T 0110/25 - (II) Deleting figure label violates Art. 123(2)

Key points

• The proprietor withdrew the main request after the Board had announced its conclusion that the amendment of Figure 6 (by deleting the label of the vertical axis) in the grant procedure violated Article 123(2). Nevertheless, the Board's reasons can be inferred from the decision, to a degree. 
• The Board, in translation: "39. The question of whether the deletion of the ordinate label in Figure 6 prior to the grant of the patent infringes Article 123(2) or Article 100(c) EPC or is permissible as a correction within the meaning of Rule 139 EPC and therefore does not lead to an inadmissible extension was the subject of the contested decision (point 11, pages 4 to 7) and was also raised again in the appeal."
• " In its appeal, the appellant [opponent] argued that the removal of the original ordinate label in Figure 6 violated the prohibition of inadmissible extension (Article 123(2) in conjunction with Article 100(c) EPC). Figure 6 was essential for assessing inventive step. The deletion did not serve as a correction but enabled alternative technical statements, which constituted an inadmissible technical extension and conferred an unfair advantage on the patent proprietor. The deletion eliminated the original reference of the diagram to the absolute histamine degradation capacity, but no correct indication replaced the deleted ordinate label. This enabled alternative statements in the eyes of a person skilled in the art"
• " In its appeal, the appellant argued that the removal of the original ordinate label in Figure 6 violated the prohibition of inadmissible extension (Article 123(2) in conjunction with Article 100(c) EPC). Figure 6 was essential for assessing inventive step. The deletion did not serve as a correction but enabled alternative technical statements, which constituted an inadmissible technical extension and conferred an unfair advantage on the patent proprietor. The deletion eliminated the original reference of the diagram to the absolute histamine degradation capacity, but no correct indication replaced the deleted ordinate label. This enabled alternative statements in the eyes of a person skilled in the art"
• The auxiliary request seeking to address the issue is not admitted, as it was filed late.
• "The [proprietor's] assertion that it has never been explained what new technical teaching was introduced by deleting the ordinate label in the original Figure 6 is also incorrect. As already stated several times, the appellant argued in its appeal that deleting the ordinate label in the original Figure 6 eliminated, rather than correcting, the reference to histamine degradation capacity. The bar chart without ordinate labels allows for several technical interpretations that differ from the original information because the figure descriptions on pages 10 and 19/20 are contradictory both internally and in relation to Figure 6. Specifically, the appellant argued that, contrary to their previous meaning, the groups "HIT" and "no symptoms" could be related to sensitivity, and the group "symptoms" to specificity. The respondent readily admitted that these alternative technical statements, arising from the interpretation of Figure 6, were relevant to the inventive step. However, the respondent denied these alternative interpretations of both the original and granted Figure 6, and thus also the existence of a "new technical teaching." It insisted that the original Figure 6, viewed in conjunction with the original application as a whole, allowed for only one interpretation. 
• Not mentioned, but likely highly relevant is G 2/21.

EPO 

The link to the decision is provided after the jump.

T 0592/24 - Effect of claimed embodiment over other embodiment

Key points

• " In any event, the Board holds that reliance on post-published evidence to demonstrate an improved technical effect of the claimed subject-matter over a further embodiment originally claimed does not normally change the nature of the invention, as long as the technical effect is derivable from the application as filed and the improvement is not in contradiction with the original disclosure."
• compare: T655/24: "Applying the principles of G 2/21, the board does not consider that an improvement of an effect, here further reduced effector functions mediated by the Fc region, is encompassed by the technical teaching and embodied by the same originally disclosed invention merely because the effect itself (but not the improvement), was shown to be achieved in the application as filed (see G 2/21, Headnote, Reasons 67 and 72)."
• compare T 314/20: 

6.24 Summarising the above, the Board concludes that the technical teaching of the claimed invention that the skilled person, with the common general knowledge in mind, understands at the filing date from the application as originally filed, encompasses the following.

(a) Combination 97 (i.e. the currently claimed combinations) gives rise, inter alia, to an increase in plasma levels of active GLP-1 in patients with metabolic disorders and related diseases.

(b) Combinations 165 to 168 (i.e. combinations of empagliflozin with sitagliptin, vildagliptin, alogliptin and saxagliptin, respectively), having the same level of preference, achieve the same increase in plasma levels of active GLP-1 in patients with metabolic disorders and related diseases as combination 97.

6.25 By contrast, the purported technical effect relied upon by the respondent for inventive step is an increase in plasma levels of active GLP-1 which is stronger and more prolonged in time [in Combination 97 ] than the one achieved by combinations 165 and 166, i.e. combinations of empagliflozin with sitagliptin and vildagliptin, respectively (see point 6.9 above).

6.26 It follows from the analysis made in points 6.20 to 6.24 above that the skilled person, having the common general knowledge in mind, and based on the application as originally filed, would not derive the increase in plasma levels of active GLP-1 relied on by the respondent (see point 6.25 above) as being encompassed by the technical teaching of the claimed invention and embodied by the same originally disclosed invention.

EPO 

The link to the decision is provided after the jump.

T 0655/24 - Post-published evidence for inventive step

Key points

• In the opposition case at hand, it is unclear if the distinguishing feature provides "a" technical effect or an improvement over the closest prior art. The case is about antibodies, and the distinguishing feature is a mutation (D265A) at a certain position (265). 
• The proprietor  referred to additional data provided in post-published documents D25 and D26 as evidence that the effect of further reduced effector function was achieved by essentially all claimed subject-matter.
• "The board, however, notes that such evidence (data) can only be taken into account when the technical effect that it is purported to show is already credible from the disclosure in the application as filed itself."
• "Applying the principles of G 2/21, the board does not consider that an improvement of an effect, here further reduced effector functions mediated by the Fc region, is encompassed by the technical teaching and embodied by the same originally disclosed invention merely because the effect itself (but not the improvement), was shown to be achieved in the application as filed "
•  The board is aware that a different approach to this issue was taken in decisions T 1989/19, T 2716/19 and T 840/22 and makes the following observations (...)
• "the approach taken in decisions T 1989/19, T 2716/19 and T 840/22 would allow an applicant to solely rely on post-published evidence to establish inventive step by filing an application disclosing an effect that was already known from the prior art or formed part of common general knowledge and subsequently invoking an improvement of said effect as "implicitly derivable" from the application as filed. This scenario goes against the principle that patents should not be granted for subject-matter whose inventive contribution is identified only after their effective date. Such an outcome directly contradicts the "first to file" principle enshrined in the EPC and confirmed in decisions G 1/03 and G 2/10. It is also in evident tension with the framework established by decision G 2/21 "
• "The board therefore must turn to the disclosure in the application as filed to determine if the evidence for a further reduced effector function of the FEA variant compared to the FE variant reported in post-published documents D25 and D26 can be taken into account."
• "In conclusion, the board considers the improved effect of decreased CD69 release of the FEA variant compared to the FEFE variant to have been credibly disclosed in the application as filed. Thus, while it is not strictly necessary to consult the evidence in documents D25 and D26, it can be noted that their disclosure supports the improved effect shown in the application as filed. "
• The Board considers the claimed subject-matter to be non-obvious based on said technical effect.
• The Board indicates that it considers the claimed subject-matter also non-obvious as an alternative.
• Hence, the whole point about the interpretation of G 2/21 seems obiter.
• I think the Board's proposed approach is very strict, especially if the applicant was unaware of the prior art cited by the opponent. If you find your molecule has a good score for a certain property, is there really a necessity to carry out comparative testing before filing the patent application (and against which prior art?)

EPO 

The link to the decision is provided after the jump.

T 1950/23 - Plausibility and generic statement of advantages

Key points

• The Board has to decide on inventive step.
• "Claim 1 of the main request is distinguished from the composition of example 23 of D1 solely in the presence (in claim 1) of "a detergent selected from sulfonate, phenate, or a mixture thereof"."
• "It is undisputed that the patent does not disclose a technical effect specifically linked to this distinguishing feature."
• " The respondent [proprietor] submitted that the effect of the distinguishing feature was an improvement in extreme pressure performance. Evidence of this effect was provided by the appellant's experimental tests D16, submitted in opposition proceedings."
• " The appellant [opponent] did not contest that this effect was demonstrated in D16 as described above, but rather argued that it could not be derived from the application as filed. Therefore, in view of Enlarged Board of Appeal decision G 2/21, it could not be relied upon for inventive step, and hence also not in the formulation of the objective technical problem underlying claim 1."
• "Page 20, lines 15 to 22 ... states that the lubricating oil compositions may further comprise additives that can impart or improve any desirable property of the lubricating composition. Such additives are listed on page 20, lines 22 to 27 and include detergents. Detergents are mentioned in this list as one of many possible additives." In addition, "page 1, lines 20 to 22 states that the lubricating compositions of the invention exhibit both improved friction characteristics and extreme pressure performance"
• "However, further disclosures in the application as filed point to the specific importance of detergents in the claimed lubricating compositions: claim 7, which is dependent on claim 1, stipulates that the composition further comprises a detergent selected from sulfonate, phenate, or a mixture thereof. Claim 8 is the only other claim dependent on claim 1 and related to a further additive, namely a friction modifier. Since dependent claims are generally directed to preferred embodiments of the invention (Rule 43(3) EPC), this indicates a higher ranking for detergents and friction modifiers as additives over other additives listed in the application as filed. "
• "Furthermore, the lubricant compositions of all examples (table 1, page 31) comprise either a sulfonate or phenate detergent, and it is demonstrated for the inventive examples that adequate extreme pressure performance can be achieved ... . Therefore there is a link in the application as filed between the compositions of claim 7 and the effect of extreme pressure performance set out on page 1 as stated above.
• "it is not reasonable to expect patent applicants, at the time of drafting the application, to safeguard against the citation of then unknown prior art, for example in opposition proceedings, by providing comparative data showing an improvement for all potential distinguishing features over all potentially later cited closest prior art documents. Not only would this be unreasonably burdensome, it would also suffer from the shortcoming that not knowing the nature of the disclosure of the newly cited closest prior art, the information required to set up appropriate comparative tests representative thereof would not be at hand."
• " it would be an overly strict interpretation of G 2/21 to require that the application as filed demonstrate that the improvement of a technical effect disclosed in the application as filed and relied on by the patent proprietor is specifically attributed to the distinguishing feature. In such a situation, it would suffice for opponents to cite new prior art differing in the distinguishing feature compared to the prior art known when the application was drafted to invalidate the patent. More specifically, since relying on post-published data would be excluded under such a strict interpretation of G 2/21, such patents would be likely to face revocation."
• "Hence, this effect may be relied upon for inventive step, and consequently in the formulation of the objective technical problem underlying claim 1."

EPO 

The link to the decision is provided after the jump.

T 0883/23 - Plausibility and priority

Key points

• In this appeal, the Board found the second medical use claim to be valid (novel and inventive and sufficiently disclosed in the patent). Still, the Board - obiter it seems - held that the priority was invalid because, whereas the application as filed contained the results of a clinical trial, the priority document contained only the protocol for that study (without the results).
• Hence, the 'plausibility' or credibility requirement of G 2/21 r. 74 and r.77 for second medical use claims applies by analogy to the priority application, it seems.
• The Board's headnote formulates it differently: "The Enlarged Board of Appeal determined in G 2/98 that it is a condition for the compliance with the requirement of "the same invention" that the claimed subject-matter is directly and unambiguously derivable from the earlier application. However, the Enlarged Board did not conclude that the requirement of "the same invention" is necessarily satisfied if this condition is fulfilled, irrespective of any technical information associated with the claimed subject-matter, which is only described in the subsequent patent application."

EPO 

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

T 1847/23 - Plausibility and common technical problems in the technical field

Key points

•  For inventive step: "The opposition division considered that the technical information provided by Annex 3 had to be taken into account for the assessment of an allegedly unexpected effect. In its decision, the opposition division explained that it was convinced that the problem of stability is a common technical problem in the technical field of pharmaceutical compositions comprising an active pharmaceutical compounds. This view is also shared by the respondent. The Board however disagrees with this conclusion."
• The Board recalls G 2/21.
• "In the present case, the technical effect shown in Annex 3 is not derivable from the application. The reasons are the following:
•  the application as filed does not contain any observation in relation to the stability of the claimed compositions, even less at specific low or very low temperatures or after freeze/ thaw cycles; none of theses aspects are mentioned or derivable from the original application.
•  the preparation and/or storage of a drug composition at low or very low temperatures is neither systematic nor widely practiced. Indeed, there is no indication in the application as filed or in the prior art that the compositions comprising maropitant have to be prepared and/or stored under these conditions. Hence, the preparation and/or the storage at extremely low temperatures, as well as the behaviour of the claimed compositions at these temperatures does not appear to constitute a property tipically sought by a person skilled confronted with the problem of preparing this class of compositions.
• This is confirmed in particular by the teaching of other documents such as D10 which indicates that the [particular type of] injectable formulation is to be stored at controlled room temperature of 20 to 25°C (see D10, page 3), or D40 which recommends to not freeze the commercial injectable product comprising maropitant (see page 6).

• Consequently, the behaviour of compositions comprising maropitant under low or very low temperatures cannot be considered as a common problem as argued by the opposition division in its decision.

  In view of the above, the Board considers that the skilled person would not derive the effects considered in the experiments of Annex 3 as being encompassed by the technical teaching and embodied by the originally disclosed invention. Thus, these effects cannot be relied upon in light of decision G2/21."

• However, "Examples 5 and 6 of the contested patent show convincingly a good injection site tolerance and antimicrobial efficacy. Accordingly, the problem is the provision of an alternative composition comprising maropitant suitable for administration to veterinary animals which leads to a low level of pain on injection."

• The claim defines a range of 7-18 mg/mL for a certain compound; the prior art teaches 20 mg/mL. The interested reader may read the entire decision to find out why the Board considers the claim to be inventive.

• 
  

EPO 

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

T 1456/23 - A non-obvious alternative (soft gelatin capsule)

Key points

• "In appeal, the appellant [opponent]  takes the hard gelatin capsule of formulation 9, example 1 of D11 as sole starting point for the assessment of inventive step."
• " The subject-matter of claim 1 differs from formulation 9 of D11 in that the claimed capsule is a soft gelatin capsule with a soft capsule shell as defined in claim 1."
• "The [proprietor] relies, among others, on D5 (Annex III and Annex IV) and D83 (Annex V) as evidence of a technical effect on bioavailability associated with the differentiating feature." "The [opponent] contests that these post-published data can be taken into account in view of G 2/21,"
• "The application as filed mentions the problem of providing immediate release calcifediol solid oral formulations having improved bioavailability. As a solution to this problem, the application as filed proposes, in its broadest disclosure, a soft capsule comprising a further undefined soft capsule shell. The particular soft capsule shell composition of present claim 1 is however disclosed on page 9, lines 24-27 and is embodied by the single soft capsule shell prepared in the examples"
• The Board: " It is not debated that the evidence in the application as filed, comparing soft capsules with ampoules, is not suitable to show an effect over the hard capsules of D11. However, the Board considers that the skilled person, based on the application as originally filed, would derive the effect of improved bioavailability associated with the soft capsule including a soft capsule shell composition of present claim 1 as being encompassed by the technical teaching and embodied by the same originally disclosed invention. Considering the preference for and presence of the specific soft capsule shell of claim 1 in the examples studying bioavailability, the link between bioavailability and not only a soft shell generally but also, as the case may be, the now claimed specific soft shell composition, does not change the nature of the claimed invention."
• As a comment: the remark about "the link between bioavailability and not only a soft shell generally but also, [...]  the now claimed specific soft shell composition,' appears to refer to the "no cross-reliance" part of G 2/21 hn. 2: "would derive said effect as being ... embodied by the same originally disclosed invention." 
• "  the Board concludes that the problem is the provision of soft capsules with improved bioavailability of calcifediol"
• Perhaps the reference to 'soft capsules' is a slip of the pen, because the prior art Formulation 9 is about hard capsules, so 'soft capsules' is part of the claimed solution.
• For the obviousness, it is important that claim 1 is directed to an "An immediate release soft capsule" containing calcifediol. Immediate relese formulations and 'modified release formulations' are two different types of formulations. 
• "The gist of D11 is to provide modified release formulations containing wax, and D11 further mentions as one benefit an improved bioavailability []. While some immediate release formulations are shown in D11, this is for comparative purposes only. 
• The choice of D11 as starting point for the assessment of inventive step defines the framework for further developments. The skilled person, seeking to improve the bioavailability of the formulation, would not do away with the key feature of D11 pertaining to a modified release formulation. 
• In this respect, the results reported in D11 do not point to the claimed formulation. ... the [comparative ]  immediate release formulation 9 of example 1 leads to a lower calcifediol bioavailability than the wax-comprising, modified release formulations 3 and 4 of Example 1 (see table 5 of D11). The skilled person, seeking to provide calcifediol formulations with improved bioavailability, is thus not led to the claimed solution.
  
• As a comment, perhaps the above reasoning would also apply in the case of providing an alternative as the objective technical problem. 

• On the type of evidence ofr the improved bioavailability: "the Board considers that a party filing experimental data is not under the obligation to perform any specific statistical analysis of these data, and that, in establishing whether a certain technical effect alleged by a party has been achieved, the EPO has to apply the general principle of free evaluation of evidence (see T 2717/17, point 4.3.5 of the reasons). The decisions cited by the appellant in this regard were either taken in the particular context of qualitative results in tests with a subjective character (see T 1962/12, point 1.5.1 and 1.5.2 of the reasons; T 275/11, point 3.5.2 of the reasons) or in situations where the data were considered not reliable for various reasons which do not characterise the present case, i.e. not simply on account of the small number of tested individuals (see T 785/07, point 2 of the reasons). In the case at hand, the above data are sufficiently convincing considering the information given on the methodology and the absence of demonstration to the contrary. In addition, these in vivo data in dogs are in line with the in vitro data on file (see 3.3.2(b) above). Under these circumstances, the Board considers that, even taking into account the small group of dogs tested (i.e. 3 dogs) and the alleged high inter-individual variability, the effect of improved bioavailability is shown to a sufficient degree of credibility."

EPO 

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

T 0867/23 - Post-published evidence for sufficiency of second medical use claim

Key points

• The case is about a second medical use claim. Can the proprietor rely on post-published evidence to show that the medical method works? 
• The Board: "The Enlarged Board of Appeal in decision G 2/21 did not extend the scope of the referred questions beyond the issues for assessing inventive step to the assessment of sufficiency of disclosure (see points 8-11 of the reasons). Nevertheless, the Enlarged Board of Appeal cited several Board of Appeal decisions addressing the issue of reliance on post-published evidence for a purported technical effect in the context of sufficiency of disclosure, and in particular in the case of second medical use claims (see points 73-76), from which the Enlarged Board concluded the following (see point 77):
• "The reasoned findings of the boards of appeal in the decisions referred to above make clear that 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."
• In the [TBA's] Board's view, this statement, taken in its context, does not set a new standard for reliance on post-published evidence in the context of sufficiency of disclosure, i.e. a standard which would depart from the previously cited case law it summarises (as noted in T 979/23, see point 13 of the reasons). "
• "Following G 2/21, a reliance on post-published evidence is not ruled out generally in the context of sufficiency of disclosure for second medical use claims. The reliance on post-published evidence can also not be limited to situations where it serves no useful purpose, i.e. it is not limited to cases where the effect is already convincingly proven in the application to such a point that the use of post-published evidence as a superfluous confirmation of the already proven effect would be of no relevance. In other words, the scope of reliance on post-published evidence is not zero.
• "In the present case, the Board considers that the application as filed contains experimental data reflecting an effect on primary negative symptoms of schizophrenia, and thus discloses the suitability of cariprazine for the claimed therapeutic indication (see T 609/02, point 9 of the reasons). In these circumstances, the post-published evidence D13 may be taken into account to backup the findings in the application as filed ".
• The Enlarged Board in G 2/21, point 77 of the reasons, as cited by the TBA, with emphasis added: "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." (emphasis added).
• T 979/23, cited above, the Board's conclusion was that "From the technical teaching of the application as filed, even taking into account the prior art, it was not credible that fenfluramine achieved a therapeutic effect in Dravet syndrome patients when given as a monotherapy. In line with decision G 2/21, the board has not taken the post-published data (document D3) into account".
• "13. The Enlarged Board of Appeal endorsed the conclusions in decision T 609/02 (see G 2/21, point 75 of the Reasons) and decisions T 754/11 and T 887/14 (see point 76 of the Reasons). The expression "proof of a claimed therapeutic effect" in point 77 of the Reasons cannot therefore be interpreted as a deviation from the established case law in the context of second medical uses: it does not apply a stricter requirement than the established case law prior to decision G 2/21."
• Indeed, the EBA seems to have confirmed T 609/02. I'm not sure if all TBAs considered T 609/02 to be correct in 2021. 
• 
  

EPO 

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

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."
• It is not entirely clear what the Board means by the last sentence. 
• "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.

T 0509/22 - Technical effect not mentioned, G 2/21 still complied with

Key points

• The Board, in translation: " It is correct that these effects - improvement in lubrication performance and leak detection - are not explicitly mentioned in the patent in question.
• " However, it is not required that an effect be explicitly mentioned in the patent or patent application in order for it to be taken into account in the assessment of inventive step. Indeed, the condition set out in the decision of the Enlarged Board of Appeal G 2/21 requires only that the skilled person, on the basis of the application as filed, would consider the said effect to be included in the technical teaching of the patent application. "
• Mentioning the technical effect is, hence, neither a necessary nor a sufficient condition. It really depends on the technical field. 
• "In the present case, the board is of the opinion that the skilled person, when searching for compositions for use in refrigeration systems, inevitably takes into account lubrication and leak detection effects, in particular because these effects are indispensable for the effective use of the compositions as a refrigerant. The problems of achieving these effects are therefore subsumed within the more general problem of making refrigerant compositions available.
• Therefore, the Chamber takes into account the test results described in document D27."
• " Document D27 therefore reveals that the presence of HCC-40 in composition A increases the usefulness of the composition as a refrigerant compared to a composition B which does not contain HCC-40. The technical effect produced by the distinguishing feature therefore consists at least in that a preparation containing a small amount of HCC-40 is characterized by improved leak detection."
• The Board, in the present case, does not discuss if the application makes it prima facie credible that the technical effects are achieved by the claimed invention. 

EPO 

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

T 0816/22 - Even more than plausibility is required

Key points

• With all the attention for G 2/21 r.74 (which requires the application as filed to make the claimed therapeutic use credible), it is easy to overlook that even more is required for second medical use claims. 
• The opponent had filed post-published evidence of failure of clinical trials with the (example) compound of the invention: "Even a plausible disclosure of a therapeutic effect (which was missing in the present case) still had to be subject to refutation by evidence that the therapeutic effect was not in fact attained (which was provided by documents D15, D16 and D54), the standard of proof being "serious doubts, substantiated by verifiable facts"."
• Why would the opponent oppose if the compound ("Cinryze") failed in the clinical trials? Perhaps because claim 1 is not limited to a specific compound and reads: " Claim 1 of the main request reads as follows: "1. A C1 esterase inhibitor (C1-INH) for use in a method of treating antibody-mediated rejection (AMR) of an organ allograft in a patient in need thereof, wherein the method comprises intravenous administration of the C1-INH at a dose of 5,000 units to 20,000 units given in divided doses over 10 to 20 days, and wherein the organ is kidney.""
• The Board: "The board therefore concludes that the only relevant data in the patent are finding CG [a type of rejection of the organ allograft]  in 1 out of 7 patients in the Cinryze arm [treatment arm] compared with 3 out of 7 patients in the placebo arm"
• "In view of the small number of patients, the opponent considered that a treatment effect had not been demonstrated. The board, however, does not deem it necessary to establish this and instead starts from the assumption that the opposition division was correct in finding that the experimental data provided in the patent (see above), together with the mechanistic explanation provided in paragraphs [0032] to [0039] and Figure 1, made it plausible (or credible) to the skilled person at the time of filing that a therapeutic effect on AMR could be achieved; however, this in itself is not enough to demonstrate that the invention is sufficiently disclosed if the opponent provides evidence which raises serious doubts that the therapeutic effect can indeed be achieved (see below)."
• "Post-published documents D15, D16 and D54 relate to the phase III clinical trial NCT02547220 (SHP616-302), which was carried out using the same dosage regimen as in the examples of the patent and falling under the terms of the claim"
• " Document D54 shows the complete absence of any therapeutic effect with the claimed dosage regimen. "
• " In conclusion, a phase III clinical trial with the same setup as the examples in the patent and using the dosage regimen which is an embodiment of the claim could not reproduce the claimed subject-matter as exemplified in the embodiment under discussion as it did not exhibit any efficacy after 36 months. The patent proprietor has not dispelled the serious doubts regarding the presence of a treatment effect in view of these data. Therefore, the invention as claimed is not reproducible."
• "The board therefore considers that the patent does not disclose the claimed invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art (Article 83 EPC)."
• Question: can the proprietor file post-published evidence that the invention works? E.g. for another C1 esterase inhibitor than Cinryze?

EPO 

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

T 0294/20 - Sufficiency (plausibility) for second medical use claim

 Key points

• "Claim 1 is drafted in the form of a purpose-limited product claim, pursuant to Article 54(5) EPC, and is directed to a compound that reduces the activity or expression of a Programmed Cell Death-1 (PD-1) polypeptide (in the following "PD-1 inhibitor") for use in the treatment of nodular lymphocyte predominant Hodgkin lymphoma (NLPHL)"
• Sufficiency of disclosure in the sense of G 2/21 is at issue (i.e., former plausibility).
• "According to decision G 2/21 (OJ EPO 2023, A85, point 77 of the Reasons), "[i]n 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." 
• This intermediate conclusion of the Enlarged Board of Appeal can be understood as confirming the established case law that post-published evidence cannot be used to remedy a lack of sufficient disclosure in respect of a medical use (cf. T 609/02, headnote).
• By this statement, the Enlarged Board of Appeal can also [i.e., additionally] be seen to have endorsed the jurisprudence of the boards of appeal that attaining a claimed therapeutic effect is a limiting functional technical feature of a claim directed to the use of a substance or composition in a method of treatment (see also G 2/21, point 74 of the Reasons). 
• [...]  in decision G 2/21 the Enlarged Board of Appeal focussed on the issue of whether or not post-published evidence can be used by an applicant or patent proprietor in the assessment of Articles 83 and 56 EPC, but did not address the question of the level of proof in an application as filed required to substantiate a therapeutic effect as a prerequisite for using post-published evidence for assessing the requirements of Article 83 EPC."
• "The board therefore does not understand G 2/21 to have quashed the principles established by leading decision T 609/02 despite having qualified the term "plausibility" merely as a generic catchword. Indeed, as decision T 609/02 clearly sets out, a balance should be struck between enabling early patent protection for therapeutic uses and avoiding that the claimed invention is only completed at a later point in time. As a consequence, in order to fulfil the requirements of Article 83 EPC, the suitability of the product for the claimed therapeutic application must be derivable from the application, unless this is already known to the skilled person at the priority date (see T 609/02, point 9 of the Reasons and T 895/13, points 3 to 5 of the Reasons)."
• "The board cannot accept the appellants' [proprietors'] line of argument, that "plausible" in this context means that the "technical concept" and hence the suitability of the claimed compounds for the claimed therapeutic application is "plausible" as long as it is not shown to be "implausible". That would be in direct contradiction with the principles set out in decision T 609/02. 
• The current Board then adds some reasoning: "The burden to show the suitability is on the applicant (see G 1/03, OJ EPO 2004, 413, point 2.5.3 of the Reasons: "When an application for a patent is filed, the process of making the invention has to be completed. The requirement of sufficiency of disclosure ensures that a patent is only granted if there is a corresponding contribution to the state of the art. Such a contribution is not present as long as the person skilled in the art is not able to carry out the invention. Therefore, the decisive date for fulfilling the requirement has to be the date of filing or priority, as the case may be. Deficiencies in this respect cannot be remedied during the proceedings before the EPO."). This burden cannot be discharged or shifted to the EPO or the public by merely alleging that a claimed therapeutic effect has to be regarded as having been demonstrated as long as it has not been disproven."
• Cited point 2.5.3 of G 1/03 (about non-disclosed disclaimers) may not directly address the issue of the burden of proof. The current Board uses "see", probably in the strict legal sense of that term  ("See [] is used when the cited authority clearly supports a proposition but there is an inferential step between the proposition as stated and the cited authority." - link) 
• It would have been useful if the Board had spelt out the 'inferential step' since the case at hand is an opposition appeal, and the general case law is that attacks under Article 100(b)  EPC require serious doubts substantiated by verifiable facts. 
• "The board therefore assesses below what can be inferred from the information provided in the patent as to a direct effect of a PD-1 inhibitor on a metabolic mechanism specifically involved in NLPHL."
• The Board, after reviewing the technical details, "the appellants [proprietors] on the one hand argued that tumours are characterised by T cell exhaustion and on the other hand that PD-1 expression is concomitant with T cell exhaustion. This explanation would lead to the conclusion that all cancers may be treated by PD-1 blockade, which manifestly is not the case. This is acknowledged in the declaration D55 submitted by the appellants: "All cancers are distinct and it is not possible to predict that a specific pathway, such as the PD-1 pathway, is present in any given type of cancer".
• The Board concludes that the application as filed does not provide support for the second medical indication in the sense of G 2/21, r.77. 
• The argument that post-published evidence shows that the compound works (allegedly), therefore, "must fail".

EPO

The link can be found after the jump. 

T 2157/21 - Embodied by the same originally disclosed invention

Key points

• The Board  applies G2/21, hn.2, the part about  "would derive said effect as being [...] embodied by the same originally disclosed invention." (without mentioning the decision).
• A crystalline form of a compound is claimed. After some amendments, the claim meets Article 123(2) EPC and defines the crystalline form quite specifically in terms of XRD peaks.
•  "Claim 1 of auxiliary request 12, which is identical to claim 1 of auxiliary request 12A, claims a crystalline form designated as "Form II" which is characterised by an XRPD pattern comprising lines at 2Theta values measured using CuKa radiation, wherein the X-ray powder diffraction pattern is the same as that shown in Figure 7." (i.e. the claim refers to Figure 7 that is also included in the claim and shows the XRD spectrum as an image.
• "Thus, the question that is decisive for the acknowledgement of an inventive step is whether the claimed polymorph provides an unexpected advantage in comparison with forms disclosed in the prior art. The patent proprietors relied, in this regard, on the data presented in Examples 14 to 16 of the patent in suit."
• "Examples 14 and 15 of the patent in suit compare "Form II" of the patent in suit with the so-called "patent form" disclosed in US8877938B2 (i.e. the US equivalent of D3) in terms of moisture uptake and flowability. It was not in dispute that the comparative experiments reported in Examples 14 and 15 represent a comparison of "Form II" with the crystalline form of trisodium valsartan sacubitril as disclosed in document D3. The reported outcome is that "Form II" showed better flowability (Example 15) and less moisture uptake when exposed to humidity (Example 14). "
• So far, so good.
• "However, it is not disclosed in the patent specification whether the samples tested according to Examples 14 to 16 were obtained according to the process of preparation described in Example 6, or according to the process described in Example 7. In both Examples 6 and 7, the respective product that was prepared is designated as "Form II"."
• "it cannot be confirmed on the basis of the available evidence that the crystalline products of Example 6 and Example 7 are indeed identical, as argued by the patent proprietors. As a consequence, the exclusive use of the term "Form II" in Examples 14 to 16 does not permit the reader to infer that, specifically, the product according to Example 6 and corresponding Figure 7 and Table 4 was tested in these examples. For this reason, it cannot be confirmed that the specific product claimed in claim 1 of auxiliary requests 12 and 12A, which is characterised by the diffractogram in Figure 7, indeed exhibited the favourable properties described in Examples 14 to 16."
• Inventive step is denied.
• For the lower-ranking auxiliary request, the claim refers to Figure 8 instead of Figure 7.
• "By analogy, the same reasoning applies: since it cannot be confirmed that the crystalline product prepared according to Example 7, as characterised by Figure 8 (and Table 5), was used in the experiments described in Examples 14 to 16, it has not been conclusively shown that the claimed product has superior properties in comparison with the crystalline form of D3. Accordingly, the same objective technical problem and the same conclusions regarding obviousness apply as those set out above with respect to auxiliary requests 12 and 12A."
• In other words, likely the compound of Example 14 was either the one of Figure 7 or Figure 8, but the ambiguity prejudices basing inventive step on the effects shown in Example 14. 

EPO 

The link to the decision and an extract of it can be found after the jump.

T 0228/23 - The requirements for a technical effect

Key points

• This decision illustrates that there are four requirements for acknowledging a technical effect: procedural admissibility, support in the application as filed (G2/21, hn.2) and proof of the effect; the support requirement in turn comprising two requirements: same technical teaching and same invention.
• "The appellant - patent proprietor relied [during the oral proceedings] for the first time in the entire proceedings on an alleged improvement of friability (even if based on data contained in the documents on file) as a technical effect in the context of inventive step. In particular as argued by appellants - opponents 2 and 4 during oral proceedings friability and hardness are two different properties evaluated by different methods (see D33, paragraphs 17.5.3 and 17.5.4). Moreover, none of these two properties was relied upon by the appellant - patent proprietor as a technical effect for the issue of inventive step in the present proceedings before. This argument therefore constitutes an amendment to the case of the appellant - patent proprietor (Article 12(4) RPBA, 1**(st) sentence). Since this amendment was filed after notification of the communication under Article 15(1) RPBA, its admittance is to be decided on the basis of Article 13(2) RPBA."
• "the Board does not admit the submission of the appellant - patent proprietor of 30 July 2024 in section B.6 concerning friability into the appeal proceedings (Article 13(2) RPBA)."
  
  
• Turning to a further technical effect: "According to the appellant - patent proprietor, the use of dry granulation to prepare the present tablets would result in a faster and more complete drug release compared to tablets prepared by direct compression. This technical effect would be substantiated by the experimental data provided in document D61. Post-published evidences could be taken into account in the present case in line with G 2/21."
• "In the present case, the Board considers that the alleged specific effect of faster and more complete release profile is indeed derivable from the original application in view of the references to immediate release, desired dissolution profiles and dissolution performance (see e.g. Title and page 2 of the original application). In particular, as underlined by the appellant - patent proprietor during oral proceedings, the description of the immediate release profile in the context of the invention on page 4 lines 21-31 of the original application defines an increase of the release percentage and/or a reduction of the release time. This passage suggests that a faster and more complete release profile constitutes a purpose of the invention. This technical effect is thus encompassed by the technical teaching of the original application as required by G 2/21."
• "It remains to be determined whether the second criteria set in G 2/21 was met, i.e. whether the effect is embodied by the same originally disclosed invention. The Board agrees with the appellants - opponents that the original application discloses that the tablets can be prepared by direct compression or dry granulation and does not indicate whether one of these methods is preferred over the other in relation to its effect on the release profile of the tablet. However, the fact that all the examples of the original application concern dry granulation indicates that dry granulation would be preferred over direct compression in general in the context of the application. Moreover, the original application describes merely two preparation processes (dry granulation and direct compression). In this specific case of a very limited number of embodiments defined in the original application, one of these being also the subject-matter of the closest prior art and the other one being generally preferred, and in the absence of any legitimate reason at the effective date to doubt that the alleged effect could be achieved with the claimed subject-matter (see T 116/18, reasons 11.14), the Board is of the opinion that the appellant - patent proprietor should be entitled to specify a preference for one of said originally disclosed embodiments over the other in connection with said effect. In the present case, the alleged effect of faster and more complete release profile for tablets obtained by dry granulation compared to direct compression does thus not change the nature of the claimed invention, as defined in G 2/21 (see last sentence of paragraph 93), so that it is embodied by the same originally disclosed invention in the sense of G 2/21."
• "In line with G 2/21, the alleged technical effect of faster and more complete release profile in so far as it is supported by the post-published experimental data on file is thus to be taken into account when assessing the inventiveness of the claimed subject-matter. "
• "Each of the parties provided comparative experiments based on different reworkings of the example disclosed on page 19 of D1 (see D61 submitted by the appellant - patent proprietor and D40, D66, D56 and D71 submitted by the appellants - opponents). Varying results were obtained, showing: - either a faster and more complete release of the drug when using dry granulation (D61 [filed by the proprietor]), - or no significant difference in the release rates between tablets obtained by dry granulation or direct compression (D40/ D66 and D71, in particular in case of experiments 1 and 4 of D71 [filed by the opponents]).
•   The Board observes that the comparative examples referred to by each party appear to fulfil the standard criteria to appropriately substantiate an effect of the distinguishing feature (the preparation method - dry granulation or direct compression - being the sole difference between each comparative example). The Board considers that the lack of certain details in the example of document D1 required the parties to fill the gaps, leading to different comparative compositions."
• " Furthermore, as argued by appellant - opponent 7, variants of the prior art are usually permitted for comparative tests as long as the features common with the claimed invention are identical and the sole difference remains the distinguishing feature. There is therefore no fundamental reason to consider the experiment of document D61 as having a higher probative value than those of documents D40/D66 and D56/D71."
• "when taking into account all the experimental data on file, an improvement of the release rate for tablets obtained by dry granulation compared to direct compression has not been convincingly substantiated throughout the tested compositions. Hence, the alleged technical effect cannot be considered to credibly occur over the whole breadth of the claims. "
• This is the proof of the technical effect (across the whole scope of the claim) as required by T 939/92 (see also G/03 r.2.5 for the case of a few non-working embodiments).
• The patent is revoked. 


EPO

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

T 0708/21 - The technical problem of matching foundation and skin tone

Key points

•  "The invention is about recommending make-up foundations that match a person's skin tone, [0002] and [0003] of the published application."
• The issue is inventive step. 
• "Method for selecting a foundation intended for a person, comprising the steps of:

  - acquiring (100) an image of a complete view of a person's face in a controlled lighting environment,  ... [digitally processing data and] presenting (420) to the person the foundation(s) comprised in the personalized color matrix"

• The Board does not comment on whether the method is industrially applicable. The Board dismisses the appeal of the applicant against the refusal of the application for lack of inventive step. Therefore there was no need to comment on Art. 57. Perhaps it was not even an objection of the Examining Division. Still, I think that in 1973, or perhaps 20 - 30 years ago, a method of "recommending make-up foundations that match a person's skin tone" would perhaps not be treated as an industrial method. 

• Regarding inventive step: "Therefore, the Board considers that the differences may be assessed separately for inventive step, as the examining division did in the decision under appeal.

• 2.6.1 Concerning feature 1), lightness and hue define a 2D colour space that is simpler than the 3D colour spaces mentioned in D1 (HSV and RGB), yet still suitable for representing human skin tones and foundation shades (see also page 10, first paragraph of the published application). Therefore, the Board considers that the technical problem solved by this feature is to find a simpler colour space for representing skin tones and foundation shades."

• "Hence, the skilled person seeking a simpler colour space would apply the teaching of D5 to the method of D1, and thereby arrive at feature 1) in an obvious manner."

• "The appellant submitted that human skin appeared desaturated under illumination, while suitable foundations typically had higher saturation levels to create a more radiant effect. If saturation was taken into account in the matching process, the selected foundations would be less saturated, resulting in a duller appearance, which was undesirable. By ignoring the saturation from the colour matching, the invention eliminated unwanted noise and provided more relevant matches. During the oral proceedings, the appellant supported this argument with experimental data showing significant differences between the saturation levels of skin and foundation measurements, and the impact of saturation on the recommended products."
• "However, according to the jurisprudence of the Boards of Appeal, an alleged technical effect cannot be considered for inventive step unless it is at least hinted at in the original application, or can be deduced by the skilled person from the application as filed considered in relation to the nearest prior art (Case Law of the Boards of Appeal, I.D.4.4.3 b, second paragraph). This is not the case here since the application as filed does not suggest that saturation is a noise factor and that ignoring it leads to more accurate results. It merely states that lightness and hue are chosen for simplicity, and that saturation can be disregarded since it is less important for foundation colours (page 10, top). Simplifying a process by removing irrelevant data does not imply or suggest an improvement in accuracy."


• Is this an application of G 2/21, headnote 2?

EPO 

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

T 0314/20 - Interpreting G 2/21

Key points

• This decision was issued in writing on 20.12.2024.  The decision was taken on 16.11.2023 (!). 
• No communication under Art. 15(9) RPB is visible in the public online file. We must trust the President of the Boards was informed of the delay as prescribed.
• The catchword is "On the interpretation of decision G 2/21 ",  so I can see why the Board needed some time.
• Claimed is the combination of empagliflozin with linagliptin. 
• "In support of the alleged  [technical effect of] "increase in GLP-1", the respondent [proprietor] referred to post-published documents D55 and D56."
• "As explained below, the technical effect relied on by the respondent for inventive step (see point 6.9 above) and possibly shown by document D56 cannot be taken into account for formulating the objective technical problem in light of decision G 2/21 "
• "he current Board identifies three challenges in interpreting point 2 of the order of decision G 2/21."
• "First, the requirements "encompassed by the technical teaching" and "embodied by the same originally disclosed invention" were not used in the plausibility case law underlying questions 2 or 3 of the referral. Therefore, their relation to this case law remains to be defined, particularly in terms of whether, and to what extent, they replace, align with, or modify it."
• "Second, the Enlarged Board did not expressly define these requirements. It could be argued that the dependent clause "because such an effect does not change the nature of the claimed invention" in point 93 of decision G 2/21 (see point 6.12.2 above) serves as their definition. However, if this were the case, it would be unclear why the Enlarged Board did not simply state that a patent applicant or proprietor can only rely on a technical effect if such an effect does not change the nature of the claimed invention, instead of introducing two distinct requirements. "
• "Finally, the Enlarged Board did not expressly state the purpose of these requirements."
  
  
• " In decision T 116/18 [of July 2023, after the remittal], the competent [Technical] Board reached a number of conclusions on the relationship, the purpose and the content of the two requirements outlined in point 2 of the order of decision G 2/21."
• See my blog post on that decision.
• " This Board faces two issues with the interpretation of decision G 2/21 given in the passages quoted from decision T 116/18 in point 6.13.4 above. [...]
• "the [TBA in T116/18 of July 2023] effectively adopted what it defined in the referral T 116/18 as the "ab initio implausibility" standard."
• "some of the inferences drawn in the passages quoted above from decision T 116/18 are not supported by the text of decision G 2/21. "
  
  
• "In the present case, the current Board does not need to give a definitive answer as to whether it can endorse all the conclusions of decision T 116/18 regarding the two requirements set out in point 2 of the order of decision G 2/21. The Board considers that the purpose of these requirements is to prevent patents from being granted for inventions that are not complete at the filing date. Such speculative applications arise where either the existence of the claimed technical effect or its generalisation is speculative. This may occur because relevant data have not yet been generated or, if available to the patent applicant, have not been disclosed in the patent application.
• " If the Board's understanding of the purpose of the two requirements - which aligns with the view in T 116/18 - is correct, the respondent cannot rely on the technical effect in this case. This is because a skilled person would not expect the technical effect in question - an increase in active GLP-1 levels from the combination of empagliflozin and linagliptin compared to increases in active GLP-1 levels achieved with combinations of emplagliflozin with sitagliptin and vildagliptin, respectively - on the basis of the original disclosure of the application itself. This effect is not only unsupported and not made credible by the application as originally filed; it even contradicts its technical teaching. Therefore, whatever the meaning of the two requirements in G 2/21, they cannot be met in the present case if patenting for inventions not made at the filing date is to be excluded."
  
  
• "as observed by the appellants [opponents] at the oral proceedings, the application as originally filed presents combinations of empagliflozin with linagliptin, sitagliptin, vildagliptin, saxagliptin or alogliptin at an equal level of preference. This is apparent from the paragraph directly below Table 1 (see page 33, lines 2 to 5). This paragraph explains that among the 176 combinations exemplified in Table 1, the combinations numbered "97", "165", "166", "167" and "168" are most preferred. Combination 97 pertains to the currently claimed combinations, i.e. combinations of empagliflozin and linagliptin or a pharmaceutically acceptable salt of it []. Combinations 165 to 168 relate to combinations of empagliflozin with sitagliptin, vildagliptin, saxagliptin and alogliptin, respectively []"
• "the purported technical effect relied upon by the respondent [proprietor] for inventive step is an increase in plasma levels of active GLP-1 which is stronger and more prolonged in time than the one achieved by combinations 165 and 166, i.e. combinations of empagliflozin with sitagliptin and vildagliptin, respectively (see point 6.9 above)."
• The Board states it like this. It is not entirely clear to me what D2, the closest prior art, discloses. 
• "The Board concludes that the technical teaching of the claimed invention that the skilled person, with the common general knowledge in mind, understands at the filing date from the application as originally filed, encompasses the following.

  (a) Combination 97 (i.e. the currently claimed combinations) gives rise, inter alia, to an increase in plasma levels of active GLP-1 in patients with metabolic disorders and related diseases.  (b) Combinations 165 to 168 (i.e. combinations of empagliflozin with sitagliptin, vildagliptin, alogliptin and saxagliptin, respectively), having the same level of preference, achieve the same increase in plasma levels of active GLP-1 in patients with metabolic disorders and related diseases as combination 97."

• "It follows from the analysis made in points 6.20 to 6.24 above that the skilled person, having the common general knowledge in mind, and based on the application as originally filed, would not derive the increase in plasma levels of active GLP-1 relied on by the respondent (see point 6.25 above) as being encompassed by the technical teaching of the claimed invention and embodied by the same originally disclosed invention."

• "From the above it follows that the objective technical problem is to provide a specific combination of a glucopyranosyl-substituted benzene derivative of formula I as shown in document D2 with a DPP IV inhibitor in the context of diabetic diseases."

• "In the board's judgement, the proposed solution would have been obvious having regard to the state of the art. The reasons are as follows."

• "In such cases of arbitrary selections, the prior art does not need to contain a pointer towards the compounds claimed, i.e. empagliflozin and linagliptin.  Instead, all possible solutions have to be regarded as being equally suitable and obvious candidates for solving the objective technical problem as defined above "

• The request for a referral to the Enlarged Board is refused. "in the case at hand, the Board also believes that any tenable interpretation of the requirements introduced in decision G 2/21 would lead to the conclusion that the respondent cannot rely on the alleged "increase in GLP-1" of the claimed combination"

• To cite a few more paragraphs: 

• "Irrespective of how the term "technical effect" in point 2 of the order of decision G 2/21 is to be interpreted, it remains that the technical effect relied upon by the respondent for acknowledgement of inventive step rests on experimental data (i.e. document D56, Figures 1 to 3 and Table 1) which does not confirm the technical teaching conveyed by the application as originally filed (i.e. the same increase in active plasma levels of active GLP-1 for combinations 97, 165 and 166). Rather, these experimental data teach against it. "

•  As regards the respondent's argument that the technical effect relied on did not change the nature of the claimed invention since the claimed combination was disclosed in the application as originally filed and no additions or changes to this combination were required to arrive at this effect, the Board notes that this is not sufficient for the requirements stated in point 2 of the order of G 2/21 to be met. More precisely, it is not enough that the claimed invention is disclosed in the application as originally filed in terms of its technical features and that these same features (possibly) achieve this effect without requiring any modification. Rather, it is the purported technical effect relied on for inventive step that must be derivable by the skilled person, having the common general knowledge in mind, and based on the application as originally filed, as being encompassed by the technical teaching and embodied by the same originally disclosed invention. These requirements are not met in the case at issue. "" 

• "For the reasons set out above, the technical effect "increase in GLP-1" associated specifically with the combination claimed would be unexpected to the skilled person in view of the application as originally filed. As a consequence, the alleged "increase in GLP-1" relied upon by the respondent for acknowledgement of inventive step cannot be taken into account for the formulation of the objective technical problem."

EPO 

T 1994/22 - The application is silent on photostability

Key points

• Claim 1 of the patent as granted reads as follows: "1. A Form-II crystal of [selexipag] [with certain XRD peaks].
• "D32 is a post-published document filed by the respondent [opponent] before the opposition division. [] From this light stability test, it is concluded in D32 that Form II (according to claim 1 of the main request) is more photostable than Form III (comparative)."
• "The appellant submitted that the application as filed made no mention of the photostability of Form II, let alone contained any evidence of it."
• "According to G 2/21 (headnote 2), "a patent applicant or proprietor may rely upon a technical effect for inventive step if the skilled person, having the common general knowledge in mind, and based on the application as originally filed, would derive said effect as being encompassed by the technical teaching and embodied by the same originally disclosed invention."
• I note that G 2/21 was, first of all, about effects that are mentioned in the application as filed but without any support for them.
• Separately, already since T 0184/82, there is case law about technical effects that are not mentioned the application. They can be relied on provided that "the skilled man could recognise the [asserted technical effect] as implied or related to the problem initially suggested [in the application as filed]".
• To me, it seems useful to keep the requirements separate. However, the present decision illustrates how G 2/21 can also be applied to the first issue (effects not mentioned at all in the application as filed).
• "Considering order no. 2 of G 2/21, the question to be answered in the present case is thus whether the effect relied on by the respondent and demonstrated in the post-published experimental data (D32), namely that of improved photostability of Form II, can be derived by the skilled person, having the common general knowledge in mind, and based on the application as filed, as being encompassed by the technical teaching (requirement (i)) and embodied by the same originally disclosed invention (requirement (ii))."
• "All that is disclosed in paragraph [0005] of the application as filed (paragraph [0006] of the application as published), as relied on by the respondent, is a "thing of a high quality for which constant effect can be always shown and of a form which is handled easily industrially". "
• From Espacenet: "It is hoped that medicament bulk is a thing of a high quality for which constant effect can be always shown and of a form which is handled easily industrially. The present inventors have earnestly studied. As a result, the present inventors have found a novel crystal of compound A, and have completed the present invention."
• " If such a sweeping statement was 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, in more concrete terms, the application as filed is in fact directed to particle size (table 1), residual solvent content (table 2) and amount of impurities (table 3). These properties are entirely unrelated to photostability."
  
• "Therefore, based on these properties [from the tables], having the common general knowledge in mind, the skilled person would by no means have recognised that (improved) photostability is 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 (point 11.13.3 of the Reasons). Hence, the effect of photostability is not encompassed by the teaching of the application as filed."
• "even if it were wrongly concluded in the respondent's [proprietor'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 (point 11.10). More specifically, points (1) to (3) of paragraph [0006] of the application as filed (paragraph [0007] of the application as published), claims 1 and 2, and points [1] to [3] on page 37 of the application as filed, as relied on by the respondent, refer to Form I, Form II and Form III in equal terms. These passages do not teach that Form II, i.e. the form claimed in claim 1 of the main request, is the preferred polymorphic form of selexipag, let alone that it should exhibit a photostability that is improved compared with Form I and Form III. Hence, the effect of improved photostability together with Form II is not encompassed by the teaching of the application as filed."
• Turning to inventive step: "the selection of Form II is an arbitrary selection from the host of alternatives covered by the closest prior art. Such an arbitrary selection without any unexpected balance of properties being produced cannot contribute to inventive step. The subject-matter of claim 1 of the main request therefore does not involve an inventive step in view of D10 as the closest prior art."

•  

EPO 

The link to the decision and an extract of it can be found after the jump.