Measures for Compulsory License for Patent Exploitation (2012)

Measures for Compulsory License for Patent Exploitation (2012) Order of the State Intellectual Property Office (No. 64) The Measures for Compulsory License for Patent Exploitation, as deliberated and adopted at the executive meeting of the State Intellectual Property Office, are hereby promulgated and shall come into force on May 1, 2012. Director General: Tian Lipu March 15, 2012 Measures for Compulsory License for Patent Exploitation Chapter I General Provisions Article 1 To standardize the granting, royalty determination and termination procedures regarding compulsory license for the exploitation of invention patents or utility model patents (hereinafter referred to as “compulsory license”), these Measures are formulated in accordance with the Patent Law of the People's Republic China (hereinafter referred to as the “ Patent Law ”), the Detailed Rules for the Implementation of the Patent Law of the People's Republic China and the relevant laws and regulations. Article 2 The State Intellectual Property Office shall be responsible for the acceptance and examination of requests for compulsory license, requests for royalty determinations for compulsory license, and requests for the termination of compulsory license, and making decisions thereon. Article 3 Requests for compulsory license, requests for royalty determinations for compulsory licenses, and requests for the termination of compulsory licenses shall be handled in written form and in Chinese. Where any certificate or certification document submitted in accordance with these Measures is in a foreign language, the State Intellectual Property Office may, when it deems necessary, require the party to submit a Chinese translation of the certificate or certification document within a specified time limit; where the translation is not submitted within the specified time limit, the certificate or certification document shall be deemed to have not been submitted. Article 4 To handle compulsory licensing matters, a foreigner, a foreign enterprise or any other foreign organization that has no regular residence or place of business in China shall entrust a legally formed patent agency to handle the relevant matters. A party that entrusts a patent agency to handle compulsory licensing matters shall submit a power of attorney, indicating the scope of the power entrusted. Where in one party there are two or more members and none of them has entrusted a patent agency, unless otherwise stated, the first member designated in the submitted written documents shall be deemed as the representative of this party. Chapter II Presentation and Acceptance of Requests for Compulsory License Article 5 Where it has been three years since the date the patent right was granted and four years since the date the patent application was submitted, and the patentee, without any justifiable reason, fails to have the patent exploited or fully exploited, an entity or individual that satisfies the conditions for patent exploitation may request a compulsory license in accordance with the provisions of Article 48 (1) of the Patent Law . Where the patentee's exercise of the patent right is confirmed as monopolistic behavior pursuant to law, for the purpose of eliminating or reducing the monopolistic behavior's negative impact on competition, an entity or individual satisfying the conditions for patent exploitation may request a compulsory license in accordance with the provisions of Article 48 (2) of the Patent Law. Article 6 Where a national emergency or any extraordinary affair occurs, or where the public interest so requires, the relevant competent department of the State Council may, in accordance with the provisions of Article 49 of the Patent Law , recommend that the State Intellectual Property Office grant a compulsory license to a designated entity satisfying the conditions for patent exploitation. Article 7 For the purpose of public health, an entity satisfying the conditions for patent exploitation may, in accordance with the provisions of Article 50 of the Patent Law , request a compulsory license for the manufacture of a drug for which a patent right has been obtained, and which is exported to the following countries or regions: 1. a least developed country or region; or 2. a developed or developing country that is a WTO member and that notifies the WTO and expresses its desire to be an importer in accordance with the relevant international treaty. Article 8 Where an invention or utility model for which a patent right has been obtained represents a major technological advance of remarkable economic significance as compared with an earlier invention or utility model for which a patent right has already been obtained, and the exploitation of the latter relies on the exploitation of the former, the patentee of the later invention or utility model may, in accordance with the provisions of Article 51 of the Patent Law , request a compulsory license for the exploitation of the earlier patent. Where the State Intellectual Property Office has granted to the earlier patentee a compulsory license for the exploitation of the earlier patent, the earlier patentee may also request a compulsory license for the exploitation of the later patent. Article 9 A petitioner who requests a compulsory license shall submit a written request for a compulsory license, which shall indicate the following items: 1. the name or title, address, postal code, contact person and telephone number of the petitioner; 2. the nationality of the petitioner or the petitioner's country or region of registration ; 3. the name, patent number, filing date of the application, and date of authorized announcement of the invention patent or utility model patent for which a compulsory license is requested, and the name or title of the patentee; 4. reasons, facts and term of the request for a compulsory license; 5. where the petitioner has entrusted a patent agency, the name and organization code of the entrusted patent agency and the name, practice certification number and telephone number of the patent agent designated by the agency; 6. the signature or stamp of the petitioner, and, if there is an entrusted patent agency, the stamp of the agency is also required; 7. a list of the attached documents; and 8. other items that need to be indicated. The written request and its attached documents shall be made in duplicate. Article 10 Where a request for a compulsory license involves two or more patentees, the petitioner shall submit the written request and the duplicates of the attached documents based on the number of patentees. Article 11 A petitioner requesting a compulsory license in accordance with the provisions of Article 48 (1) or Article 51 of the Patent Law shall provide evidence to prove that such petitioner, under reasonable terms, requested the patentee's permission for the exploitation of the patent, but failed to obtain such permission within a reasonable period of time. A petitioner requesting a compulsory license in accordance with the provisions of Article 48 (2) of the Patent Law shall submit an effective judgment or decision of a judicial organ or anti-monopoly law enforcement institution that rules, pursuant to law, that the patentee's exercise of the patent right is monopolistic behavior. Article 12 Where the relevant competent department of the State Council recommends the grant of a compulsory license in accordance with Article 49 of the Patent Law , it shall indicate the following items: 1. the compulsory license shall be granted where a national emergency or any extraordinary affair occurs, or where the public interest so requires; 2. the name, patent number, filing date of the application and date of authorized announcement of the invention patent or utility model patent for which the grant of a compulsory license is recommended, and the name or title of the patentee; 3. the recommended term of a com......