Covid vaccine makers to clash in London over mRNA patent dispute

Moderna will clash with Pfizer and BioNTech in a pivotal London patent trial over the development of Covid-19 jabs that will help determine who pioneered the technology behind the coronavirus vaccines that saved millions of lives in the pandemic.

The High Court is due on Tuesday to hear a legal complaint brought by Moderna, which alleges that its competitors infringed two of its patents in their use of the mRNA platform that was key to their vaccines. BioNTech and Pfizer have said the patents are invalid.

The case is the latest in a series of intellectual property battles that companies are fighting around the world over mRNA technology, which has helped generate billions in revenues for the pharmaceuticals industry.

If successful, Moderna would be in line for a share of the profits Pfizer and BioNTech generated from their joint vaccine, Comirnaty. Legal experts said the London ruling could also influence litigation in other jurisdictions — and boost the reputations of the winners.

“This is a legal battle, but it’s a PR battle in many ways,” said Ana Santos Rutschman, a law professor at Villanova University in the US state of Pennsylvania, who is an expert in life sciences intellectual property. “It’s about becoming the lead player in the mRNA field.”

Moderna, Pfizer and BioNTech were three of the biggest corporate winners from the pandemic, with their jabs the widest used across the world.

Moderna generated sales of $18.4bn in 2022 from its Spikevax vaccine. Germany-based BioNTech struck a deal with Pfizer to help develop and commercialise Comirnaty and the two companies agreed to split profits. Pfizer generated $37.8bn in sales from the vaccine in 2022 and BioNTech €17bn.

The vaccines were the first to use mRNA technology. Messenger ribonucleic acid is one of the body’s building blocks, a genetic code that instructs cells to create proteins.

The Covid vaccines that used MRNA instructed cells to recreate the so-called spike protein that the Sars-Cov-2 virus uses to enter cells. This primes the body to recognise the virus if infected and make an immune response.

In legal cases being run simultaneously across Europe and the US, Moderna is not seeking to stop the use of the BioNTech/Pfizer vaccine but it wants judges to declare its patents have been infringed and ultimately to receive compensation.

In its London lawsuit filed with the High Court, Moderna said BioNTech and Pfizer had obtained “significant benefits” from the sale of “infringing products”.

Earning some royalties from Comirnaty would help compensate for falling sales of Spikevax, Moderna’s only commercialised product, which declined to $6.7bn last year as demand for protection against Covid has faded.

“The sales of these products have fallen off a cliff so it’s all about past damages. BioNTech [also] doesn’t have any other products so it’s a lot of cash to have to pay,” said Christopher Sharp, an IP lawyer at Pinsent Masons.

While money from Covid vaccine sales is a key driver of the dispute, the patent battle could prove influential for the development of future mRNA-based products.

One of the disputed patents is specific to respiratory virus vaccines based on mRNA technology. The other is more “foundational” for how mRNA treatments are delivered, said Charlie French, an intellectual property lawyer at London law firm Bristows. “Potentially, this is much broader than Covid vaccines or vaccines in general.”

The patent that Moderna filed in 2011 relates to how mRNA can be tweaked to reduce the immune response when it is introduced into cells. BioNTech and Pfizer have described a similar patent filed in the US as “unimaginably broad” in American proceedings.

Clarifying which companies are responsible for innovations will be “even more important” as pharma companies explore uses for mRNA in cancer, autoimmune diseases and other viruses, said Anna Wolters-Höhne, a partner at Allen & Overy, who expects more “patent battles” as the technology matures.

Innovations and “high economic expectations” around the technology have led to 2,300 mRNA-related inventions as of 2021, according to the European Patent Office, with Moderna filing 96 sets of patents, the highest of any company.

While a verdict in the London case is not expected until the summer, decisions in some others have gone against Moderna. The European Patent Office in November declared the company’s 2016 patent invalid, while in Dutch proceedings in December judges declared the 2011 patent invalid. Moderna is appealing against the rulings and litigation is expected to drag out over the years ahead.

Another case in the federal court of Massachusetts has recently been paused pending a decision by the US Patent Office on whether two of three Moderna patents under dispute there are valid.

But judges elsewhere have yet to rule on a key element of the London case that will be watched more widely: a dispute centred on when the Covid pandemic ended.

In October 2020, Moderna pledged not to enforce intellectual property rights for vaccines “intended to combat the pandemic”. Moderna then amended the pledge in March 2022 to say that in wealthy countries it expected rivals to “respect” its intellectual property and that it was willing to license its technology “on commercially reasonable terms”. It is for after this period that it is seeking damages.

Pfizer and BioNTech will dispute Moderna’s ability to withdraw the pledge when it did, given the World Health Organization did not declare the end of the “global health emergency” until March 2023.

The question will be discussed in a parallel trial starting in May. Such pledges have been made in other industries such as technology, with software groups offering not to enforce their rights to help facilitate the development of open source platforms.

Any verdict could be significant for other European courts under the European Patent Convention, lawyers said, although they will reach their own conclusions on the validity of Moderna’s commitment.

“The pledge is fascinating: it’s not something we’ve ever seen before in a dispute in the UK,” said Sharp. “It’s clearly very important because this is the first one going to trial. The Irish court when they get to this, the Dutch court, the Belgian court, more likely than not are going to follow the English court’s approach.”

Additional reporting by Oliver Barnes in New York