Imminent infringement at the core of Novartis' UPC claim against Celltrion (2024)

The morning of the hearing was muggy, nevertheless room BZ5 at Düsseldorf local division was almost full. Large international teams were in force for both parties. The hearing took place in English and in hybrid form. Several representatives from both sides listened in via video without actively participating.

The case concerns formulation patent EP 3 805 248, belonging to Novartis and Genentech. 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: ACT_18551/2024 UPC_CFI_166/2024 and ACT_18492/2024 UPC_CFI_165/2024).

EP 248 covers a specific formulation of the active ingredient omalizumab. It allows the monoclonal antibody to be stored stably in liquid form so that it can be administered, for example in pre-filled syringes. 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.

In enforcing this patent, Novartis wants to prepare the ground for cases in which circumstantial evidence points to a direct risk of infringement – a borderline case regarding imminent infringement, as the plaintiff puts it.

Biosimilar on the horizon

The plaintiffs’ counsel presented various pieces of evidence, such as statements made by a representative of Celltrion to the head of dermatology of a Belgian hospital that a new biosimilar of omalizumab would be available by the end of the year. Novartis and Genentech saw this as evidence that at least samples of the product already existed.

“This is only the tip of the iceberg. While the case developed, we became aware of activities of the defendant that would probably already qualify as infringing acts,” said Frank-Erich Hufnagel in his pleadings. Hufnagel is a partner of Freshfields Bruckhaus Deringer in Düsseldorf and representative of both plaintiffs. He added, “It is not far fetched to come to the conclusion that there have been more activities that our clients are not aware of.”

A matter of likelihood

In the eyes of Novartis and Genentech, this constitutes an imminent infringement, because an infringement is “more likely than not”. In order to prevent an actual infringement, the patent holders applied to the UPC for an injunction against Celltrion.

Celltrion rejected the accusation of imminent infringement. The aim was not to launch the biosimilar before the expiry of EP 248. Rather, the early market authorisation and the activities mentioned by the patent holders served to prepare for a timely market entry upon expiry. Regulatory requirements in the pharmaceutical sector require a certain lead time and preparation. According to Celltrion’s representatives, these were wrongly interpreted as an indication of imminent infringement.

Extensive international teams represented both sides. In addition to the German Freshfields team led by Hufnagel, lawyers from the Amsterdam office also play a role in the case. The practice is also conducting the parallel national proceedings in The Hague under the leadership of Rutger Kleemans.

In the oral hearing in Düsseldorf a team from assisted the Freshfields team on technical issues. Patent attorney and partner Cameron Marshall pleaded the question of priority and validity. The mixed London IP law firm is also acting for Novartis and Genentech in the pending EPO opposition. In the parallel proceedings in the UK, Bristows is representing Novartis and Genentech.

Celltrion turns to Bird & Bird

Celltrion relied on a team from . Düsseldorf partner Oliver Jüngst, who regularly acts for generics manufacturers, and The Hague partner Marc van Wijngaarden took the lead. Patent attorney and Bird & Bird counsel Andreas Obermeier provided technical support, alongside Leonard Werner-Jones from Hoffmann Eitle. The latter is also conducting the EPO opposition proceedings for the client. Originally, Obermeier filed the opposition for Celltrion. In May 2024, Werner-Jones from Hoffmann Eitle took over the representation in the opposition case.

Bird & Bird’s London team is also representing the client in parallel proceedings in the UK. In the Netherlands, Marc van Wijngaarden has the lead.

The bench comprised presiding judge Ronny Thomas, judges Bérénice Thom and Alima Zana and technical judge John Petersen. The court will hand down its judgment on 6 September. The decision is likely to have an impact on future proceedings involving the imminent market entry of generics or biosimilars.