But groups such as Doctors Without Borders say the agreement with the Medicines Patent Pool excludes key manufacturing countries.
Merck and theMedicines Patent Pool have signed a voluntary licensing agreement to facilitate affordable global access for the investigational oral antiviral COVID-19 medicine molnupiravir.
The agreement will help create broad access for molnupiravir use in 105 low- and middle-income countries following regulatory approvals for the antiviral treatment of mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization, Merck said in a news release.
Molnupiravir was invented at Emory University and licensed to Ridgeback Biotherapeutics by Drug Innovation Ventures at Emory. It is being develop by Merck in collaboration with Ridgeback.
As part of the agreement with the Medicines Patent Pool, Merck, Ridgeback, and Emory will not receive royalties on the sale of molnupiravir for as long as COVID-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization.
But the agreement doesn’t go far enough, Doctors Without Borders (DWB)/Médecins Sans Frontières (MSF) said in a news release. The license excludes “key upper-middle-income countries like Brazil and China from its territory, where there is strong, established capacity to produce and supply antiviral medicines,” Yuanqiong Hu, senior legal and policy advisor for MSF’s Access Campaign, said in a statement.
Middle-income countries excluded from the license had 30 million COVID-19 infections — 50% of all infections in low- and middle-income countries — in the first half of 2021, Hu added
In addition, the license contains an “unacceptable clause undermining the rights to challenge patents on molnupiravir,” Hu said. "This provision, put forth by molnupiravir’s original patent holder Emory University, could stifle the production and supply of more affordable and available generic molnupiravir.”
In addition, the provision could be considered unlawful in some jurisdictions for its anti-competitive effects, according to Hu.
MPP, through the license granted by Merck, will be permitted to further license non-exclusive sublicenses to manufacturers and diversify the manufacturing base for the supply of quality-assured or WHO-prequalified molnupiravir to countries covered by the MPP License, subject to local regulatory authorization, Merck said.
The FDA is reviewing molnupiravir for emergency use authorization (EUA). If approved, it would be the first oral treatment for COVID-19.
“The interim results for molnupiravir are compelling and we see this oral treatment candidate as a potentially important tool to help address the current health crisis,” said Charles Gore, executive director of MPP. “This transparent, public health-driven agreement is MPP’s first voluntary license for a COVID-19 medical technology, and we hope that Merck’s agreement with MPP will be a strong encouragement to others.”