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.

https://www.epo.org/en/boards-of-appeal/decisions/t230228eu1