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 

https://www.epo.org/en/boards-of-appeal/decisions/t200314eu1