Medicinal Patent Pools, an Idea Whose Time has Come
“If we can do this for war, why can’t we do this for HIV/AIDS?” (And COVID-19, subsequently) –
James Love, 2002 AIDS Conference
Introduction
In late 2021, Merck and Pfizer entered to license agreements with the Medicines Patent Pool for Molnupiravir,
Nirmatrelvir and Paxlovid respectively. In both these cases, the drugs were licensed even before they were launched.
Further, the deal with Pfizer includes nearly 35 companies from 12 countries to produce generic life-saving drugs.
As of March 2022, 27 generic manufactures have signed agreements with MPP to produce generic versions of
patented COVID-19 antiviral medicine molnupiravir and 35 to produce oral COVID-19 treatment nirmatrelvir in
combination with ritonavir. These sublicenses will enable an increase in the supply of the medicines in 105 low-
and middle-income countries (LMIC). Moreover, as per the survey (updated on January 10,2023) conducted by Our
World in Data, nearly 800 million people in the world have opted for Pfizer and have been administered its COVID-
19 vaccination. Pfizer’s increasing popularity in the world in consonance with the recent deal with MPP is evidence
enough to call for the use of patent commons through the Medicinal Patent Pool. These licenses are pertinent to
achieve the mandate of not only the global production of vaccines but also access to and equitable dissemination of
the same, during the pandemic and beyond.
What are MPPs and How do they Work?
The Medicinal Patent Pool was first established in the year 2010 by the United Nations as a response to the
HIV/AIDS health crises. With the financial aid provided by the global health organisation UNITAID, the MPP
slowly expanded its scope to cover fatal diseases like tuberculosis, hepatitis-C, and now COVID-19 as well. The
MPP negotiates licenses between the originator firms and generic pharmaceutical firms to produce patented
medicines at affordable prices. It is a voluntary licensing and patent pooling mechanism with a mandate to accelerate
access to affordable, appropriate and quality-assured treatments and drugs in developing and least developing
countries.
The figure below shows the working of the MPP –
Source: Multidisciplinary Pharmaceutical Research for Improving Access to Essential Medicines.
Backed by a Strong Precedent
During the HIV/AIDS crises that plagued nearly half the world and affected low -and middle-income countries the
most, the MPP enabled multiple generic pharmaceutical firms to produce the patented medications for HIV and
distribute the same and lower drug prices in the World Bank designated list of LMICs, India and Kenya being some
of them. Within a decade, the MPP secured licenses from patent holders for 13 HIV drugs, 3 Hepatitis C drugs and
1 for tuberculosis.
Although various originator firms, like Gilead entered into cross-licensing voluntary agreements with generic firms,
the MPP posits a better alternative as it benefits any third party country that is a member of the MPP, which pulls
into its ambit nearly 100 LMICs. Moreover, large scale compulsory agreements may lead to issues of patent thickets
which is a gridlock of multiple overlapping patents, acting antithetical to its goal of easy accessibility.
Source: Multidisciplinary Pharmaceutical Research for Improving Access to Medicines
The MPP offers a mechanism that is transparent and flexible and is tasked with the ability to adapt to circumstances
with the objective to achieve public health goals. It promotes the early entry of generic drugs and ensures faster
R&D, increased global manufacture with a wider geographical scope, strict quality assurance policies and quick
availability of medicines. In its brief history, it has successfully worked in the case of HIV, HCV and Tuberculosis.
Additionally, it focuses on public health implications while negotiating a licence agreement with the freedom to
create fixed dose formulations and combinations that are appropriate for developing countries with limited or no
manufacturing capability. Furthermore, MPP grants immediate, non-exclusive licenses which induce competition
amongst generic producers. This causes a reduction in drug pricing and an increase in profit sales therefore
favouring both patent-holders as well as increasing access to essential medicines. This arrangement works perfectly
for the Public Health triad –originator firms, generic manufacturers, residents of LMIC.
Why is there a need to use MPPs now?
In 2023, amidst the global impasse on Intellectual Property Rights, there has been a shift in the paradigm with
respect to the stance of Pharmaceutical Companies concerning MPPs. Understanding that MPPs originated from
the fear of globalisation of pharmaceutical patenting which had a chilling effect on developing countries leading to
increase in prices of essential medicines, it would be commonplace to draw the conclusion that pharmaceutical
companies are opposed to the idea.
However, the threat of a waiver has made MPPs a more attractive option, even to originator firms. In response to
the waiver, pharmaceutical firms like Merck and Pfizer have been quick to license their patents to the MPP. The
shift from being lukewarm toward the idea due to IP globalisation to being open and willing toward it due to the
fear of IP liberalisation is indicative of the urgency with which such a pertinent opportunity needs to be utilised.
As Victor Hugo said – “Nothing is more powerful than an idea whose time has come” - it is time for political leaders
to seize the opportunity generated by the rapid licensing of antiviral drugs to MPPs by Big Pharmaceutical
conglomerates for affordable and equitable production and supply, and make the same a routine protocol. This
would also attract further R&D into the working of MPPs to include not just small biomolecular drugs, but
therapeutics and vaccinations as well.
It is pertinent to examine the implications of TRIPS on the worldwide production of equitable, accessible and
affordable pharmaceuticals, now more than ever.
MPPs, initially, were wrought with systemic fallacies like for instance, the Gilead Scandal in 2014. The process to
run checks and balances on the patents licensed by the Pharmaceutical Companies was inadequate and time
consuming leading to multiple counterfeit products. Critics argue that patent-pools may not necessarily lead to
increased access to medicines, particularly in low-and middle-income countries, as there may still be barriers to
access beyond intellectual property rights and other institutional roadblocks such as – (i) limited participation, (ii)
complexity, (iii) uncertainty, (iv) challenging enforcement strategies.
However, two decades down the lane. The MPP is now a seasoned mechanism which is well-equipped to deal with
the dynamic nature of the Patent systems in Life Sciences, particularly during a time of crisis and it should be our
go-to to rely upon during the IP-intensive doomsday regime that is the post-Covid era of the modern day.
