UPC Inventive Step Assessment Begins to Crystallise with Beginning of Issuance of Decisions

With the frequency of issuance of UPC decisions on the merits beginning to increase, the long-sought answer to the question of how the UPC will assess inventive step is beginning to form. As of yet, the approach taken across the divisions has been somewhat uniform at least in its relatively freeform nature, forgoing the rigid structure favored by the EPO and instead assessing inventiveness in manners befitting the particulars of the relevant cases.

Burden of proof

Inventive step assessment was a key part of the first UPC decision on the merits issued, in the Franz Kaldewai v Bette 3 July decision from the Dusseldorf Local Division. In assessment of the main request of the patent (later found to lack an inventive step over the prior art), the Panel iterated that “An invention is present if it does not result from the usual approach of the person skilled in the art, but requires an additional creative effort on their part”. Based on this, the use of rigid plastic foam to form profile pieces and tub support was deemed a “routine consideration” for the person skilled in the art, due to their common use in the prior art and known advantageous properties. A defence that the skilled person would not normally choose this material due to its risk of breaking was dismissed by the Panel, who judged that choosing an appropriate degree of hardness of the foam could be performed without inventive activity.

This patent was, however, found inventive in an auxiliary request after the defendant’s inventive step objections were found unconvincing. The Panel reminded the defendant that the burden of proof fell with them to substantiate their arguments, as the defendant failed to explain why the skilled person would combine one document with the common general knowledge, two other documents together, or why the combination of said two documents would disclose the claim in question.

A choice between possible protocols

The Paris Local Division in DexCom v Abbott, 4 July, interpreted that the task of determining inventiveness necessarily included “to determine whether, given the state of the art, a person skilled in the art would have obtained the technical solution claimed by the patent using their technical knowledge and carrying out simple operations”, emphasising that “Inventive step is defined in terms of the specific problem encountered by the person skilled in the art”. When assessing the inventiveness of the claim in question, the Panel found that in implementing the system disclosed in the cited prior art, the skilled person would have to make a selection between possible protocols. As the novel feature of the claim related to the choice of one protocol, said protocol lacking a “particular or surprising effect” to its implementation and indeed already used at an earlier point in the method, it was deemed obvious that the skilled person would continue to use it.

Divergence from the EPO?

16 July saw the issuance of the third decision on merits, in the revocation decision on Sanofi v Amgen from the Central Division (Munich), one of the first UPC actions filed. This decision provided some of the most detailed guidance around the assessment of inventive step yet, including some divergence from EPO practice. 

The Central Division iterated at the start of their inventive step assessment by expressing that “An objective approach must be taken to the assessment of inventive step. The subjective ideas of the applicant or inventor are irrelevant”. This statement was later referenced and endorsed by the Dusseldorf Local Division in their assessment of inventive step in Seoul Viosys v expert e-Commerce, 10 October, and the Central Division (Munich) in NanoString v the President and Fellows of Harvard College, 17 October.

After disagreement between the parties on which document was the “closest prior art”, the Panel set forth that “assessment of inventive step starts from a realistic starting point in the prior art”, “there can be several realistic starting points”, and “it is not necessary to identify the “most promising” starting point”. This appears to be a pointer away from usage of the problem-solution approach favoured by the EPO, in which determination of the closest prior art is the first step to assessing inventiveness. A realistic starting point was deemed to be one whose “teaching would have been of interest to a skilled person who, at the priority date of the patent at issue, was seeking to develop a similar product or method to that disclosed in the prior art which thus has a similar underlying problem as the claimed invention”.

In giving a general definition of obviousness, the Panel put forward that a claimed solution is obvious “if the skilled person would be motivated to consider the claimed solution and would implement it as a next step in developing the prior art”. Whilst the Panel conceded that expected difficulty of taking the next step was a factor, they emphasised that “the absence of a reasonable expectation of success (or more in general: non-obviousness) does not follow from the mere fact that other ways of solving the underlying problem are also in the prior art and/or (would) have been pursued by others”.

In response to Amgen’s argument that the skilled person would not have inevitably ended up with antibodies falling within the scope of the claim of the patent, even upon considering an antibody approach for treatment of hypercholesterolemia targeting PCSK9, the Panel stated that “it is not the question whether the skilled person would inevitably arrive at the same result (falling within the scope of the claim or not). Rather, it is sufficient (but also necessary) for denying inventive step that the skilled person would without inventive contribution arrive at a result which is covered by a claim”.

On 19 July, a few days after Sanofi v Amgen’s decision, the Central Division (Paris) issued their first decision on merits in the revocation action Meril v Edwards. The Panel quoted the Paris Local Division in their decision, and followed the guidance set out in the DexCom v Abbott to assess the inventive step challenge, specifically referring to the necessity to “determine whether, given the state of the art, a person skilled in the art would have arrived at the technical solution claimed by the patent using their technical knowledge and carrying out simple operations”, confirming again that “inventive step is assessed in terms of the specific problem encountered by the person skilled in the art”.

In their final remarks, the Panel noted that the problem-solution approach “is not explicitly provided for in the ‘EPC’ and, therefore, does not appear to be mandatory”. However, the Panel went on to confirm that “applying the “problem-solution approach” to the present proceedings would not lead to a different conclusion”. The Central Division (Paris) went on to refer to the earlier decision from the Paris Local Division again in the 29 July decision in Bitzer v Carrier, quoting the same portions cited above in their assessment.

Or maybe not? 

However, it appears that some judges in the UPC may not have completely abandoned the problem-solution approach just yet. In the second DexCom v Abbott decision, issued by the Munich Local Division on 31 July and concerning a divisional of the patent concerned in the first DexCom decision, the Panel instead explicitly formulated the objective technical problem solved by the claim, and assessed inventiveness in light of this problem much how the EPO would. 

17 October saw the Central Division (Munich) issue their decision in NanoString v the President and Fellows of Harvard College, in which the Central Division emphasised that “hindsight needs to be avoided. The question of inventive step should not be answered by searching retrospectively, with knowledge of the patented subject matter or solution, for any (combination) prior art disclosures from which that solution could be deduced”. A similar sentiment against “one-sidedness” was echoed by the Dusseldorf Local Division in Seoul Viosys v expert e-Commerce, 10 October.

Meanwhile, in NJOY v Juul, 5 November, the Central Division (Paris) expressed that whilst limiting the evaluation of inventive step to the closest prior art “generally bears the risk of introducing subjective elements into the evaluation”, it was a useful structure to focus the debate on certain elements of the prior art, helping procedural efficiency. Further, the Panel went on to say that references to inventive step indicate that what is to be evaluated is an activity, and that “an activity can be motivated by an underlying problem”. Based on this, the Panel deemed that “It is then decisive, whether what is claimed as an invention did or did not follow from the prior art in such a way that the skilled person would have found it in his attempt to solve the underlying problem”; this formed the basis for their decision that the patent in suit was valid over the submitted prior art. 

Overall, no one size-fits-all approach has yet formed to assessing the inventive step, but with the Court still in its infancy that is perhaps to be expected. The overall preference certainly seems to be to approach the question of inventiveness on a more flexible basis to enable each patent in dispute to be properly assessed, addressing the question based on the context of the field and the invention, rather than with a rigid EPO problem-solution formulaic approach. However, the same key principles regarding taking an objective approach to the assessment, avoiding hindsight, and requiring a genuine creative effort on the part of the Inventor have reoccurred across divisions and cases, and suggest that the UPC are unlikely to adopt a wildly different approach to inventive step as compared to national European courts.