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Gilead's AIDS Drug Awaits Patent in India

American bio-pharmaceutical major Gilead, which has entered into generic licensing deals with 10 Indian pharma firms to distribute its HIV drug Viread, is hoping to get a patent in India soon.

"We have made considerable progress in implementing our access programme and licensed Indian pharmas to manufacture Viread which originally announced a pricing of $1 a day for the pill," Gregg Alton, senior vice president and general counsel, Gilead Sciences, told IANS.

"After much discussion, Gilead now believes that a larger number of manufacturers will intensify competition and drive down prices even further," said Alton whose team was in Delhi last week.

Now, Gilead's application for a patent is pending before the Indian Patent office as it believes that it has a right to protect its intellectual property.

Indian pharma major Cipla has filed a pre-grant opposition against the patent application for Viread before the patents office.

But Alton said: "We believe that protecting the intellectual property of companies who engage in drug research and development is a critical part of the treatment access equation. Intellectual property protection, when used responsibly, encourages research and discovery of newer and more effective molecules.

"Gilead respects Cipla's right to oppose the issuance of a patent for Viread or any drug. But more importantly, we reaffirm our desire to work with Cipla whether or not a patent is issued," said Alton.

Gilead has signed generic licensing deals with 10 Indian pharma majors to distribute Viread in India and 94 other resource-limited countries.

More than 5.1 million people are believed to be infected with HIV in India - the second highest incidence of the disease after South Africa.

According to Alton, Viread (tenofovir disoproxil fumarate) is on its way to becoming the frontrunner drug across Europe for HIV/AIDS due to its low toxicity and resistance levels observed in patients.

The tablet-a-day dosage of the drug also helps in better regimen and compliance among the HIV/AIDS patients taking it.

Alton also pointed out that he expects generic versions of Gilead's anti-retrovirals to be available from several of its partners within the next few months.

When asked whether the drug would become unaffordable if Gilead was granted a patent for Viread in India, Alton assuaged fears voiced by critics and NGOs.

"The company plans to use this patent responsibly and has made its intention clear in the act of issuing non-exclusive voluntary licenses to Indian companies," he said.

"We have also planned a direct contact programme with NGOs and this open mode of communication will enable NGOs and Gilead to work on a common platform and fight the epidemic of AIDS together."

Currently, Gilead has signed agreements with Alkem Laboratories Ltd., Aurobindo Pharma Ltd., Emcure Pharmaceuticals, FDC Ltd., Hetero Drugs, Matrix Laboratories Ltd., Medchem International, Ranbaxy Laboratories Ltd., Shasun Chemicals & Drugs Ltd and Strides Arcolab Ltd.


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