GSK and CureVac settle mRNA patent spat with Pfizer/BioNTech
Given the labyrinth of patent litigation ongoing between companies that were working on mRNA vaccines during the pandemic, a merger agreement between two of them – BioNTech and CureVac – raised questions about how it could be resolved.
Now, it seems the prospect of the merger may actually have unlocked the door to ending the conflict.
CureVac and partner GSK say they have settled a dispute with BioNTech and its partner, Pfizer, over intellectual property (IP) covering mRNA vaccines for infectious diseases, with hundreds of millions of dollars set to change hands.
The complicated legal wrangling has been brought to a close after CureVac and BioNTech settled their mRNA patent litigation in the US – in the wake of BioNTech's recent agreement to acquire its former rival in a $1.25 billion deal.
In the litigation, CureVac had variously accused Pfizer and BioNTech of infringing patents on 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, with the two defendants counter-suing.
If the BioNTech takeover goes through – it is still subject to regulatory approvals – patent disputes outside the US will also be settled, according to the companies.
As part of the settlement, CureVac and GSK will receive $740 million plus single-digit percentage royalties on sales of Pfizer/BioNTech COVID-19 vaccines in the US from the start of this year. In return, Pfizer and BioNTech will get a non-exclusive license to the disputed mRNA IP from CureVac and a release from any liability on mRNA vaccine US sales made prior to 1st January.
CureVac will make an upfront settlement of $370 million to GSK, although separate lawsuits between GSK, Pfizer, and BioNTech are unaffected by the deal.
GSK, meanwhile, has unrelated, ongoing lawsuits against Moderna, which has filed a counterclaim and is also trading legal blows with Pfizer/BioNTech on mRNA vaccine IP.
In a statement, GSK said it would receive $320 million from CureVac in cash, with the remainder going towards "a significant reduction in royalties to be paid by GSK on our potential future mRNA influenza, COVID-19 and influenza/COVID-19 combination products," as well as a 1% royalty on US sales of influenza, COVID-19 and related combination mRNA vaccine products by BioNTech and Pfizer.
Moreover – assuming the BioNTech/CureVac merger completes – GSK stands to receive another $130 million in cash and a 1% royalty on Pfizer and BioNTech vaccine sales outside the US. Pfizer has also agreed to reimburse BioNTech for $80 million and half of the royalties payable to GSK on sales of mRNA-based COVID-19 products going forward if CureVac becomes part of BioNTech.
BioNTech said the settlements "do not in any way constitute an admission of liability with respect to any allegation raised by CureVac or GSK."
