Just over a year after the Unified Patent Court (UPC) commenced its activities, the first rulings on substantive issues of patentability, in particular on the existence of an inventive step pursuant to Art. 56 EPC (Art. 65(2) UPCA in conjunction with Art. 138(1)(a) EPC), have now been issued. Of particular interest is the extent to which the case law of the UPC differs from that of the European Patent Office (EPO). If the hurdles for recognizing an inventive step are higher than at the EPO, many patents that have survived opposition proceedings before the EPO may subsequently be declared invalid by the UPC. This may sometimes favor the national courts when filing an action.
Inventive step at the European Patent Office
An inventive step is usually examined by the EPO using what is known as the “problem-and-solution approach”, which has three inherent phases:
- Identifying the closest state of the art,
- Formulating an objective technical problem with regard to this closest prior art and
- Examining obviousness with reference to another document from the state of the art.
The closest prior art is that which discloses in a single citation the combination of features which represents the most promising starting point for a development leading to the invention. When selecting the closest prior art, it should first be noted that it must be directed to a similar purpose or effect as the invention, or at least belong to the same or a closely related technical field as the claimed invention. In practice, the closest prior art is generally that which corresponds to a similar use and requires a minimum of structural and functional changes to arrive at the claimed invention (see T 606/89).
In the second phase, the objective technical problem to be solved is determined. For this purpose, the application (or patent) is compared with the closest prior art, and the distinguishing features between the claimed invention and the closest prior art are determined. The objective technical problem is then determined from the technical effect resulting from the distinguishing features. In the context of the “problem-and-solution approach”, the technical problem means the objective and the task of modifying or adapting the closest prior art in order to achieve the technical effects that the invention offers over the closest prior art.
In the third phase, the question to be answered is whether there is a teaching in the prior art as a whole which, in view of the objective technical problem, would (not only could; “could-would-approach”) lead a person skilled in the art to modify or adapt the closest prior art in the light of this teaching. They would thus arrive at something which corresponds to what is claimed and reach what the invention achieves as a result. In other words, the issue is not whether a skilled person could have achieved the invention by adapting or modifying the closest prior art, but whether a skilled person would have done so because the prior art led them to do so in the expectation of a particular advantage (see T 2/83).
According to the practice of the EPO, the examination of whether an inventive step is involved follows strict criteria, whereby the existence of an inventive step is more likely to be assumed in case of doubt. This strict approach to the examination of inventive steps has been adopted by many national courts, such as those in France, Italy and Sweden. The first UPC rulings dealing with this issue were eagerly awaited to see whether the UPC would also apply the “problem-and-solution approach”.
UPC Local Chamber Munich 10x Genomics vs. Nanostring Technologies
A first ruling of the UPC was issued by the Local Division in Munich on 19 September 2023. In this case, 10x Genomics asserted an infringement of the European unitary patent EP 4 108 782 (the injunction patent) by Nanostring Technologies’ “CosMx” products and applied for a preliminary injunction against Nanostring Technologies in Europe. In anticipation of the infringement issue, the probable validity of the injunction patent had to be clarified.
The patent claims of the injunction patent relate to a method for detecting a large number of analytes in a cell or tissue sample. The UPC Local Chamber Munich determined “with sufficient certainty” that the patent was legally valid and had been infringed; it ordered the issuance of a preliminary injunction.
The inventive step played a particular role in the question of the validity of the patent. The court recognized the existence of an inventive step by applying the criteria of the “problem-and-solution approach”. With regard to the closest prior art, the Court of First Instance stated that the (closest) prior art is generally a document which discloses an object which was developed for the same purpose or with the same objective as the claimed invention and which has the most important technical features in common with it, i.e., which requires the fewest structural changes. The similarity of the technical problem was also an important criterion in selecting the most promising starting point. The local division was of the opinion that the prior art referred to by the respondent did not qualify as the closest prior art and was convinced that the patent would be upheld in nullity proceedings.
UPC Court of Appeal 10x Genomics v. Nanostring Technologies
The Court of Appeal overturned the first instance ruling; in particular, it came to a different conclusion when examining the inventive step. The Court of Appeal found that the document referred to in the first instance “would have been of interest” to a person skilled in the art; this was already sufficient to qualify a starting point for the examination of the inventive step. Taking this document into account, the method claimed in the patent in suit was a logical “next step”. The Court of Appeal overturned the ruling of the first instance and justified this by stating that claim 1 of the patent was “more likely than not” to prove obvious. The test applied by the UPC Court of Appeal to assess the inventive step thus differs significantly from the approach taken by the EPO, both in the choice of the closest prior art and in the criteria used to assess obviousness.
UPC Central Chamber – Sanofi v. Amgen and Regeneron v. Amgen
In two further rulings of the Central Division (Munich Section) of 16 July 2024, which deal with the European patent EP 3 666 797 B1, the Central Division emphasizes the importance of an objective approach when assessing an inventive step and clarifies that neither the subjective ideas of the applicant or inventor, nor the fact that the invention is the result of chance or systematic work with (possibly costly and laborious) experiments, are relevant. According to the court, the decisive factor is what the claimed invention actually contributes to the state of the art.
One of the key points in the rulings of the Central Division is that a starting point is required when examining an inventive step. The court explains the choice of starting point and states that a “realistic starting point” must be chosen, which is not necessarily the closest prior art. Several realistic starting points may be considered without the need to identify the “most promising” one. Following the ruling of the UPC Court of Appeal in 10x Genomics v Nanostring, it is sufficient if the starting point would have been of interest to a skilled person.
As a next step, in its rulings the Central Division firstly focuses on and points out the differences between the starting point and the claimed solution. The Central Board considers that a claimed solution is obvious if a skilled person “would be motivated to consider this solution” in order to implement it “as the next step in the development of the prior art”. Furthermore, the Central Board states that it may also be relevant in this examination whether a skilled person would have expected particular difficulties in implementing the next steps.
The Central Division also emphasizes that a technical effect or an advantage that the claimed subject matter achieves over the prior art can be an indication of an inventive step. Conversely, a feature arbitrarily selected from several possibilities cannot generally contribute to an inventive step. After a detailed analysis, the Central Division came to the conclusion that a skilled person in this case would have arrived at the claimed subject matter in an obvious manner.
In particular, it rejects the patent proprietor’s arguments based on the excessive effort required to achieve the result according to the invention and the random nature of the result obtained.
Conclusion
France, Italy and Sweden assess inventive steps in a similar way to the EPO, using a problem-and-solution approach. The Netherlands also uses a similar approach, but does not exclude others.
Germany takes a different approach to inventive steps than the EPO. One key difference is that the EPO requires a strict determination of the closest prior art, whereas Germany is more liberal and requires a reasonable starting point. When assessing inventive steps, the German courts examine whether a skilled person would be motivated, in view of their knowledge, to consider the claimed solution and implement it in the expectation of success.
The UPC appears to take a middle ground between EPO practice and German court practice by being more liberal in its choice of starting point, but taking greater account of the solution to the technical problem.
Author
Dr. Bernd Janssen, LL.M.
Uexküll & Stolberg PartG mbB, Hamburg
Patent Attorney, European Patent Attorney, European Patent Litigator (UPC)
janssen@uex.de
www.uex.de