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Implementing Regulations of the Patent Law of the People's Republic of China (2010)

(Promulgated by Decree No. 306 of the State Council of the People's Republic of China on June 15, 2001, amended the first time on December 28, 2002 according to the Decision of the State Council on Amending the Implementing Regulations of the Patent Law of the People's Republic of China, and amended the second time on January 9, 2010 according to the Decision of the State Council on Amending the Implementing Regulations of the Patent Law of the People's Republic of China)

Compulsory License for Exploitation of Patent

Rule 73. The insufficient exploitation of its or his patent mentioned in Article 48, subparagraph (1) of the Patent Law means the manner or scale of the exploitation of patent by the patentee and/or the licensee authorized by it or him cannot satisfy the demands of the domestic market for the patented product or patented process.

The pharmaceutical product to which patent right has been granted as mentioned in Article 50 of the Patent Law means any patented product, or product directly obtained by a patented process, of pharmaceutical sector needed to address public health problems, including the patented active ingredients necessary for the manufacture of the product and the diagnostic kits needed for its use.

Rule 74. Any entity or individual requesting a compulsory license shall submit to the patent administration department under the State Council a request for compulsory license, state the reasons thereof, and attach relevant certifying documents

The patent administration department under the State Council shall send a copy of the request for compulsory license to the patentee, who shall make his or its observations within the time limit specified by the patent administration department under the State Council. Where no response is made within the time limit, the patent administration department under the State Council will not be affected in making its decision.

Before making a decision to reject a request for compulsory license or to grant a compulsory license, the patent administration department under the State Council shall, notify the requesting person and the patentee the decision that is to be made on the request and the reasons thereof.

The decision of the patent administration department under the State Council on granting a compulsory license in accordance with Article 50 of the Patent Law, shall be also in conformity with the provisions of the relevant international treaties on granting compulsory license for the purposes of addressing public health issue, to which China is party, except for provisions on which China has made reservation.

Rule 75. Where any entity or individual requests, in accordance with the provisions of Article 57 of the Patent Law, the patent administration department under the State Council to adjudicate the fees for exploitation, it or he shall submit a request for adjudication and furnish documents showing that the parties concerned have not been able to conclude an agreement in respect of the amount of the exploitation fee. The patent administration department under the State Council shall make an adjudication within three months from the date of receipt of the request and notify the parties concerned accordingly.