The Indian Patent Office has rejected a drug patent application from Abbott Laboratories for its HIV/AIDS combination drug Kaletra, on the grounds of non-inventiveness.

The Office decided that the patent application, which was filed in March 2006 for a method of preparing a heat-stable form of Kaletra (rinotavir and lopinavir), does not represent a product which is new or novel “and hence not involving inventive step.” Therefore, it is not an invention “as per section 2(l)0)” of India’s Patent Act, according to the decision.

As a result, Indian drugmakers can continue producing and exporting generic versions of the product, and drug access campaigners have welcomed the decision as not only paving the way for access to life-saving medication for HIV/AIDS patients around the world but also setting “an important precedent to stop pharmaceutical companies from gaming the patent system.”

The impact of the case is “tremendous,” says the Initiative for Medicines, Access & Knowledge, a non-governmental organisation which filed an opposition to the application in August 2008, along with Indian drugmakers Cipla, Matrix Laboratories and Okasa Pharmaceuticals. Of the more than 33 million people worldwide currently living with HIV, nearly 15 million require access to HIV drugs, and the 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 treatment who currently lack access, says I-MAK.

“That is 130,000 lives that could be saved from opening up the market for this drug alone,” the group adds.

“Abbott’s track record on pricing this drug unfairly for poorer countries motivated us to take on this case,” said I-MAK director Tahir Amin. “They have gamed the patent system for nearly 20 years to extend the patent life on this drug.”

Recently, the Clinton Health Access Initiative negotiated a price of $4,400 per patient per year for generic versions of Kaletra from four suppliers, while enabling competition among Indian manufacturers has been shown to drive down the prices of HIV/AIDS drug treatments from $10,000 per patient per year in 2000 to as little as $79 today, the group says.

According to I-MAK, Abbott holds at least 75 patents on lopinavir/ritonavir, and the rejected patent application is one of several which the firm has filed with the Indian authorities and which are being opposed.

Abbott has said it is reviewing the decision.

Meantime, in another major test case, Indian drugmaker Natco Pharma has begun the process of seeking the first compulsory licence for Pfizer’s HIV/AIDS drug Celsentri (maraviroc). Natco has requested a voluntary licence from Pfizer, stating that it can produce the drug and sell it at about one-fifth the price charged by Pfizer in India. Pfizer has until May to respond to Natco’s application.