The Indian Patent Office has granted a patent to Gilea Sciences Inc. (NASDAQ:GILD) for Sovaldi (sofosbuvir), its drug for treating hepatitis C.
Many patient groups – Delhi Network of Positive People, I-MAK and Sankalp Rehabilitation Trust as well as generic companies (India Cares, BDR Pharma and Optimus) were against America-based Gilead’s attempt to get a patent in the nation. They argued that the drug was old technology, not unique and did not fulfill the standard required for patenting in India.
In India, the cost of the treatment will not rise due to intense market competition. However domestic pharma organizations – those intending to export the key raw material or planning to debut the drug in India will be affected.
Gilead already has licensing deals in place with Indian companies. Hence generic versions of the molecule are obtainable at a relatively low rate of $335 for a 12 week course of treatment.
However, the order will stop an affordable supply of key raw materials for manufacturing the drug in nations such as Pakistan, Bangladesh and Egypt. This will adversely affect the availability of affordable medicines especially in those nations.
Lawyer and manager of Médecins Sans Frontières’ Access Campaign in India, Leena Menghaney said that the order will hit the domestic companies intending to have an independent presence in the market to bring the drug not just to Indian patients but also to middle income nations that were not covered by the patent.
Gilead’s Sovaldi is among the most expensive drugs at $1000 a pill in America. This works out to be $84,000 for a treatment course of 12 weeks. The drug is also priced very highly in other developed nations.
The drug was turned down for a patent by the Indian patent authority early last year. The reason was the patent office determined that it had just minor changes to an earlier formulation and the organization already had licensing agreements with producers in India.
After Gilead appealed the order, the New Delhi based Indian Patent Office accepted its application for the medicine stating that the molecule was novel as well as inventive.
