Source: Financial Times
16 Jan 2015
India’s patent controller has rejected a patent application from Gilead Sciences for a key compound for its blockbuster hepatitis C drug Sovaldi, a refusal that activists said would allow Indian companies immediately to start producing cheap generic versions of the medicine.
The ruling marks another example of India’s sceptical approach to pharmaceuticals patents a month after Bayer of Germany lost its bid to block a cheap version of its Nexavar cancer drug from being produced in the country.
Gilead’s patent application was challenged by Natco Pharma, a Hyderabad-based generic drugs manufacturer, and a New York non-profit group called Initiative for Medicines, Access & Knowledge.
The patent controller ruled that the active compound in Sovaldi, also known as Sofosbuvir, was not sufficiently different to a previously-known molecule.
Leena Menghaney, a campaigner for Médecins Sans Frontières’ Access to Medicines campaign, said the decision appeared to pave the way for “open competition” for the medicine in the Indian market.
She said its price could drop as low as $1 a pill compared with $1,000 in the US.
While the application for the final form of the drug is still pending in India, lawyers and activists say the rejection of the patent on the base compound significantly increases the likelihood that a patent will be refused for the final compound. However, activists expect Gilead to challenge the rejection, starting a long court battle over the issue.
Sovaldi, which cures hepatitis C within 12 weeks in more than 90 per cent of cases, has become the latest flashpoint for activists campaigning for wider access to low-cost medicines in the developing world.
The drug generated $8.6bn of sales in the first nine months of last year, a record for a new medicine, but its high price has caused controversy in the US as well as overseas.
In September, Gilead signed a licensing agreement with seven leading Indian generics producers to make Sovaldi for 90 developing countries, a move that the US company said would ensure affordable access.
But activists complained that many of the countries with the highest hepatitis C burden were excluded from the arrangement.
Gilead said it would introduce Sovaldi itself to the Indian market at about $300 per bottle, or $900 for a full course, about 1 per cent of the US price.
Ms Menghaney said the Indian patent controllers’ rejection of the application for the base compound of Sovaldi would create a truly free market for the drug in India.
“What Gilead was introducing was managed competition, but now there is going to be open competition with companies other than those who have signed licences with Gilead,” she said.
She added that the plunging price of the drug in India would draw international attention to the low cost of manufacturing the medication, increasing pressure for price cuts elsewhere. Gilead did not respond to requests for comment.
India’s patent controller rejected the application on the grounds that the compound did not fulfil the criteria laid out in Indian patent law. The relevant clause states that any compound derived from a previously known compound can only be patented if it can show a substantial improvement in efficacy.