India says no to AIDS drug patents, reaffirms role as ‘pharmacy’ of poor countries

LONDON - India has rejected applications from two US companies for patents on two key AIDS drugs in a move that could mean more people in poor countries will have access to life-saving medicines.

According to a report in Nature News, the decisions are the latest in a string of legal victories for Cipla, India’s largest generic drug maker.

The move could also signal that patent offices in emerging economies are set to take a tougher line than industrialized countries on which drugs deserve patents.

India’s patent office rejected claims by Gilead on Tenofovir - a nucleoside reverse transcriptase inhibitor, which is a frontline drug against HIV/AIDS in poor countries - and by Tibotec on Darunavir, a newer and more expensive protease inhibitor used as a second-line drug.

Both drugs block enzymes that HIV needs to replicate.

The rejection of patents on the two drugs opens the way for India to not only produce cheaper generics for its own population, but also export them to countries where the drug is not patented - reaffirming India’s role as the ‘pharmacy’ of poor countries.

“We are delighted that we have been vindicated,” said Yusuf Hamied, chairman and managing director of Cipla.

The major battle was over Tenofovir, given its extensive use.

In 2006, Cipla and a group of Indian and Brazilian non-government organizations (NGOs) independently filed oppositions to Gilead’s patent applications on the drug - marking the first time foreign NGOs had joined Indian ones in contesting a drug patent, a move motivated by the fact that the decision could impact pricing of the drug in Brazil.

Gilead responded by striking a deal the same year with 13 other Indian generic manufacturers, giving them a license to make the drug for a 5 percent royalty.

“Gilead was worried that they might lose, so they offered licenses, but these came with a sting in the tail,” said Michelle Childs, director of Medecins sans Frontieres’s Access to Essential Medicines Campaign.

Manufacturers could only buy the active ingredient - the most expensive part of a drug - from Gilead-approved suppliers, and they could only sell the drug to 95 of the poorest countries, not to middle-income countries such as China and Brazil which nonetheless have substantial poor populations.

Together these restrictions limited the price reductions the generic makers could offer, according to Childs.

“The Indian patent office decision now guarantees such countries access to a cheap generic supplier,” she said.

“Cipla decided to fight rather than sign up to the license; it took a risk and it has paid off,” said Childs. (ANI)