T 0832/18 - Post-published evidence and Art. 83

Key points

• The decision is dated 09.12.2024; by Board 3.3.04,  and the written decision was issued 30.10.2025. I assume there were exceptional circumstances, such as the illness of a Board member.
• The interesting point is the importance of a post-published document for the sufficiency of disclosure of an in vitro diagnostic method claim."
• ""1. A method for determining the likelihood of effectiveness of an EGFR tyrosine kinase inhibitor [a class of medicaments] to treat cancer [, the method] comprising: determining whether the erbBl gene obtained from a biological sample obtained from said patient comprises at least one nucleic acid variance, selected from [ a list of mutations] 

  wherein the biological sample is a sample of tissue or fluid isolated from the patient and wherein the presence of the at least one nucleic acid variance indicates that the EGFR tyrosine kinase inhibitor is likely to be effective;

• "Post-published document D132, ... shows that lapatinib, another EGFR-TKi inhibitor, is a better inhibitor of wild type EGFR (EGFR-wt) than of EGFR-L858R mutant ...  the board considers that ... that lapatinib has been shown to be less effective, or ineffective, in inhibiting EGFR-TK and in treating cancer in patients with a nucleic acid mutation according to claim 1(b) or (c), compared to patients who do not have such a mutation.
• "Documents D134, D132, D50 and D72 thus provide serious doubts based on verifiable facts that there is no increased therapeutic effectiveness of EGFR TKis in patients affected with cancer comprising at least one mutation as set out in claim 1. Some TKis, such as lapatinib or neratinib, do not have or have a lower effect on such patients in comparison with patients comprising a wild type EGFR. Hence, the subject-matter of claim 1 of the main request is not sufficiently disclosed (Article 83 EPC)."
• As a comment, it remains interesting that post-published documents cannot be used in some aspects of Article 83, also for functional features (such as second medical use claims), while such documents can be used in other aspects of Art. 83.
• G 2/21, r.77 : "the scope of reliance on post published evidence is much narrower under sufficiency of disclosure (Article 83 EPC) compared to the situation under inventive step (Article 56 EPC). In order to meet the requirement that the disclosure of the invention be sufficiently clear and complete for it to be carried out by the person skilled in the art, the proof of a claimed therapeutic effect has to be provided in the application as filed, in particular if, in the absence of experimental data in the application as filed, it would not be credible to the skilled person that the therapeutic effect is achieved. A lack in this respect cannot be remedied by post-published evidence.
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• EPO

The link to the decision is provided after the jump.

https://www.epo.org/en/boards-of-appeal/decisions/t180832eu1