In what was evidently a co-ordinated move, the UPC’s Court of Appeal has handed down two judgments on the same day – one from each of its two panels – on the critical issue of the court’s approach to inventive step. The first case was between various Meril companies and Edwards Lifesciences Corporation (“Meril v Edwards”[1]) concerning a prosthetic heart valve. The second was between (i) Amgen, Inc and (ii) various Sanofi companies and Regeneron Pharmaceuticals (“Amgen v. Sanofi”[2]) and related to biotechnologically-produced drugs to lower cholesterol.
Despite the very different subject matters, both judgments set out the same general inventive step principles word-for-word in their reasons (see r. 128-136 in Meril and r. 123-132 in Amgen).
Both note that the EPO and European countries use the problem/solution approach, whereas the UK and Germany use a more “holistic” approach. The UPC has now explicitly adopted an approach that has aspects of each.
First, the nature of the person skilled in the art (and their common general knowledge) is to be decided, noting that this person “has no inventive skills and no imagination”.
This is followed by the identification of an “objective problem”, as assessed by the skilled person, “by establishing what the invention adds to the state of the art, not by looking at the individual features of the claim, but by comparing the claim as a whole in the context of the specification and the drawings”. This assessment also considers the “inventive concept underlying the invention” based on the technical effects achieved by the invention, as understood by the skilled person.
The objective problem must not contain any pointers to the claimed solution, to avoid hindsight.
The court then must consider whether the skilled person, starting from any realistic starting point in the state of the art in the relevant field of technology, wishing to solve the objective problem, would (and not only could) have arrived at the claimed solution. The judgments also make it clear that a technical improvement over the prior art is not necessarily required for there to be an inventive step.
Thus, this approach shares with the EPO’s the need to identify a ‘problem’ and its ‘solution’, but the way this is done appears to be less formulaic and more ‘holistic’ – considering an “inventive concept” is a distinctly British approach.
It is made clear that multiple ‘starting points’ may be considered (as often happens in practice before the EPO) so there is no consideration of the closest prior art, though only realistic starting points are relevant. Another point of interest is the need for the skilled person to have some motivation or pointer to the claimed solution – i.e. would the person skilled in the art “take the next step, prompted by the pointer or as a matter of routine, and arrive at the claimed invention”.
In both Meril v Edwards and Amgen v. Sanofi, only a single problem was considered in relation to multiple ‘starting point’ prior art references, despite the problem being described as ‘objective’. It remains to be seen whether a different approach will be taken in cases where the starting point prior art references relied upon differ significantly from each other in their technical disclosures.
Interestingly, in both cases, the Court of Appeal held that there was an inventive step. In doing so, the judgment in Meril v Edwards was upheld and that in Amgen v. Sanofi was overturned.