NEW DELHI, NOVEMBER 16: GlaxoWellcome has threatened action against Cipla if the Indian drug company continues to export its anti-AIDS drug Duovir to Ghana. The multinational alleges that Cipla has been exporting Duovir in violation of its patent rights on the drug’s lamivudine/zidovudine combination.
In a letter to Cipla, Glaxo Group Limited’s Global Intellectual Property Department said Glaxo had “exclusive rights under the following patents that cover lamivudine and zidovudine formulations in Ghana: AP11, AP136, AP162 and AP3000.” The letter said that since the export was called a “donation”, the multinational was not seeking immediate redress but itthreatened Cipla with action against further acts of infringement.
In its reply, Cipla countered that three of GlaxoWellcome’s four African Regional Industrial Property Organisation (ARIPO) patents — AP11, AP136 and AP182 — “are unenforceable in Ghana since the country did not allow patent protection for pharmaceutical production per se until 1 July 1993, and these patents were granted before then.” Ghana beganallowing pharmaceutical product patents on July 1, 1993, and any product patents registered before that would not apply.
“GlaxoWellcome does not hold the patents in Ghana, as the only patent (AP 300) granted after July 1 also just relates to crystalline lamivudine and we’ve written to them saying so,” Amar Lulla, Director, Cipla, told The Indian Express. “They still haven’t replied, so as of now, the export will continue.”
Sandhya Janorkar from Glaxo India, meanwhile, maintained that Duovir exports have “stopped for the moment”, but stressed that the action was taken by the parent company and Glaxo India was not involved.
The sole importer of Duovir tablets to Ghana, Healthcare Services Limited, refuses to comment on the issue but indicates that it will respect the patent rights of GlaxoWellcome, if they do exist.
Duovir is a fixed-dose combination of two drugs that costs one-fifth the price of GlaxoWellcome’s anti-AIDS drug in Ghana. Unlike other anti-AIDS drugs that have to be taken following a complex regimen, Duovir has to be taken in the same dose every day, thus ensuring better compliance. Though there is no cure for AIDS, Duovir reduces the possibility of patients contracting secondary diseases.
Patents on live-saving drugs is a major issue, and drug multinationals have repeatedly assured the international fora in the past that they would not insist on patent rights on HIV drugs in African countries other than South Africa.