Key points
- Point II of the order G 2/21 is rather vague, probably intentionally. Provisionally, I think it permits both a liberal and a strict approach to plausibility and does not prescribe or specifically approve of any of the former / established approaches (plausible, not implausible, or no plausibility threshold at all).
- Hence, I don't agree with the interpretation suggested by R. Hughes on the IPKat, that "the interpretation that G 2/21 supports the established "lack of ab initio implausibility" standard" (to the extent that this quote suggests G 2/21 supports the "lack of ab initio implausibility" any more than the "plausibility" standard). I also disagree with "A second interpretation of G 2/21 proposed by the referring Board is that the decision confirms the existing case law on the standard of evidence required for inventive step. Particularly, G 2/21 confirms that, in order to be relied on for inventive step, there should not be substantiated doubt that the invention actually achieves the said technical effect (i.e. ab initio lack of implausibility)" to the extent that it would be settled case law that there should not be substantiated doubt that the invention actually achieves the said technical effect (i.e. ab initio lack of implausibility)". That is only one of the three lines in the case law. To the extent that specific line would be "confirmed" by G2/21, the two other lines are also confirmed by G 2/21.
- The relevant para 72 of G 2/21 reads in the relevant part: "Applying this understanding [i.e. point 2 of the order] to the aforementioned decisions, ... the Enlarged Board is satisfied that the outcome in each particular case [applying the test of point 2 of the order of G 2/21] would not have been different from the actual finding of the respective board of appeal." The aforementioned decision includes T 488/16. Hence, the outcome of T 488/16 is also correct or permitted under G 2/21. The outcome of the more liberal decisions is also permitted under G 2/21.
- Turning to the present case: "According to the appellant [applicant], the technical effect resulting from this distinguishing feature is an improved insulin sensitivity, in particular a synergistic interaction of compound (A) and compound (B) as demonstrated by the supplemental experimental data provided on 11 April 2019 (see D16)."
- " As argued by the appellant, a therapeutic effect of the claimed combination on metabolic disorders would have been expected at the priority date because both compounds were each known at the priority date as useful for the treatment of metabolic disorders (compound (A), see D4) and in the treatment of PPID in horses (compound(B), see D14). Furthermore, an improved effect in terms of insulin sensitivity when monotherapy with one or more dopamine receptor agonist is insufficient was generally described in the original application on page 4 lines 9 to 11. Hence, the Board agrees with the appellant that the therapeutic synergistic effect substantiated in D16 was derivable from the original application, and that the data of D16 only provided a quantification of the obtained improvement in insulin sensitivity described in the original application."
- "the Board considers that the synergistic effect relied upon by the appellant was encompassed by the technical teaching of the original application in light of the common general knowledge regarding the therapeutic effects of compound (A) and compound (B) and was embodied by the present combination since it was clearly the preferred combination in the original application (see page 22 line 25, claim 5 and all the examples). In line with G 2/21, the technical effect demonstrated by the post-published experimental data provided in D16 is thus to be taken into account when assessing the inventiveness of the claimed subject-matter".
- "The combination of compounds (A) and (B) for use in the treatment of the present disorders per se might have appeared obvious when combining the teachings of D14 (disclosing compound (B) for said use) and of D4 (disclosing compound (A) for use in the treatment of metabolic disorders which are known to appear in PPID). However none of the cited prior art documents suggests a synergistic effect on insuline concentrations for the combination of compound (A) and compound (B). It follows that the skilled person would not have found in the prior art any suggestion towards the present solution to the above defined objective technical problem."
- In other words, the synergistic effect is unpredictable over the prior art and renders the claim inventive over what would otherwise be an obvious combination of the compounds A and B for their known use; this synergistic effect was shown first by D16, which is post-filed.
- "Examples 1-3" are, in fact, statements of study protocols without any results; these are all "examples" of the application as filed. These are cited by the Board as part of the 'technical teaching’ in the sense that the now-claimed compounds are preferred. It may be observed that perhaps no technical basis for the applicant's preference can be derived from a study protocol without any results. The Board does not expressly acknowledge the nature of the "examples" as being study protocols without results.
- As said at the beginning, the "no plausibility" is permitted under G 2/21, but a stricter plausibility hurdle as well, in my view. What the right approach is can, therefore, not be answered completely by reference to G 2/21 only, it seems.
- T 2465/19: "The Board notes that the technical effect of an invention over the closest prior art need not be explicitly stated in the application, as long as it is derivable from the original application, in particular since the closest prior art may not have been known to the applicant when drafting it (see also decision G 2/21, Headnote II.)."
- T 1394/21 - "Thus, under Article 83 EPC, the application as filed must render it credible that the claimed antagonistic anti-VISTA antibody and antagonistic anti-PD-L1 antibody are suitable for treating cancer unless this is already known to the skilled person at the filing date (see G 2/21, especially Reasons 74 and 77)."
EPO
The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.
source http://justpatentlaw.blogspot.com/2023/07/t-087321-applying-g-221.html
