Big Pharma loses a battle for sofosbuvir patent…
New hepatitis C treatment drug, sofosbuvir, was already patented in numerous countries, including the United States. On 13 January 2015, the Indian Patent Office made a striking decision that can become one of the most prominent ones in modern medical history. A patent application for the new direct-action antiviral drug sofosbuvir – used in a combination as the new hepatitis C treatment – was rejected.
The main reason for rejection is that sofosbuvir lacks novelty or inventive manufacturing steps required under the Indian Patents Act.
How is it possible? Is this decision final?
New hepatitis C treatment at affordable price? Myth or reality?
Final or not, this decision means that new hepatitis C treatment will be soon available – and at price that doesn’t bite, too! – to hepatitis C sufferers in India and poor neighboring countries. Some patients in middle- and high-income countries, where access to treatment is restricted, might also benefit from new affordable hepatitis C treatment in India.
Big Pharma loses a patent… and signs licensing agreements to produce new hepatitis C treatment in India
Gilead, the pharmaceutical company applying for sofosbuvir patent, seems to be prepared for this turn of events. Three months ago, on 15 September 2014, it already signed voluntary license deals with seven Indian generic manufacturers. These deals will allow boosting the production in India by transferring Gilead’s manufacturing process to the licensees in exchange for 7% royalty payment. The generic manufacturers are free to set their own pricing strategy for Indian market. The launch of generic versions of sofosbuvir is expected by the third quarter of 2015.
Gilead was already accused for extortionate prices of new medicines for hepatitis C in the US. At $1,000 per pill, it is highly unlikely that the original version of Sovaldi™ can make it to the Indian market. This smart move with licensed generics will allow Big Pharma getting their share from new hepatitis C treatment in India and securing their revenue coming from the third world – the revenue that otherwise would not have existed at all.