2026-11-10 - LD The Hague - GlaxoSmithKline v. Pfizer et al. - UPC-CFI-0001511/2025
- Aktenzeichen:
- UPC-CFI-0001511/2025
- Datum:
- Spruchkörper:
- Court of First Instance - The Hague (NL) Local Division
- Art:
- Decision
- Parteien:
- GlaxoSmithKline Biologicals SA v. C.P. Pharmaceuticals International C.V., Pfizer Export B.V., Pfizer B.V., Pfizer Manufacturing Belgium N.V., Pfizer Service Company B.V./S.r.l., Pfizer S.A./N.V., Pfizer Luxembourg SARL, Pfizer Inc., Pfizer Corporation Austria Gesellschaft m.b.H, Pfizer ApS, Pfizer Oy, Pfizer S.A.S., Pfizer Pharma GmbH, Pfizer S.r.l., Laboratórios Pfizer, Lda., Pfizer Romania S.R.L., Pfizer AB, Pfizer, spol. S.r.o., Pfizer Hellas A.E., Pfizer, S.L., Pfizer Croatia d.o.o., Pfizer Gyógyszerkereskedelmi Kft., Pfizer Polska Sp. Z.o.o., Pfizer Trading Polska Sp. Z.o.o., Pfizer AG, Pfizer AS, BioNTech SE, BioNTech Europe GmbH, BioNTech Manufacturing GmbH, BioNTech Manufacturing Marburg GmbH
Kernaussage: 1.
2026-11-10 - LD The Hague - GlaxoSmithKline
v.
Pfizer et al.
UPC-CFI-0001511/2025
1. Patent on liposomes for RNA vaccine delivery held (mostly) valid and infringed.
2. The claimed range of pKa 5.0-6.8 is not to be interpreted as containing rigid cut-off limits
in the present case. The claim, which includes a specific measurement method, should be
read together with the description which contains a reference to a measurement
imprecision for this method of +-0.2 pKa units.
3. The patent is entitled to partial priorities. The patent may rely on P1 (US830) for the range
of pKa 5.0-6.7 (so partially according to G1/15), with date 6 July 2010 and for the claim with
upper pKa limit 6.8 on P2 (US 837), dated 31 August 2010.
4. WO799 which discloses DLinDMA (pKa 5.8) is not intervening prior art in the sense of Art.
54.3 EPC for the relevant range of pKa 5.0-6.7. Both the patent (in view of P1) and WO799
can invoke as earliest date 6 July 2010. This means that WO799 does not have a date prior
to the (partial) priority date of the patent.
5. For the assessment of novelty, the claims of a prior art patent or patent application form
an integral part of its technical disclosure and must be read together with the description.
This does however not mean that any combination of (features from) claims of a prior art
patent necessarily forms a direct and unambiguous disclosure of the subject-matter of this
combination, in particular if the combination implies a(n arbitrary) selection. When the
combination is not unambiguously derivable for the skilled person, it is not an enabling
disclosure that anticipates the patent at issue. What matters is whether the skilled person
understands that such an assembly of (features from) claims is disclosed and reflects the
technical teaching of the document (see EPO BoA T 1658/12).
6. Common General Knowledge (CGK) is not primarily related to a specific document, but
rather to a specific knowledge. This knowledge is typically found in textbooks that
introduce the field of technology in question. For information to qualify as CGK, it should
be present in more than one document. In highly specialised areas, the document may be
a review article, handbook or handbook chapter. However, the issue is not whether the
information asserted to be CGK is contained in a well-known and widely accepted
document. To determine the scope of CGK, the real issue is whether the relevant factual
information is so elementary, convincing and consensual that a person skilled in the
2
relevant field will necessarily know it and whether the relevant community has accepted it
as an established empirical fact.
7. The interdependent, integrated and centrally controlled operational structure of PBNT
means that individual subsidiaries, including the (thirty) Defendants, perform or contribute
as joint infringers, to infringing acts which concern various jurisdictions, without the precise
scope of the infringing or contributory act of each individual Defendant being
distinguishable. Infringing acts in the Relevant Territory are however, jointly attributable
to the Defendants.
8. Jurisdiction and territorial scope of the injunction and other measures extend to all EPC
countries where the patent is valid, with the exception of Ireland and the UK.
RNA vaccines, partial priority, common general knowledge, joint infringement, longarm
jurisdiction.
notable
The The Hague Local Division held GSK's patent on liposomes for RNA delivery valid except for claim 13 and infringed by Pfizer and BioNTech's Comirnaty vaccines, granting an injunction for all EPC states except Ireland and the UK. On claim construction, a claimed numerical range tied to a measurement method in the description includes the method's stated imprecision; on priority, the Court applied partial priority under G 1/15 so that an application with the same effective date was not prior art under Art. 54(3) EPC. On inventive step, it adopted a restrictive concept of common general knowledge: information qualifies only if it is so elementary, convincing and consensual that the skilled person necessarily knows it, which a single recent review or patent publication cannot establish; claim 13, a medical-use claim, was insufficient because a protective immune response was not credible across the claimed breadth of RNA. On jurisdiction, defendants domiciled in UPC territory are subject to universal jurisdiction under Art. 4 Brussels I, and centrally coordinated group entities serve as anchor defendants under Art. 8(1) Brussels I for the other EU, Lugano and US defendants; the integrated group structure made all defendants joint infringers, and the injunction for non-UPC EU and Lugano states issued under the condition subsequent set by the CoA in Fujifilm v Kodak. Applying proportionality, the Court granted the injunction as the rule but deferred its enforceability until a final decision plus three months to obtain a licence, as the non-practising patentee itself requested.
Nichtigkeitsgründe
Art. 138 EPCNovelty
Patent survived (this ground)Art. 54 EPC · Art. 138(1)(a) EPC
“Novelty over WO748 failed because combining claims 1, 4, 5 and 11 required an arbitrary selection of DC-Chol and amounted to mosaicking ([141]-[145]); WO799 was not Art. 54(3) EPC prior art because it shared the partial priority date of 6 July 2010 ([146]-[147]).”
Inventive Step
Patent survived (this ground)Art. 56 EPC · Art. 138(1)(a) EPC
“All three attacks failed: WO748 and WO152 were not realistic starting points and gave no pointer to RNA or to the pKa range; Martinon was a realistic starting point but neither it nor the narrowly defined CGK pointed to an ionisable cationic lipid with the claimed pKa ([184]-[200]).”
Insufficiency of Disclosure
Patent invalid (this ground)Art. 83 EPC · Art. 138(1)(b) EPC
“The attack, directed at claim 13 only, succeeded: as a medical-use claim it required the protective immune response to be credible, which the srRNA-only data did not make credible for non-self-replicating mRNA or across the pKa range; claim 13 revoked ([201]-[209]).”
Priority
Patent survived (this ground)Art. 87 EPC · derivative
“The attack on priority failed: under G 1/15 the patent was entitled to partial priority from P1 (6 July 2010) for pKa 5.0-6.7 and from P2 (31 August 2010) for the upper limit 6.8 ([134]-[138]).”