Mumbai: After a three-year hearing, India’s patent office has rejected an application filed by US drug multinational Abbott Laboratories for its anti-HIV drug Aluvia, a combination of the drugs lopinavir and ritonavir, according to a copy of the decision seen by Mint on Monday.
The patent claim of Abbott was opposed by three Indian companies, including the country’s largest generic drug maker Cipla Ltd, Hyderabad-based Matrix Laboratories Ltd and Okasa Pvt. Ltd.
The application was first opposed in 2007 by the US non-profit healthcare group, Initiative for Medicines, Access and Knowledge (I-MAK), soon after it was filed in India.
The patent office concluded after the prolonged hearing that the drug doesn’t seem to be a new invention.
The tablet had been claimed to be a heat-resistant version of an earlier combination of lopinavir and ritonavir. The drug is marketed as Kaletra in a major part of the world and as Aluvia in Africa and a few other markets.
Abott holds at least 75 patents in several countries for these drugs which posted total sales of about $2 billion (Rs8,934 crore) in 2009. India follows a comparatively stringent set of measures to qualify a drug for the grant of a patent.
“Abbott is reviewing this decision and determining its next steps,” wrote Scott Stoffel, director, external communications, corporate public affairs, at Abbott Laboratories, in an email response to queries.
“New formulations of Kaletra have provided physicians and patients with real improvements in its use, dosing and convenience,” he wrote. “The heat-stable tablet solves specific convenience limitations of Abbott’s earlier version, which required refrigeration and had to be taken with food. These challenges have been resolved with the new tablet and there is significant benefit for patients in developing countries and resource limited settings,” he added.
Abbott is expected to challenge the patent rejection, said S. Majumdar, partner at law firm S. Majumdar and Co., who argued the case for one of the opponents of the patent.
The rejection will enable access to the drug for “all and would save a lot of HIV patients who cannot afford the Abbott product”, Majumdar added. The Abbott drug combination is considered to be the best second-line treatment of HIV-positive patients.
According to non-government healthcare lobbies, the Indian patent office’s decision paves the way for access to the medication to HIV patients across the world. There are some 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 versions of these drugs in 43 low and middle-income countries would be sufficient to start 130,000 new patients on HIV treatment, I-MAK estimates. “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,” I-MAK said in a statement on Monday.