First UPC decision on Second Medical Use

🎂Short & Sweet 

On 13 May 2025, the Düsseldorf Local Division of the Unified Patent Court handed down a landmark decision in the long-running dispute between Sanofi/Regeneron and Amgen relating to PCSK9 antibodies (case UPC_CFI_505/2024).

The Court upheld the validity of Regeneron’s patent EP 3 536 712 but decided there was no infringement by Amgen’s Repatha® medicinal product.

🤷‍♀️Issues considered 

According to the Court, to establish infringement of a second medical use claim, the patentee must prove two things:

1. an objective element: that the product is offered or placed on the market in such a way that it leads or may lead to the claimed therapeutic use; and 
2. a subjective element: the alleged infringer knows or reasonably should have known to expect this claimed therapeutic use.

Whether these requirements are met depends on the specific circumstances of the case, including:

• the wording of the SmPC (the document describing the properties and the officially approved conditions of use of a medicine) and the PIL (patient information leaflet), which are important but not decisive;
• the awareness level of the alleged infringer regarding the infringing use of its product;
• market factors, such as the share of the claimed use compared to other uses, 
• existing (prescription and dispensing) practices of the claimed use; and 
• actions taken by the alleged infringer to encourage or dissuade the patented use.

In this case, it was held that Sanofi/Regeneron did not manage to show any marketing efforts by Amgen ‘aimed at “selling” the drug for the claimed use’.  

🫵What does this mean for you? 

If the future case law follows these principles, patentees may face hurdles enforcing second medical use patents, particularly when the claimed use is not an approved indication for the medicinal product. Indeed, the patentee may need to provide evidence of how the product is marketed or actually used in practice.

With thanks to Evelina Marchesoni for this update.