Moderna (NASDAQ:MRNA)
Moderna (NASDAQ:MRNA) just announced that it is filing a patent infringement suit against Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) in the US and Germany over mRNA intellectual property. At the same time, this wasn’t necessarily a surprise since most instances of a breakthrough biopharma treatment end up setting off a flurry of patent lawsuits. It doesn’t imply that Moderna has a case.
Although the in-court phase has been delayed for some time now, in 2020, Moderna said it wouldn’t enforce its COVID-related mRNA vaccine patent as the pandemic raged on. Later this year, an updated statement from the company explained that it didn’t plan on enforcing the patents for any vaccine deployed in the 92 low-income and middle-income countries listed in the GAVI “advanced market commitment” agreement but that other companies were expected to license the technology in other markets. The company has now revealed that both Pfizer and BioNTech didn’t do this resulting in the patent lawsuit.
More specifically, Moderna (NASDAQ:MRNA) claims that patents filed between 2010 and 2016 were infringed upon, citing two features in particular. The company says that Pfizer took a number of mRNA vaccine candidates into clinical trials, including some that wouldn’t have infringed but ended up choosing one that had the exact mRNA chemical modification as theirs.
According to Moderna (NASDAQ:MRNA), the company started developing its mRNA vaccine back in 2010 and became the first to validate its efficacy in human trials five years later. Without going into too many details, the company talks about pseudouridine incorporation in its lawsuit.
The most important thing to be aware of is that the pseudouridine idea featuring higher levels of transcription and lower immunogenicity was discovered in 2008 by two scientists, after which Moderna and BioNTech then licensed the patents. Clearly, this will be a tough case considering that Moderna claims it made its own modification that BioNTech later copied.
Despite having access to a variety of options, Pfizer and BioNTech copied Moderna’s approach used to “encode for the full-length spike protein in a lipid nanoparticle formulation,” according to a statement by the company. Moderna (NASDAQ:MRNA) asserts that it had developed this approach while working on a MERS vaccine, the newest coronavirus outbreak in humans before COVID.
Likelihood of Multiple Lawsuits
While the development of cationic lipid nanoparticles for nucleic acid formulation and delivery has a long history, Moderna’s press release fails to mention one critical detail. At least two other companies have filed lawsuits against Moderna, claiming it infringed on their cationic lipid IP. Furthermore, BioNTech seems to have been dosing mRNA in lipid nanoparticles in clinical trials as far back as 2014, meaning the lawsuit is going to take quite a bit of time to iron out all these details.
Additionally, Moderna claims that none of the patent rights that are being contested are related to IP developed during its collaboration with the NIH, insisting that this began only after the patented technology at issue was proven effective in clinical trials conducted in 2015 and 2016. However, the company’s press release fails to mention that the NIH is also filing a lawsuit against Moderna due to the company failing to list three of the institute’s scientists as investors in the patents. Going forward, it remains to be seen whether this dispute will be enjoined in the case.
Ultimately, this case seems likely to drag on for years unless all parties can reach some sort of agreement. Before a settlement is reached, the main challenge is that all parties will want to have their day in court and see how things play out before re-strategizing again based on the legal outcome.
Featured Image: Megapixl @Piter2121
