COVID-19 Patent Disputes Expand to Europe
The unprecedented success of the COVID-19 vaccines, both therapeutically and commercially, has prompted fierce competition. Multiple companies around the world are fighting to claim patent rights related to these vaccines.
The mRNA vaccines, for example, involve several components including the mRNA itself as well as its lipid delivery vehicle. Each of these components is subject to patent protection and patent-related disputes.
As Reuters reported, in Delaware federal court Alnylam Pharmaceuticals Inc. accused Pfizer Inc. and Moderna Inc. of infringing its newly obtained patent for lipid nanoparticle (LNP) technology for delivering genetic material into human cells. The company filed suit the same day the US Patent and Trademark Office (USPTO) issued the patent.
Earlier this year, as Reuters also reported, Arbutus Biopharma Corp filed suit against Moderna, claiming that Moderna misused its technology for delivering mRNA, which Arbutus said allowed Moderna to develop its COVID-19 vaccine at “record speed.”
Allele Biotechnology and Pharmaceuticals, a San Diego biotech company, sued Pfizer and its partner BioNTech SE in 2020, arguing they used its patented fluorescent protein without permission in developing their vaccine. Allele eventually dropped its lawsuit.
Now, CureVac has filed what appears to be the first COVID-19 vaccine-related patent infringement complaint outside the US. The complaint, filed in the Dusseldorf Regional Court, accuses BioNTech of infringing four of CureVac’s patents.
According to IAM,
CureVac, which is developing a second-generation mRNA covid-19 vaccine after its first attempt faltered at the clinic, describes itself as the “earliest pioneer in mRNA technology”. The patents-in-suit relate to the engineering of mRNA molecules, including sequence modifications to increase stability and enhance protein expansion and mRNA vaccine formulations specific to SARS CoV-2 vaccines. CureVac says these are essential to the design and development of BioNTech’s product.
According to the Financial Times, before the COVID-19 pandemic there were no approved vaccines based on mRNA technology, which directs the immune system to recognize and fight a virus based on its genetic code. And, indeed, as Nature notes, although mRNA-based vaccines for COVID-19 were rapidly developed and approved in response to the global pandemic, the history of mRNA vaccine is more than 20 years old, with many scientists adding their contributions.
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For example, in 1987, Robert Malone, a graduate student at the Salk Institute, mixed mRNA with fat droplets and showed that human cells incubated in those droplets started translating the mRNA and producing proteins. These results suggested that mRNA might someday be used as a drug. In 2000, Ingmar Hoerr of Tübingen University injected mRNA into mice and elicited immune responses. Hoerr later founded CureVac.
According to dw.com, CureVac’s own attempt to create a COVID-19 vaccine failed when its version was only 47% effective, compared to 94.6% for the BioNTech-Pfizer version. CureVac isn’t seeking an injunction against the sale of vaccines based on the BioNTech technology but is seeking “fair compensation” for the alleged infringement of its patents.
BioNTech’s worldwide sales were 19 billion Euros in 2021, according to IAM. CureVac’s sales were 103 million Euros in 2021. Fierce Pharma reported that pharmaceutical analyst Zhiqiang Shu wrote in a note to clients that $20 billion worth of BioNTech’s COVID-19 vaccine revenue could be subject to the suit and that there was $500 million in “potential upside” for CureVac based on an optimistic royalty rate of 2% to 3%.
These high-stakes legal battles, that will likely last for years, can serve as a reminder of the important role of patents in businesses centered on cutting-edge technologies. Proper offensive and/or defensive patent strategies are critically important for technology-based ventures for them to reap the full benefit from research and development investments and protect their businesses. As many of the relevant patents have a life span until the mid- or late- 2030s, those venturing into mRNA vaccines and related fields would be wise to consider circumventing or patent licensing strategies to avoid threats by such patents.
