Rituximab – Netherlands

Rituximab – Netherlands

On May 22, 2017, Court of The Hague published its judgment in Injunction proceedings against biosimilar of Rituximab. Biogen is the holder of European patent EP 2055313 (hereinafter referred to as EP 313 or the patent) entitled ” Treatment of hematologic malignancies associated with circulating tumor cells using anti-CD20 chimeric antibody ”  In the Netherlands Rituximab Roche -licentienemer Biogen – marketed under the name MabThera. MabThera is also approved for use in the treatment of several other diseases, including non-Hodgkin’s lymphoma and rheumatoid arthritis.
On May 13, 2016 Celltrion brought revocation proceedings against Biogen in this court under the VRO regime. In this procedure CellTrion requests that (the Dutch part of) EP 313 on the basis of added matter, and lack of novelty and inventiveness. Plea in this case is scheduled for 19 May 2017. The indictment announced Celltrion that it plans to launch its biosimilar of Rituximab in Netherlands through Mundipharma.
Following the publication going to do a press on February 17, 2017 granted marketing authorization for Truxima by the European Medicines Agency (EMA) Mundipharma on February 22, 2017 with the following statement: Mundipharma to launch Truxima (rituximab), the first biosimilar monoclonal antibody for the treatment of cancer, in seven European markets.
In March 2017, Biogen applied to the Landgericht M√ľnchen against Mundipharma brought a lawsuit or regarding EP (DE) 313 sought an injunction against infringement. After the Regional Court had given its preliminary views on the strength of EP 313, Biogen hearing on April 19, 2017 withdrew its claim. Biogen progresses, by judgment enforceable, Celltrion to prohibit to infringe upon, to be or are involved in any way in and / or to take advantage of the unlawful acts related to the Dutch part of EP 313, at least the claims 7 and 15 thereof, on pain of a penalty, and condemnation of CellTrion  in the costs. Celltrion carries a reasoned defense. It argues briefly that Roche is inadmissible because no proprietor, and that the patent is invalid because there is additional material and it is not new nor inventive.

Court finally denied injunction because there are reasonable chance that the patent will be invalidated due to added matter.

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