The mRNA rush

By Tony Shaw PhD, Candace Wu PhD, Alexandra Moloney
Intellectual Property Patents & Trade Marks

In brief 6 min read

There is great potential for mRNA technology to revolutionise future vaccines, and treatment of various conditions such as rare genetic disorders, other infectious diseases and even cancer. The enthusiasm for the technology – or the 'mRNA rush' – is reflected by a spike in patent filings over the past five years, and the growing patent portfolios of key mRNA pioneers and market players.

Key takeaways

  • mRNA vaccines deliver an mRNA sequence to a cell and tell it to make a protein for a specific antigen (eg a protein that's used by a certain virus), allowing our bodies to build immunity against a disease (eg to fend off the actual virus).
  • There are several market leaders in mRNA therapeutics, many of which are entering licensing or joint research collaboration agreements.
  • Over the past five years, there has been an increase in patent filings directed to the mRNA technology. The mRNA vaccine field continues to develop rapidly, and it is anticipated that, as companies innovate, collaborate and compete, IP issues will become increasingly important in the commercialisation of this technology.

What are mRNA vaccines and how do they work?

Many of us have recently received an mRNA vaccine, and it may be surprising to learn that this 'new' mRNA technology is not a recent scientific development. From the 1970s, scientists have experimented with ways that mRNA can be transported into cells for vaccine and drug delivery. The earlier years of mRNA research were marked by a number of technical challenges that took a great deal of effort to overcome. Decades of research and innovation paved the way for today's rapid development of COVID-19 mRNA vaccines.

mRNA (or messenger ribonucleic acid) is a type of genetic material required to carry out protein synthesis in a cell. mRNA vaccines provide cells with genetic material that give the body instructions to produce antigens in a way that is different from a traditional vaccine. In a 'traditional' vaccine, antigens from a pathogen – eg isolated proteins, or a weakened or inactivated pathogen – are administered to activate the immune system, and ultimately generate antibodies that can bind to one or more antigens on the pathogen's surface. When a person later encounters the pathogen, this antibody-antigen binding initiates a complex process that involves recruitment of immune cells that kill the pathogen.

An mRNA vaccine – eg the COVID-19 mRNA vaccine – does not contain a weakened or inactive form of the COVID-19 virus; it contains an mRNA that encodes a COVID-19 spike protein. When injected with the COVID-19 mRNA vaccine, the mRNA is transported to the ribosome, and the ribosome translates the COVID-19 mRNA and creates COVID-19 spike proteins. When infected with COVID-19, it is the COVID-19 spike protein that makes us sick. By having the instructions to make the COVID-19 spike protein, our cells display the COVID-19 spike protein on the cell surface, which triggers activation of our immune system to fight the foreign antigen. This allows us to develop an immune defence against COVID-19 without being exposed to the virus. This form of technology is extremely advantageous in a global pandemic, as, unlike a traditional vaccine, an mRNA vaccine does not require years to develop and attenuate a live virus. An mRNA vaccine can be made as soon as the genetic sequence of a pathogen is known. Theoretically, if the genetic sequence of a protein is known, the mRNA technology could allow our bodies to sequence proteins relevant for cancers and various other infectious diseases. The mRNA technology thus carries enormous potential for creating a variety of vaccines and treatments in less time, and at lower costs, than traditional methods.

mRNA patents – who are the key players?

From 2017 onwards, there has been a sharp rise in patent filings directed to the mRNA technology. These include applications related to the use of mRNA-based vaccines and therapeutics to treat a range of infectious diseases, cancer and rare genetic disorders, as well as methods to deliver mRNA to the cell. Many mRNA technology market leaders are collaborating and entering joint research and development agreements, as well as IP licensing agreements, to leverage their knowledge and skills to advance the technology.

Moderna, CureVac, BioNTech and GlaxoSmithKline (GSK) collectively own nearly half of the mRNA vaccine patent applications globally.

Moderna has reportedly been granted more than 350 patents related to the mRNA technology in the United States, Europe, Japan and other jurisdictions (based on Moderna's website under 'Intellectual Property'), and has a further several hundred pending patent applications worldwide. It is developing a range of different mRNA-based therapeutics to treat the herpes simplex virus and shingles. Moderna is also applying the mRNA technology to immuno-oncology and developing personalised cancer vaccines.

BioNTech is developing a range of mRNA therapeutics targeting cancer and infectious diseases. In collaboration with Genentech, it is developing patient-specific cancer antigen therapy for melanoma, colorectal cancer and solid tumours. It is also in the pre-clinical stages of developing a range of mRNA vaccines for infectious diseases including influenza (in collaboration with Pfizer), malaria, tuberculosis (in collaboration with the Bill & Melinda Gates Foundation) and HIV (also in collaboration with the Bill & Melinda Gates Foundation). Earlier this year, BioNTech announced that it had entered a multi-target discovery collaboration agreement with Crescendo Biologics to develop novel immunotherapies for the treatment of cancer and other diseases.

CureVac is another key player in the mRNA field. It is currently in the process of developing a range of mRNA vaccines, alone and in conjunction with other biotechnology companies, to target a range of diseases. In partnership with GSK, CureVac is developing mRNA-based COVID-19 and influenza vaccines. It is also developing a rabies vaccine candidate, and has been granted a patent in the United States for the use of mRNA encoding the Respiratory Syncytial Virus F-protein for vaccination of infants up to two years of age, with pending applications in other jurisdictions. CureVac is also studying a range of mRNA-based cancer immunotherapies, one of which is in a Phase 1 Clinical Trial, and enrolling patients with melanoma and certain types of carcinoma.

Other players in the mRNA field include Sanofi, Arcturus and eTheRNA. In addition to vaccines, Sanofi is developing various mRNA-based cell and immunotherapies to target tumorous cancers and rare diseases. Through use of its proprietary lipid-mediated nucleic acid delivery system called LUNAR®, Arcturus is developing mRNA-based vaccines and therapeutics to treat COVID-19, influenza, ornithine transcarbamylase deficiency and cystic fibrosis. Belgium-based biotech company eTheRNA is developing a range of mRNA vaccines to promote T and B cell immune responses, as well as vaccines against respiratory viruses.

What's on the horizon for mRNA technology?

The potential for mRNA technology seems endless. Patent filings involving mRNA technology will no doubt continue to increase as more pharmaceutical and biotechnology companies look to mRNA as a key part of future medicine, and join the race to develop and distribute mRNA-based vaccines faster and more widely. We anticipate this new era for vaccine technology will evolve significantly as companies continue to innovate, collaborate and compete, and IP protection will be a critical part of the 'mRNA rush'.