US biopharmaceutical firm Gilead Sciences on Wednesday said it is currently in negotiations with “several” generic drugmakers in India for voluntary licence to manufacture antiviral drug ‘remdesivir’ potentially for COVID-19 treatment in developing countries. However, patient groups have raised issues with this, either seeking that Gilead’s patent for the drug be revoked in India or claiming the model is problematic and might block access for patients in other countries.
Remdesivir, an investigational antiviral drug earlier tested by Gilead for ebola, has now shown some promise as a potential therapy for patients infected with the novel coronavirus. While the drug is still undergoing clinical trials, some countries like the US have given emergency approval to use the drug for their critical COVID-19 patients. As part of its strategies to accelerate and maximise access to the drug, Gilead said in a release that it is negotiating “long-term voluntary licenses with several generic drugmakers in India and Pakistan” to produce it for developing countries.
“Gilead will provide appropriate technology transfers to facilitate this production,” it said. The company is also in “active discussions” with the Medicines Patent Pool to license remdesivir for developing countries.
It is unclear what stage the talks between Gilead and Indian generic firms are at, and which firms have been narrowed down for an agreement. In response to emailed queries, Gilead said the negotiations were ongoing and more information would be provided when it is available.
Companies involved in these discussions include Dr Reddy’s Laboratories (DRL) and Cipla Ltd, industry sources said on condition of anonymity. A DRL spokesperson said the company does not comment on market speculations, while Cipla declined to comment “at this point in time”.
“Right now, Gilead is assessing the capabilities of those who can make the drug here … it’s a difficult molecule to make,” said an industry source.
Meanwhile, the Cancer Patients Aid Association (CPAA) on Wednesday wrote to DPIIT Secretary Guruprasad Mohapatra seeking that one of the patents granted to Gilead for remdesivir in February 2020 be revoked.
“The drug, remdesivir, may be useful in treatment of coronavirus and should be made available to all those who need it. We state that the patent/monopoly rights were wrongly granted and the patent should be revoked on grounds of public interest and on grounds of lack of novelty and inventive step,” stated CPAA chairman YK Sapru in an email.
Patient access group Médecins Sans Frontières (MSF) feels there isn’t sufficient data in the public domain to ascertain how effective remdesivir is in COVID-19 treatment. “In the context of public health, especially during a pandemic, voluntary licences are very limited. We’ve seen countries like Malaysia, Ukraine and Brazil get excluded in the past due to such licences,” said Leena Menghaney, Regional Head (South Asia) at the MSF Access Campaign.
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