BioNTech wins round in CureVac mRNA patent dispute

Shares in CureVac have plummeted after a German court ruled that a patent it holds on mRNA-based COVID-19 vaccines was invalid.

The validity of the patent is at the heart of patent litigation between CureVac and fellow German biotech BioNTech and its partner Pfizer, claiming infringement by their Comirnaty coronavirus shot.

CureVac – which is developing mRNA-based vaccines for COVID-19 and influenza with GSK – filed suit in the Düsseldorf Regional Court last year, claiming infringement of five patents.

A judgment on four of those was deferred until next year, with the remaining one due for a verdict on 28th December. That is now unlikely to take place after the ruling on the fifth patent (EP 1 857 122 B1) by the German Federal Patent Court, the result of a bid to strike it down filed by BioNTech.

The invalidation has come out of the blue for CureVac, which said earlier in the year that the patent court had supported its position in earlier opinions.

In a statement, the company said it plans to appeal the verdict before the German Federal Court of Justice and insisted it does not affect “ongoing litigation in Germany regarding seven other intellectual property rights.” However, that did not stop a run on its shares that drove down their value by around 40%.

The German and EU patents at issue cover the engineering of mRNA molecules, including sequence modifications to increase stability and enhance protein expression, as well as mRNA formulations specific to SARS COV-2 vaccines.

“We consider the patent court’s decision unfortunate also in view of the positive preliminary opinion on EP 1 857 122 B1 the court provided earlier this year,” commented Dr Alexander Zehnder, CureVac’s chief executive.

He stressed, however, that the decision “is only one of many that will be made regarding the use of CureVac’s intellectual property in the development of Comirnaty.”

The Tübingen-based company was unable to bring a COVID jab to market during the pandemic after a false start in its development programme, but it is continuing to work with partner GSK on monovalent and bivalent, modified mRNA vaccine candidates for various respiratory diseases.

“While we do not seek to diminish the value of mRNA vaccines in changing the course of the COVID-19 pandemic, we strongly believe that CureVac’s role in laying the scientific groundwork for those vaccines needs to be recognised,” said Zehnder.

“We will continue to defend our claim for recognition and fair compensation and will take appropriate action by appealing this decision.”

In the US, Pfizer and BioNTech filed a lawsuit against CureVac in July 2022, seeking confirmation that Comirnaty does not infringe three CureVac patents, and the latter has since filed a counterclaim referencing 10 patents.

BioNTech welcomed the German patent court’s decision, saying “We will continue to vigorously defend our innovations against all allegations of patent infringement including this case.”

A judgment that Comirnaty infringed CureVac’s patents could result in a big financial windfall for the company, given cumulative, global sales of Comirnaty are on track to reach upwards of $80 billion.