Partial victory for Moderna in UK trials over patent pledge and RNA vaccine used during the Covid-19 pandemic

A legal dispute between Moderna on one side, and Pfizer/BioNTech on the other, over patents covering mRNA vaccines used during the Covid-19 pandemic, has resulted in a mixed ruling following two recent decisions from the High Court in England and Wales, both issuing on 2 July 2024. In the first judgement, the UK High Court found that Moderna’s European patent, EP3,590,949 (“EP ‘949”), which covers modified mRNA structures, is valid and infringed by Pfizer/BioNTech’s Covid-19 vaccine called “Comirnaty”. However, the Judge also found that another of Moderna’s patents, EP3,718,565 (“EP ‘565”), which covers a coronavirus mRNA vaccine formulated in a lipid nanoparticle (LNP), was invalid. On the same day, the Court also made a second judgement, this time relating to Moderna’s patent pledge which they made on 8 October 2020, in which they stated (in a piece of “positive PR”) that they would not enforce their Covid-19 patents against anyone developing vaccines to help stop the pandemic. In this decision, however, it was found that Moderna’s pledge was effectively withdrawn by their subsequent statement on 7 March 2022, which resulted in patent infringement by Pfizer/BioNTech after this date. These UK decisions are the latest in a global legal battle between these companies, with parallel proceedings taking place in several jurisdictions, including the U.S., the Netherlands, Germany, Belgium, Ireland, and before the European Patent Office.

Background

The dispute began in 2022, when Moderna sued Pfizer/BioNTech, alleging that Pfizer/BioNTech’s “Comirnaty” vaccine, infringed two of Moderna’s patents, EP ‘949 and EP ‘565. In response, Pfizer/BioNTech launched proceedings against Moderna in an attempt to revoke EP ‘949 and EP ‘565, claiming that they were invalid. Infringement was not considered in the first UK judgement, and was effectively admitted, with Pfizer/BioNTech not disputing infringement on any interpretation of the claims of both EP ‘949 and EP ‘565. The validity of Moderna’s two patents was considered by High Court Judge, Mr Justice Meade ([2024] EWHC 1695 (Pat)).

EP ‘949

The first patent, EP ‘949, relates to a modified form of mRNA, in which the uracil bases are replaced with N1-methyl-pseudouridine (m1Ψ), in order to increase protein translation and stimulate a stronger immune response. The main claims of EP ‘949 at issue were claims 3 & 5, both of which Moderna said were valid and infringed.

Independent claim 3 of EP ‘949 reads:

“An mRNA wherein 100% of nucleotides comprising uracil in the mRNA are replaced with nucleotides comprising N1-methyl-pseudouridine.”

Claim 5 of EP ‘949 is drawn to:

“An mRNA according to any of claims 3 or 4 comprising a polyA tail.”

Pfizer/BioNTech attempted to revoke EP ‘949 for lacking novelty over WO 2007/024708 A2 (“UPenn”), and for being obvious over UPenn or an article by former BioNTech employee (and 2023 Nobel Prize winner), Katalin Karikó (Karikó 2008). Firstly, Pfizer/BioNTech argued that the subject matter of claims 3 and 5 lacks novelty in view of UPenn. However, the Judge disagreed and found that m1Ψ was only one compound in a long list disclosed in UPenn, with no indication that it was preferred, which would have been required were it to be novelty-destroying. Additionally, the Judge found that there was no disclosure in UPenn to replace 100% of the uracil bases in an mRNA strand, as claimed by EP ‘949. Therefore, the Judge rejected Pfizer/BioNTech’s novelty attack.

The Judge next considered whether the subject matter of EP ‘949 lacked an inventive step. Pfizer/BioNTech argued that the data for pseudouridine (Ψ) in UPenn was promising, and that, therefore, the skilled person would have explored other nucleoside modifications, especially those similar to Ψ, including specifically m1Ψ. Pfizer/BioNTech further argued that had the skilled person made m1Ψ, it would then have been obvious to modify 100% of the uracils in mRNA (as per claim 3), and to include a polyA tail (as per claim 5). However, the Judge disagreed and found that UPenn did not direct the skilled person towards using pseudouridine derivatives, such as m1Ψ, nor did it give any explanation as to why pseudouridine worked so well. Indeed, the Judge alleged that the skilled person would have to resort to “blind trial and effort with no idea of what is likely to succeed or why”. Furthermore, the Judge agreed with Moderna that a review article about the use of pseudouridine in RNA, would have taught the skilled person away from the use of m1Ψ. The Judge also considered Karikó 2008, and found that this document overlapped significantly with UPenn, and similarly did not teach the skilled person to use m1Ψ.

The Judge, therefore, concluded that EP ‘949 was not obvious over either prior art document, and so found the patent to be valid.

EP ‘565

Moderna’s second patent, EP ‘565, relates to a (beta)coronavirus mRNA vaccine formulated in a lipid nanoparticle (LNP), and its use to target betacoronavirus disease, i.e. COVID. Claims 1, 2, 6, 7 and 10 of EP ‘565 were at issue.

Claim 1 of the granted patent is as follows:

“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.”

Pfizer/BioNTech challenged EP ‘565 for added subject matter, and for lacking novelty and inventive step over an earlier Moderna PCT application, WO 2016/164674 (“WO ‘674”). In short, the Judge concluded that EP ‘565 is obvious over WO ‘674, and therefore, only dealt with the issues on novelty and added matter briefly. In doing so, the Judge noted that he would have concluded that EP ‘565 is novel over WO ‘674, but is invalid for added matter.

When considering inventive step, the Judge agreed with Pfizer/BioNTech, concluding that coronaviruses were widely regarded as important vaccine targets, especially for SARS and MERS, and that it was recognised that there was a high risk of outbreaks that would need to be addressed quickly. The Judge also considered that WO ‘674 provides a clear pointer towards developing an effective coronavirus mRNA vaccine based on the Spike protein using the LNP platform, and so he concluded that EP ‘565 was obvious over WO ‘674.

Moderna’s Patent Pledge

A separate UK High Court trial, adjudicated by Judge Richards, dealt with the patent pledge which Moderna made at the start of the pandemic on 8 October 2020 ([2024] EWHC 1648 (Pat)), in which they stated that “while the pandemic continues, Moderna will not enforce our COVID-19 related patents against those making vaccines intended to combat the pandemic”.

The main issue related to the duration over which patent pledge was understood to operate. Moderna argued that the pledge was withdrawn by their subsequent public statement, which they made on 7 March 2022, stating: “Moderna is now updating our patent pledge to never enforce our patents for COVID-19 vaccines against companies manufacturing in or for the 92 low- and middle- income countries”. In contrast, Pfizer/BioNTech argued that Moderna’s pledge remained in force until 5 May 2023, the date on which the World Health Organisation (WHO) Emergency Committee declared that Covid-19 no longer constituted a public health emergency.

The Judge found that Moderna’s initial 8 October 2020 statement did provide Pfizer/BioNTech with non-contractual consent to perform otherwise infringing acts under Section 60 of the UK Patents Act, by selling Comirnaty. However, the Judge dismissed Pfizer/BioNTech’s arguments, and instead found that the pledge was in force until 7 March 2022, when Moderna’s second statement withdrew the original pledge, and not 5 May 2023.

Moderna have not claimed injunctive relief, but, subject to any appeals, Pfizer/BioNTech may be liable to pay damages to Moderna for the UK sales of Comirnaty that took place from 8 March 2022, when Moderna’s pledge was withdrawn.

Final thoughts

It remains to be seen whether the parties will appeal the UK High Court’s decisions, though Pfizer/BioNTech are expected to appeal the ruling of EP ‘949. These UK High Court decisions are mostly in Moderna’s favour, however, this is just one part of a wider, global patent battle. Moderna were also successful at the EPO in May 2024, where the Opposition Division (OD) upheld EP ‘949 in amended form. In particular, the OD held that EP ‘949 should be limited to claim 3 as granted, and as such, these amendments do not affect the claims on which Moderna bases its lawsuit in the UK. Conversely, in December 2023, the District Court of The Hague in the Netherlands found EP ‘949 to be invalid for lack of novelty. Therefore, it will be interesting to see if the decisions of other courts, including the German, Belgian, Irish and US courts, will be similar to these recent UK decisions.

Venner Shipley has several attorneys specialising in vaccine patents, in particular, in the RNA vaccine space, and we will provide further updates as the “patent war” continues.