Moderna patent on mRNA Vaccine against COVID-19 revoked
On Tuesday 21 November 2023, an Opposition Division of the European Patent Office declared Moderna’s patent EP 3 718 565 B1 invalid. Moderna, however, indicated to be willing to file an Appeal to defend the patent, so this is not the final word.
EP 3 718 565 B1 is one of two patents (see below for the other one) under which Moderna had challenged BioNTech and Pfizer in the US, Germany and the UK, alleging infringement of their protection rights.
The patent has a very huge file, it can be accessed here.
The main claim reads:
“1. A betacoronavirus (BetaCoV) messenger RNA (mRNA) vaccine comprising at least one mRNA polynucleotide having an open reading frame encoding at least one BetaCoV antigenic polypeptide;
wherein the at least one BetaCoV antigenic polypeptide is (a) a spike (S) protein or immunogenic fragment thereof, or (b) an S1 subunit or an S2 subunit of S protein or an immunogenic fragment thereof;
wherein the BetaCoV vaccine is formulated in a lipid nanoparticle, wherein the lipid nanoparticle comprises 40-60% cationic lipid, 5-15% non-cationic lipid, 1-2% PEG lipid, and 30-50% cholesterol.”
Both Moderna (under the tradename Spikevax®) and BioNTech (under the tradename Comirnaty®) are marketing mRNA based vaccines against Corona Virus SARS-CoV-2-Virus (a betacoronavirus as mentioned in the claim above). This virus, which is an RNA virus, that is, its genes are coded in RNA, not DNA, causes the well-known disease, COVID-19.
Both vaccines comprise chemically modified mRNA against a specific protein of the virus that binds to receptors in the human respiratory tract. Based on clinical trials before the marketing authorisation, these vaccines cause epithelial cells from the mRNA template to produce spike protein which is then exposed and causes the immune system to produce antibodies against the viral protein. This provides a better immunity against COVID-19 disease by interfering with the binding of the spike protein of this RNA virus to the receptor and triggering immune response against the virus which exposes the spike protein on its surface. Lipid nanoparticles are required to facilitate the entry of the modified mRNA into cells, these formulations are most important for the effectiveness of the mRNA vaccines. In the patent above, this is reflected in the “formulated in a lipid nanoparticle” part (last paragraph of the claim above).
Another Moderna patent in Europe, EP 3 590 949, is presently also prone to a pending opposition, see here. This patent relates to modified mRNA.
The Researchers who, before the commercial development of Comirnaty® and Spikevax®, originally discovered the possibility to make use of vaccination using modified mRNA and who laid the fundament for the later development of vaccines like those from Moderna and BioNTech, Katalin Karikó and Drew Weissman, have just been awarded the Nobel Prize in Physiology and Medicine, see here. These two scientists discovered the general principle that the inflammatory response against mRNA which prevented it to be useful as basis for protein production in cells and thus specific antibody production is almost abolished when base modifications are included in the mRNA. These results were published in 2005. For more details, please consult the above Nobel Prize link. See here .
The mRNA vaccination technology allows for very fast development of vaccines, as exemplified for the COVID-19 mRNA vaccines.
Various companies and institutions apart from BioNTech and Moderna, including CureVac, Arbutus, Acuitas, Arcturus, University of Pennsylvania and the University of British Columbia are involved in Research on mRNA vaccines.
This has resulted in a huge patent landscape and several litigation proceedings. See an example here.
We will keep you informed on more litigation on COVID-19 and other mRNA vaccines.
