Is this the start of COVID-19 patent wars?
Moderna has filed a patent infringement lawsuit against Pfizer and BioNTech (Pfizer’s German partner) over mRNA technology Moderna claims to have developed prior to the COVID-19 pandemic, as it seems that the cooperation shown during the COVID-19 pandemic that led to such rapid vaccine development is starting to wear off.
In a recent statement, Moderna asserts the Pfizer and BioNTech COVID-19 vaccine, Comirnaty, infringes patents filed by Moderna between 2010 and 2016. The technology in these patents were critical to the success of Moderna’s own mRNA vaccine, Spikevax. In response, Pfizer and BioNTech stated they were ‘surprised’ by the lawsuit and that it intends to ‘vigorously defend against all allegations of patent infringement”. Moderna is not aiming to remove Pfizer’s vaccine from the market. Moderna also is not seeking damages relating to sales to the US government or AMC 92 countries, or for any activities occurring before 8 March 2022, when there was a barrier to vaccine access. In the statement, Moderna simply says that it expects companies such as Pfizer and BioNTech to respect its IP rights, and would consider a ‘commercially reasonable license’, should it be requested.
Moderna asserts that Pfizer and BioNTech have copied two key features of its mRNA technology platform: (i) an mRNA chemical modification; and (ii) the delivery of the full-length S protein in a lipid nanoparticle (LNP) formulation for a coronavirus.
Moderna states that Pfizer/BioNTech clinically tested four different vaccine candidates, including candidates that would not have infringed the patents, but ultimately chose to proceed with the candidate comprising the same mRNA chemical modification as Spikevax. The mRNA technology, first used commercially in COVID-19 vaccines, includes a modification to replace the uridine nucleotide with a pseudouridine derivative (1-methylpseudouridine). Incorporation of pseudouridine has been found to limit the body’s inflammatory response to foreign mRNA, as well as to increase mRNA stability. Moderna claim they started development of this technology in 2010, and were the first to validate it in human trials in 2015. However, Weissman and Karikó, two scientists at the University of Pennsylvania, state they discovered the advantages of replacing uridine in mRNA in 2005. A patent obtained by Weissman and Karikó in 2008 (six years earlier than the filing of Moderna’s patents) discloses the 1-methylpseudouridine modification claimed by Moderna.
The use of LNPs in COVID-19 vaccines provides a solution to the delivery issues associated with mRNA therapeutics. Nucleic acids are hydrophilic, which can make uptake across the cellular lipid membrane challenging. By using LNPs to encapsulate the modified mRNA, it may be protected and delivered intact across the cell membrane. The LNP formulation used includes four different lipid types: ionisable cationic lipids, phospholipids, cholesterol and PEG-conjugated lipids. Adding cationic lipids to the LNP provides it with a positive charge, enabling it to bind to the negatively charged backbone of mRNA. Moderna claims that it developed its approach while working on the MERS vaccine, years before the emergence of COVID-19. However, Moderna has been targeted by Alnylam and Arbutus, two other pharmaceutical companies developing LNP technologies, for alleged patent infringement relating to the use of cationic lipid LNPs in its vaccines.
Moderna stated in 2020 that it would not enforce patent claims during the COVID-19 pandemic, in order to help other countries, with less resources, to develop their own vaccines. In March 2022, Moderna issued an updated patent pledge requesting respect for its IP rights in non-AMC 92 countries. It is clear however that the “pandemic” phase of COVID-19 is now over, so it appears that Moderna is now looking to recoup some of the costs associated with developing its vaccine. Moderna is also engaged in an ongoing dispute with the US National Institutes of Health (NIH) after failing to list three of its researchers as co-inventors in its recent COVID-19 vaccine patent application.
It will be interesting to see what part patent litigation has to play as we emerge from the COVID-19 pandemic.