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 München
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.
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