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GSK withdraws Combivir patent plea

P.T. Jyothi Datta

Not under pressure, but as `a routine business decision'


Withdrawal syndrome
Combivir, a fixed dose combination of two existing drugs, zidovudine and lamivudine, is used in the first line of treatment and is the backbone of AIDS therapy
Patient networks hope that Combivir's withdrawal will set a precedent for other AIDS drugs such as abacavir, tenofovir, nevirapine syrup and atazanavir which are also under challenge.

Mumbai , Aug. 20

Drug-maker GlaxoSmithKline (GSK) has confirmed that it has withdrawn its patent application in India for the AIDS-drug Combivir.

The move sets a precedent and comes even as local HIV/AIDS-patient networks challenge patent applications on a clutch of AIDS drugs at the Indian Patent Office.

Denies pressure

Patient networks had in March opposed the multinational's patent application on Combivir at the Patent Office in Kolkata. But GSK denies that it was pressure from these networks that forced the withdrawal.

The withdrawal is a "routine business decision" and was done months prior to these demonstrations, GSK Pharmaceutical's spokesperson in India told Business Line confirming the development.

Last week, GSK said in a communiqué from Thailand: "In June 2006, GSK instructed its agents in Thailand and India to withdraw this patent application. This means that GSK has no patent protection on Combid/ Combivir in Thailand or India, and is not seeking any."

Combivir is used in the first line of treatment and is the backbone of AIDS-therapy. It is a fixed-dose combination of two existing AIDS drugs - zidovudine and lamivudine.

GSK's patent application on Combivir was opposed in India on technical and health grounds by the Manipur Network of Positive People, under the aegis of the Indian Network of People Living with HIV/AIDS.

But the GSK official said that conditions prevailing in India earlier merited the patent application. Subsequently, as part of a constant review, the decision was taken to withdraw the application, he added.

Decision welcomed

GSK's decision to withdraw the patent application is a good development and it should stick to its commitment, said a representative with the access- programme of international humanitarian group Medecins Sans Frontieres (Doctors without Borders).

GSK should officially intimate other stakeholders in India, such as the positive-people's networks on the withdrawal, as it has done in Thailand, the representative said.

Meanwhile, legal-representatives for the patient-networks say that their enquiries at the Patent Office in Kolkata have not come up against an official intimation on the withdrawal from GSK.

Precedent

But patients are hoping that the withdrawal sets a precedent and spills over to other AIDS drugs such as abacavir, tenofovir, nevirapine syrup and atazanavir whose patent applications are also being challenged by patient-networks.

But for starters, they are reserving their celebrations till they get an official intimation from GSK on the withdrawal of Combivir's patent application.

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