Earlier this month, the Indian Patent Office (IPO) in New Delhi gave its approval to Gilead Sciences Inc, allowing the company to market its treatment against hepatitis C in the country. The drug Sovaldi (sofosubvir) was rejected in January of 2015, based on the opinion that modifications from a previous formulation were only of a minor nature. Following an appeal by Gilead, the IPO has reverted its decision finding the compound to be “novel” and “inventive”
The approval of Sovaldi has been a sensitive case as Gilead’s compound is already licensed to 11 Indian drug producers including major corporations such as Cipla, Hetero Labs Ltd and Aurobindo Pharma Ltd to produce generic versions of the molecule (sofosubvir) to be sold in 101 low and middle income countries.
Various health activists as well the international medical humanitarian group Medecins Sans Frontières (MSF) have explicitly voiced their opposition to such a decision. They claim that retail prices would be unaffordable for a major section of the population, and that the raw materials exported to other countries would become unavailable with regards to production of the drug. Indeed, organisations such as MFS are highly dependent on generic treatment for their operations and activities around the world, calming that the approval of Gilead’s treatment could potentially stop affordable copies of the drug being made.
In 2013, the US Food and Drug Administration (USFDA) approved the use of Sovaldi which is sold at a price of 1,000 dollars per pill. Countries such as Pakistan, South Africa, Uganda, Nigeria and the European Commission have also approved the molecule, and it is yet unknown how much Gilead will charge for its treatment on the Indian sub-continent.
The use of Sovaldi remains disputed in many countries. In Brazil and Thailand, official patent offices have given market approval, but various groups have filed oppositions. Resistance has also been observed in Argentina, Russia and countries in the European Union. As of today, China, Ukraine and Egypt have not yet approved Gilead’s drug.