The EPO Revoked BMS’s 480mg Opdivo Patent Because the Trial Behind It Dosed by Weight
- EPO Technical Board of Appeal 3.3.04 dismissed Bristol-Myers Squibb’s appeal and confirmed revocation of EP 3 288 980, which claimed nivolumab at a flat dose of 480 mg every four weeks as monotherapy in PD-L1-positive melanoma. The decision issued 6 May 2026 and reached the register on 29 July. The sole ground was Article 123(2), added matter.
- The case turned on the word monotherapy. BMS argued that a negative feature excluding nivolumab plus anti-CTLA-4 combinations redefined the term so that other anti-cancer agents remained permitted. The Board held monotherapy carries its ordinary meaning of a single drug, that the negative feature is not drafted as a definition, and that it introduced ambiguity rather than resolving it.
- The decisive finding was evidential. The application as filed established no link between the 480 mg flat dose and monotherapy, because the only clinical example described a trial using body-weight-based dosing. The Board accepted the underlying insight was real, then held claim 1 specified one of many flat doses and frequencies rather than that concept.
- All five opponents were straw men: three df-mp partners, Kraus & Lederer, and Pajaro Limited. BMS filed 29 auxiliary requests and withdrew all but one at oral proceedings, where two opponents did not appear. This is the second nivolumab patent BMS has lost at the EPO recently, after EP 3 322 731.
CI read
The trade framing is that biosimilars moved closer to market. They did not, at least not on this timeline. The compound patent EP 2 161 336, with its supplementary protection certificates and data exclusivity, holds nivolumab in Europe to the end of 2030, and nothing in this decision touches it. What has been dismantled is the layer built to extend protection past that date. The outcome is therefore less interesting than the mechanism, and the mechanism travels a long way.
- The claim died because the trial dosed by weight. BMS claimed 480 mg every four weeks, but the only clinical example in the application as filed used body-weight-based dosing, and no passage tied the flat dose to monotherapy. The Board went out of its way to accept that the invention was genuine, that PD-L1-positive melanoma patients gain nothing from adding an anti-CTLA-4 antibody, and then held that claim 1 did not cover that concept but one arbitrary coordinate in a space of doses and frequencies. Added matter is the least forgiving ground at the EPO precisely because clinical merit cannot repair it.
- Read-across, and it is wide. The entire checkpoint class migrated from weight-based to flat dosing after its original filing dates, and those flat-dose regimens are routinely patented as lifecycle assets. Any such claim whose priority application exemplified only weight-based dosing carries the exposure BMS has just discovered. If you hold a flat-dose regimen patent in oncology, or you are attacking one, point 16 of this decision is the paragraph to read before the next filing goes out.
- Look at who is actually in the room. The decision names five opponents and not one is a pharmaceutical company: three partners at df-mp, the firm Kraus & Lederer, and Pajaro Limited, which is Bird & Bird’s vehicle for anonymous oppositions. df-mp acts regularly for Amgen, whose ABP 206 is in Phase 3. Kraus & Lederer acts regularly for Sandoz, which reports a nivolumab biosimilar in clinical development. The register is telling you the biosimilar field has organised a coordinated attack on the thicket beyond 2030 while leaving the compound patent alone. Watch the four related oppositions still pending, and note that EP 4 679 094 was filed only recently and sits in examination, which is BMS rebuilding the layer at roughly the speed it is being removed.
Read the original source (EPO Boards of Appeal, T 0715/24) →
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