UPDATE: Gilead announced on Friday that the company would appeal the Indian Patent Office's decision to reject patent protection for Sovaldi. The rejection came as multiple India-based companies, including Natco Pharma and the NGO Delhi Network of Positive People, staked out opposition to the patent claim.
"Gilead strongly defends its intellectual property," said Gilead's EVP of Corporate Medical Affairs in a statement announcing the appeal. "The company will be appealing the decision as well as exploring additional procedural options."
- The Indian patent office has rejected Gilead's application for a patent for Sovaldi (sofosbuvir), with the explanation that Sovaldi does not offer significant improvement over other existing compounds.
- Many drug makers are convinced that India does not offer sufficient patent protection and this case only amplifies that contention.
- On the other side, many groups, such as Doctors Without Borders, are celebrating the decision as a win for poor patients who can neither afford nor access Sovaldi. The drug costs $1,000 per pill in the US, with a total cost of $84,000. These groups hope that the onslaught of generic treatment options, which is almost guaranteed, will provide much cheaper alternatives to branded Sovaldi.
While 28% of surveyed drug-makers feel that India does not offer sufficient patent protection for branded pharmaceuticals, India contends that a lack of true innovation should not be rewarded with a patent. The decision comes as a surprise, however, because Gilead signed an agreement with seven India-based generics manufacturers in fall 2014 to sell cheaper versions of Sovaldi in 91 countries. Nonetheless, Gilead has not been able to control the outcome of this decision, which represents a form of protest against what many feel is an unsustainable cost.