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21 May 2024NewsBiotechnologyMarisa Woutersen

Moderna prevails in COVID-19 vaccine row at EPO

Despite attempts by Pfizer and BioNTech to invalidate the patent, the ruling strengthens Moderna’s position in ongoing global litigation | Pfizer is considering an appeal, while BioNTech remains steadfast in defending its innovations.

Moderna has scored a win over Pfizer and BioNTech in Europe in its global dispute concerning its COVID-19 vaccine technology.

In an oral verdict delivered on May 16, the European Patent Office (EPO) upheld the validity of one of Moderna's patents in its COVID-19 vaccine, Spikevax, a development first reported by the Financial Times.

Pfizer and BioNTech had attempted to invalidate Moderna’s European Patents EP (UK) 3 590 949.

The ‘949 patent describes and protects specific alterations to mRNA molecules designed to lower its immunogenicity, bypass the immune system and boost its translation in the body—as well as the potential uses of the modified mRNA.

The pair now have two months to appeal the EPO’s decision—an action Pfizer is considering, according to the Financial Times.

BioNTech said in a statement to the media outlet, that despite the verdict, it will “continue to vigorously defend our innovations against all allegations of patent infringement including this case”.

Case background

In 2022, Moderna filed lawsuits against the pair across Europe and in the US. Moderna alleged that the defendants had infringed and intended to continue infringing EP ‘949 and EP (UK) 3 718 565.

It claimed that Pfizer and BioNTech obtained significant benefits from the sale of infringing products and sought compensation for acts of infringement after March 7 2022.

In September 2022, Pfizer and BioNTech also raised challenges against the validity of the patents.

For EP 949, Pfizer and BioNTech argued that claims one and three lack patentability as they were not new at the priority date of the patent.

They claimed that the inventions described in the patent were already part of the public domain based on prior art.

Additionally, they argued that none of the claims of EP 949 involve an inventive step.

The subject matter of the patent was obvious to a person skilled in the art given the state of the art and common general knowledge available at the time, according to BioNTech and Pfizer.

In December 2023, the EPO invalidated the ‘565 patent which protects respiratory virus vaccines.

Ongoing global litigation

Litigation over the patents and additional patents is ongoing in the US, Germany, the Netherlands, Ireland, Belgium, and the UK.

The trials in the UK commenced in April 2024, where the Chancery Division of the High Court heard claims by Moderna accusing BioNTech and Pfizer of infringing its mRNA technology vital to Spikevax.

Moderna wants a share of the profits from its two competitors' vaccine, Comirnaty, which it will receive if it successfully proves patent infringement in the court—a decision yet to be handed down.

The case not only concerned a dispute over Moderna’s patents but revolved around Moderna’s October 2020 pledge not to enforce its COVID-19-related patents against those making vaccines intended to combat the pandemic “while the pandemic continues”.

Over in the US litigation, a Massachusetts federal judge granted a stay on the case, on April 12, 2024, pausing it until the resolution of two inter partes review proceedings initiated by the Patent Trial and Appeal Board (PTAB).

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More on this story

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16 May 2024   As the company challenges Pfizer and BioNTech over COVID-19 vaccine patents, issues over the enforceability of pledges made during the pandemic may make pharma think twice in future, finds Marisa Woutersen.
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19 September 2023   Moderna alleges that rivals’ vaccine infringes patents filed covering a foundational mRNA technology | Big pharma firm must “specifically describe” awareness of Moderna's work in the mRNA vaccine sphere before the end of the month.