Key points
- This decision (by Board 3.3.04) was taken during oral proceedings on 10.10.2024. The written decision was issued on 23.12.2025. Two communications under Art. 15(9) RPBA were issued, in January and July 2025, indicating ‘the current workload’ as the reason for the delay in the issue of the written decision.
- Hence, Article 15(9) RPBA was complied with, so we can’t complain about that. Whether taking more than a year to write the decision is sound caseload management is not something for me to speculate about. But it is remarkable that the Board chose to delay this decision for so long.
- “According to claim 1, IL-2, which may be either human IL-2 or aldesleukin, is the active agent responsible for the therapeutic effect of treating systemic lupus erythematosus in a human subject.” Claim 1 also specifies “to be administered at a dose of between 1 MIU/day and 3 MIU/day”.
- "D5 [a patent application] discloses two case studies reporting a therapeutic effect of IL-2 administered intravenously at a dose of "500 U" for 14 days in the treatment of SLE"
- " In view of the early filing date in 1987 [of D5], it cannot be confirmed that the doses disclosed in D5 were established according to the WHO standard for IU."
- " The subject-matter of claim 1 differs from the disclosure in document D5 in the dosage of between 1 and 3 MIU/day of IL-2, which is not derivable from D5."
- The claimed dosage range of between 1 and 3 MIU/day provides dosages below 3 MIU/day. This range is not selected arbitrarily, because the administration of higher IL-2 doses (not excluded by the teaching of D5) also stimulates Teffs, which is an undesirable effect"
- "While D5 provides isolated case studies of the treatment of two patients having SLE with IL-2, these do not prove statistical significance, and furthermore, the dosage used is not apparent from the information provided in D5.
- Moreover, D5 does not provide any rationale that might guide the person skilled in the art in selecting a suitable dosage. The general range of 35 to 2000 units proposed in D5 (column 6, lines 40 to 56) is very broad. The use of un-standardised "units" and the vague description of the dosage regimen applied in the reported clinical cases does not permit any conclusions with regard to the dosage levels proposed, or the actual dosages used in the clinical cases."
- The Board considers the claim to be allowable.
- See also T1108/22 - 3.3.04 - 18.11.2024 - 22.12.2025 (no Art. 15(9) communication visible) - 9 opponents, case remitted to OD for further prosecution (so the delay in the written decision
actuallymatters for the actual decision on the allowability of the claims!). - See also T 1048/21, 10.10.2024 - 22.12.2025 - 3.3.04.
EPO
The link to the decision is provided after the jump.