Sanofi Biotechnologies SAS, Regeneron Pharmaceuticals Inc. v. Amgen Inc. , Amgen GmbH, Amgen Europe B.V., Amgen NV, Amgen S.R.L., Amgen B.V., Amgen S.A.S.LD, Düsseldorf 13 May 2025. Case no. UFC_CFI_505/204
In an Order of 13 May 2025, the Local Division Düsseldorf has provided insight into how the UPC deals with infringement of second medical use claims.
At stake was the alleged infringement by Amgen on Sanofi’s claim relating to a PCSK9 inhibitor for use in reducing the level of L(p)a cholesterol in the blood. Although it was undisputed that Amgen’s PCSK9 inhibitor lowered L(p)a values by at least 25%, the Local Division held that infringement could not be made out.
The Order sets out the legal framework for the assessment of infringement of second medical use claims, for which there was no harmonized approach in the UPC.
As is well accepted, the purpose-limited nature of second medical use claims means that infringement can only be established if the claimed therapeutic “use” is proven.
The Court held that this standard entails both an objective and a subjective element: the offering or marketing of a product must be such that it may lead to the claimed therapeutic use, and the alleged infringer must reasonably know that this is the case. Whether this applies is dependent on the circumstances of the case. The wording of the SmPC and PIL was held to be important but not decisive in the assessment. Of equal importance was the extent to which the alleged infringer is, or should be aware of the patented use. Economic circumstances such as market share of the claimed use compared to other uses, and existing (prescription and dispensing) practices on the relevant markets can play a role here.
So far nothing truly groundbreaking – the same balanced approach is followed in national jurisdictions such as The Netherlands and Germany. But as always the proof is in the eating. And interestingly, the Order does seem to attach substantial weight to the wording and content of Amgen’s SmPC, as the information on L(p)a levels and the conclusions that doctors may draw therefrom were held to be of key importance.
On the infringement question, the Court considered that it was not likely that doctors would prescribe the contested PCSK9 inhibitor for the patented use. Although it could be inferred from the SmPC and other sources that the product led to reduction in L(p)a levels by at least 25%, the product had only been approved for lowering another type of cholesterol (LDL). This was held to be decisive for prescription practices – particularly in view of perceived hurdles for the prescription of off-label use (such as the need for medical justification and the risk of refusal of reimbursement).
This seems to place a fairly high burden on the patentee, but the question remains to which extent the Court’s findings are tied to the specific circumstances of the case.
For example, Sanofi had failed to provide compelling evidence that doctors were actually prescribing Amgen’s product for the patented use. Furthermore, there were doubts on the perceived clinical relevance of lowering L(p)a cholesterol in the treatment of cardiovascular diseases, and other risk factors such as elevated levels of LDL were considered to be more important targets for treatment.
Overall, the Order does seem to suggest that off-label use cannot simple be presumed, and must be clearly shown to occur in practice to constitute knowledge of patented use by an alleged infringer.
Finally, the Order makes clear that the steps taken by an alleged infringer to prevent the infringing use must also be factored into the infringement analysis. However, as in the present case the knowledge-hurdle was not overcome, the Order does not provide any details on the extent of the responsibilities that must be placed on the alleged infringer in this respect.
The Order can be read here.
