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?
I'm not a chemist so what I write now is likely no help to anybody. But replies to my comment might help me.
ReplyDeleteLet us suppose that the drafter of the patent application knows the prior art exhaustively, and so knows all about D11, 12 and 18. The challenge is to get a useful claim allowed as inventive. Might it be clever, to put aripiprazole into the pre-characterizing part of the claim and write that the problem is to further develop such compositions? I mean, the EPO and the courts must always be vigilant to do justice as between a skilful drafter and a skilful opponent/competitor, both having full knowledge of the relevant prior art. The EPO's "same purpose or effect" filter: is it open to exploitation by skilful and omniscient patent drafters?
I'm not so sure if it is wrong for a patent system to reward carefully drafted patent applications. On the other hand, it seems counterintuitive that the order of features in a claim would matter.
DeleteIncidentally, in the case at hand, the claim had no "characterised in that" clause, but still recited aripiprazole before the first "wherein" clause.
Thanks for that answer and, of course, I agree with you that there should be no prejudice against claims drafted "carefully". What I had more in mind is a claim in which the features of the pre-characterizing part are "artificial", and do not correspond to a real life technical problem. Claims that fail to recite a solution and, instead, merely state a problem to be solved, are of dubious validity. Likewise (perhaps) those in c-i-t form that recite the solution in the pre-characterizing part, thereby to disqualify the closest prior art as a feasible CPA "starting point" and thereby clear the way to allowance and grant. I continue to suspect that EPO CPA is open to abuse by applicants that i) know the closest prior art intimately and ii) are skilled in their formulation of the "subjective technical problem"
DeleteIt is a highly interesting topic, but I have a running opposition case touching on the point, so I prefer to not comment too much here.
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