Moderna files lawsuit against Pfizer vaccine

A clash of the Covid-19 mRNA vaccine titans Pfizer and Moderna has sent shockwaves through the pharmaceutical world this week. US company Moderna has filed claims against its rival in both America and Europe alleging that patents relating to key components of the mRNA vaccine technology - which was used for the first time clinically and has proved game-changing during the Covid-19 pandemic - have been infringed. With huge revenues at stake from the technology, there’s a lot riding on the verdict. Clare Bryant is an immunologist at the University of Cambridge and has also worked previously in the pharmaceutical industry herself. As she explains, it’s not altogether clear who owns what…

Clare - Basically, we've done the massive world clinical trial using a new technology, the mRNA vaccine technology, and shown that this technology is great for making vaccines. So we're now at the point that this technology's been invested in and companies are saying, "okay, how can we use these kinds of technologies to make new vaccines for other diseases," for example, HIV, which would be the holy grail. This now has been triggered because we are not in the pandemic as it was before. So the ethical issues around making vaccines to treat the world, to protect everybody against a pandemic disease, have gone into the background. And we're now moving forwards, looking very closely at the technology, looking at who owns what, in order to trial up new vaccines for other diseases, and to make the big money that's really out there if we can use this technology more widely.

Chris - And what's at stake? What are they arguing over? What's the technology that one says the other has nicked?

Clare - To make the mRNA vaccine work - which is a way of introducing mRNA into the cells of your body to make, in this case, the spike protein from the COVID virus, and then you can make an immune response against it - that immune response is there onboard in your body to tackle the next strain of virus that comes along. So to do that, normally mRNA and cell is made just when you need a protein, the mRNA is then broken down and it disappears. So you've got to do a number of different things. You're introducing a foreign RNA. A foreign mRNA is what you see if you get, for example, a virus infection on board. So the body makes an immune response against the RNA in its own right and that makes you feel really sick. That's called toxicity. Two scientists made a really neat discovery, which was that the coding sequence, the nucleic acid coding sequence for the mRNA, they could change one of the nucleotides and chemically modify it. And what that did was then two things: it decreased the toxicity (you didn't feel so rubbish when you have the vaccine), but the other thing it did was make the translation of proteins much more efficient. So you're generating a molecule that makes the proteins against the virus much more efficiently, much more of it. And people don't feel as sick when they get this modified messenger RNA.

Chris - Now, who did that? Did Moderna do that? Did Pfizer do that or did someone else make that crucial step?

Clare - Two scientists, Weissman and Kariko, did this around the mid 2000s. And this was actually done six years before Moderna picked up the technology that they then patented themselves. So this is part of the controversy that's going on, which is that this discovery was made and patented, in fact, before Moderna came in, so there's already complexity around that patenting as well.

Chris - And is that what Moderna say Pfizer have copied - it's that crucial modification of the genetic message that they're alleging that Pfizer are copying.

Clare - So there's three things actually. That's one of them and that's absolutely crucial. They're also arguing that the way in which the messenger RNA is packaged up into a lipid particle is a Moderna discovery. And then finally, they're also arguing that because Moderna made some vaccines against MERS, which was a similar virus to COVID 19, that they used in the MERS vaccine, full length, spike protein. They used a similar approach to make their COVID 19 vaccine, which was the full length spike protein, and Pfizer did something very similar. So it's the modification of the messenger RNA., it's the lipid particle wrapping up to make it go into cells efficiently, and then it is also the full length spike protein that they've used for their vaccine. So there's three elements to it. And it seems to be really murky. There's a lot of discussion amongst the lawyers as to what's valid and where this is going to go. It's interesting and complicated and big bucks involved and that's the reason for the problem.

Chris - They must have a reasonable chance of success to their mind because otherwise they wouldn't have launched into this in the first place. Or is it a question of damned if they don't damned if they do?

Clare - These things are never straightforward. The patent lawyers certainly think there is a decent case to be answered here. I think it's going to be really interesting to see how this comes out in the wash because Moderna had been working on this for a long time. They've made MERS vaccines, which was successful. The whole strategy was in place. So it's reasonable, but Pfizer argues that they too have had this kind of program going on for a long time. And the difficulty for us as outsiders is we don't know what the companies have been doing, how long they've been working on it and what the intellectual property right position is behind all this, because it's all wrapped up in secrecy. So the lawyers, certainly the media releases from all the lawyers, suggest that they have cases, but we will wait and see exactly how this all pans out.