Can data which was not present in a patent application be used to demonstrate a technical effect which supports an inventive step argument?
The EPO has confirmed that the answer is yes; ‘post-filed’ data can be used, with one important caveat. That is, the technical effect demonstrated by the post-filed data must be ‘encompassed by’ the technical teaching and the invention disclosed in the patent application. The full decision can be viewed here.
This decision means that there needs to be some sort of commonality between the technical effect which the data supports and the technical effect which was stated (and probably demonstrated) in the application as filed. Convergence of claims around specific embodiments of an inventive concept in the application will almost certainly be helpful in arguing that the post-filed data does demonstrate a legitimate technical effect.
The decision seems to set out a sensible middle ground between the ‘post-filed data is unallowable’ and the ‘all post filed data is allowable’ positions.
The former position would be unfair to applicants who demonstrated a technical benefit in their application but were confronted with new prior art during examination which anticipated only a portion of their claim. The latter position would have created a free for all on armchair patenting. That is, the filing of applications for large numbers of ‘inventions’ without any idea whether they actually work or not, and only later obtaining and filing data to demonstrate that some of those inventions happen to work.
There is obviously still room for argument about how linked a technical effect (demonstrated by post-filed data) is to a technical benefit/invention as demonstrated in the application as filed.
An interesting distinction was made between the use of post-filed data for demonstrating the sufficiency of a claim (where a strict approach is taken) and its inventive step where there is a more flexible approach. An example given was that it should be difficult to use post-filed data to demonstrate a medical benefit required for sufficiency of a second medical use claim. In Europe, second medical use claims are used when a new use of a know medicament has been found. They have the format ‘a compound X for the treatment of disease Y’.
Summary
It is noted that some patent practitioners have a policy of avoiding committing to particular technical effects in the description and relying solely on the disclosure of technical features to support their amendments and patentability arguments. This is perhaps due to a fear that, in some territories, stating technical effects for particular features might prove to be too limiting when it comes to enforcement.
However, we don’t think that this decision changes the best practice for drafting patent specifications which will be used in Europe.
Applicants should, if they are aware of several technical effects or different classes of technical effect, actually commit to explaining them in the application as filed. This is especially important when data demonstrating technical effect across the whole claim scope is incomplete, which in chemical patents is almost always the case. Preferably some reasoning about how those technical effects are provided should also be included, even if that reasoning is only a postulated mechanism of action.