Bird & Bird Successfully Defends Celltrion in UPC Infringement Case Against Novartis
Written By
Partner
Germany
I have been with our firm since the opening of its first German office in Düsseldorf in 2002. I have 20 years' history of litigating patents on both sides of the "v."
Partner
Netherlands
I am a partner in our Intellectual Property Group, co-managing partner of our offices in the Netherlands and co-head of our Dutch Life Sciences Group. I specialise in patents and other IP rights, as well as trade secrets.
Bird & Bird has secured a significant victory for Celltrion in the Unified Patent Court (UPC) after Novartis and Genentech’s attempt to impose a preliminary injunction (PI) against Celltrion’s biosimilar to Xolair was dismissed. The Düsseldorf local division ruled that there was no imminent threat of infringement, a crucial outcome for Celltrion.
The case revolved around Novartis and Genentech’s patent EP 3 805 248, which protects a specific formulation of omalizumab, the active ingredient in Xolair, used to treat allergic asthma. Novartis and Genentech alleged that Celltrion’s biosimilar formulation would infringe upon this patent, as Celltrion had obtained EU market authorisation under the brand Omlyclo.
However, presiding judge Ronny Thomas and the panel ruled that Celltrion’s market preparations were not sufficiently advanced to constitute imminent infringement. Despite obtaining market authorisation, Celltrion had not engaged in pre-launch steps like price negotiations or product sample presentations, which led the court to reject the PI.
Bird & Bird’s international team played a crucial role in defending Celltrion, led by Düsseldorf partner Oliver Jan Jüngst and The Hague partner Marc van Wijngaarden, supported by Moritz Schroeder, Andreas Obermeier, Carlos van Staveren, Emilia Zalewska and Pippa van Hengel.
The team’s expertise ensured that Celltrion avoided the immediate threat of a PI, allowing it to focus on future legal battles. These include an upcoming revocation action in The Hague, where Celltrion will challenge the validity of the Novartis patent.
This result reinforces Bird & Bird’s reputation as a leading advisor in complex patent litigation across multiple jurisdictions.