Drug is used in second-line treatment of AIDS.

The directive paves the way for access to life-saving medication for patients across the world, said a note from I-Mak, the not-for-profit organisation behind the legal action.

P.T. Jyothi Datta

Mumbai, Jan. 3

In what is seen as a New Year's gift of sorts to people living with HIV/AIDS, the Indian Patent office has rejected Abbott's patent application on its heat-stable version of the Lopinavir/Ritonavir drug.

Sold under the Kaletra brandname, the drug is used in the second-line treatment of AIDS, when patients are resistant or do not respond to the first line of medicines.

On December 30, the Indian Patent Office (Mumbai) rejected Abbott's patent application, on grounds including that it did not involve an inventive step. The Patent Office's directive was in response to pre-(patent) grant oppositions by I-Mak (a group of lawyers), Cipla, Okasa Ltd and Matrix Lab Ltd.

The directive paves the way for access to life-saving medication for patients across the world, said a note from I-Mak, the not-for-profit organisation behind the legal action. The development sets an important precedent to stop pharmaceutical companies from gaming the patent system, it added. Abbott officials, when contacted, said they would respond. The US-based company's reply was awaited at the time of going to press.

Impact

India is a supplier of generic-versions of medicines, including HIV drugs, across the world. There have been serious concerns raised by several stake-holders on how India's amended Patent Law would affect the ability of local companies to make inexpensive generic medicines. A patent allows the patent-holder exclusive sales for 20 years, and this leads to monopolistic pricing, that would in-turn keep medicines beyond the reach of those who may need it, health advocacy workers have told Business Line in the past.

There are over 33 million people living with HIV today and of these nearly 15 million require access to HIV drugs, the note said. Further, it adds, cost-savings generated over a three-year period by introducing generic Lopinavir/Ritonavir to 43 low- and middle-income countries would be sufficient to start 130,000 new patients on HIV treatment who currently lack access. That is 130,000 lives that could be saved from opening up the market for this drug alone, it said.

Recently, the Clinton Health Access Initiative had negotiated a price of $440 a patient, an year for generic versions of this drug from four suppliers.

Enabling competition amongst Indian suppliers has been demonstrated to consistently drive down prices on HIV medicines, from $10,000 a patient an year in 2000, to as little as $79 today, the note added. I-MAK adds that Abbott holds 75 patents on the said drug (Kaletra).

(This article was published in the Business Line print edition dated January 4, 2011)
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