Novartis’ imminent infringement suit against Celltrion fails

Celltrion will not face a PI from the Unified Patent Court against its biosimilar of Novartis' asthma drug Xolair. Today, Düsseldorf local division dismissed the PI application by Novartis and Genentech as there is no imminent threat of infringement. The parties will fight another round in the Netherlands in October over the validity of Novartis' patent.

At the end of July, Düsseldorf local division held a PI hearing concerning imminent infringement. Claimants Novartis and Genentech had challenged defendant Celltrion over the formulation patent EP 3 805 248. The patent is in force in all UPC contracting member states except for Malta.

The patent belongs to Novartis and Genentech and covers a specific formulation of the active ingredient omalizumab. It allows the stable storage of the monoclonal antibody in liquid form for administration in pre-filled syringes, for example. Previously, omalizumab was only marketed in solid form as a powder that had to be dissolved in liquid before each application. The active ingredient forms the basis for Novartis’ biologic Xolair, which is used to treat allergic asthma and chronic hives.

Preparations for market entry

The two patent holders accuse Celltrion of wanting to bring a biosimilar of Novartis’ Xolair onto the market despite the fact that patent protection still exists (case ID:  UPC_CFI_165/2024 and UPC_CFI_166/2024). The EPO granted EP 248 in 2023 but Celltrion believes it is invalid. The company filed an opposition at the EPO and revocation actions at the UK High Court and the District Court The Hague.

In the Düsseldorf hearing, Novartis and Genentech presented various evidence which they believe pointed towards imminent infringement by Celltrion. Among other things, Celltrion had applied for market authorisation for the EU for a biosimilar containing the patented formulation, marketed under the brand name Omlyclo. Celltrion received authorisation for its Hungarian subsidiary in May 2024.

The patent holders applied to the UPC for an injunction to prevent an actual infringement. However, Celltrion rejected the accusation. The company argued it was merely preparing for a timely market entry for its biosimilar once EP 248 expires.

Not yet infringed

Now presiding judge Ronny Thomas, judges Bérénice Thom and Alima Zana, and technical judge John Petersen have dismissed Novartis’ application for provisional measures. The judges ruled that “at the time of the Court’s order, there is not yet sufficient evidence that the infringement is imminent.”

But they also pointed out that Celltrion’s formulation makes use of the technical teaching of EP 248 and that eight Celltrion subsidaries are cumulatively liable for their actions. Therefore, in the opinion of the court, Celltrion is currently protected above all by the fact that it is not yet marketing its own product.

Pre-launch steps not fulfilled

In their reasoning, the judges stated that an infringement can only be considered imminent if all pre-launch preparations have been completed to such a degree that an offer can be made at any time. In the present case, the judges “cannot find that the Defendants have already completed all the pre-launch preparations”.

The judges stated, “It is true that the Defendant obtained a marketing authorisation for the challenged embodiment. And the Defendant clearly promoted the challenged embodiment at the EAACI Congress (…) However, this advertising message did not show any specific timeline and there is no specific information that any price negotiations or reimbursement applications by the Defendants have already started or are ongoing. Nor is there any specific situation in which samples were actually presented to potential customers.”

The case had also attracted interest in the industry because it was unclear whether the UPC was responsible for the imminent infringment issue at all. Celltrion had disputed this, arguing that its previous activities had no connection to UPC territory. However, the Düsseldorf judges rejected this argument and unequivocally affirmed the UPC’s jurisdiction.

Additionally, the court ordered the claimants to pay interim costs of around €139,000,00. It also set the value in dispute at €7,500,000.

Next stop The Hague

Furthermore, Celltrion had also questioned the validity of EP 248. However, the UPC judges did not comment on this. Celltrion must now hope for a better outcome at the District Court of The Hague in October. Celltrion has initiated a revocation action in the Netherlands against the Dutch part of EP 248 and applied for a declaration of non-infringement (case ID: C/09/660292/24/082).

Meanwhile, the EPO Opposition Division recently stated in its preliminary opinion that the granted claims of EP 248 comply with the EPC and that the oppositions should be rejected. Celltrion has opposed the grant, as has the London patent attorney firm Kilburn & Strode as a straw man. The oral hearing will not take place until early 2025.