On 13 May 2025, the Düsseldorf Local Division (LD) of the UPC issued the first decision about a second medical use patent, EP 3 536 712, in force in five UPC member states (Belgium, France, Germany, Italy, and the Netherlands).
The dispute between Sanofi and Regeneron’s Praluent, and Amgen’s Repatha involving several patents began in 2014, and since 2023, new disputes have been escalated before the UPC. These drugs are commonly used to lower the cholesterol. EP712 protects the administration of PCSK9 inhibitory antibodies for reducing lipoprotein levels (hereinafter “Lp(a)”).
Düsseldorf LD held Regeneron’s second medical use patent valid but not infringed by Amgen’s product Repatha.
Key takeaways:
- Medical use claims:
- Assessment of the novelty according to article 54(5) of the EPC: Düsseldorf LD recalled that the assessment of novelty is limited to the specific use claimed, which shall not be comprised in the state of art. Such therapeutic use can be a new indication, as a disease not yet treated by the claimed substance, or an indication for a new group of patients.
- Prior use part of the prior art: The PCSK9 inhibitory antibodies were already known for the therapeutic use of lowering LDL-C levels for patients at risk of developing a cardio-vascular disorder.
- New therapeutic use protected by EP712: However, no prior art disclosed the use of PCSK9 inhibitory antibodies for reducing the Lp(a) levels for patients exhibiting a level above 30mg/dl.
- Validity: The patent is held valid despite various grounds of revocation raised by Amgen, in particular based on priority, lack of novelty, lack of inventive step, insufficiency and added matter.
- Infringement:
- Düsseldorf LD recalls that in order to find infringement of a purpose-limited product claim, the claimant must therefore prove that the allegedly infringing product fulfils the therapeutic use features of the claim, i.e. the product must be offered or placed on the market in such way that it leads or may lead to the patented therapeutic use of which the alleged infringer knows or reasonably should have known that it did.The behaviour of the alleged infringer is assessed regarding several facts and circumstances of the case at hand, in particular the extent of the alleged use, the actions taken by the alleged infringer, namely the encouragement of the patented use or the existence of measures preventing the use of the product for the patented use, the information on the leaflet product, or its SmPC (Summary of product characteristics).In the present case, the claimant fails to demonstrate that the alleged infringer had marketed the patented use, that physicians will prescribe the product to reduce Lp(a) for patients with a high level of Lp(a), and that the defendants were aware that their product was used for the patented therapeutic use.
- The Düsseldorf LD concluded that there is no infringement, even though Repatha, when reducing LDL-C might have the windfall effect of reducing an elevated Lp(a) value, as it was not a therapeutic indication for this drug and considering the above.
This decision is likely to be appealed.
