Sanofi & Regeneron v Amgen (UPC_CFI_505/2024)
Decision date:
13 May 2025
Osborne Clarke summary
- This was the first UPC case dealing with second medical use claims. The case was part of a long running dispute between Sanofi/Regeneron and Amgen. This decision involved an infringement action in respect of a second medical use patent concerning the use of PCSK9 inhibitors for reducing Lp(a) in patients at risk of cardiovascular disease brought by Sanofi and Regeneron (Regeneron as patent proprietor and Sanofi as exclusive licensee) against various Amgen entities. Amgen made a counterclaim for revocation.
- The validity of Regeneron's patent was upheld but the Düsseldorf LD decided that there was no infringement by Amgen's Repatha product.
- The Düsseldorf LD held that to prove infringement of a second medical use claim, Sanofi/Regeneron would have to show that: i) the alleged infringing product (here, Repatha) was offered or placed on the market in such a way that either led to or may lead to the claimed therapeutic use (here, reducing Lp(a) levels in a patient from the relevant patient group); and ii) the alleged infringer (Amgen) knows or should reasonably have known that offering or placing the medical product on the market led to or may lead to the claimed therapeutic use.
- The second (subjective) element was where Sanofi/Regeneron had failed to make their case. There were doubts that Amgen's placing Repatha on the market led to the claimed use (or even that it may lead to the claimed use) and Sanofi/Regeneron did not dispel those doubts. Sanofi/Regeneron did not show that any marketing efforts by Amgen were aimed at "selling" Repatha for the claimed use. The information in the SmPC was determined not to lead to the claimed use of reducing Lp(a) level and there was no substantial likelihood that physicians would prescribe Amgen's product for such use.
- In respect of Amgen's counterclaim for revocation, Sanofi/Regeneron validly claimed priority from two priority documents as the combination of features in claim 1 were directly and unambiguously disclosed in the priority documents. The patent was held to be novel and inventive over the prior art. There was no unambiguous disclosure of the use of PCSK9 inhibitors for reducing Lp(a) levels in the claimed patient group, and the skilled person would not have been motivated to implement the claimed use due to prevailing hypotheses and genetic evidence. The patent sufficiently disclosed the claimed invention, including the therapeutic effect of reducing Lp(a) level in the patient group, and the combination of features in claim 1 was held to be unambiguously disclosed in the original application.
Issue
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