Key 3 mRNA vaccine techs are not Moderna's nor Pfizer's

A ‘mRNA Vaccine Patent Analysis Report’ was published by KIPO

Introduced key patents on antigen optimization, mRNA synthesis, and lipid nanoparticles

The three key technologies required for developing mRNA vaccines were revealed.

 

These are technologies related to antigen optimization, mRNA syntehsis·modification, and manufacture of lipid nanoparticles (LNP) that correspond to steps 1, 2, and 4 of the 5-step vaccine manufacturing process.

 

The explanation was that a biopharmaceutical company aiming to develop COVID-19 vaccines or anticancer treatments using mRNA must secure the technologies mentioned above.

 

Even Pfizer and Modera, which produce the mRNA COVID-19 vaccines, are said to have secured patents related to the abovementioned technology through a licensing agreement.

 

On the 8th, the Korean Intellectual Property Office (KIPO) published an ‘mRNA Vaccine Patent Analysis Report' and introduced the key technologies required for the production of mRNA vaccines.

 

According to the report, a total of 691 mRNA vaccine-related patent applications have been filed globally.

 

Moderna had filed for the most with 211, followed by CureVac’s 108, TranslateBio’s 67, Pfizer·BioNTech’s 60, and GSK’s 25 applications.

 

However, the report showed that the core patent required for the production of mRNA vaccines is not owned by Pfizer nor Moderna.

 

mRNA vaccines are produced in five steps: ▲antigen optimization ▲mRNA synthesis and modification ▲ Separation & Purification ▲LNP production ▲formulation.

 

Among these, technologies for antigen optimization, mRNA synthesis and modification, and LNP production are the key technologies required for vaccine production.

 

Map of COVID-19 mRNA vaccine technology relationships between companies (Source: KIPO)

The technology for antigen optimization is owned by the US National Institute of Health (NIH).

 

NIH had applied for 3 patents on ‘COVID-19 spike protein antigens,’ and one of the three has been registered in the US.

 

Companies that develop mRNA COVID-19 vaccines like Pfizer·BioNTech, Sanofi, and GSK have signed licensing agreements with the NIH for the relevant patent.

 

It is not confirmed whether Moderna, which had jointly developed a COVID-19 vaccine with NIH, had signed a licensing agreement for the said patent.

 

In mRNA syntehsis·modification, patents on the ‘modified nucleic acid’ is key.

 

Cellscript owns the patent on ‘the method reducing immunogenicity using pseudouridine.’ The patent, which had previously been owned by the University of Pennsylvania, was transferred to Cellscript.

 

Moderna and BioNTech secured the technology through a licensing agreement with Cellscript.

 

Two companies have the key technology related to lipid nanoparticles as patents- ‘Arbutus’ and ‘Acuitas.’ Arbutus owns multiple patents on “lipid-nucleic acid particle composition containing cationic lipids,’ and Acuitas owns multiple patents related to ‘lipid-nucleic acid particles containing cationic lipids and PEG-Lipid.’ Both play a vital role in the manufacturing of lipid nanoparticles.

 

Pfizer·BioNTech had signed a license agreement with both companies to secure the technology.

 

On the other hand, Moderna only signed a license agreement with Acuitas Therapeutics and is in a patent dispute with Arbutus in the US and Europe with regards to the technology.

 

KIPO said, “Korean pharmaceutical companies and research institutions wishing to develop mRNA vaccines would need to acquire or evade the license of these patents.

 

However, only 17% of the 691 patents related to mRNA are registered in Korea, therefore, Korean mRNA vaccine developers are less likely to get embroiled in patent dispute compared to those in the US or Europe.”