Gilead’s $1000 Hepatitis C pill Sovaldi (Sofosbuvir) gets a patent in India

Gilead’s $1000 Hepatitis C pill Sovaldi (Sofosbuvir) has received a patent in India.The Indian patent Office granted Gilead this patent on Monday. What is interesting however is the fact that the price of treatment will not increase as there is enough competition in the market; though domestic pharma companies wanting to export the key raw material (API) or planning to launch the drug in india will be hit.

A number of patient groups like Sankalp Rehabilitation Trust, I-MAK and Delhi Network of Positive People -and generic companies (Optimus, BDR Pharma and India Cares) had opposed Gilead's application for a patent in India; stating that the medicine did not meet standards for patenting in India, as it was “old Science.”

Generic versions of the drug are available at $335 for every 12 week treatment, as Gilead is already into licensing deals with Indian companies. However, supply of key raw materials (APIs) for producing the drug in countries like Egypt, Bangladesh and Pakistan would be blocked, affecting supply of affordable drugs particularly in the stated countries.

"It will also impact those domestic companies which were planning to enter the market independently to supply not just patients in India but also high-burden middle income countries that were not covered by the voluntary license," Leena Menghaney , lawyer and manager of MSF's Access Campaign in India, told TOI.
The entry of generic versions would have led to drug prices being reduced in the future.

Priced exorbitantly at $1000 per pill ($84,000 for a 12week treatment) Gilead's sofosbuvir (sovaldi) a US based medicine is being sold at an equally high price across developed countries.

Having dismissed all opposition raised to grants the Patent Controller said in his order: "I find claimed compounds are novel, inventive and patentable under Patents Act. Accordingly , the instant application is allowed to proceed for grant with finally amended claims 1 to 8 as filed on 29th April, 2016 by the applicant."

Senior counsel Prathiba M Singh representing Gilead said, the order explained that section 3 (d) does not act as a bar for grant of patents, provided proper efficacy data was submitted.

Loon Gangte, Delhi Network of Positive People, opposing the patent said, "This decision proves that there is no sovereignty in the Indian patent system anymore. These are very scary times for the patient communities globally who rely on affordable generic medicines coming from India. "