Thai Government to Petition Court to Allow Production of Videx EC While Appeal is Pending

Thailand's Government Pharmaceutical Organization yesterday said that it planned to petition the Central Intellectual Property and International Trade Court for permission to produce a generic version of the antiretroviral drug Videx EC, Reuters reports (Thepgumpanat, Reuters, 10/9). The ITC last week ruled that U.S. drug maker Bristol-Myers Squibb no longer had the exclusive right to market Videx in Thailand because part of its patent on the drug was invalid. Under the court ruling, Bristol-Myers retained the exclusive right to produce Videx only in doses from five milligrams to 100 milligrams, while other drug companies can produce the drug in larger doses (Kaiser Daily HIV/AIDS Report, 10/2). Although Bristol-Myers has one month to appeal the ruling, GPO is requesting permission to produce the drug while the appeal is pending (Reuters, 10/9). In the lawsuit, GPO alleges that Bristol-Myers' entire patent on Videx is invald because the drug is "merely a combination of an antacid and the active ingredient didanosine," which Bristol-Myers does not hold a patent on. The company developed Videx after licensing didanosine from NIH, but maintains that Videx is patentable because the antacid improves the drug's effectiveness (Noikorn, Associatd Press, 10/9). Thongchai Thavichachart, managing director of GPO, said that the agency is prepared to produce the drug in a dose larger than 100 milligrams if the court approves it, and GPO's board is set to approve the lawsuit on Oct. 17. AIDS advocates in Thailand report that as many as 100,000 HIV-positive Thais need antiretroviral therapy but that only 5% of them can afford the drugs' current costs (Reuters, 10/9).