Last week the country’s patent officer awarded a compulsory licence to Natco, a domestic manufacturer, over a cancer-treating drug patented by Bayer. The decision was welcomed by patient groups but has made originator pharmaceutical companies nervous.
Dilip Shah spent the first half of his career with Pfizer India. Now he is secretary-general of the Indian Pharmaceutical Alliance, part of the International Generic Pharmaceutical Alliance.
He told Managing IP that since almost 90% of the sales of originator drugs companies are in North America, Europe and Japan, the Bayer decision will have few financial implications for them.
“If they don’t make money for R&D from developing countries, we don’t see any impact on their R&D budget,” he said.
Shah added that generic drugs companies have been waiting to file applications for a compulsory licence under section 84 of the Patent Act and that more will be filed, even if – as many expect – the Bayer decision is appealed up to the Supreme Court.
“There will be a couple more, but I can’t disclose the product or name of company. This is only the beginning. The new applications will not be dependent on the outcome of the Bayer case.”
When India began to protect pharmaceutical products in 2005, many IP professionals predicted a new era for Indian drug makers: that its powerful generic players would be incentivised to invent and that the cultural gap with foreign originator companies would shrink.
But the decision in the Bayer case serves as a reminder that political and cultural concerns about the availability of medicines and the morality of patenting pharmaceuticals are still very much alive in India.
The reaction to the decision from originator companies appears coordinated but restrained – after all, few pharmaceutical companies want to be regarded as unsympathetic to the health needs of the poor. Novartis, for example, which is fighting to patent the active ingredient in its anti-cancer drug Glivec in India, is already receiving plenty of criticism from patent activists and patients.
The Association of the British Pharmaceutical Industry referred Managing IP to a statement issued by Swiss-based industry group IFPMA, the tone and wording of which is similar to that provided by OPPI (the Organisation of Pharmaceutical Producers of India), whose members include Merck, Pfizer and Novartis.
Both acknowledge the right of developing countries to use flexibilities in the law, but say that compulsory licensing should be used as a last resort.
They also emphasise the chilling effect such use of compulsory licences could have on research and development.
“If compulsory licences are routinely issued in the absence of a public health emergency the impact will be to dramatically discourage investment in new medicine for patients and halt medical progress for the millions worldwide suffering from diseases without adequate or without any effective treatments,” said Ranjit Shahani, president of OPPI.
