The newly revised Measures for Compulsory Licensing of Patent Implementation has been approved and will come into force as of May 1, 2012, released by the State Intellectual Property Office (SIPO) on March 20. 

According to the revised measures, in the fields involving the public interest such as medicine, compulsory licensing may bring more affordable medicine and benefit more people. 

The Measures for Compulsory Licensing of Patent Implementation was promulgated in 2003. In the revision this time, the SIPO integrated the version in 2003 and the Measures for Compulsory License on Patent Implementation concerning Public Health Problems promulgated in 2005 and formed a draft for new measures. The SIPO publicized the draft for opinions in October 2011. 

In the officially issued measures, the compulsory licensing items concerning emergent condition, public interest and medicine catch eyes. 

Based on the Measures, when emergent or unusual situations occur in the country or public interest is considered, competent authorities of the State Council can advise the SIPO to give compulsory licensing to the designated qualified entities in accordance with the provisions of Article 49 of the Patent Law. 

For the purpose of public health, under Article 50 of the Patent Law, qualified entities can request for compulsory licensing to manufacture patented drugs and export them to the following countries or regions: the least developed countries or regions, and the developed or developing members that express their expectation to import such medicine through informing World Trade Organization (WTO) in accordance with relevant international treaty. 

This is not the first time for China to publicize laws concerning drug compulsory licensing. The Measures for Compulsory License on Patent Implementation concerning Public Health Problems promulgated in 2005 by the SIPO has included these two pieces and relevant articles in the revised Patent Law in 2008 were also amended accordingly. 

Although China had worked out laws on applying for medicine compulsory licensing since the year 2005, Chinese pharmaceutical manufactures had never filed any applications for compulsory licensing on generic drugs. 

Based on what experts analyzed, the low profits in manufacturing generic drugs and the inactivity of governmental departments in promoting compulsory licensing are the main reasons leading to ineffective implementation of drug compulsory licensing in China. 

Just one week earlier before the publication of the Measures, the Patent Office of India issued the first compulsory licensing to a generic drug manufacturer, ending the era in which only German pharmaceutical company Bayer produced sorafenib tosylate used for kidney cancer and liver cancer in India. Thus, the price for sorafenib tosylate will be reduced from over $5,500 per month to $175 each month in India, with a decrease of nearly 97%. 

In China, the public has been expecting compulsory licensing related to drugs for hepatitis B, tuberculosis and AIDS. In 2008, public interest organization Beijing Yirenping Center joined hands with 1,843 HBV carriers and HIV- infected persons to appeal to the Ministry of Commerce to issue compulsory licensing for Lamivudine. In July 2011, Shanghai Aurisco Pharmaceutical Limited planned to organize domestic non-governmental organizations to apply for patent compulsory licensing for Tenofovir disoproxil used for AIDS.