(As published in the September issue of the CIPA Journal)
Sanofi-Aventis Deutschland GmbH, Sanofi Winthrop Industrie S.A., Sanofi-Aventis Group v. Amgen Inc. · ORD_598362/2023 · 16 July 2024
Regeneron Pharmaceuticals Inc. v. Amgen Inc. · ORD_598363/2023· 16 July 2024
The Munich seat of the UPC’s Central Division recently published its full decision on the very first revocation action to be lodged at the UPC, invalidating a patent on the basis of a lack of inventive step.
In this instance, the Central Division ordered two cases to be considered jointly: the first being a revocation action filed by Sanofi-Aventis against Amgen’s patent EP 3 666 797 B1 (EP’797), and the second being a counterclaim for revocation filed by Regeneron against EP’797. The counterclaim for revocation was filed in response to an infringement action brought by Amgen against Regeneron.
Claim Interpretation
When interpreting the claims of EP’797, the Central Division followed and expanded upon the legal framework that had already been laid down by the Court of Appeal of the UPC in NanoString/10x Genomics.
Priority
In response to a challenge to priority, the Central Division chose to align with the EPO, applying Article 87 EPC and citing a Decision from the EPO Enlarged Board of Appeal (G2/98) when assessing whether the “same invention” requirement was met.
Inventive Step
When addressing inventive step, the Central Division laid down some basic steps to follow:
There are obvious similarities between the above approach and the classic problem-solution approach taken by the EPO. Both require comparison with a selected starting point, and frame the question of obviousness in terms of the underlying problem and motivation to arrive at the claimed solution. See the Division’s comments at section 8.8:
“In general, a claimed solution is obvious if, starting from the prior art, the skilled person would be motivated […] to consider the claimed solution and to implement it as a next step […] in developing the prior art.”
This mirrors the so-called “could-would” approach taken in Europe.
The decision also aligned with the European approach in respect of the acceptability of combining multiple prior art disclosures, the avoidance of hindsight, and the burden of proof lying with the party asserting invalidity.
However, the Central Division have notably diverged from the EPO approach in some respects.
For example, the formulation of the underlying problem has been done based on the general teachings of the Patent itself, absent consideration of the prior art. The “aim” of the Patent was deduced based on the technical background provided in the description (see section 5.16). This is in contrast to Europe, where the problem is formulated based on the comparison with the prior art.
Another difference arises from the choice of prior art for comparison. In Europe, the “closest prior art” is identified, which is defined as the “most promising” starting point. The Central Division, however, have decided that there is no need to identify the most promising starting point (see section 8.6), and have instead taken the position that assessment of inventive step need only start from any realistic starting point, of which there could be several. The determination of whether a piece of prior art is realistic is based in part on the underlying problem, which is another key difference with the EPO approach, where the problem is formulated based on the prior art.
Taking all of the above into account, the Division found that the claims of the Main Request (and, consequently, all of the Auxiliary Requests) lacked an inventive step.
Conclusion
This decision seems to tell us that we can expect a fairly good degree of alignment between the UPC and the EPO. However, the Central Division have carved their own path in some respects when assessing inventive step.
These are only the first steps in building an established inventive step position within the UPC, and other Divisions may adopt different approaches to that taken here. As more cases are decided, this will be an interesting space to watch.