Mumbai: In what could be a major setback to access to treatment in high-burden countries, the Indian Patent Office on Monday granted a patent to Gilead Pharmasset on Sovaldi (sofosbuvir), its blockbuster drug for hepatitis C, for which the company charges $1,000 per pill in the US.
Several patient groups - Sankalp Rehabilitation Trust, I-MAK and Delhi Network of Positive People - and generic companies (Optimus, BDR Pharma and India Cares) had opposed US-based Gilead's application to obtain a patent in the country, arguing that sofosbuvir was "old science," not novel and did not meet the standard needed for patenting in India.
In India, the price of the treatment will not increase due to enough competition in the market, experts say, but domestic pharma companies - those planning to export the key raw material (API) or planning to launch the drug here - will be hit.
Gilead has already entered into licensing deals with Indian companies, so generic versions of the drug are available for as little as $335 per 12-week treatment. However, the order will block a sustainable supply of key raw materials (APIs) for producing the drug in countries like Egypt, Bangladesh and Pakistan, affecting supply of affordable drugs particularly in those 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 a reduction in prices in the future.
Gilead's sofosbuvir (sovaldi) is one of the most exorbitantly priced medicines at $1,000 per pill ($84,000 for a 12-week treatment) in the US, and has charged similarly high prices across developed countries.
Dismissing all pre-grant oppositions, 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."
When contacted, senior counsel Prathiba M Singh representing Gilead said the order shows that section 3 (d) does not act as a bar for grant of patents, provided proper efficacy data is submitted.
Says Loon Gangte, Delhi Network of Positive People, who was opposing the patent: "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. "
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