“We are relieved that the Delhi High Court is allowing I-MAK and DNP+ an opportunity to be heard on the legality of the decision granting the base compound patent to the US Company Gilead Sciences. The patent just granted this week (9th May) by India’s patent office was initially rejected in January 2015, just before President Obama’s visit to India, which was seen as vexing the US.
While Gilead has signed licences with multiple generic manufacturers in India to produce the drug and sell it in the world’s poorest countries, these producers are prohibited from selling more affordable versions of sofosbuvir to many middle-income countries, where approximately 50 million people with hepatitis C live. This is leaving patients in these countries – including our treatment projects - vulnerable to the high prices Gilead chooses to charge.
In addition, India’s decision to reverse the patent rejection of 2015 to an order for grant on the base compound of sofosbuvir this week has provided the US pharma giant Gilead with the tools to disrupt and stop future exports of key raw materials needed to produce the drug to countries like Egypt, Bangladesh, Pakistan and even Latin America, giving it significant control on the supply of key raw materials globally”.
Leena Menghaney, South Asia Head, MSF Access Campaign
There are 150 million people living with the virus and burden of the disease increasing with people left to suffer from symptoms of untreated Hepatitis C such as cirrhosis, liver failure and cancer.
The first approvals by the EMA and the USFDA of a new generation of HCV medicines known as direct-acting antivirals (DAAs) started with sofosbuvir in 2013. The exorbitant price tags of $84,000 price tag per 12-week treatment course with sofosbuvir in the United States and $47,000 in European countries like France gave worldwide recognition to the out of control spiralling costs of patented medicines. Gilead has earned more than $15.5 billion in sales from the drug over 2014 and 2015 alone.
Generic companies in high burden countries like Egypt and India have developed and started to market low cost DAAs and are key sources of quality generics.
Gilead Sciences has been seeking patents for the hepatitis C drug sofosbuvir in many developing countries among them India and Egypt. The Egyptian patent office found after a technical examination of the sofosbuvir compound that it is not novel chemically, and therefore does not fulfill the criteria of novelty and inventiveness, both of which are necessary for a pharmaceutical compound to be patented.
The patent applications in India have been challenged by groups of people living with hepatitis C and HIV through ‘pre-grant oppositions.
Last year, Mr. Hardev Karar, Deputy Controller of Patents rejected Gilead’s the compound patent claims, ruling that “there are a number of earlier compound structures that are very close to what Gilead is trying to get a patent for”. Gilead managed to get the patent claims resent for examination to the Delhi Patent Office on the ground that there were issues with the process that was followed. Now another official of the same patent office the Deputy Patent Controller of the Delhi Patent Office, Dr. Rajesh Dixit has granted the patent.
Patents for sofosbuvir have been rejected in Egypt, China and Ukraine, and further patent oppositions have been filed in Argentina, Brazil, Russia, Thailand and the EU. Another key application on the prodrug of sofosbuvir is pending before the Kolkata patent office in India, and several oppositions to its grant have been filed by patient and public interest groups.