Cipla Tests South African Government with Compulsory License Request

Indian generic drug manufacturer Cipla Ltd. on Wednesday asked the South African government to grant the company a compulsory license to make eight antiretroviral HIV drugs, the Wall Street Journal reports. If granted, the compulsory license would "sidestep" the current lawsuit brought by 39 pharmaceutical companies challenging a 1997 South African law that would allow the manufacture and importation of generic drugs. Cipla's request "tests claims by the drug companies that the legislation under dispute is unnecessary because patent law allows the government alternatives, such as granting compulsory licenses in emergencies, to achieve the same goal," the Journal states. The request could also "prove to be a trial of the government's allegations that the drug firms' reluctance to provide affordable medicines is at the heart of its own poor response to the country's AIDS epidemic," the Journal continues. Some critics contend that the government "might be using the lawsuit to shift blame to the drug companies to restore its own credibility," after it earlier questioned the link between HIV and AIDS and called some AIDS drugs "toxins." They add that the government "risk[s] slipping back into disrepute if it squander[s] the Cipla opportunity." Some government officials expressed "worr[y]" that if Cipla wins a license, the government will lack the resources to distribute the drugs. Mirryena Deeb, head of the Pharmaceutical Manufacturers Association of South Africa, which brought the lawsuit against the government, said the organization does not intend to challenge Cipla's request. "On the contrary, we welcome it because it proves what we have been saying all along: that we are only against [the 1997 law] and not [against] access to cheaper drugs," she said. However, she added that some firms may challenge the offer on their own.

Request Under Review
Cipla on Wednesday told the South African Registrar of Patents that it "deserved a compulsory license because the large pharmaceutical companies had failed to meet demand 'on reasonable terms.'" The government must now hear any challenges from patent holders and examine Cipla's argument. Stephen Saad, CEO of South African generic manufacturer Aspen Pharmacare, which has a deal with a rival Indian firm to make three generic AIDS drugs, said that the government could declare a national emergency and grant compulsory licensing "at any time." Aspen Pharmacare is "just waiting for the government to give the word. It's just not coming," he added (Block, Wall Street Journal, 3/9).