Activists win court battle in campaign for generic production of ddI

Thai activists campaigning to reduce the cost of antiretrovirals won an important victory in October when a Bangkok judge ruled invalid part of a patent held by Bristol-Myers Squib (BMS).

Two people with HIV and two non-governmental organisations, the Thai Organisation of People Living with HIV/AIDS and AIDS ACCESS, took the case to court. They said the American company improperly sought to extend its patent on ddI (didanosine, Videx) to cover dosages beyond those for which it originally applied. The ruling on the antiretroviral ddI EC allows activists to proceed with a lawsuit seeking to completely overturn BMS’s patent on the drug in Thailand and let other companies manufacture generic versions. This could halve the price of ddI in Thailand.

Thailand’s Central Intellectual Property Court ruled that BMS’s patent covers only pills containing between 5 and 100mg of ddI and paves the way for other drug makers to market pills with dosages above 100mg. Judge Kornkanya Suwanpanich’s ruling also affirmed that non-governmental organisations and individuals could challenge patents on social grounds, such as public health. Previously, only companies with a commercial interest in such cases had been complainants.

“This is the first court victory of HIV/AIDS patients,” said Nimit Tienudom, executive director of AIDS ACCESS. “We expect this ruling will set a precedent for other AIDS advocacy groups and patients to follow.”

The two Thai PWAs and the organisations said in their complaint to the court that giving BMS exclusive rights to make the drug prevented other firms producing cheaper remedies for Thai PWAs.

The plaintiffs told the court that BMS’s ddI currently cost 40 baht (£0.59) a pill, but the state-owned drugs firm could sell it at half that price if BMS’s rights were limited.

BMS had argued that the AIDS foundation could not act on behalf of PWAs in Thailand and the patent it was holding was valid in other countries.

The company has 30 days to appeal to the country’s Supreme Court. A BMS spokesperson said he would not comment on the case until the company had seen details of the ruling.

The ruling has “opened a new chapter of debate with regard to access to treatment” for people with HIV/AIDS in Thailand, Mukdawan Sakboon writes in an opinion piece for Thailand’s Nation.

Sakboon states that the ruling is significant because it is the first case of its kind to be decided by the court and has “set a precedent” for the second case. Whatever the outcome of the court cases, the consequences “will have great impact on a country hard hit by the AIDS epidemic where access to drug[s] is a big issue,” and will serve as a measure of how governments should balance intellectual property protection with public health needs, Sakboon concludes.

Thailand has around 700,000 PWHIV and sees 20,000 to 25,000 new cases of infection each year.

More than 40 million people are living with HIV/AIDS, most of them in developing nations. The United Nations estimates AIDS will kill 70 million people over the next 20 years unless there are more treatment and prevention initiatives.