Navigating the complex and ever-expanding mRNA patent landscape

This article is part of our Biotech Review of the Year - Issue 12 publication.

Following the success of Covid-19 vaccines, the mRNA patent landscape has continued to grow, becoming broader and more complex every year. Companies are competing for a position in the market, looking for ways to innovate and unlock the transformational potential of mRNA whilst protecting and increasingly enforcing their proprietary technology. 

In this article we provide an overview of the mRNA patent landscape and how the field has developed since our article in Issue 10 of our Biotech Review of the Year, focussing on the litigation taking place across Europe as well as the development and collaboration strategies being adopted. 

Optimisation of mRNA technology 

Briefly, the technology surrounding synthetic mRNA can be viewed as a platform, with a major advantage being the potential in speed of design and scalability. This makes it an attractive investment for companies looking to build a portfolio of products. However, there is an ever-increasing amount of patent protection of essential elements of successful mRNA technology. 

The two key strands forming the basis of mRNA technology are (1) the delivery system, and (2) the coded mRNA, which expresses the desired encoded protein. Optimisation and innovation of mRNA technology is ongoing, with research focused heavily on overcoming the obstacles in successful mRNA therapy. 

mRNA is very unstable and must be delivered to host cells without degrading. Lipid nanoparticles (LNPs) encapsulate mRNA, protecting it from degradation before cellular uptake, after which the mRNA is efficiently released into the cell. LNPs are the only delivery technology currently approved for use in mRNA vaccine technology. The stability of mRNA can also be improved by directly tailoring the structure of the mRNA molecule, for example by optimising non-coding sequences and chemical modifications. Correct translation within the cell is essential, with enough expression of the encoded antigens to lead to a therapeutic response, but not so much that an adverse immune response is triggered. The incorporation of modified nucleosides, a 5’ cap and longer poly(A)tails has led to improvements in this respect.

Recent growth

The global mRNA vaccine and therapeutics market was valued at approximately $40bn in 2024, an increase from $27bn in 2020, and is estimated to reach almost $70bn by 2030. This growth has not come as a surprise given the revolutionary nature of mRNA technology and its potential in various therapies. In recent years, it has become evident that the intellectual property landscape surrounding mRNA technology is complex, leading to highly anticipated patent litigation cases giving rise to a variety of partnership and licensing arrangements, as well as significant fundraising and investment. 

Moderna and BioNTech have the most wide-ranging patent estates in relation to mRNA technology, with other key players including CureVac, GSK, Sanofi, CSL and Arcturus. At the end of 2023, the European Patent Office (EPO) reported a steep increase in mRNA patent filings, including international patent applications, demonstrating multinational commercialisation strategies and the significant economic expectation in this field. As a result, there is an interconnected web of protected technology, some of which is foundational and therefore vital to the development of further successful vaccines at present, for example the LNP delivery system and nucleoside-modified mRNA, which has been recognised as key to the high efficacy of the Moderna and Pfizer vaccines.

Key litigation in Europe

Litigation has so far primarily related to the development of the Covid-19 vaccines, and is taking place in parallel to related patent challenges at the United States Patent and Trademark Office and the EPO. We discuss two high-profile patent litigation cases and the decisions handed down in Europe to date.

Moderna v Pfizer and BioNTech

Moderna’s dispute with BioNTech and Pfizer is perhaps the most high-profile patent litigation case relating to mRNA technology, particularly in light of the ‘patent pledge’ made by Moderna in 2020. Moderna stated that it would not enforce its Covid-19 related patents whilst the pandemic was ongoing. Moderna updated its pledge in 2022, in effect withdrawing from the commitment by stating that the non-enforcement of the patents would apply only to vaccines destined for 92 low- and middle-income countries.

Moderna initiated proceedings against BioNTech and Pfizer in the UK, Germany, the Netherlands, Belgium and Ireland in 2022, seeking a declaration that its patent rights were infringed. Moderna sought monetary compensation for any infringement, rather than an injunction; its aim was not to remove Pfizer and BioNTech’s product from the market. 

The proceedings concern two of Moderna’s EP patents:

• EP 3718565 (EP 565), directed to an mRNA vaccine comprising the SARS-CoV-2-spike (S) protein and an LNP; and 
• EP 3590949 (EP 949), directed to a method of synthesising an mRNA comprising a chemically modified nucleotide. 

The Pfizer/BioNTech vaccine included (i) the use of mRNA that codes for the relevant spike protein, (ii) the use of LNPs to encapsulate mRNA, and (iii) the replacement of uracil with N1-methylpseudouridine in the mRNA.

Both patents are under opposition at the EPO by multiple parties. EP 565 was revoked by the Opposition Division in December 2023, whereas EP 949 was upheld by the Opposition Division in May 2024. Both decisions have been appealed.

The UK High Court decision aligns with the EPO: EP 949 (UK) was held valid and infringed, but EP 565 (UK) invalid for obviousness over the prior art and added matter. Permission to appeal this decision was granted in September 2024. Moderna’s patent pledge was also examined by the UK High Court in parallel to the infringement/validity trial. Moderna argued that damages should be due from March 2022 (when it modified its pledge), whereas Pfizer/BioNTech argued that the commitment instead only ended in May 2023. The Judge agreed with Moderna, meaning damages would be due from March 2022. 

In Germany and Ireland, infringement proceedings for the respective national designations of EP 949 were stayed pending a decision from the EPO on validity. As the Opposition Division upheld EP 949, the German and Irish proceedings can continue, with the German hearing scheduled for 21 January 2025. In contrast to the UK and EPO decisions, EP 949 (NL) was revoked in the Netherlands.

CureVac v BioNTech

BioNTech has also been involved in high-stake patent litigation cases in the UK and Germany against CureVac. CureVac initiated proceedings against BioNTech in the German Regional Court in Düsseldorf in June 2022, alleging infringement of two of its EP patents. Similarly to Moderna, CureVac stated it had no intention of seeking an injunction, but sought recognition and royalties from past and future sales. The key patents in dispute are:

• EP 1857122 (EP 122), which protects a process that improves the expressions of mRNA in cells; and 
• EP 3708668 (EP 668), which relates to split poly(A) tail technology. 

In response to CureVac’s infringement claims, BioNTech launched invalidity proceedings against EP 122 (DE) and an opposition against EP 668 at the EPO. 

The German Federal Patent Court nullified EP 122 (DE), and in the UK, the trial on EP 122 (UK) was adjourned as CureVac accepted its invalidity on the current state of the law.

In October 2024, Mr Justice Meade handed down a judgment finding EP 668 (UK) invalid for insufficiency (in particular, lack of plausibility), because the technical effect did not in fact exist over substantially the whole scope of the claims. At the EPO, a hearing on the validity of EP 668 is due to take place before the Opposition Division on 25 March 2025. 

Collaboration and investment strategies 

Collaborative approaches are viewed as a productive way to circumvent otherwise inevitable disputes, and also facilitate the rapid development and commercialisation of technology. Pfizer and BioNTech successfully collaborated in 2020 to develop their Covid-19 vaccine, sold under the Comirnaty brand, and have since engaged in a further collaboration to develop an mRNA-based shingles vaccine. Other significant collaborations include GSK and CureVac (mRNA vaccines for infectious disease); CSL Sequiris and Arcturus Therapeutics (late-stage self-amplifying mRNA vaccine platform technology); and Merck and Orna Therapeutics (new generation of mRNA technology programs, including vaccines, oncology and infectious diseases). Moderna has also collaborated with OpenAI to advance mRNA medicine, looking to take advantage of the ever-developing AI capabilities. 

Collaborative approaches do not always avoid disagreement, and due to the complex patent landscape of mRNA technology, such strategies remain challenging and likely to involve high transactional costs alongside risk of disputes down the line. Notably, BioNTech is currently involved in disputes in relation to a licensing agreement with the US National Institute of Health, and there are also ongoing discussions between BioNTech and the University of Pennsylvania over royalty payments for licensed technology regarding nucleoside-modified mRNA.

Our take

The recent growth and development in this field highlights the value placed by companies on this technology. On one hand, it seems that companies are increasingly looking to enter into collaboration agreements in order to combine expertise and technology for more streamlined development of new mRNA technology, reducing the risk of infringing patent rights. 

However, high-stake patent litigation cases further emphasise the value placed on this technology, and the decisions suggest there may be some difficulties in patenting certain mRNA technology in a way that is sufficient and not overly broad to the extent it impedes innovation in the field unfairly. Of particular significance may be the invalidation of Moderna’s patent to LNP technology, which may open the door for companies to take advantage of key technology.

Although the recent boom in this field was triggered by the development of Covid-19 vaccines, the scope of the technology spans far beyond, having potential for various viral targets as well as for the treatment of cancer. mRNA technology can be developed very quickly, making it vital for the rapid treatment/prevention of disease. The balance between allowing rapid development/commercialisation and respecting IP rights, and the court decisions on patents protecting mRNA technology will be influential in shaping the landscape and strategies required for success in this field.

Stemming from this, an interesting dynamic arises in this field. Pharmaceutical companies have so far been actively mindful of the balance required, looking to allow access to foundational mRNA technology for new products to be developed. This is evidenced by patent pledges (although these can be easily unilaterally withdrawn) as well as voluntary engagement in licensing deals for certain strands of technology, with varied success. 

The introduction of standard essential patents (SEPs) is a potential solution. SEPs are a familiar concept to at least the technology sector at present. The aim of SEPs is to create a predictable and fair licensing model for essential patents. Due to the foundational nature of some strands of mRNA technology, it is feasible that the SEP model could be introduced in this field in order to facilitate necessary licenses and promote rapid development of life-saving technology. That being said, SEP-designation would not be a magical solution as evidenced by the persisting SEP litigation in the telecoms space over recent years. In any case, the complex and evolving patent landscape of mRNA technology is certainly an interesting one to watch.