The rejected application was on Nevirapine syrup — vital for kids living with HIV, as they face difficulties in swallowing tablets. The medicine is a standard one given in mother-to-child prevention programme.
After hearing arguments of Ingelheim and civil society groups, N R Meena, assistant controller of patents and design, gave his ruling on June 11, as the company failed to substantiate the syrup’s enhanced efficacy.
This is the first decision from the Indian Patent Office on patent opposition filed by the civil society groups against HIV-related medicines. Big players like GSK, Novartis, Abott Laboratories, Gilead Sciences Inc and Hoffmann-La Roche had made patent claims in India on some of their medicines.
But civil groups and a network of positive people opposed their claims on the ground that they were merely repackaged versions of known medicines.
“We opposed the patent application on Nevirapine Hemihydrate to ensure that it remains available for our children and the government doesn’t say it is too expensive to provide,” said P Kousalya, president of Positive Women Network.
The company can challenge the ruling in its appellate authority and subsequently in a high court and the Supreme Court. But there is no such movement till date.
While improved particle size and its stability were two key arguments furnished by the company, Meena ruled there were no data on which one could conclude that improved particle size and stability translate into better therapeutic effect.
The opposition had argued that the particular application was not patentable in India because the hemihydrate form of Nevirapine was just a “new form” of an already known substance without any increased efficacy.
This is the second victory for the groups lobbying for cheap HIV/AIDS medicine.
The first one was last year’s Chennai High Court verdict turning down a Novartis petition challenging the legality of certain sections in the Indian Patent Act while claiming a patent for its own drug Glivec.