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.

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EPO 

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

https://www.epo.org/en/boards-of-appeal/decisions/t231847eu1