“Moderna, Pfizer, and BioNTech Face Off in London Patent Trial Over Covid-19 Vaccine Technology”

In a landmark case set to shape the future of the pharmaceutical industry, Moderna is set to face off against Pfizer and BioNTech in a pivotal London patent trial over the development of Covid-19 vaccines. The outcome of the trial will determine who pioneered the technology behind the coronavirus vaccines that have saved millions of lives during the pandemic.

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

This case is the latest in a series of intellectual property battles being fought globally over mRNA technology, which has generated billions in revenues for the pharmaceutical industry. If Moderna is successful, it could be entitled to a share of the profits Pfizer and BioNTech generated from their joint vaccine, Comirnaty. Legal experts suggest the London ruling could also influence litigation in other jurisdictions and enhance 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 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 vaccines being the most widely used across the world. Moderna generated sales of $18.4bn in 2022 from its Spikevax vaccine, while Pfizer generated $37.8bn in sales from the vaccine in 2022 and BioNTech €17bn.

The vaccines were the first to use mRNA technology, 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, priming the body to recognise the virus if infected and make an immune response.

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.

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.”

The outcome of this case will undoubtedly have far-reaching implications for the future of the pharmaceutical industry and the development of mRNA-based products. As the world continues to grapple with the Covid-19 pandemic, the stakes have never been higher.