First-ever voluntary license to patent pool in the pandemic excludes key manufacturing countries and contains harmful clause that prolongs status quo
NEW YORK, OCTOBER 27, 2021—US-based pharmaceutical corporation Merck announced today a voluntary license agreement with the UN-backed Medicines Patent Pool (MPP). The agreement grants MPP permission to sublicense the new oral antiviral COVID-19 treatment molnupiravir to manufacturers in multiple countries to supply people in 105 low- and middle-income countries (LMICs) with the medicine.
While it is the first fully transparent voluntary license covering a COVID-19 medical tool on a royalty-free basis, Doctors Without Borders/Médecins Sans Frontières (MSF) is disappointed with the limitations of the license, as well as a harmful provision that undermines the right of generic companies that sign the license to challenge patents to facilitate generic drug production.
Molnupiravir is currently under review for US Food and Drug Administration Emergency Use Authorization. If approved, it would be the first oral treatment for COVID-19 and could be a major advance in treating patients in resource-limited settings, where billions of people remain unvaccinated and vulnerable to the disease.
Yuanqiong Hu, senior legal and policy advisor for MSF’s Access Campaign, said of the announcement:
“After more than a year of secrecy around companies’ bilateral deals in a pandemic, it is a welcome step forward to have the first fully published voluntary license from MPP covering a COVID-19 medical tool.
“However, a closer look reveals its limitations for increasing access to one of the first promising antiviral drugs for COVID-19. It’s disappointing. 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. As per an estimate, middle-income countries excluded from the license had 30 million COVID-19 infections in the first half of 2021, 50 percent of all infections in low- and middle-income countries.
“Furthermore, the license contains an unacceptable clause undermining the rights to challenge patents on molnupiravir. 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. The provision could be considered unlawful in some jurisdictions for its anti-competitive effects.
“This clause is especially egregious given the fact that Emory University’s development of molnupiravir was heavily funded by the US government. Yet the rights to the medicine went to the pharma companies Merck and Ridgeback. This is yet another terrible example of publicly funded research and development for COVID-19 being privately monopolized.
“Since the start of the pandemic, we’ve said we can’t rely on limited voluntary measures by the pharma industry. Molnupiravir is a case in point. It illustrates the urgent need to adopt the TRIPS waiver, which could empower countries to rapidly lift the main intellectual property barriers, including patents, for all COVID-19 medicines, as well as vaccines and tests. It also highlights the importance of countries being able to use all available legal options at the same time to address access challenges.
“This new voluntary license continues pharma’s ‘business as usual’ approach. We call on Merck to grant global licensing to molnupiravir with no territorial restrictions and for Emory University to withdraw its patent claims globally. Additionally, MPP and all parties involved in this license negotiation, particularly Emory University, must remove the harmful clause undermining the legal rights of challenging patents to increase the drug’s access for people. Doing so will greatly help change the deadly status quo still seen in this pandemic.”
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