European Patent EP 2 825 558 concerns a combination therapy of bevacizumab and paclitaxel for platinum-resistant ovarian cancer. The claim was supported by Phase III AURELIA clinical trial results disclosed in the Patent.
Initially, nine Oppositions were filed but six Opponents withdrew their Oppositions. Maiwald led by Dr. Regina Neuefeind and Asim Q. Akbani represented STADA Arzneimittel AG as an Opponent in these proceedings.
On 24-25th of March 2025, oral proceedings were held by video conference. The Opposition Division of the EPO revoked the Patent in its entirety. The Main Request and Auxiliary Request 1 were found to lack novelty, while Auxiliary Requests 2 and 3 were considered to not involve an inventive step.
A discussion point under novelty was whether the claimed medical use opened a truly new clinical situation. Roche argued that positive results of the randomized Phase III AURELIA clinical trial in the Patent leading to approval of the claimed combination therapy by regulatory authorities reflected a new clinical situation. They emphasized that prior art disclosure on the claimed medical use could not be considered “reliable”, and it was only now that the combination therapy could be administered “outside the experimental setting”. Maiwald, however, argued that there is no basis in the EPC for such a legal fiction of erasing all prior art evidence before the effective date of the Patent just because Phase III results were not available, and the treatment was not approved by regulatory authorities.
One of the closest prior art documents was the Phase III AURELIA clinical trial protocol itself. Of note, Roche had filed several Expert declarations to emphasize that the results of the Phase III AURELIA clinical trial were allegedly extraordinarily surprising reflecting the presence of an inventive step. The Opposition Division, nevertheless, concluded that the medical use claim lacked an inventive step over the Phase III AURELIA clinical trial protocol.
Maiwald is looking forward to the Board of Appeal finalizing the Opposition Division’s decision in subsequent appeal proceedings.
