Covid vaccines: The manufacturers’ legal battles – Economic Mail

mRNA vaccines for Covid have been a lifesaver for millions of people, but at the same time hugely profitable for the manufacturers. So much so that the conflict between the producers inevitably came. Moderna will clash with Pfizer and BioNTech in a crucial patent trial in London over Covid-19 vaccine development that will help determine who pioneered the technology behind the coronavirus vaccines.

The Supreme Court is set to hear on Tuesday a legal complaint filed by Moderna, which claims its competitors infringed two of its patents when using the mRNA platform that was key to their vaccines. BioNTech and Pfizer have said the patents are invalid.

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The case is the latest in a series of intellectual property battles fought by companies around the world over mRNA technology, which has helped generate billions in revenue for the pharmaceutical industry.

If settled, Moderna would be entitled to a share of Pfizer and BioNTech’s profits from their joint vaccine, Comirnaty. Legal experts said the London ruling could also affect disputes in other jurisdictions, and boost the reputation of the winners.

“This is a legal battle, but it’s also a public relations battle in many ways,” Ana Santos Rutzman, a law professor at Villanova University in the US state of Pennsylvania who specializes in intellectual property in health sciences, told the Financial Times.

The winners of vaccines

Moderna, Pfizer and BioNTech have been three of the biggest corporate gainers from the pandemic, with their vaccines widely used around the world.

Moderna has sales of $18.4 billion in 2022 from the Spikevax vaccine. Germany-based BioNTech has entered into an agreement with Pfizer to help develop and commercialize Comirnaty, and the two companies have agreed to share profits. Pfizer made $37.8 billion in sales from the vaccine in 2022 and BioNTech €17 billion.

In other lawsuits across Europe and the US, Moderna is not seeking to stop the use of the BioNTech/Pfizer vaccine, but wants judges to declare that the patents have been infringed and ultimately receive damages.

Comirnaty’s acquisition of some rights will help offset falling sales of Spikevax, Moderna’s sole commercialized product, which fell to $6.7 billion last year as demand for Covid protection has waned.

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

Moderna’s patent

Moderna’s 2011 patent relates to how mRNA can be modified to reduce the immune response when introduced into cells. BioNTech and Pfizer have described a similar patent filed in the US as “unimaginably broad” in US proceedings.

Clarifying which companies are responsible for the innovations will be “even more important” as drug companies explore uses for mRNA in other diseases, and more “patent battles” are expected as the technology matures.

Innovations and “high financial expectations” around the technology led to 2,300 mRNA-related inventions by 2021, according to the European Patent Office, with Moderna filing more applications than any other company.

While a verdict in the London case is not expected until the summer, other rulings have gone against Moderna.

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

In October 2020, Moderna pledged not to enforce intellectual property rights on vaccines “intended to combat the pandemic.” Moderna then amended the pledge in March 2022, saying that in rich countries it expected competitors to “respect” its intellectual property and that it was willing to license its technology “on commercially reasonable terms.” It is after this time that he seeks compensation. The issue will be discussed in a parallel trial that will begin in May.

Any verdict could be significant for other European courts under the European Patent Convention.