Measures for Carrying Out Compulsory Licensing of Patents on Issues Involving Public Health (CECC Full Translation)
SIPO Directive (No. 37) The "Measures for Carrying Out Compulsory Licensing of Patents on Issues Involving Public Health" have already undergone review and discussion by the Office, now are published, and from January 1, 2006 will be implemented. Office Director November 29, 2005 Measures for Carrying Out Compulsory Licensing of Patents on Issues Involving Public Health Article 1 For resolving national public health problems and helping related countries and regions address public health problems, implementing the WTO Doha Round "Doha Declaration on the TRIPs Agreement and Public Health" (hereafter called "Doha Declaration") and the WTO General Council's "Decision on Implementation of Paragraph Six of the Doha Declaration on the TRIPs Agreement and Public Health" (hereafter called "General Council Resolution"), according to the "PRC Patent Law" (hereafter called "Patent Law"), institute these measures. Article 2 These Measures regard infectious diseases AIDS, TB, and malaria as well as other infectious diseases regulated by the "PRC Infectious Disease Prevention Law" that are causing public health problems. These measure regard any patented product or product made pursuant to a patented process, including components necessary for making the aforesaid products effective and diagnosing reagents necessary for using the aforesaid products that are used in the medical field to treat the infectious diseases that are mentioned in paragraph 1. Article 3 The prevention or control of the emergence or spread of infectious diseases in China as well as treatment of infectious diseases, [taking] actions described in Article 49 of the Patent Law [are] for the purpose of public rights and benefits. The emergence and spread of infectious diseases [will] lead to a public health crisis belonging to a state of national emergency described in Article 49 of the Patent Law. Article 4 For drugs under Chinese patent for treating certain types of infectious diseases, where China possesses the production capability, the relevant ministries under the State Council may, according to Article 49 of the Patent Law, request that SIPO award the implementation of a compulsory patent license (hereafter "compulsory patent"). Article 5 For drugs under Chinese patent for treating certain types of infectious diseases, where China does not possess the capability to manufacture that drug or the manufacturing capability is insufficient, ministries under the state council may request SIPO issue a compulsory license, allowing the licensee to import from WTO Members that the General Council Resolution clarifies [may] make this kind of drug for China to resolve a public health problem. Article 6 Under a compulsory license awarded by SIPO under Article 5, the licensee or any other unit or individual must not export to any other country or region the drugs imported pursuant to the compulsory license decision. Article 7 Under a compulsory license awarded by SIPO under Article 5, a reasonable royalty should be paid by the licensee to the patentholder. But, where the producer has already paid the patentholder a royalty, the licensee need not pay a royalty to the patentholder. Article 8 For drugs under Chinese patent for treating certain types of infectious diseases, any unit or individual buying in other countries or regions drugs produced and sold by the patentholder or drugs produced and sold under a license from the patentholder, may import those drugs to China without having to request a compulsory license from SIPO. Article 9 WTO Members according to the General Council Resolution clarification mechanism announcement of the WTO Trips Council, wishing to import drugs for treating certain types of infectious diseases or non-WTO member Least Developed Countries via diplomatic channels notify the Chinese government that they wish to import drugs for treating certain types of infectious diseases from China, ministries under the State Council may request the award of a compulsory license from SIPO, permitting the licensee to use the General Council Resolution clarification system to make this type of drugs and export them to the above-mentioned members and nations. Article 10 Under a compulsory license awarded by SIPO under Article 9, in making the decision on the compulsory license SIPO should clearly record the relevant requirements of the General Council Resolution. The licensee should abide by the requirements of the compulsory license decision stipulations. Article 11 Under a compulsory license awarded by SIPO under Article 9, the licensee should pay a reasonable royalty to the patentholder. Article 12 Requests for compulsory licenses under Articles 4, 5, and 9 of these measures, except where there are special stipulations, will apply the stipulations of the "Measures for Implementing Compulsory Licenses of Patents." Article 13 These measures will be effective from January 1, 2006. November 29, 2005
The following is a translation prepared by the Congressional-Executive Commission on China of the "Measures for Carrying Out Compulsory Licensing of Patents on Issues Involving Public Health," issued by the State Intellectual Property Office (SIPO) on November 29, 2005. The Chinese text was retrieved from the Puyang City Intellectual Property Office Web site on February 28, 2006.
SIPO Directive (No. 37)
The "Measures for Carrying Out Compulsory Licensing of Patents on Issues Involving Public Health" have already undergone review and discussion by the Office, now are published, and from January 1, 2006 will be implemented.
Office Director
November 29, 2005
Measures for Carrying Out Compulsory Licensing of Patents on Issues Involving Public Health
Article 1 For resolving national public health problems and helping related countries and regions address public health problems, implementing the WTO Doha Round "Doha Declaration on the TRIPs Agreement and Public Health" (hereafter called "Doha Declaration") and the WTO General Council's "Decision on Implementation of Paragraph Six of the Doha Declaration on the TRIPs Agreement and Public Health" (hereafter called "General Council Resolution"), according to the "PRC Patent Law" (hereafter called "Patent Law"), institute these measures.
Article 2 These Measures regard infectious diseases AIDS, TB, and malaria as well as other infectious diseases regulated by the "PRC Infectious Disease Prevention Law" that are causing public health problems.
These measure regard any patented product or product made pursuant to a patented process, including components necessary for making the aforesaid products effective and diagnosing reagents necessary for using the aforesaid products that are used in the medical field to treat the infectious diseases that are mentioned in paragraph 1.
Article 3 The prevention or control of the emergence or spread of infectious diseases in China as well as treatment of infectious diseases, [taking] actions described in Article 49 of the Patent Law [are] for the purpose of public rights and benefits.
The emergence and spread of infectious diseases [will] lead to a public health crisis belonging to a state of national emergency described in Article 49 of the Patent Law.
Article 4 For drugs under Chinese patent for treating certain types of infectious diseases, where China possesses the production capability, the relevant ministries under the State Council may, according to Article 49 of the Patent Law, request that SIPO award the implementation of a compulsory patent license (hereafter "compulsory patent").
Article 5 For drugs under Chinese patent for treating certain types of infectious diseases, where China does not possess the capability to manufacture that drug or the manufacturing capability is insufficient, ministries under the state council may request SIPO issue a compulsory license, allowing the licensee to import from WTO Members that the General Council Resolution clarifies [may] make this kind of drug for China to resolve a public health problem.
Article 6 Under a compulsory license awarded by SIPO under Article 5, the licensee or any other unit or individual must not export to any other country or region the drugs imported pursuant to the compulsory license decision.
Article 7 Under a compulsory license awarded by SIPO under Article 5, a reasonable royalty should be paid by the licensee to the patentholder. But, where the producer has already paid the patentholder a royalty, the licensee need not pay a royalty to the patentholder.
Article 8 For drugs under Chinese patent for treating certain types of infectious diseases, any unit or individual buying in other countries or regions drugs produced and sold by the patentholder or drugs produced and sold under a license from the patentholder, may import those drugs to China without having to request a compulsory license from SIPO.
Article 9 WTO Members according to the General Council Resolution clarification mechanism announcement of the WTO Trips Council, wishing to import drugs for treating certain types of infectious diseases or non-WTO member Least Developed Countries via diplomatic channels notify the Chinese government that they wish to import drugs for treating certain types of infectious diseases from China, ministries under the State Council may request the award of a compulsory license from SIPO, permitting the licensee to use the General Council Resolution clarification system to make this type of drugs and export them to the above-mentioned members and nations.
Article 10 Under a compulsory license awarded by SIPO under Article 9, in making the decision on the compulsory license SIPO should clearly record the relevant requirements of the General Council Resolution. The licensee should abide by the requirements of the compulsory license decision stipulations.
Article 11 Under a compulsory license awarded by SIPO under Article 9, the licensee should pay a reasonable royalty to the patentholder.
Article 12 Requests for compulsory licenses under Articles 4, 5, and 9 of these measures, except where there are special stipulations, will apply the stipulations of the "Measures for Implementing Compulsory Licenses of Patents."
Article 13 These measures will be effective from January 1, 2006.
November 29, 2005
国家知识产权局局令（第37号）
《涉及公共健康问题的专利实施强制许可办法》已经局务会议审议通过，现予公布，自2006年1月1日起施行。
局 长
二○○五年十一月二十九日
涉及公共健康问题的专利实施强制许可办法
第一条 为了解决我国面临的公共健康问题，并帮助有关国家、地区解决其面临的公共健康问题，落实世界贸易组织多哈部长级会议《关于TRIPS协议与公共健康的宣 言》（下称“多哈宣言”）和世界贸易组织总理事会《关于实施TRIPS协议与公共健康的多哈宣言第6段的决议》（下称“总理事会决议”），根据《中华人民 共和国专利法》（下称“专利法”），制定本办法。
第二条 本办法所称传染病，是指导致公共健康问题的艾滋病、肺结核、疟疾以及《中华人民共和国传染病防治法》规定的其他传染病。
本办法所称药品，是指在医药领域用于治疗本条第一款所述传染病的任何专利产品或者通过专利方法制造的产品，包括制造前述产品所需的有效成分和使用前述产品所需的诊断试剂。
第三条 在我国预防或者控制传染病的出现、流行，以及治疗传染病，属于专利法第四十九条所述为了公共利益目的的行为。
传染病在我国的出现、流行导致公共健康危机的，属于专利法第四十九条所述国家紧急状态。
第四条 治疗某种传染病的药品在我国被授予专利权，我国具有该药品的生产能力，国务院有关主管部门可以依据专利法第四十九条的规定，请求国家知识产权局授予实施该专利的强制许可（下称强制许可）。
第五条 治疗某种传染病的药品在我国被授予专利权，我国不具有生产该药品的能力或者生产能力不足的，国务院有关主管部门可以请求国家知识产权局授予强制许可，允许被许可人进口世界贸易组织成员利用总理事会决议确定的制度为我国解决公共健康问题而制造的该种药品。
第六条 国家知识产权局授予本办法第五条所述强制许可的，被许可人以及其他任何单位或者个人不得将依照该强制许可决定进口的药品出口到其他任何国家或者地区。
第七条 国家知识产权局授予本办法第五条所述强制许可的，被许可人应当向专利权人支付合理的报酬。但该药品的生产者已经向该专利权人支付报酬的，被许可人可以不向专利权人支付报酬。
第八条 治疗某种传染病的药品在我国被授予专利权，任何单位或者个人在其他国家或者地区购买专利权人制造并售出的或者经专利权人许可而制造并售出的该种药品，将其进口到我国的，无需请求国家知识产权局授予强制许可。
第九条 世界贸易组织成员按照总理事会决议确定的机制通报世界贸易组织TRIPS理事会，希望进口治疗某种传染病的药品的，或者非世界贸易组织成员的最不发达国家 通过外交渠道通知我国政府，希望从我国进口治疗某种传染病的药品的，国务院有关主管部门可以请求国家知识产权局授予强制许可，允许被许可人利用总理事会决 议确定的制度制造该种药品并将其出口到上述成员或者国家。
第十条 国家知识产权局授予本办法第九条所述专利强制许可的，应当在其作出的强制许可决定中明确记载总理事会决议规定的有关要求。被许可人应当遵守该强制许可决定规定的要求。
第十一条 国家知识产权局授予本办法第九条所述强制许可的，被许可人应当向该药品的专利权人支付合理的报酬。
第十二条 依照本办法第四条、第五条和第九条请求强制许可的，除本办法有专门规定的以外，适用《专利实施强制许可办法》的规定。
第十三条 本办法自2006年 1月1日起施行。