The COVID-19 pandemic brought with it something of an IP truce, with major pharmaceutical companies seemingly happy to co-exist. However, it now seems that a battle is about to commence with three of the major players in the COVID-19 vaccine industry now in dispute.
Moderna v Pfizer/BioNTech
Moderna
Moderna, a company based in Cambridge, Massachusetts, USA (and founded as recently as 2010) was an early developer of the mRNA technology. The company's vaccine comprises mRNA that expresses a viral protein and generates an immune response training the body to fight off a real virus when it comes into contact with it.
Moderna obtained approval for its vaccine in a matter of months when the US Food and Drug Administration, ("FDA") granted "emergency use authorisation" for the company's COVID-19 vaccine in December 2020. At the same time, the FDA had already also granted authorisation to Pfizer/BioNTech (just one week earlier).
Moderna's action against Pfizer/BioNTech
Moderna is now suing Pfizer and its German partner BioNTech for patent infringement. Actions have been brought in both the USA and Germany. Moderna claims that Pfizer/BioNTech copied two key elements of its patented technology. The first involves a "chemical modification", which has the effect that the vaccine does not provide an "undesirable immune response". The second is to do with the way both vaccines target the distinctive spike protein on the outside of the virus.
Moderna alleges that Pfizer/BioNTech, without permission, copied the mRNA technology that Moderna had patented between 2010 and 2016, well before COVID-19 emerged in 2019. Moderna's chief executive Stéphane Bancel is quoted as follows:
"We are filing these lawsuits to protect the innovative mRNA technology platform that we pioneered, invested billions of dollars in creating, and patented during the decade preceding the COVID-19 pandemic."
Moderna's explanation for its action
No doubt alive to the sensitivities surrounding COVID-19 vaccines, Moderna has seen fit to explain its action in some detail. In a statement, it said that Pfizer/BioNTech's alleged IP theft related to two things.
- An mRNA structure that Moderna claims it started developing in 2010 and that was validated in human trials in 2015. It said that Pfizer/BioNTech took "four different vaccine candidates into clinical testing, which included options that would have steered clear of Moderna's innovative path". Yet it chose "to proceed with a vaccine that has the same exact mRNA chemical modification to its vaccine."
- The coding of a full-length spike protein that Moderna claims it developed in the creation of a Middle East Respiratory Syndrome ("MERS") vaccine. The MERS vaccine was, in fact, never commercialised, but its development helped Moderna rapidly roll out its COVID-19 vaccine.
Pfizer's response to the action
Pfizer, in a statement, said that it was "'surprised' by the patent claim because its vaccine was based on its own proprietary mRNA technology". It went on to say: "We remain confident in our intellectual property supporting the Pfizer/BioNTech vaccine and will vigorously defend against the allegations of the lawsuit."
The times they are a-changing
In the early days of the pandemic, Moderna undertook that it would not enforce its patent rights, so that other companies could develop their own jabs, particularly in poorer countries. But in 2022, Moderna said that companies like Pfizer and BioNTech would need to respect its patent in higher-income countries, although it did undertake that it would not claim damages for any activity that had occurred 2022.
Essentially, what this means is that Moderna has changed course on its public commitment not to enforce the patents. It has been suggested that perhaps Pfizer might argue that the court should hold Moderna to its public pledge. However, it is questionable whether or not this would be a successful approach given the dearth of legal precedents for such a circumstance.
Is it all about the money?
Moderna is, in its court action, seeking unspecified monetary damages. That is perhaps no surprise because there is a lot money at stake. Moderna's COVID-19 vaccine - its lone commercial product - has brought in revenue of USD10.4-billion in 2022, whereas Pfizer's vaccine has brought in some USD22-billion.
Other litigation
It's worth noting that both Pfizer/ BioNTech and Moderna are involved in other disputes.
BioNTech is facing a claim from a company called CureVac, which claims infringement of patents linked to the engineering of certain mRNA molecules, and is demanding financial compensation. Pfizer and BioNTech have responded by filing a complaint with a US district court, to seek a declaratory judgment that there was no infringement of the CureVac US patents and also recently filed similar proceedings at the High Court of England and Wales seeking a non-infringement declaration of CureVac's European patents.
Pfizer and Moderna have both been in the firing line from Alnylam Pharmaceuticals who has filed an action in the USA seeking damages for infringement of its patent relating to the use of its lipid nanoparticle technology in the mRNA COVID-19 vaccines.
Moderna is in a dispute with Canadian-based Arbutus Biopharma and its licensee, Genevant over six key patents relating to lipid nanoparticles that protect mRNA that Arbutus claims have been infringed by Moderna. In response, Pfizer's Canadian partner Acuitas Therapeutics counter-sued Arbutus.
That truce? Well, it was nice while it lasted!
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