Gilead Sciences, Inc. (NASDAQ:GILD) faced a setback in India when the Patent Office rejected its patent application for blockbuster Hepatitis C drug, Sovaldi. This created the opportunity for local pharmaceuticals to launch generic versions of the drug at a lower price; Sovaldi costs $1,000 per pill.
The application was opposed by Indian drug-maker Natco Pharma Ltd, and New York-based NGO Initiative for Medicines, Access & Knowledge (I-MAK), which claimed that Sovaldi (sofosbuvir) did not have any significant differences from an earlier version of the drug developed by another company, according to the documents issued by the Indian Patent Office. Under the Indian patent regulatory system, a third party is allowed to raise a claim against a patent application pending at the Patent Office.
The Patent Office justified the rejection of the patent by claiming that the minute modifications in the drug’s molecules did not make it significantly better than the earlier drug, and that it did not demonstrate improved efficacy either. Gilead’s spokesmen did not comment on the matter.
Sovaldi, Gilead’s blockbuster drug, was approved by the US Food and Drug Administration (FDA) in December 2013. It generated $8.5 billion in revenues for the company in the first three quarters of 2014. The drug costs $84,000 for a 12-week course in the US.
Gilead offered to market Sovaldi in India in August 2014 at a highly discounted price of $900 for the 12-week treatment, as it signed license agreements for the drug with seven India-based pharmaceuticals last year. The discounted price is even cheaper than the currently available Hepatitis C treatments in India, which cost about $6,000 and have adverse side-effects.
However, the much lower price tag for the Indian market also faced criticism, as there had been a growing uproar by doctors and campaigners regarding the highly expensive treatments for the disease. These doctors and campaigners have been trying to make the treatments available at affordable prices in developing countries, which lack proper health insurance infrastructure. The major chunk of the population of developing countries lives below the poverty line, making expensive drugs unaffordable for most of the affected patients.
Gilead’s patent rejection comes as positive news for the Indian pharmaceutical industry, which is known as the hub for generic drug production. It creates the opportunity for Indian drug makers to develop cheaper versions of the Hepatitis C treatments for the 12 million people affected by the deadly virus in the country, according to estimates by the World Health Organization (WHO).
Sovaldi is not the first drug rejected by the Indian Patent Office; several companies have been facing patent issues due to Indian pharmaceuticals filing against them. According to a report compiled by the US International Trade Commission, 28% of pharmaceutical companies feel that India fails to provide adequate protection for patents and intellectual property.
India has been facing pressure from the US government to modify its patent policies, but foreign companies have continued to face patent rejections.