Building upon a case study of the Medicines Patent Pool, this blogpost aims to set the Medicines Patent Pool/Merck License for Molnupiravir in a processual context.

About the License Agreement

Recently, on October 27, 2021, the Merck & Co., Inc. Kenilworth NJ USA (MSD) and the Medicines Patent Pool (MPP) jointly announced the signing of a license agreement for Molnupiravir. Molnupiravir is an “an investigational oral antiviral medicine“ against Covid-19 that has shown promising results in Phase 3 clinical trials. The drug is currently under review by the European Medicines Agency (EMA). The voluntary license and technology transfer agreement for Molunpiravir allows generic manufacturers from anywhere in the world to produce the drug and supply it to 105 low-and middle income countries (the “territory”). Manufacturers can license royalty free for the time of the pandemic

While the medical non-governmental organization Médecins Sans Frontières (MSF) criticizes the agreement for excluding “half of the world’s population and important upper-middle-income countries (UMICs) with robust manufacturing capacity, such as Brazil and China”, other medicine policy experts such as James Love or Peter Maybarduk celebrate the agreement as an “impressive achievement” or a “starting point and an example” to increasing access to Covid-19 therapies in LMICs. James Love commented that the “licensed area is large enough (more than half the world’s population) to induce efficient generic entry and economies of scale”. 

To understand the impacts of this license agreement, we take a closer look on the patent pool mechanism that is leveraged here. 

About the Medicines Patent Pool 

The Medicines Patent Pool is an UN-backed public health organization that assembles a variety of stakeholders: patent holders, generic manufacturers, universities, patient groups, NGOs and a facilitating organization called the Medicines Patent Pool Foundation (MPPF). Founded in 2010 as a response to the HIV-crisis in developing countries, it expanded its mandate over the years and now addresses public health challenges such as tuberculosis, hepatitis C, or Covid-19. Its aim is to “reduce patent thicket problems” through a “non-profit voluntary licensing mechanism” that is leveraged to increase access to medical treatments and technologies and foster innovation in LMICs. The MPPF functions as a clearinghouse to enable this mechanism. After prioritizing certain fields of action, MPPF’s main tasks are to negotiate licenses with volunteering patent holders and sub-license them to “multiple generic manufacturers”. Building upon these licenses, sub-licensees “develop the licensed medicine, including new formulations and combinations”.

Analyzing the openly accessible licenses and the press releases on MPP’s website, we see that the MPP has been continuously growing over the past 10 years. By now, 19 products are sub-licensable. Following MPP’s annual report 2020, 23 product developers and generic manufacturers are engaged in using them. When looking at the decision process that leads to a sublicense, we see that it is highly collaborative. Not one of the sublicenses would come into being without other stakeholders’ decisions in advance:

As a facilitating organization, the MPPF is often involved in this decision process but also depends on other stakeholders to get the MPP running. Similar to sub-licensing, mandate expansions – such as the one that was announced as a response to the Covid-19 outbreak – play a crucial role for MPP’s growth. They motivate already engaged patent holders to share additional patents of other disease contexts, invite new patent holders to join, and encourage new generic manufacturers or long-time sub-licensees to expand their product portfolio. A mandate expansion always requires a feasibility study by multiple stakeholders (universities, pharmaceutical companies, intergovernmental organizations) who contribute to assess whether the MPPF is capable to handle additional tasks and negotiations linked to an expansion. 

The Role of Time for Establishing the MPP

Accordingly, the MPP is a collaborative effort that more than 30 organizations brought into life over the past decade. MPP’s secret sauce for operating the patent pooling mechanism is not a single foundation but rather the mutually created trust that builds upon years of mutually positive experiences for its various stakeholders. Achieving this trust requires probably one resource that is particularly scarce during a pandemic: time. 

Building upon an established mechanism, the MPP/MSD deal provides hope for real impact for LMICs to fight the pandemic. As other license agreements in the past, too, it could further be a precedent for other patent holders to follow with voluntary and royalty-free licenses. At the same time, the case of the MPP provides strong evidence that institutions particularly effective in fighting an imminent rely on building upon and adapting mechanisms established prior to the health crisis. This might be one reason, why we don’t have open source vaccines in the current pandemic: the necessary organizational frameworks for such an approach have not been established and it is very hard to establish them during an already raging pandemic.