Patents, Profits and Squabbles for Share in Profit Pie – Pandemic Story of Moderna

In February 2022, the South African civil society groups issued an open letter to the Big Pharma Company Moderna to immediately withdraw the mRNA vaccine patents it has filed in South Africa and provide technical expertise to the World Health Organisation (WHO) mRNA Technology Transfer Hub in South Africa.

There has been a long-standing demand in South Africa to reform the domestic patent law. A technical brief by MSF and PHM South Africa outlines the vaccine patents that have been issued in favour of Moderna. At least three mRNA vaccine patents will start expiring only after a decade in 2034. These include:

1. a patent with very broad claims covering the method of production of an mRNA vaccine,
2. one with claims on the gene sequences relevant to mRNA vaccine, and
3. one containing broad claims on the technique of delivering biological moieties into cells that are useful for the production.

The brief also notes that Moderna has additional patent applications pending with South Africa’s patent office, including some with long-overdue renewal payments.

Moderna spokesperson Colleen Hussey has reportedly confirmed it had filed for patents "related to both the COVID-19 vaccine and Moderna's platform technology" in South Africa and elsewhere.

The activists argue that several equivalent patents in other countries, such as Australia, Canada, China, India, Israel, Japan, Mexico, Singapore and South Korea, have been withdrawn or abandoned by Moderna or rejected by the respective national patent offices.

Although Moderna had made public announcements earlier that it will not enforce patents on its COVID-19 vaccine during the pandemic, the activists have argued that “Given that Moderna itself may decide when the ‘pandemic is ‘over’, this is hardly a reassuring pledge and may potentially undermine the Hub’s current and future functioning and research, at the expense of all LMICs.”

SKYROCKETING INCOME FROM COVID-19 VACCINE SALES

Big Pharma companies have made merry since the world has been in the grips of the COVID-19 pandemic. Pfizer’s revenues jumped by 95% - from about $42,000 million to $81,000 million, and its net income rose by 140% between 2020 and 2021. Moderna, a much younger company, established in 2010, also recorded a huge jump in net income in 2021 from a loss situation in 2020 (Figure 1).

While the net income of Moderna was recording a negative figure till 2020, the COVID-19 pandemic suddenly made him a Big Pharma giant with more a registered net income of USD 12,000 million in 2021.

Moderna’s revenues jumped from USD 803 million in 2020 to USD 18,471 million in 2021 – a 2200% jump! For 2022, the company has already signed Advanced Purchase Agreements (APAs) for product sales of approximately USD 19,000 million.

Encouraged by this unfettered growth, Moderna is vigorously expanding its empire. As part of Moderna’s expansion plans, it would be sending its commercial teams to Belgium, Denmark, the Netherlands, Norway, Poland and Sweden and four countries in Asia, namely, Hong Kong, Malaysia, Singapore and Taiwan. In 2021, it built commercial subsidiaries in Italy, France, Germany, Spain, the U.K. and Switzerland to produce its COVID-19 vaccine Spikevax.

In all this, it has maintained that it would not share the technology with any manufacturer. It also did not extend any help to the WHO anchored vaccine hub in South Africa, which successfully replicated the mRNA vaccine. Earlier, instead of joining in the WHO efforts, Moderna announced plans to open its mRNA manufacturing facility in Africa. Still, even that has not seen the light of the day.

These profits for Moderna have come by focusing their sales in the High-Income Countries (HICs) and Upper Middle-Income Countries (UMICs) with a share of 75% in its total sales. Many of them are located in Africa; the Low-Income Countries account for only a 1% share of its total sales (Figure 2). 

In terms of its contribution to the WHO vaccine sharing platform COVAX, Moderna has failed miserably. As of February 14, out of total production of about 761 million doses, Moderna has supplied only 50 million doses to the COVAX, that is, only 7% of its production. 

PATENT WAR - MODERNA EMBROILED IN LAWSUIT

Arbutus Biopharma and Genevant Sciences have filed a lawsuit against Moderna for infringement of U.S. patents related to Moderna's mRNA COVID-19 vaccine. Reportedly, Arbutus claims to have developed the lipid nanoparticles (LNP) that enclose genetic materials known as messenger RNA or mRNA. The patents related to these were licensed to Genevant Sciences, a joint venture between Arbutus and Roivant Sciences Ltd. Moderna, though, denies the allegations.

The pharma companies have sought “fair compensation for Moderna’s use of our patented technology that was developed with great effort and at great expense, without which Moderna’s COVID-19 vaccine would not have been successful.”

In another controversy, Moderna had excluded three scientists from the National Institutes of Health (NIH) as co-inventors of a central patent for the company's COVID-19 vaccine in its application. In December, it relented as it decided not to pursue its U.S. patent application for a key part of its COVID-19 vaccine, thus managing to defer a possible court battle between the company and the government.

It appears that in the race to extract as many profits as possible from a global crisis, Moderna has left no stone unturned and has allegedly resorted to unethical means too. Despite repeated appeals from the WHO for sharing vaccine technology with manufacturers, Moderna remains adamant in not sharing technology and opposing the TRIPS waiver proposal at the WTO, along with other Big Pharma.