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
