Bangkok/Mumbai, July 12 (Reuters): India’s Cipla, a pioneer in supplying cheap generic AIDS drugs in Africa, has patented its three-in-one combination tablet Triomune in South Africa, in a move that will surprise many industry watchers.

The company is also seeking patents on the product in 17 other countries in Africa, the epicentre of the AIDS pandemic.

Cipla confirmed the move today after the patents were uncovered by people familiar with the AIDS situation and attending the 15th International AIDS Conference in Bangkok.

“The patent has been granted in South Africa... this is our invention,” Amar Lulla, Cipla’s joint managing director, said in Mumbai.

Triomune contains copies of three drugs — GlaxoSmithKline’s lamivudine, Bristol-Myers Squibb’s stavudine and Boehringer Ingelheim’s nevirapine — which are themselves still under patent protection.

Cipla argues its scientists found the way to put them together to produce the combination pill, which needs to be taken only twice a day.

Patents have also been filed in the Democratic Republic of Congo, Namibia and the 15 members of the African Regional Industrial Property Organisation — Botswana, Gambia, Ghana, Kenya, Lesotho, Malawi, Mozambique, Sierra Leone, Somalia, Sudan, Swaziland, Tanzania, Uganda, Zambia and Zimbabwe.

Fixed-dose combination drugs from generic producers such as Cipla have been lauded by AIDS activists as a cheap, convenient alternative to more expensive patented brand medicines. According to charity ActionAid, they can be bought for as little as $140 per patient a year compared with $470 for patented products.

Cipla’s entry into the patent arena may offer it commercial protection from rivals looking to copy its know-how in combining the three original medicines. But it could prove politically embarrassing.

Lulla declined to comment on Cipla’s pricing strategy, although he said the firm would consider licensing the drug to whoever wanted it in South Africa. Cipla is registered to sell cheap anti-retroviral drugs in a total of 65 countries worldwide.

Until recently, doubts had persisted about the clinical effectiveness of copycat fixed-dose combinations. But a study published in Britain’s The Lancet medical journal this month found Triomune performed as well as brand drugs in Cameroon.

The WHO has judged Triomune and another Indian combination called Triviro, from Ranbaxy Laboratories, to be safe and effective under a scheme that “pre-qualifies” them for use.

The US Food and Drug Administration has also announced a fast-track scheme for copycat drugs to get the FDA seal of approval for safety and quality in a move that would allow recipients of US grants to use them instead of brands. No FDA approvals for combination AIDS pill have yet been given.

Meet controversy

A controversy erupted at a global AIDS conference today over whether abstaining from sex or using condoms was more effective to prevent the disease.

Ugandan President Yoweri Museveni brought the issue, which has set many AIDS activists at odds with Washington, into the open at the first full day of the AIDS conference by saying abstinence was the best way to stem the spread of the killer virus. “I look at condoms as an improvisation, not a solution.”