India has rejected an HIV drug patent application filed by US-based Abbott Laboratories, as it lacked “novelty” under domestic laws. The denial of patent will help domestic drug-makers to produce and market low-cost versions of this drug in the developing world.
The rejection of Abbott’s patent application over a combination of lopinavir and ritonavir, sold under the brand name Aluvia, ended the four-year long intellectual property battle between the company and four pre-grant opponents.
In its order on December 30, Mumbai patent office said the drug lacked novelty and did not have any innovative production steps to qualify for patent protection under domestic laws. The Indian Patent Act does not permit patenting of incremental innovations of known substances.
Hailing the verdict, civil society groups said it sets an important precedent to stop pharmaceutical companies from “gaming” the patent system.
“New formulations of Kaletra (another brand name) have provided physicians and patients with real improvements in its use, dosing and convenience. The heat stable 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. Abbott is reviewing this decision and determining its next steps,” wrote Scott Stoffel, spokesperson of Abbott in an e-mail response.
The pre-grant opposition against Abbott’s patent application was filed by a non-profit organisation, Initiative for Medicines, Access & Knowledge (I-MAK) and domestic pharmaceutical companies Cipla, Okasa and Matrix. According to I-MAK, the combination of lopinavir and 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,” a statement from I-MAK said.
The Clinton Health Access Initiative had recently negotiated a price of $440 (about Rs20,000) per patient per year for generic versions of this drug from four suppliers.
According to I-MAK, Abbott holds at least 75 patents on this particular combination drug. The verdict can be challenged in the appellate body, the Intellectual Property Appellate Board. It is not clear whether Abbott would do so.