Landmark Amgen v Sanofi and Regeneron case sets out inventive step test to be applied at the UPC

The first UPC decisions on inventive step in main proceedings were handed down recently, including the long-awaited Court of Appeal (CoA) decision in Amgen v Sanofi and Regeneron which involved HOFFMANN EITLE partners Gregor König and Michael Pfeifer. In the first instance the Central Division (Munich) had closely followed the Nanostring v 10x Genomics “next step” inventive step approach and revoked Amgen’s patent. In the appeal decision, the UPC CoA also applies the “next step” approach, but appears to modify this by incorporating elements of EPO case law, and overturns the first instance decision.

The concept of the reasonable expectation of success was introduced by decisions of the EPO’s Boards of Appeal, such as T 2/83 and T 149/93, and further developed by numerous decisions of the EPO. In the Nanostring v 10x Genomics case relating to provisional measures, the UPC CoA held that “problems that regularly arise” in the technical field at issue would not have prevented a skilled person from carrying out the relevant tests. This approach of the CoA is consistent with the notion that, in accordance with EPO practice, certainty of success is not required.

In the Amgen v Sanofi and Regeneron case, reasonable expectation of success was described as follows: “A reasonable expectation of success implies the ability of the skilled person to predict rationally, on the basis of scientific appraisal of the known facts before a research project was started, the successful conclusion of that project within acceptable time limits” (headnote 19).

The CoA focused on the therapeutic effect described in the claim. To meet this requirement, the treatment must produce a noticeable improvement in patients’ medical condition – in other words, it must have a genuine therapeutic benefit. When assessing what the object of the invention is by establishing what the invention adds to the state of the art, the CoA looks at the overall inventive concept rather than the individual distinguishing features of the claim.

The CoA confirms the general rule that a claimed solution must be considered obvious when the skilled person would take the next step prompted by the pointer or as a matter of routine, and arrive at the claimed invention and in expectation of finding an envisaged solution of their technical problem. According to the Court, this is generally the case when the results of the next step were clearly predictable, or where there was a reasonable expectation of success (headnote 17).

The CoA appears to suggest two alternative paths to obviousness: clear predictability or a reasonable expectation of success. However, the CoA in headnote 19 above defines the reasonable expectation of success as rational predictability.

Applying this concept to the facts and specifically to the obviousness of the therapeutic effect defined by the CoA as “a noticeable improvement of the medical condition of the patient suffering from the disease mentioned in the claim”, the CoA concludes that the skilled person at any rate required, but did not have a sufficient indication that the pathway taught by the prior art was sufficiently relevant in vivo (i.e., at physiological level) for the claimed approach to result in the claimed therapeutically effective treatment.

It remains to be seen whether this is intended as a new UPC approach with a higher threshold for obviousness.

In this regard, it is interesting to note that the UPC currently requires a “realistic starting point” in the prior art but does not adhere to the concept of selecting a “closest prior art” document for the assessment of inventive step, suggesting that the UPC does not apply the EPO’s problem-solution approach strictly (UPC 1/2023, headnote 3). This approach taken by the UPC resembles that of the German Federal Court of Justice (FCJ). The similarity between these courts’ views on inventive step may help promote further interplay between the UPC and the FCJ on inventive step in the future.