Gilead Sciences office (REUTERS/Stephen Lam/File Photo)
Gilead Sciences’ exclusivity over remdesivir may face compulsory licensing (CL) if the company is unable to keep up production with demand. The company currently has a 15-year patent on remdesivir – which is a under trial, potential drug for treatment of COVID-19.
If the drug is successful, it could bring big profits for the company worldwide, but attorneys say this would be subject to Gilead scaling production up to demand – regardless of the patents, said a report by Bloomberg.
The company has already secured three patents and has an unknown number of patent applications for remdesivir pending. Additionally, a 5-year exclusivity from the United States Food and Drug Administration (US FDA) if the drug is successful.
“This is an emergency use drug, so the federal government will certainly want to make this drug available to everyone who needs it… Gilead would be very vulnerable to licensure if it can’t ramp up production,” Steven Roth, a partner and intellectual property attorney with Lucas & Mercanti, LLP in New York said as per the report.
“March-in” rights provisions government to seize patents for inventions created with government funding and license them to other entities. This has so far never been invoked.
CL meanwhile applies even on drugs not funded by the government, but ensures the administration pay the patent holder royalties. On previous occasions, threat of CL caused Bayer AG to lower prices for anthrax after the 9/11 attacks.
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Besides availability, the company is also facing pressure from the public and Democrats to price the drug affordably, and make public supply chain plans.
The company received emergency use authorisation from the US FDA and White House on May 1, and clinical trials are on to test the success of the drug in treating COVID-19 patients.
Gilead did not respond to queries on the matter, as per the report.
Some others however believe Gilead may work out its own licensing deals before being forced into CL by the government.
Not many are worried about profitability, as analysts say that even if that while Gilead said it has spent $1 billion this year on remdesivir, if treatment is priced at $4,500 the company would easily recover $2 billion in revenues.Follow our full COVID-19 coverage here