the patentee concerned.
The right(s) granted under a compulsory license shall not be assigned, entrusted, inherited, licensed or pledged except for any of the following circumstances:
1. where a compulsory license is granted pursuant to Subparagraph 1 or Subparagraph 3, Paragraph 2 of the preceding Article and is assigned, entrusted, inherited, licensed or pledged with the business involving the exploitation of the patent; or
2. where a compulsory license is granted pursuant to Subparagraph 2 of Paragraph 2 or Paragraph 5 of the preceding Article and is assigned, entrusted, inherited, licensed or pledged with the patent right of the licensee.
Article 89
Repeal of a compulsory license
Where a compulsory license granted pursuant to Paragraph 1 of Article 87 is considered no longer necessary by the central government authorities in charge of the business, the Specific Patent Agency shall repeal the compulsory license upon a notice from the said authorities.
The Specific Patent Agency may, upon request, repeal a granted compulsory license under any of the following circumstances:
1. where the fact warranting the compulsory license has been changed and compulsory licensing is no longer necessary;
2. where the licensee fails to properly exploit the patent as required in the compulsory license ; or
3. where the licensee fails to pay the remuneration as determined by the Specific Patent Agency.
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.
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