The US has raised fresh concerns about compulsory licences issued by India to local drug companies for producing copies of life-saving patented medicines without the patent-holder’s consent. But India maintains it has not broken any rules.
A second round of compulsory licences being considered by India for anti-cancer medicines produced by US-based Bristol Myers Squibb and Swiss company Roche has global pharmaceutical companies worried about the safety of their patents in India, a US government official has said.
US Under Secretary of State for Economic Growth, Energy and Environment Robert Hormats, at a meeting with Commerce and Industry Minister Anand Sharma on Wednesday, said patent owners needed to be reassured that their rights would be respected in India, a Commerce Department official told
Sharma pointed out to Hormats that India had not violated TRIPS, the international agreement on intellectual property rights, as flexibility to issue compulsory licences was part of the agreement.
“The Minister told the US official that the right to issue compulsory licence was something that India had negotiated for in the TRIPS Agreement. The licences were being considered only for life-saving medicines that were unaffordable by the common person,” the official said. The first compulsory licence issued by India was to Hyderabad-based Natco for selling generic, or copied, version of Bayer's anti-cancer drug Nexaver last year.
This had also led to protests from developed countries, including the US. Natco was allowed by the Indian Patent Office to sell the copied version of Nexaver at Rs 8,800 for a month’s treatment compared to Bayer’s price of Rs 2.8 lakh. The Government is now examining a proposal for issuing compulsory licences to three more anti-cancer drugs — Trastuzumab, Ixabepilone and Dasatinib.
‘Not an executive order’
Sharma clarified that in India the decision to grant a compulsory licence was an adjudicated process and not an executive order.
The TRIPS Agreement allows governments to issue compulsory licence to domestic industry to produce a patented product/process without the consent of the patent owner to address public health concerns.
The compulsory licence can be issued only three years after a patent has been granted, and a royalty has to be paid to the patent-holder by the producer based on rates fixed by the government.
Brazil and Thailand are among other developing countries that have issued compulsory licences for medicines to cure life-threatening diseases such as AIDS and cancer.