16/06/2025
A recent decision of the EPO Opposition Division has diverged from a decision of the UPC Central Division, highlighting some interesting questions on the extent to which the UPC will align with the EPO.
There have been a number of interesting developments recently in the long standing litigation between Amgen and Sanofi around PCSK9 antibodies. The Dusseldorf local division of the UPC recently decided on infringement and validity of a medical use patent owned by Sanofi (UPC_CFI_505/2024) and we will be providing some thoughts on that decision in due course.
Amgen has also asserted patents against Sanofi and Regeneron, and the UPC issued an early decision in July 2024 on the validity of an Amgen medical use patent relating to the Evolocumab (Repatha) product. The UPC Central Division concluded that the patent in question (EP3666797) lacked inventive step and therefore revoked the patent across the UPC states (UPC 1/2023).
In an interesting turn of events, an Opposition Division of the EPO has recently upheld the same patent as being inventive. In the final paragraphs of the decision, the Opposition Division (OD) refers to the parallel decision of the UPC Central Division and seeks to distinguish their approach from that of the UPC. The key point of distinction appears to be around the question of whether there was a “reasonable expectation of success” in using the claimed agent to treat the claimed diseases. The UPC judgement perhaps suggests that for this case the question of whether there was a reasonable expectation of success is less important for determining inventive step (paragraph 8.56). Although, the decision does seem to go on to consider this question in further detail and ultimately concludes that the patentee’s arguments on this point were not persuasive.
The OD seemed to focus on paragraph 8.56 of the UPC decision, and stressed that for a medical use claim, reasonable expectation of success plays a crucial role in considering whether a claim is inventive. The OD considered whether based on the prior art and common general knowledge, there would be a reasonable expectation that the claimed agent would be therapeutically effective at treating the recited conditions. In this case, the OD concluded that there was an absence of a reasonable expectation of success so the claims were inventive.
The OD suggests that while the reasoning provided by the UPC Central Division might be applicable for a product claim, for a medical use claim, a reasonable expectation of success plays a crucial role. This suggests that the OD has taken quite a different approach to assessing inventive step; however, it does seem that the OD may have focused on the passage at 8.56 of the UPC judgement without considering the subsequent reasoning of the court. Ultimately, both the UPC and the OD appear to have considered the question of a reasonable expectation of success, but the OD simply drew a different conclusion after considering this question and the evidence before them.
It must be stressed that the decision of the UPC central division and the Opposition Division are both first instance decisions, so the approach taken by the EPO and UPC could yet align on appeal. We are expecting a decision from the UPC Court of Appeal soon, and the Technical Board of Appeal have decided to expedite the appeal procedure and have already set a date for oral proceedings (April 2026), which is especially rapid given that the first instance decision was only issued on 21 May 2025. This shows that the Technical Board of Appeal are willing to expedite appeal proceedings where parallel litigation is underway at the UPC.
The EPO has always appeared to pursue an independent approach to assessment of validity and is rarely swayed by national proceedings. It is thus unsurprising that the OD has taken a different approach and drawn different conclusions in this case.
The UPC inevitably looks to the jurisprudence of the EPO boards of appeal as guidance for how to consider matters of validity, although the UPC ultimately can deviate from the EPO approach. For example, some early decisions (including UPC 1/2023) did not use the problem solution approach for assessing inventive step. Our earlier article, considering the NanoString decision UPC 252/2023, discusses how the UPC diverged from the typical problem solution approach of the EPO when considering inventive step.
As more decisions are issued by the UPC, it will be interesting to see how the jurisprudence develops and whether the UPC decides to follow the EPO on validity or take the opportunity to deviate in some areas.
These two diverging validity decisions do highlight that there are very good reasons for third parties to pursue revocation at both the EPO and at the UPC. Of course, the EPO has the power to revoke across all EPC member states which is a much larger combined territory than the territory over which the UPC has jurisdiction. However, with potential divergent approaches to validity, there could be even more merit in bringing parallel actions before both forums.
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This article is for general information only. Its content is not a statement of the law on any subject and does not constitute advice. Please contact Reddie & Grose LLP for advice before taking any action in reliance on it.
