Key points
- Under the PSA, the CPA or starting point document must be a 'feasible' document. What happens if you try the PSA from a document that is not suitable?
Claim 1 as granted defines: "A medical device containing a separately prepared freeze-dried cake composition comprising aripiprazole as an active ingredient in a storage container whose inner wall is treated with silicone, wherein there is a space between the inner wall of the storage container and the cake composition."
"The patent addresses the specific issue of the agglomeration of aripiprazole following resuspension when it is provided as a cake composition in a storage container of a medical device, such as a syringe, of which the inner wall is treated with silicone"
" The patent teaches in this context that by reducing the contact of the cake composition comprising aripiprazole with the silicone this agglomeration can be suppressed ... . The patent presents experimental results in support of this teaching"
"According to the established jurisprudence (see [CLBA] I.D.3.4) a central consideration in selecting the closest prior art is that it must be directed to the same purpose or effect as the claimed invention; otherwise, it cannot lead the skilled person in an obvious way to the claimed invention. "
"if an inventive step can be acknowledged starting from a particular prior art that is convincingly identified as the most promising starting point and therefore indeed constitutes the closest prior art, the attempt to deny an inventive step starting from a less promising starting point must fail"
The concept of the closest prior art in the problem solution approach not only obviates the need to address repetitive lines of argument, it also allows for the due appreciation of specific effects in relation to the prior art that may be associated with the distinguishing features
Document D2 describes the preparation of a formulation comprising aripiprazole by freeze-drying a suspension in a vial
"documents D12, D11 and D18 describe silicone-treated medical devices comprising freeze-dried formulations without mention of aripiprazole or problems resulting from the presence of silicone. Documents D12, D11 and D18 therefore do not address a similar purpose or effect as the patent. Arriving at the development of a freeze-dried composition comprising aripiprazole in a silicone-treated container of a medical device as disclosed in the patent starting from these documents would require the clueless choice of aripiprazole from all possible candidates of active ingredients, which the Board does not consider a reasonable proposition."
The Board therefore considers that documents D12, D11 and D18 do not represent reasonable alternative starting points in the assessment of inventive step, irrespective of the number of other features shared with the claimed subject-matter.
- Now, as a question: how could a national court assess inventive step over D12, assuming the court cannot disregard D12 as a starting point, as the Board did?