On 16 July 2024, the UPC Munich Central Division issued its first decision on the merits in the dispute between Sanofi and Regeneron (the Claimants) and Amgen (the Defendants). The UPC’s decision to revoke Amgen’s European Patent, EP3666797, is effective across all 17 UPC Member States and highlights the significant impact of UPC decisions across Europe. This decision was issued just over a year after the UPC opened its doors on 1 June 2023 demonstrating the pace at which cases can progress at the UPC.
This Central Division decision follows the revocation action filed by Sanofi at the Central Division on 1 June 2023 (ACT_459505/2023 UPC_CFI_1/2023) and also the revocation counterclaim served by Regeneron following the infringement action filed by Amgen at the Munich Local Division, also on 1 June 2023. Following Regeneron’s counterclaim (CC_586764/2023), the Central Division ordered the revocation action and counterclaim to be dealt with jointly. The Oral Hearing for both actions took place on one day, 4 June 2024.
This early case highlights the potential of the UPC as a significant forum for patent disputes in Europe. It also provides useful early guidance on how the UPC will address fundamental questions of substantive patent law as well as insights into the approach to antibody patenting.
The Amgen patent in dispute concerned antibodies for use in treating conditions associated with high cholesterol. The case was heard by a panel of three judges, one each from Germany (presiding judge), The Netherlands (legally qualified judge) and Denmark (technically qualified judge). The judges concluded that the patent was invalid for lack of inventive step over a single prior art document.
In reaching the decision, the Central Division was required to construe the features of a second medical use claim wherein the antibody for use in treatment was functionally defined. In doing so, it followed the legal framework laid down by the UPC Court of Appeal in decision UPC_CoA_335/2023 (NanoString/10x Genomics). With regards to claim interpretation, it is expressly stated in the current decision:
When interpreting a patent claim, the person skilled in the art does not apply a philological understanding, but determines the technical meaning of the terms used with the aid of the description and the drawings. From the function of the individual features in the context of the patent claim as a whole, it must be deduced which technical function these features actually have individually and as a whole. The patent description may represent a patent’s own lexicon. (Headnote 1)
It is notable that, adopting this approach, significant consideration was given to the description in interpreting the features of the claim, particularly the functional definition of the antibody.
In considering inventive step, the Central Division set out the legal framework under which the assessment should be made and although there is no explicit mention of the European Patent Office’s (EPO) problem-solution approach, the framework adopts several principles common to EPO practice.
In terms of the starting point for inventive step analysis, the Central Division has deviated slightly from the EPO notion of “closest prior art” and has said:
The assessment of inventive step starts from a realistic starting point in the prior art. There can be several realistic starting points. It is not necessary to identify the “most promising” starting point. (Headnote 3)
The more familiar EPO approach is reflected in the Central Division’s conclusion that:
In general, 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. (Headnote 1, 1st sentence)
Amgen’s patent was ultimately found lacking in inventive step on the basis that, starting from the prior art document identified as a “realistic starting point”, the skilled person would have been motivated to develop antibodies according to the functional definition in claim 1, for the purposes of treating conditions associated with high cholesterol.
It is important to note that Amgen’s patent was directed to use of an antibody defined by function and not structure. Antibody claims wherein the antibody is functionally defined are notoriously challenging to prosecute, often giving rise to support and sufficiency objections before many of the major national/regional offices including the EPO. Amgen’s corresponding US patent had already been held invalid by a landmark US Supreme Court decision wherein the claims were held to lack enablement.
It follows, that although the UPC’s decision to revoke Amgen’s antibody patent may, on first glance, seem worrying for those seeking to pursue and defend antibody claims in Europe, it is arguably not entirely inconsistent with the position adopted in other jurisdictions. As such, we do not consider this decision a cause for alarm for those of us in the Biotech sector but an extremely useful insight into how our new European court will operate. It is worth noting also, that this decision is unlikely to be the final word in this dispute since Amgen has the opportunity to appeal to the UPC Court of Appeal.
