Indian firms to benefit

The Brazilian government's decision to override the patent rights of Merck's HIV/AIDS drug Stocrin (efavirenz) and buy reverse engineered generic versions of the drug at low cost has come as a boon for Indian pharmaceutical companies manufacturing generic versions of efavirenz such as Cipla, Ranbaxy, Aurobindo Pharma and Strides Arcolab.

On Friday, Brazilian President Luiz Inacio Lula da Silva announced invoking the compulsory licensing provision for pharmaceuticals under the World Trade Organisation's (WTO) agreement on intellectual property - the TRIPS (Trade-Related Aspects of Intellectual Property Rights) - to buy copycat versions of efavirenz from laboratories certified by the World Health Organisation.

With over 200,000 registered cases, Brazil has the most AIDS patients in Latin America. Of them, only 75,000 patients are currently treated with efavirenz.

Welcoming the Brazilian government's move, Amar Lulla, joint managing director of Cipla, said it was heartening to note that Brazil has invoked the compulsory licensing provision to treat its HIV/AIDS patients with affordable generic drugs.

"The compulsory licensing provision of the TRIPS help countries to protect the rights of its citizens. We welcome the Brazilian move," he said.

Lulla confirmed that the Brazilian government was negotiating with Cipla for the supply of generic versions of efavirenz. "Talks are on with Brazil for supply of the drug. We are not in a position to reveal more details," he said.

A Ranbaxy spokesperson declined to comment on the development. Aurobindo Pharma and Strides Arcolabs spokespersons were not available for reaction.

Efavirenz tablets are used as a frontline anti-retroviral drug to treat human immunodeficiency virus (HIV) infection in patients with or without acquired immunodeficiency syndrome (AIDS).

Also marketed by Bristol Myers Squibb as Sustiva, it is used in combination with other anti-retroviral agents for the treatment of HIV infections and is a key component of drug regimens for patients who are on concurrent treatment for tuberculosis.

Aurobindo Pharma and Strides ArcoLab had recently received tentative approval from the US Food and Drug Administration (US FDA) for efavirenz capsules.

Ranbaxy, which has 12 anti-retroviral drugs in the WHO pre-qualification list for HIV/AIDS therapy, has its versions of efavirenz 600mg tablets and 200mg capsules, besides some other combination drugs with efavirenz.

Thailand had broken the patent on efavirenz in November, last year and Ranbaxy was a major gainer as it got an order for 66,000 bottles of the drug.

Thailand also used the compulsory licensing provision on Kaletra, another anti-HIV/AIDS drug made by the US firm Abbott Laboratories, and Plavis, a blood-thinning drug made by Sanofi-Aventis.

Meanwhile, Merck said it was disappointed by Brazil's decision to allow generic version in Brazil. "This expropriation of intellectual property sends a chilling signal to research-based companies about the attractiveness of undertaking risky research on diseases that affect the developing world. As the world's 12th largest economy, Brazil has a greater capacity to pay for HIV medicines than countries that are poorer or harder hit by the disease," the company said in a statement.