In a recent decision of Düsseldorf Local Division (UPC) in the case UPC_CFI_505/2024, both the revocation and infringement actions have been dismissed. This case raises important methodologies and perspectives regarding how to handle infringement of second medical use claims where allegedly infringing product is launched with a therapeutical indication (Section 4.1 of SmPC) not falling into the claim wording. In this decision, it is particularly elaborated whether the standard clinical findings in Section 5.1 of the SmPC would induce prescription by a physician towards an infringing use.
Claimants: Sanofi Biotechnology SAS and Regeneron Pharmaceuticals Inc.
Defendants: Amgen group entities
Patent: EP 3 536 712 B1 – second medical use of PCSK9 inhibitors to reduce Lp(a) in certain cardiovascular risk patients.
Alleged Infringement: Amgen’s product Repatha® (evolocumab), a PCSK9 inhibitor.
Patent Claim: The patent is a second medical use claim, protected under Art. 54(5) EPC. It claims a specific therapeutic use: reducing lipoprotein(a) [Lp(a)] in patients with >30 mg/dL serum levels, at risk of CVD or thrombotic diseases, patient not on a statin regimen.
The court has put forward a legal test for infringement in the case of second medical use, Accordingly, infringement of a second medical use claim requires both:
o An objective element: The product is marketed in a way that leads or may lead to the claimed use.
o A subjective element: The alleged infringer knows or should have known of this use.
Analysis must be fact-specific, considering product presentation, SmPC (Summary of Product Characteristics), market behavior, and prescriber’s knowledge.
COURT’S REASONING REGARDING NON-INFRINGEMENT:
SmPC Did Not Support Infringement
• Repatha is authorised only for LDL-C–related indications; lowering Lp(a) appears merely in the pharmacodynamic section 5.1, not as an approved therapeutic indication. While Repatha®’s SmPC mentions an Lp(a)-lowering effect (Section 5.1), this:
- appears in pharmacodynamic data, not therapeutic indications.
- is not sufficient to suggest promotion for the claimed therapeutic use.
• The product is not approved for Lp(a) reduction, and no clinical benefit for that use is claimed in the SmPC.
Lack of Evidence for Actual Use or Inducement
• Claimants failed to show that:
o doctors prescribe Repatha® specifically to lower Lp(a) in the claimed patient population.
o Amgen knew or should have known that such prescriptions occurred.
• Expert testimony from both sides showed uncertainty in clinical practice, with some doctors considering Lp(a), but no clear prescribing trend based on it. Claimants pointed to no marketing that promoted Repatha for Lp(a) lowering; the product dossier, pack-leaflet and sales materials were silent.
No Off-label Promotion or Encouragement
• Amgen did not market Repatha® for the patented Lp(a)-lowering use.
• The mere presence of pharmacodynamic data on Lp(a) lowering is not enough to constitute infringement under the UPC’s standards.
Reimbursement controls require prescribers to document approved (LDL-C) indications; off-label Lp(a) prescriptions were neither shown nor reasonably foreseeable.
KEY TAKEAWAYS AND IMPLICATIONS FOR FUTURE
Second medical use claims require specific evidence of targeted use. Passive inclusion in SmPC would not be enough. “Know or should have known” standard requires substantial proof. Mere plausibility or market presence won’t suffice. Objective marketing behavior is critical. Infringement depends not only on product properties but also on how it’s positioned.
Patent owners bear the burden to quantify and qualify prescriber behaviour; mere presence of efficacy data in an SmPC will rarely suffice. More rigorous evidence will be needed to prove infringement of second medical use claims, particularly around physician behavior and manufacturer intent. Suppliers should still audit their SmPCs/marketing for inadvertent inducement, but can rely on clear indication in wording and regulatory constraints to mitigate the risks. Patent holders must consider regulatory language, clinical practice, and prescribing data when preparing infringement cases. The decision offers the first UPC guidance on how Art. 25 UPCA applies to second-medical-use claims and is likely to become a template for future cases.
The case in hand shows also how expensive a case could be if both revocation and infringement actions were handled in the same UPC lawsuit. The value in dispute for the infringement action is set at EUR 20.000.000 and for the counterclaim for revocation at EUR 25.000.000. The ceiling of recoverable representation costs is set at a total of EUR 1.875.000 for the infringement action and the counterclaim for revocation.
Yet, the case is not finalized and can be appealed.
