T 0314/20 inzake de voorkoming van speculatieve uitvindingen vanuit de leunstoel

In T 0314/20 the inventiveness of a pharmaceutical composition was discussed. An important issue was if the application as filed disclosed the technical effect the Patentee (P) relied on for inventive step. The Board discussed the guidance that G2/21 (“reliance on a purported technical effect for inventive step (plausibility)”) provided for this situation and the interpretation that was given to G2/21 by the Board of T 0116/18 (whose referral led to the G2/21 decision). 

The technical effect of the current Appeal related to an improved effect on diabetes mellitus which the composition of claim 1 (a combination of “empagliflozin” with “linagliptin”) would have over other combinations disclosed in the closest prior art (empagliflozin with sitagliptin and with vildagliptin). 

The evidence for the technical effect was provided in a post-filed test report D56. In first instance the opposition division rejected the opposition based on the consideration that D56 evidenced improved diabetes treatment and therefore the subject matter was found inventive. 

In appeal the debate was not if the application as filed evidenced the effect on diabetes of the composition of claim 1, because that was undisputed. Instead, the question arose if this improved effect over the known compositions was disclosed in the application as filed and what the implications would be if this was not the case. 

The Appeal

The Board quoted and discussed headnote II. of G2/21 which states:

 “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 consider said effect as 1) being encompassed by the technical teaching and 2) embodied by the same originally disclosed invention”. (the numbering of the requirements is added).

The Board then assessed decision T 0116/18 (the decision the referral is concerned with) and agreed with the T 0116/18 Board that the purpose of the above requirements is to prevent speculative (armchair) inventions. 

However, the current Board did not follow the reasoning of the T 0116/18 Board that headnote II would translate to the requirements that 1) “the purported technical effect together with the claimed subject matter need only be conceptually comprised by the broadest technical teaching as filed” and for requirement 2) the question may be rephrased to “would the skilled person have legitimate reason to doubt that the purported technical effect can be achieved with the claims subject matter”. The current Board saw inconsistencies in the reasoning of the T 0116/18 Board to come to this interpretation and missed support for some of the inferences the T 0116/18 Board made from the text of the G2/21 decision. 

Therefore, the current Board did not follow this interpretation. Instead, the Board started its own reasoning with emphasizing the purpose of the requirements of G2/21: 

Then, instead of interpreting the reasoning of G2/21 to come to an interpretation of the requirements of headnote II, the Board circumvented interpreting by using the purpose in combination with the facts of the case at hand to come to a decision.

The technical effect concerned was an improved effect on diabetes (and specifically a strong and sustained effect on GLP-1 levels) of the composition of claim 1 (a combination of empagliflozin with linagliptin over other combinations disclosed in the closest prior art (empagliflozin with sitagliptin and with vildagliptin). This improved effect was demonstrated in post-filed report D56.

The Board explained that the application taught that all combinations (so also the prior art combinations) induced an increase in active GLP-1 levels. In addition, the Board pointed out that the application as filed presented combinations of empagliflozin with linagliptin, sitagliptin, vildagliptin, saxagliptin or alogliptin at an equal level of preference. Also the examples did not single out the claimed combination, instead there were three combinations in the examples including the claimed combination with equal preference and having an equal increase of GLP-1 levels.

The Board then stated: “Hence, the increase in active GLP-1 levels relied on by the respondent for acknowledgement of inventive step of the claimed subject-matter forms the basis of an invention which has not been made or disclosed at the filing date of the application. Consequently, this technical effect cannot be taken into account for formulating the objective technical problem (see point 6.14 above).”

So according to the Board the technical effect P relied on was not disclosed in the application and therefore the Board did not go along with the arguments of P (the respondent):

“In the respondent's view, point 2 of the order of decision G 2/21 solely required that the technical effect relied on for inventive step itself was encompassed by the technical teaching of the application as originally filed. In the case at hand, this effect was an increase in plasma levels of active GLP-1. How strong or prolonged this increase was compared to increases in plasma levels of active GLP-1 achieved with comparative combinations of SGLT2 inhibitors with DPP IV inhibitors or other such combinations that might be construed from the closest prior art was not the subject-matter of decision G 2/21 but rather a matter of a downstream assessment of inventive step.”

Decision of the Board

In the absence of a technical effect, the Board found the claims not inventive, and the patent was revoked.

Summary written by the NLO EPO Case Law Team