Just Patent Law Blog: T 0589/22 - Plausibility and in vitro diagnostic method claims

Key points

G 2/21 was rather vague about inventive step but very clear about second medical use claims: the application as filed must make the therapeutic indication, recited in the claim, "credible".
The present case is about a method claim directed to an in vitro diagnostic method.
Claim 1: " In-vitro diagnostic method for the identification of a subject suffering from a primary non-infectious disease having an increased risk of mortality potentially being induced by the administration of an antibiotic to said subject"
The Board: " Claim 1 is directed to an in vitro diagnostic method for the identification of a subject suffering from a primary non-infectious disease having an increased risk of mortality potentially being induced by the administration of an antibiotic to said subject. Being a diagnostic claim, the purpose of the method is a technical feature of the claim."

"Article 83 EPC requires that the application discloses the invention in a manner sufficiently clear and complete for it to be carried out by the skilled person. Since claim 1 is directed to a diagnostic method, the purpose of the method (i.e. "identification of a subject suffering from a primary non-infectious disease having an increased risk of mortality potentially being induced by the administration of an antibiotic to said subject") is an effect that has to be achieved and thus is a functional technical feature of the claim (G 1/03, OJ 2004, 413, point 2.5.2 of the Reasons). Hence, for the requirements of Article 83 EPC to be fulfilled, the patent has to provide suitable evidence that the claimed method allows the diagnosis to be made, or this must be derivable from the prior art or common general knowledge (CLBA, C.II 7.2.1, in particular T 814/12 clarifying that the requirements of Article 83 EPC for a medical use claim apply by analogy to diagnostic use claims)."

G 2/03 is about undisclosed disclaimers and point 2.5.2 of the reasons is about non-working embodiments: " If an effect is expressed in a claim, there is lack of sufficient disclosure. Otherwise, ie if the effect is not expressed in a claim but is part of the problem to be solved, there is a problem of inventive step (T 939/92, OJ EPO 1996, 309)." It is not about diagnostic methods, let alone diagnostic methods as opposed to methods in general.

"Under Article 83 EPC, the proof of a claimed therapeutic effect must 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 effect is achieved. A deficiency in this respect cannot be remedied by post-published evidence (decision G 2/21, point 77 of the Reasons). By analogy, the same applies to a claimed diagnostic effect (T 814/12, points 26 and 27 of the Reasons). Hence a reference to the BACH (Biomarkers in Acute Heart Failure) trial in post-published document D1 is of no help in this context. "

T 0814/12: "27. The board considers that by analogy thereto the same requirements of Article 83 EPC apply for diagnostic use claims."

Note, the claim in that case was a Swiss-type use claim for a diagnostic compound: "Use of protein kinase N beta or a fragment thereof, whereby such fragment realises the effects of protein kinase N beta, for the manufacture of a diagnostic agent for the diagnosis of a disease"

Note that for second medical use claims using the magic wording of Art.54(5) (or formerly, a the magic wording of a Swiss type claim), we impart the magical implicit feature of "effective" into the claim so that the claim is held novel even over a verbatim disclosure of it (typically: in the annoucnement of a clinical trial giving all details of the medical use being tested but not the results; see e.g. T2506/12). I'm not aware of the same case law applying to method claims or specifically in the case of diagnostic method claims.
Which is not to say that the decision is wrong. That depends a bit on how broadly the requirement of credibility is to be applied - will it apply to first medical use claims? Second non-medical use claims? Beyond use claims to method claims reciting a purpose?

EPO

The link to the decision can be found after the jump.

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