Düsseldorf Regional Court waits for validity judgments in CureVac v BioNTech

Tuesday marked the start of the high-profile infringement trial between CureVac and BioNTec over mRNA patents. Düsseldorf Regional Court's 4c Civil Chamber heard CureVac's claims on two patents and three utility models. The judges will wait for the German Federal Patent Court to hand down its ruling on validity in December before ruling on a basic patent of CureVac.

CureVac accuses BioNTech of infringing two patents and three utility models with its mRNA vaccine Comirnaty. CureVac filed lawsuits last summer over the EP 1 857 122 B1 and the utility models DE 20 2015 009 961 U1, DE 20 2015 009 974 U1 and DE 20 2021 003 575 U1. In spring, CureVac then filed a further suit for EP 3 708 668 B1.

EP 122, a basic patent which the European Patent Office granted in 2010, protects a process that improves the expression of mRNA in cells. BioNTech challenged the patent with a nullity suit (case ID: 3 Ni 23/22). In April 2023, the German Federal Patent Court issued a preliminary opinion confirming the validity of EP 122.

However, the patent court may still revise this opinion. A decision on the patent’s validity is expected on 19 December 2023. Consequently, the judges at Düsseldorf Regional Court’s 4c Civil Chamber have scheduled a ruling in the infringement case concerning EP 122 for 28 December (case ID: 4c O 38/22).

A Christmas on tenterhooks

During oral proceedings, the bench around presiding judge Sabine Klepsch refused to be drawn on whether BioNTech infringes the patent. In view of the Federal Patent Court’s positive preliminary decision, CureVac’s lawyers urged the judges not to wait for the patent court’s final decision and to rule quickly on infringement. In the end, however, Düsseldorf Regional Court held fast to its decision to stay proceedings on EP 122 until the Federal Patent Court has ruled on the patent’s validity.

BioNTech may then face a conviction for infringement and a claim for damages ranging into the millions. However, it is still possible that the judges will dismiss the case.

Suspension likely

Düsseldorf Regional Court has scheduled its judgment concerning all three utility models (case IDs: 4c O 46-48/22) and patent EP 668 (4c O 51/22) for 28 September.

BioNTech has also challenged the three utility models and filed cancellation actions with the German Federal Patent Court. The court has not yet scheduled oral hearings. The EPO only granted EP 688 in June 2022. Pfizer, BioNTech, Sanofi and the law firm Cooley, acting as a straw man, filed opposition suits.

As the Federal Patent Court has not yet finally confirmed the validity of the four property rights, experts believe Düsseldorf Regional Court will suspend the infringement proceedings in September.

Although CureVac argues that BioNTech’s Covid19 vaccine Comirnaty infringes its IP rights, the plaintiff is not seeking injunctive relief in Germany. CureVac is primarily seeking information and accounting for the use of mRNA technology to produce the vaccine and a share of the sales, estimated at several billion US dollars, that BioNTech and its US partner Pfizer have generated – and will continue to generate – worldwide with Comirnaty.

CureVac escalates US litigation

Meanwhile, the dispute has also expanded in the US. In 2022 BioNTech and partner Pfizer filed suit against CureVac in the US. The aim of the lawsuit filed at the District Court of Massachusetts is a declaratory judgment that the mRNA vaccine Comirnaty does not infringe CureVac’s US patents (US 11,135,312; US 11,149,278; and US 11,241,493). The case has now been transferred to the Eastern District of Virginia at CureVac’s request with the goal of expediting the litigation. According to CureVac’s press release, a trial could take place as early as 2024.

At the same time, CureVac sued for infringement of nine of its patents (US 11,135,312; US 11,149,278; US 11,286,492; US 11,345,920; US 10,760,070; US 11,241,493; US 11,471,525; US 11,576,966 and US 11,596,686), including the three patents that are the subject of BioNTech and Pfizer’s declaratory judgment action.