On 29 July 2026, the EPO published the Board of Appeal’s decision of 6 May 2026 upholding the Opposition Division’s 13 March 2024 revocation of EP 3 288 980, for a composition comprising nivolumab for use in a method of treating PD-L1-positive melanoma. The patent was opposed by 5 “strawperson” opponents.
The Boards of Appeal concluded that the claimed subject-matter of the patent, in particular the combination of nivolumab monotherapy and a flat-dose regimen (480 mg once every four weeks), extended beyond the content of the application as filed and did not meet the requirements of Article 123(2) of the EPC.
Multiple nivolumab biosimilars are under development including Sandoz’s JPB898, Xbrane/Intas’ Xdivane™, Amgen’s ABP 206, Reliance Life Sciences’ RLS-Nivolumab, Enzene’s candidate, Boan Biotech’s BA1104, and NeuClone’s candidate.