Modernatx Inc v Pfizer Limited & Ors
[2024] EWHC 1695 (Pat)
BioNTech SE & Anor v CureVac SE & Anor
8 October 2024
[2024] EWHC 2538 (Pat)
High Court
CureVac's patents on a special type of RNA were deemed invalid. The court said the patents didn't clearly explain how it worked, and tests showed it didn't always work as claimed. It also said that the idea wasn't new; scientists could have easily thought of it already.
Key Facts
- •CureVac's three patents (EP122, EP668, EP755) concerned split poly(A) tails in mRNA, said to improve protein expression.
- •EP122's validity trial was adjourned.
- •BioNTech/Pfizer's Comirnaty vaccines were not disputed to infringe if the patents were valid.
- •Numerous experiments, including litigation and CEA Notice experiments, were presented.
- •BioNTech/Pfizer argued the patents were invalid for insufficiency (lack of plausibility and lack of effect across the claims), obviousness, and added matter.
- •CureVac argued the split poly(A) tail improved expression by interfering with mRNA degradation.
- •The main dispute centered on whether the patents disclosed this effect, and whether it was plausible and achieved across the claims' scope.
Legal Principles
Plausibility: The specification must disclose some reason for supposing that the implied assertion of efficacy in the claim is true. A mere possibility is insufficient; reasonable scientific grounds are needed.
Warner-Lambert [2018] UKSC 56
Sufficiency: The invention must work across the scope of the claim. The assertion that it will work must be plausible or credible.
Regeneron v Genentech [2013] EWCA Civ 93; Fibrogen v Akebia [2021] EWCA Civ 1279
Plausibility is a separate inquiry from whether the invention actually works. Both must be considered across the claims' scope, but plausibility is only about the patent's date.
MSD v Shionogi [2016] EWHC 2989 (Pat)
Obviousness: Consider the motive to find a solution, possible research avenues, effort involved, and expectation of success.
Actavis v ICOS [2019] UKSC 15; Generics v Lundbeck [2007] EWHC 1040 (Pat)
Added matter: The claims as granted must be clearly and unambiguously disclosed in the PCT application as filed.
Nokia v IPCom [2012] EWCA Civ 567; Modernatx v Pfizer [2024] EWHC 1695 (Pat)
Outcomes
Patents invalid for insufficiency.
The patents did not disclose the alleged technical contribution (improved expression from split poly(A) tails). Even assuming disclosure, the effect was not plausible across the claims' broad scope due to insufficient understanding of mRNA degradation pathways and the lack of evidence showing the effect for substantially all claimed mRNAs. Experiments showed many constructs did not achieve improved expression.
Patents invalid for obviousness over Thess.
The skilled person, motivated by Thess's disclosure of synergistic combination of histone stem loop and poly(A) sequence, would have readily considered and tested split poly(A) tail constructs. The page 61 disclosure in Thess, while not perfectly clear, provided sufficient impetus for this.
Added matter attack fails.
The claims as granted were clearly and unambiguously disclosed in the PCT application. The court found that no new information was disclosed through the combination or selection of features in the claims.