Clinical trials: Biogen’s rituximab patent found invalid due to a clinical trial started before the priority date

Celltrion and Sandoz have raised invalidity proceedings against Biogen’s Norwegian patent on the use of rituximab in a particular treatment regimen for low-grade follicular B-cell non-Hodgkin’s lymphoma. The patented treatment regime consists of providing a specified dose of rituximab as a maintenance therapy in patients having responded to previous treatment with CVP therapy.

Oslo District Court was presented with several alternative grounds supporting Sandoz and Biogen’s claim for invalidity, herein lack of novelty, lack of inventive step, added matter and insufficiency.

On 7 February 2018 the Oslo District Court revoked the patent due to lack of novelty. The Court based its assessment in particular on a clinical trial started by the Eastern Cooperative Oncology Group (E1496) prior to the filing date of the patent application. The Court concluded that the study was novelty destroying as the doctors and patients, who had access to the study protocol and a consent form describing all the features of the invention, had to be considered as members of the general public in relation to the patent holder. The novelty requirement for a patent was therefore not met.

The case has been appealed by Biogen. The appeal court will have to assess whether there exists such a (third) possible exception from what is considered obstructive to novelty.

The appeal proceedings will probably be held early 2019, but no dates have yet been fixed. (Oslo County Court, Case no. 16-206868TVI-OTIR/05)

Kvale represents Sandoz.

 © 2018 Kvale Advokatfirma DA