BioNTech SE & Anor v CureVac SE & Anor
[2024] EWHC 2538 (Pat)
Modernatx Inc v Pfizer Limited & Ors
2 July 2024
[2024] EWHC 1695 (Pat)
High Court
Imagine two recipes: one for a special cake (EP949) and one for cookies (EP565). The judge found the cake recipe was new and clever. But the cookie recipe wasn't new because a similar recipe already existed, and its improvements were obvious to someone who already knew about making cookies.
Key Facts
- •Two actions concerning the validity of European Patents EP949 and EP565, both asserted against Pfizer/BioNTech's SARS-CoV-2 vaccines.
- •EP949 concerns mRNA with N1-methyl-pseudouridine (m1Ψ) replacing uridine; priority date 1 October 2010.
- •EP565 relates to a betacoronavirus mRNA vaccine formulated in a lipid nanoparticle; filing date 21 October 2016.
- •Infringement was effectively admitted.
- •Parallel proceedings existed in multiple jurisdictions.
Legal Principles
Determining the skilled person: consider the problem the invention solves and the established field where the problem lies.
Illumina v MGI [2021] EWHC 57 (Pat)
Added matter: amendment must be directly and unambiguously derivable from the original disclosure.
Nokia v IPCom [2012] EWCA Civ 567
Novelty: prior art must disclose the same invention.
Synthon v SmithKline Beecham [2005] UKHL 59
Obviousness: consider factors such as motive, avenues of research, effort involved, expectation of success, and whether results are surprising.
Actavis v ICOS [2019] UKSC 15
Individualised description and selection from lists: a large class disclosure is not a disclosure of each member; look for specific teaching.
Dr Reddy’s v Eli Lilly & Co [2010] RPC 9
Outcomes
EP949 is valid.
The court rejected anticipation and obviousness challenges based on UPenn and Karikó 2008. The skilled person would not have been motivated to try m1Ψ based on the prior art, lacking a clear understanding of why pseudouridine worked and facing significant uncertainties in modifying other nucleotides.
EP565 is invalid for added matter and obviousness.
The court found added matter in the claims because the combination of features was not clearly and unambiguously disclosed in the application as filed. Obviousness was established over WO674 because Example 20, proposing a MERS vaccine using the spike protein, combined with the CGK showing significant interest in developing coronavirus vaccines, made this a straightforward path for a skilled team.