4.3.3 Post-published evidence and reliance on a purported technical effect for inventive step ("plausibility")
This section has been updated to reflect case law and legislative changes up to 31 December 2023. For the previous version of this section please refer to the "Case Law of the Boards of Appeal", 10th edition (PDF). |
(i) Post-published evidence taken into account
In T 116/18 of 28 July 2023, proof or similar proof of the purported technical effect shown in post-published evidence was not contained in the application as filed. The board concluded that for requirement (ii) of Order no. 2 of G 2/21 to be satisfied, experimental proof of the purported technical effect or a positive verbal statement was not necessarily required in the application as filed. The board applied its interpretation of the legal principles stated in Order 2 of G 2/21 (see I.D.4.1.2) to the case in hand, finding that the skilled person would have no legitimate reason to doubt that the purported technical effect could be achieved with the subject-matter of claim 1 as granted. The purported technical effect was thus embodied by the same originally disclosed invention and the respondent could rely on the purported technical effect based on the application as filed.
According to the board in T 1989/19, once the criterion of derivability of a technical effect within the meaning of point 2 of the Order in G 2/21 was met, this also applied equally to any improvement of that effect. As the board explained, the skilled person, even if they have no inventive skill, will strive for further developments or technical improvements in every field of technology. Thus if a certain technical effect, such as storage stability in this case, is derivable for the skilled person within the meaning of point 2 of the Order from the application as originally filed (in this case from the described use as an inhalation product), the improvement of this technical effect can also be regarded as implicitly derivable.
In T 2716/19 the board applied Order no. 1 of G 2/21, rejecting the argument by the opponent that the application as filed did not include any evidence that the claimed bases would result in an improved PMPA yield, and that the opposition division was thus incorrect to allow the respondent to rely on post-published evidence. It found the skilled person would have immediately recognised an improvement in the yield of the desired product, here PMPA, as a fundamental objective of the disclosed method. In line with G 2/21 (Order), this technical effect could thus be relied on by the respondent, and post-published evidence confirming this technical effect could not be disregarded.
In T 728/21 the board found that the application as originally filed explicitly addressed the dissolution of tablets comprising a solid dispersion as an aspect of the disclosed invention and specifically described the claimed tablet composition as an embodiment of the disclosed invention. The effect of the optimization of the dissolution associated with the specific tablet composition defined in claim 1 of the main request, demonstrated with post-published evidence, could therefore in accordance with the principles established in G 2/21 be taken into account for the assessment of inventive step (see also T 1515/20).
In T 873/21 the board found 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. Accordingly, the board considered 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 and was embodied by the present combination since it was clearly the preferred combination in the original application. In line with G 2/21, the technical effect demonstrated by the post-published experimental data provided in D16 was thus to be taken into account when assessing the inventiveness of the claimed subject-matter.
In T 885/21 the board found the post-published experimental results in document D51 confirmed that conjugates in accordance with the main request indeed exhibited with respect to conjugates resulting from oxidation-hydrazone ligation, as well as conjugates resulting from linking an azide-modified sugar to terminal N-acetylglucosamine residues of untrimmed antibodies, optimised characteristics in terms of inter alia homogenicity, reduced Fc-gamma binding, reduced susceptibility to elastase cleavage, pharmacokinetic profile and in vivo efficacy. Taking account of the disclosure of the invention in the patent the board considered that the effects described in document D51 were encompassed by the technical teaching and embodied by the disclosed invention and could in accordance with the principles confirmed in G 2/21 be relied upon by the proprietor for inventive step.
In T 1329/21 the board noted that achieving improved sensory characteristics had already been disclosed as an objective in the original application. In addition, various sensory properties, including the absorption, stickiness and oiliness, of claimed formulations had been evaluated in the original examples in comparison to formulations without cellulose or with microcrystalline cellulose. The effect reported in the post-published comparative test was therefore clearly covered by the technical teaching disclosed in the original application. In the light of decision G 2/21, the board was consequently of the opinion that the post-published comparative test had to be taken into account.
In T 1891/21 the indicated technical effect of increasing the actual initial coulombic efficiency in comparison with the predicted value could be derived from the patent in suit and the underlying application as originally filed. The respondent's submission in their reply to the appeal, which included the calculation of additional values of some of the provided examples, merely made explicit what the skilled person would have derived from the patent in suit. The board found there was no doubt that the requirement formulated in G 2/21 (Headnote II) had been met.
In T 1445/21 the board found the post-published evidence showing a better olfactive performance for the compositions having 9% or 8.5% by weight of water in comparison to the compositions comprising 60% by water encompassed by the technical teaching of the originally disclosed invention. The comparison however was not suitable in the present case to substantiate the presence of an improvement over the prior art. Accordingly, the experimental data of the patent and of the post-published experimental report did not credibly demonstrate the existence of a technical effect linked with an amount of water not above 10% by weight.
Other decisions in which the boards of appeal have concluded that the skilled person, having the common general knowledge in mind, and based on the application as originally filed, would derive an alleged effect as being encompassed by the technical teaching and embodied by the same originally disclosed invention include: T 681/21, T 1551/22.
(ii) Post-published evidence not taken into account
In T 258/21 claim 1 of the patent at dispute described a medicament comprising an effective amount of a short acting dihydropyridine compound for use in a method of reducing ischemic stroke damage. The original application did not provide any experimental data. The board noted with reference to G 2/21 (OJ 2023, A85), point 2 of the Order, that the effect substantiated in post-published evidence had neither been contemplated nor even suggested in the original application. It followed that the technical effect therein relied upon by the applicant could not be taken into account for the assessment of inventive step in accordance with G 2/21. Even if the technical effect had been derivable from the original application, the board observed that the post-published evidence were merely abstracts reporting results of "ongoing" studies. These documents did not provide any detailed results nor any details on the protocols used. The meaningfulness of the appellant's exploitation of the data provided in these abstracts was therefore prima facie questionable.
In T 852/20 the board held that the purported technical effect evidenced by post-published data of increased water solubility and bioavailability of Form 1 over Form 2 was not disclosed or taught anywhere in the application as filed. By no means could the skilled person derive from the application as filed that one particular crystalline form, namely the claimed Form 1, had good solubility and bioavailability, let alone solubility and bioavailability that was better than that of another crystalline form (Form 2). It followed that based on the application as filed, and having the common general knowledge in mind, the skilled person would not have derived the purported technical effect as being encompassed by the technical teaching of the application as filed, let alone that the skilled person would have derived it as being embodied by the same originally disclosed invention.
An invention cannot be based solely on knowledge made available only after the effective date. In T 887/21 the board held that it was not sufficient that a technical effect could be achieved by a composition which in terms of technical features corresponded to compositions in the application as filed. In order to be taken into account in the formulation of the objective technical problem, the alleged technical effect that was supposedly shown by the post-filed evidence (in the present case, the inhibition of Salmonellae outside the context of epithelial adherence) also had to be encompassed by the technical teaching of the application as filed, i.e. the technical effect in question had to in the first place be disclosed or be at least derivable from the technical teaching of the application documents.
Chapter II.C.6.8 "Post-published documents" deals with the topic of post-published evidence with regard to sufficiency of disclosure (Art. 83 EPC). See also chapter II.C.7.2.2 " Evidence of therapeutic effect".
- T 1994/22
Abstract
In T 1994/22 the respondent (patent proprietor) inter alia had relied on post-published data D32 and submitted that Form II (according to claim 1 of the main request) as claimed had an improved photostability over Form III (comparative).
The respondent relied on the statements made in T 116/18 as regards G 2/21 and submitted that referring to the provision of a novel crystal of compound A (selexipag) and to a pharmaceutical product of "high quality for which constant effect can always be shown and a form which is handled easily industrially", the skilled person would have understood that the effect of improved photostability was implied by or at least related to the technical problem initially suggested in the originally filed application. Therefore, requirement (i) [in T 116/18], as encompassed by the technical teaching, was met. Furthermore, the respondent claimed the skilled person would not have had any legitimate reason to doubt that the improved photostability could be achieved with the claimed polymorphic form of selexipag. Therefore, requirement (ii) [in T 116/18], as embodied by the same originally disclosed invention, was also met in the present case.
In line with T 116/18, the board in the present case acknowledged that the mere fact that photostability or improved photostability was not contained in terms of a positive verbal statement in the application as filed and that the application as filed did not contain any data as regards photostability, as such, did not imply that the effect of improved photostability could not be relied on in terms of G 2/21 or T 116/18.
However, the board did not consider such a sweeping statement regarding "high quality" and "easy industrial handleability", which covers a plethora of potential advantageous properties, to encompass photostability, let alone improved photostability. If such a sweeping statement were sufficient, a reference to high quality would be sufficient to invoke whatever technical effect as being encompassed by an application as filed in the sense of G 2/21. This would essentially render the first criterion of order no. 2 of G 2/21 meaningless. In the present case, the application as filed was in fact directed to particle size, residual solvent content and amount of impurities, properties which are entirely unrelated to photostability. Therefore, based on these properties, having the common general knowledge in mind, the skilled person would by no means have recognised that (improved) photostability was relevant to the claimed subject-matter. Going from these specific properties to the effect of photostability would also clearly change the nature of the invention, contrary to what is required by T 116/18. Hence, the board found the effect of photostability was not encompassed by the teaching of the application as filed.
Furthermore, even if it were wrongly concluded in the respondent's favour that the technical teaching of the application as filed were to encompass photostability in the sense of T 116/18, it would not do so "together with the claimed subject-matter", as required by this decision.
The respondent submitted during the oral proceedings that the present case was also in line with T 1989/19 and that it was not a requirement that the application as filed disclosed improved photostability. In that case, the board held that once the criterion of the derivability of a technical effect in the sense of G 2/21 was fulfilled, this applied equally to the improvement in this effect. The board agreed with the view expressed in T 1989/19; however in the present case, photostability was not encompassed and thus not derivable from the teaching of the application as filed in the sense of G 2/21. Furthermore, unlike in T 1989/19, the application as filed in the present case referred to three polymorphic forms in equal terms, and the present case was not one in which the purported improvement was asserted to be present for the subject-matter of the application as filed over the subject-matter disclosed in the prior art.
It followed that improved photostability of Form II as demonstrated in D32 could not be taken into account in the assessment of the technical effects achieved by the distinguishing feature.