Natco's baby step may pave the way for a giant leap of sorts, where many more drug patents are subjected to this “stick” to help bring down highly excessive prices for a country like India, says Mr Shamnad Basheer, an intellectual property expert.
He was commenting on the grant of the country's first ever compulsory license by the Patent Office to Natco, allowing it to make Bayer's advanced kidney cancer drug Nexavar. Natco would have to pay Bayer a royalty of six per cent on the net sales of the drug every three months.
“Given that more than 90 per cent of MNC drugs are imported , this order may pave the way for wholesale compulsory licenses to be issued against a wide spectrum of drugs in the near future. This interpretation of “working” to mean “local working” (local manufacture within India) may in fact prove the most controversial part of the order and may perhaps attract a TRIPS challenge as well,” he pointed out.
Health advocacy groups and humanitarian organisations also lauded the judgement.
“We have been following this case closely because newer drugs to treat HIV are patented in India, and as a result are priced out of reach,” said Dr Tido von Schoen-Angerer, Director of the Médecins Sans Frontières (MSF) Access Campaign. “But this decision marks a precedent that offers hope: It shows that new drugs under patent can also be produced by generic makers at a fraction of the price, while royalties are paid to the patent holder. This compensates patent holders while at the same time ensuring that competition can bring down prices.”
OPPI downbeat
But expressing disappointment with the judgement, Mr Ranjit Shahani, President of the Organisation of Pharmaceutical Producers of India, said that the issue of compulsory licenses should be used only in exceptional circumstances.
“The poor in developing countries like India will suffer needlessly until a wide variety of issues such as lack of diagnosis, healthcare infrastructure and distribution are solved. Existence of trained healthcare staff and infrastructure, cultural acceptability of treatment, accessibility of healthcare facilities and quality of care all play a role in making medicines available,” he added. The OPPI is a platform largely for foreign drug makers.