T 1306/18 - Plausibility (Almirall II)

 Key points

• A post from the stock (decision published in  November 2021).
• Claim 1 is directed to: “A pharmaceutical composition comprising aclidinium [...] providing a metered nominal dose of aclidinium equivalent to 400 myg (plus/minus 10%) aclidinium bromide for use by inhalation in the treatment of chronic obstructive pulmonary disease [COPD].”
• “The subject-matter of claim 1 of the main request differs in the metered nominal dose of aclidinium equivalent to 400 myg (plus/minus 10%) aclidinium bromide.”
• The Board: “the [] post-published evidence [the scientific journal articles D42-D44] credibly shows that the claimed dose of 400 myg allows for an effective long term treatment of COPD without increase in side effects.”
• “According to the [opponents - 26.07.2022], the technical effects alleged by the appellant, in particular the absence of increase in toxicity, are not to be taken into account for the assessment of inventive step. The Board does not share this opinion for the following reasons.”
• “The respondents also criticise the absence of data regarding safety profile for the dose of 400 myg in the application as filed. The Board does not share this opinion for the following reasons.”
• “the Board concurs with the appellant [patentee] that these effects are sufficiently connected to the technical problem mentioned in the application as filed to justify a reformulation of the objective technical problem for the purposes of inventive step. The clinical data reported in the application as filed (see example 1) involve a once-daily treatment with, among others, a dose of 400 myg aclidinium for 4 weeks. The suitability of the claimed aclidinium dose in long-term maintenance therapy is thus sufficiently shown in the application as filed. Furthermore, at the end of the clinical study of example 1, it is observed that "Aclidinium was well tolerated, with no dose-dependent effect on ECG, laboratory parameters or adverse events" (paragraph [0043] of the application as filed) and that the 400 myg dose was selected as the investigational dose for long term clinical trials on the basis of not only efficacy but also tolerability data (paragraph [0044] of the application as filed). Accordingly, the clinical data of D42-D44 merely confirm the teaching of the application as filed and can be taken into account in the assessment of inventive step.”
  
• I've not studied if the post-published scientific articles D42-D44 are perhaps the publications of the results of the long term clinical trials. The priority date was in 2008, the publications D42-D44 are all from 2012; D44 is a "24-week, double-blind trial" .
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• The decision was taken 14.09.2021 and published 22.11.2021.

Link after the jump.

T 1306/18 -

https://www.epo.org/law-practice/case-law-appeals/recent/t181306eu1.html