License between Merck and Medicines Patent Pool for global production of promising new COVID-19 drug molnupiravir disappoints in its access limitations

First-ever voluntary license to patent pool in the pandemic does not go far enough, excluding key manufacturing countries and containing harmful clause that prolongs status quo

27 October 2021– Today US pharmaceutical corporation Merck announced a voluntary license agreement with the UN-backed Medicines Patent Pool (MPP), granting MPP permission to sublicense the new oral COVID-19 treatment molnupiravir* to manufacturers in multiple countries to supply in 105 low- and middle-income countries (LMICs). While it comes as the first fully transparent voluntary license covering COVID19 medical tool on a royalty-free basis, Médecins Sans Frontières/Doctors Without Borders (MSF) expressed disappointment with the limitations of this license, as its territory excludes nearly half of the world population and important upper-middle-income countries (UMICs) with robust manufacturing capacity, such as in Brazil and China, and contains a harmful provision undermining the right of generic companies who sign the license to challenge patents to facilitate generic-drug production.

Yuanqiong Hu, Senior Legal and Policy Advisor, MSF Access Campaign:

“After more than a year of secrecy of companies’ bilateral deals in a pandemic, it is a welcomed step forward to have the first fully published voluntary license from MPP covering COVID19 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 are 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% 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 monopolised.

“Since the start of the pandemic we’ve been saying 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 theTRIPS 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; and 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’. 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.”

 

*Molnupiravir is an antiviral treatment currently under review for US Food and Drug Administration (FDA) Emergency Use Authorization. If approved, it would be the first oral treatment for COVID-19 and could be a major advance in treating COVID-19 patients in resource-limited settings, where billions of people remain unvaccinated and vulnerable to the disease. But multiple access barriers loom for this promising drug.

**The MPPs Expert Advisory Group and the Board have both criticized the inclusion of the termination for challenge clause put forward by Merck’s upstream licensor, Emory University. MPP’s Board resolution on this license recommends MPP to work further with the contracting parties to remove this harmful clause.  

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Shailly Gupta

Ph: +41-79 203 13 02