Abbott Labs’ bid for anti-HIV drug patent to face stiff challenge

New Delhi: Less than a week after an Indian patent filing made by Abbott Laboratories Inc. for Aluvia, a heat stable version of its $1.14 billion (Rs4,696.8 crore) anti-HIV drug, was challenged by a US non-profit health group, it is becoming clear that the Illinois, US-based drug maker will face several more ‘pre-grant oppositions’ here.

Indian patient groups say they are also contemplating following the example set by Initiative for Medicines, Access & Knowledge (I-MAK), which announced its filing in the Mumbai Patent Office, on Thursday. Meanwhile, Indian generic drug maker Cipla Ltd claims it, too, might fight the Abbott patent filing.

Sold under the brand name Aluvia by Abbott, the drug is a combination of lopinavir and ritonavir drugs in a tablet form and remains chemically stable and doesn’t need refrigeration in countries such as India. Unlike its original version Kaletra, which has the same drug combination but is in the form of soft gel capsules, Aluvia also does not come with any patient dietary restrictions and also lowers the number of pills a patient is prescribed a day.

Roughly 93,000 AIDS patients in India are on antiretroviral therapy and a tenth of them are estimated to require drugs similar to Aluvia.

Public health groups say that there isn’t enough fresh ground broken by Abbott to be eligible for patent protection.

“Both the ingredient drugs, lopinavir and ritonavir, are pre-995 drugs and, hence, not patentable. The combination, which is heat stable, doesn’t deserve a patent by itself,” said drug access campaigner Leena Menghaney of Medecins Sans Frontieres or Doctors Without Borders’ Campaign for Access to Essential Medicines. Drugs that pre-date India’s Patents Acts 2005 by more than 10 years are not eligible for the so-called product patents.

The opposition by I-MAK centers on a controversial provision, Section 3(D), of the Indian patent law that bars patents on derivatives of an older drug without substantial rise in efficacy. The compliance of this provision with global trade laws was unsuccessfully challenged by Swiss drug maker Novartis AG this year and turned down by the Madras high court earlier this month. An adverse verdict for Novartis has emboldened public health activists to fight what they see as other ‘frivolous’ patents.

“Abbott’s application on the lopinavir/ritonavir tablet is not inventive and, if granted, would prevent others from supplying low-cost versions of the drug,” said Tahir Amin, I-MAK director, in a statement. “It is an egregious example of how the public is harmed by improper extension of patent life by Abbott.” I-MAK has opposed the patent in both European and Indian patent offices.

An Abbott spokesperson did not respond immediately to request for comment.

At least two Indian activist groups confirmed that they were finalizing their pre-grant oppositions to the Abbott drug, but declined to be named or give details until the filing with the Indian patent office was done. Cipla, which currently sells a generic version of the lopinavir-ritonavir drug, too, might file a pre-grant opposition, said its chief executive Amar Lulla.

Abbott’s Kaletra has been under attack in Thailand as well with the government there breaking its patent and sourcing the drug from other generic pharmaceutical firms.