Gilead’s Sovaldi gets Indian patent; critics call it “major blow” to patient access

pharmafile | May 11, 2016 | News story | Manufacturing and Production, Research and Development, Sales and Marketing India, harm, hepatitis, patent, patient access, sovaldi 

Gilead has been granted a patent for its hepatitis C drug, Sovaldi (sofosbuvir), in India which has sparked dismay among patient groups and NGOs in the region.

The drug effectively “cures” patients of the hepatitis C virus in over 90% of patients, but has been criticised in some quarters due to its high cost. Costing up to $1,000 per pill, a 12-week regimen of the drug lists for $84,000 in the US. According to the World Health Organisation, 150 million people globally have been infected with the liver-destroying hepatitis C virus.

Sovaldi was originally rejected for patent approval in January 2015. The Indian authorities indicated that it only represented a minor change from a previous formulation, and the company already had licensing deals with manufacturers in India.

Despite the original dismissal, the patent office upheld Gilead’s appeal, saying that the “claimed compounds are novel, inventive and patentable under Patents Act.”

The decision, however, has not been welcomed in many quarters, with critics claiming that the patent will harm patient access.

Leena Menghaney, the head of Médecins Sans Frontières in South Asia, says: “This decision is a major blow to the access to drug movement. There has been excessive pressure building on the Indian government to dilute the independent functioning of the patent office to ensure that patent claims are granted far more easily to US firms.

“In the process, the patent office has completely ignored recent proceedings in the US, against Gilead regarding the same application which have been found to infringe two of Merck’s (MSD) patents, clearly defeating Gilead’s claim that its application on the drug was novel.”

The case referred to above cast serious doubts on Gilead’s dominance in the market, when a judge ruled in favour of MSD and Ionis Pharmaceuticals which granted them the rights to claim royalties from Gilead’s global sales of both Harvoni and Sovaldi. Similarly, MSD’s competing drug, Zepatier, was claimed to have outperformed Sovaldi in late stage trials.

Menghaney adds: “This decision will not stop those Indian generics companies [that] were planning to enter the market independently from supplying not just patients in India but also those in middle-income countries with large numbers of people living with hepatitis C, which Gilead currently forbids from receiving sofosbuvir produced under Gilead’s licensing deal.”

The Initiative for Medicines, Access & Knowledge echoes these sentiments, stating: “Like unmerited patents, these schemes manipulate the market, violate patients’ rights and block millions of people from getting the medicines they need.”

Gilead indicates that through its voluntary licensing program and its partnership with Indian manufacturers, it enables access to medicines for as many as possible, as quickly as possible. It adds that eight of its licensees have launched sales of the drug in India in their effort to ensure these vital drugs reach “resource-challenged countries”.

Sean Murray

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