2026-07-07 - LD Munich - Pfizer et al. v. BioNTech et al. - UPC_CFI_846/2024
- Aktenzeichen:
- UPC_CFI_846/2024
- Datum:
- Spruchkörper:
- Court of First Instance - Munich (DE) Local Division
- Art:
- Decision
- Parteien:
- Promosome LLC v. BioNTech SE a.o.
Kernaussage: ENGLISH:
2026-07-07 - LD Munich - Pfizer et al.
v.
BioNTech et al. - UPC_CFI_846/2024
ENGLISH:
1. To assess whether a party is the holder of an “exclusive licence” within the meaning of
Art. 47(2) UPCA, it is decisive whether a licensee is entitled to solely use and to exclude
others, including the patent proprietor, from using the patented invention, which
includes, in the case of an infringement, the right to assert claims. This does not
necessarily mean that the right to use the patented invention can only be licensed to
one exclusive licensee in its entirety and without limitations. An exclusive licence may,
for instance, be limited in terms of its geographical scope, field of use or duration.
2. In order for a prior art disclosure to be relevant for novelty, the disclosure must be such
that the skilled person can reproduce it using common general knowledge, i.e. the
skilled person must be able to carry out the teaching of the prior art. Absent such an
enabling disclosure, there is no (complete) technical teaching in the prior art and hence
no potentially novelty-destroying disclosure.
3. In case of a mere aggregation of two independent methods, whereby the features of
these methods do not interact functionally to produce an effect that goes beyond mere
addition in solving the objective problem but are simply juxtaposed, the combination of
these two methods, both being not novel or at least non-inventive, cannot be held
inventive. The skilled person would, as a matter of routine, combine these two
Methods.
landmark
The Munich LD (Panel 2) revoked EP 2 401 365 (mRNA reengineering for increased protein production, the patent asserted against BioNTech/Pfizer's Comirnaty COVID-19 vaccines) in its entirety and dismissed both the infringement action and the conditional application to amend across 25 auxiliary requests. Granted claim 1 lacked novelty over both D2 (Matsuda — the second start codon of a bicistronic construct is a 'secondary initiation codon' within the claim) and D1 (WO '374), the Court holding that prior art is only novelty-relevant if it is an enabling disclosure the skilled person can reproduce (Headnote 2). All auxiliary requests failed on inventive step, added matter or clarity — notably AR4 (combining secondary-codon mutation with the miRNA method) was a mere aggregation of two functionally independent methods and therefore not inventive (Headnote 3, applying the CoA Amgen/Sanofi and Meril/Edwards framework). Even had the patent been valid, infringement failed: the exclusive licensee did not prove that any *actual* (as opposed to merely putative) secondary initiation codon was mutated in Comirnaty, because the observed expression increase was attributable to ordinary codon optimisation. On standing the Court gave an autonomous good-faith interpretation of Art. 47(2) UPCA, holding an exclusive licence may be limited by geography, field of use or duration and still confer standing (Headnote 1).
Nichtigkeitsgründe
Art. 138 EPCNovelty
Patent invalid (this ground)Art. 54 EPC · Art. 138(1)(a) EPC
“Granted claim 1 held not novel over D2 (Matsuda) and D1 (WO 91/01374). The second initiation codon of a bicistronic construct qualifies as a 'secondary initiation codon' within the claim [150-158]; D1's teaching to eliminate internal initiation without altering the amino acid sequence discloses all features in an enabling way [159-186]. Revocation ground succeeded.”
Inventive Step
Patent invalid (this ground)Art. 56 EPC · Art. 138(1)(a) EPC
“All auxiliary requests failed for lack of inventive step over D1 (alone or with D3). AR4 (claim 1 + miRNA method of granted claim 10) is a mere aggregation of two functionally independent methods and therefore obvious — the skilled person would combine them as a matter of routine [231-249], applying the CoA Amgen/Sanofi and Meril/Edwards framework [197-208].”
Added Matter
Patent invalid (this ground)Art. 123(2) EPC · Art. 138(1)(c) EPC
“AR2 (requiring mutation of at least each of seven specified non-canonical codons) held to add matter: the combined mutation of all seven is not directly and unambiguously disclosed; applying the Fujifilm/Kodak 'specific, individualised embodiment' test [219-221].”
Insufficiency of Disclosure
Not decidedArt. 83 EPC · Art. 138(1)(b) EPC
“Defendants pleaded insufficiency of the granted patent (no guidance to identify actual vs putative secondary initiation codons) [34], but the Court revoked on novelty and did not need to reach Art. 83 EPC for the patent itself. The enabling-disclosure standard was, however, substantively developed in the novelty context [172-180].”