Chinese Officials Approve Domestic Production of Second Generic Antiretroviral Drug

The Chinese State Drug Administration has issued a license for a domestic drug company to produce a second generic antiretroviral drug, "taking advantage of lax patent laws to produce medicines still under patent overseas," the Wall Street Journal reports. Shanghai Desano Biopharmaceutical will produce and market a generic version of didanosine, or ddI, a nucleoside reverse transcriptase inhibitor used in combination therapy that is patented and marketed as Videx by U.S. drug maker Bristol-Myers Squibb. The drug is still technically under patent in China; however, ddI has only a "process patent," meaning that only the process and formulation used to make the drug, not the drug's components, are protected. By "tweak[ing]" the process, Shanghai Desano can legally produce a generic copy, the Journal reports. Amy Guo, a spokesperson for the company, said that Shanghai Desano's version of ddI will be available in powder form instead of tablet form. She added that the company is seeking approval for generic versions of two other antiretroviral drugs used in combination therapy. The company hopes to lower the annual cost of combination treatment from the current price of $3,500 to about $400 to $600. Last month, Chinese officials granted a license for a generic version of AZT, which is also used in combination therapy. Che Fei, a spokesperson for Bristol-Myers Squibb, said that the company was not aware of the generic license granted for ddI, but noted that Bristol-Myers has reduced the price of its antiretroviral drugs in China by as much as 75%. The Journal reports that the license is "likely to be welcomed" by AIDS activists, who have been pushing for expanded access to treatment. However, it is "likely to anger" brand-name pharmaceutical companies, which have "long complained about China's porous patent laws" (Chang, Wall Street Journal, 9/16).

Newark Star-Ledger Examines Chinese Patent Debate
The Newark Star-Ledger yesterday examined the debate over patent protections in China. Several unnamed people who "track the debate about AIDS and the pharmaceutical industry's stance on patent protection" answered questions about the situation in China and its possible ramifications on drug patents worldwide (Silverman, Newark Star-Ledger, 9/15). The full article is available online.

Opinions Call for Release of AIDS Activist
China's leadership "must deal with the [HIV/AIDS] epidemic openly and realistically," a New York Times editorial states. Saying that China has recently taken "halting steps" toward addressing the extent of its HIV/AIDS problem, the Times states that the government "may finally be stirring from its denial and lethargy on AIDS." However, the government is still doing "virtually nothing" to treat people with the disease and "remains unwilling to tolerate open discussion of its health crisis," the editorial says. The best example of this second point is the recent disappearance and alleged police detainment of Wan Yanhai, an AIDS activist who was "instrumental" in revealing the extent of the epidemic in China's rural provinces, the Times states. Noting that China is applying for a $90 million grant from the Global Fund to Fight AIDS, Tuberculosis and Malaria, the Times says that there would be "no better way to demonstrate the kind of openness that is critical to any successful campaign against AIDS" than to release Wan (New York Times, 9/16). A Toronto Globe and Mail editorial states, "If China is serious about tackling AIDS, it would be wise to collate and disseminate all the information it can. Freeing Dr. Wan from his prison cell ... would be a useful start" (Toronto Globe and Mail, 9/16). Mickey Spiegel, a senior researcher in the Asia division of the New York-based organization Human Rights Watch, writes in an opinion piece appearing in the International Herald Tribune that Chinese officials must realize that "silencing the messenger will not undermine the importance of the message" and that they should release Wan. The government has failed to launch a large-scale awareness and prevention campaign, Spiegel says. He concludes that "[w]hen it wants to, China's leadership has no trouble getting its message to the public. Why not now?" (Spiegel, International Herald Tribune, 9/14).