Snippets: Indian Patent Office Rejects Abbot Laboratories’ HIV Drug Patent Application

Today’s Economic Times carries a news report, according to which Abbot Laboratories’ application for a patent on its HIV combination drug, Lopinavir/Ritonavir, has been rejected by the Indian Patent Office.

Reportedly, Abbot’s patent application was opposed by Cipla, Matrix Laboratories and I-MAK (Initiative for Medicines, Access and Knowledge). The documents pertaining to the pre-grant opposition and an overview of the entire case, including the decision, are available here.

Extracts of I-MAK’s official press release are reproduced below:

“This weekend, India rejected an unmerited drug patent application, paving the way for access to lifesaving medication for HIV patients across the world. This groundbreaking victory for patients sets an important precedent to stop pharmaceutical companies from gaming the patent system, marking a new era of hope for millions of people living with HIV all over the world.

This drug combination, Lopinavir/Ritonavir, is considered to be the front line of defense for HIV positive patients who have failed to stay healthy with the first round of medicines available today. India, the world’s leading supplier of affordable medicines, can now supply this drug to patients across the globe who are desperately waiting for treatment.

The impact of the case is tremendous. There are over 33 million people living with HIV today and of these nearly 15 million require access to HIV drugs. 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.

Cheaper generic versions of this drug are ready to reach patients in India and across the world. Most recently, the Clinton Health Access Initiative has negotiated a price of $440 per patient, per 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 per patient per year in 2000, to as little as $79 today.

This affordable pricing by generic suppliers in India is in stark contrast to the unaffordable pricing by Abbott Laboratories on HIV drugs across the world over the last decade. “Abbott’s track record on pricing this drug unfairly for poorer countries motivated us to take on this case”, stated Tahir Amin, Director of the Initiative for Medicines, Access & Knowledge, the not-for-profit organization who brought the legal action. “They have gamed the patent system for nearly twenty years to extend the patent life on this drug. The time has come to say, ‘enough is enough’.”

I-MAK reports that Abbott Laboratories holds at least 75 patents on Lopinavir/Ritonavir alone. The rejection of this patent application in India was for a combination of existing drugs and techniques. The Indian Patent Office has put a halt to Abbott Laboratories patenting which, simply put, was not an invention.”

This decision is bound to ruffle a few feathers in the Pharma industry. We will shortly discuss the key aspects of the Patent Office’s decision. Insights into the proceedings before the Patent Office are welcome!