The mRNA Vaccine Patent Fight Expands

So Moderna has announced that they are filing patent infringement suit in the US and in Germany against Pfizer and BioNTech over mRNA vaccine intellectual property. This is not completely unexpected – and by that I don’t mean to imply that Moderna necessarily has a case, because I’m not sure if they do or not. It’s just that there is almost never an example of a breakthrough biopharma technology that does not end up setting off a flurry of patent lawsuits. For better or worse, this is the norm.

The see-you-in-court phase has actually been a bit delayed, honestly. You may recall that in the fall of 2020, Moderna announced that it would not enforce its COVID-19 related mRNA vaccine patents “while the pandemic continued”. That statement was updated earlier this year, when the company said that it would never seek to enforce those patents for any vaccine used in the 92 low- and middle-income countries in the GAVI “advance market commitment” agreement, but that it would expect other companies to license its technology for other markets. They now say that Pfizer and BioNTech have failed to do this, and thus the patent lawsuit.

Specifically, they say that Moderna patents filed between 2010 and 2016 have been infringed, and in their press release they highlight two features in particular. They point out that Pfizer took several mRNA vaccine candidates into clinical testing (including some that they say would not have infringed), but ultimately picked one “that has the exact mRNA chemical modification” as theirs. They say that they began developing this in 2010 and were the first to validate it in human trials in 2015. Without seeing the lawsuit itself (which I’m sure we’ll get a look at soon), they have to be talking about pseudouridine incorporation. I am not going to try to do a detailed evaluation of Moderna’s IP here – people get paid a lot of money to do that sort of thing, because it ain’t easy – and I am not going to pass any judgment on who has a case and who doesn’t. But this is surely not going to be as straightforward as the Moderna press release makes it sound (what patent fight ever is?) The first thing to know is that the pseudouridine idea, with its higher levels of transcription and lower immunogenicity, was discovered in 2008 by Katalin Karikó and Drew Weissman and co-workers, and both Moderna and BioNTech licensed their patents. So there’s going to be a lot to work through here – not least because Moderna at first did not license this technology, claiming that it had its own modification and that BioNTech copied that. It’s a mess.

Moderna also says that “despite having many different options” that Pfizer and BioNTech “copied Moderna’s approach to encode for the full-length spike protein in a lipid nanoparticle formulation”. The company says that they developed this approach during their work on a MERS vaccine, the most recent new coronavirus outbreak in humans before COVID-19. Again, I am not going to deep-dive into this topic, but I would note that the development of cationic lipid nanoparticles for nucleic acid formulation and delivery is a story with a lot of chapters, many of which don’t necessarily have anything to do with Moderna. The press release (naturally enough) also does not mention that Moderna itself is being sued by at least two other companies who claim that their own cationic lipid IP is being infringed. BioNTech themselves were dosing mRNA in lipid nanoparticles in the clinic in 2014, and working out the differences and important details in all of these will keep the lawyers occupied for some time.

Finally, Moderna’s release specifically says that none of the patent rights that are at issue have anything to do with the IP generated during the collaboration with the NIH, stating that this “began only after the patented technologies at issue here were proven successful in clinical trials in 2015 and 2016”. Saying that is easy, but the press release does not mention that the NIH is in fact also suing Moderna, claiming that three of their scientists were left off of a Moderna patent application as inventors. Whether or not that dispute gets dragged into the Moderna-Pfizer-BioNTech lawsuit remains to be seen.

Like all of these situations, I think we can look for this one to drag on for years unless the parties can agree on some sort of settlement to make it all go away. Even if that’s how this eventually ends, it’ll be a while before everyone realizes that that’s the way to go – you generally see people giving their claims a ride in court to see how things hold up and then re-evaluating based on that legal performance. This has every sign of being long, slow, and complex, and it will keep a lot of IP attorneys occupied for years to come.