Alexion v Amgen (UPC_CoA_405/2024) Alexion v Samsung Bioepis (UPC_CoA_402/2024)
Decision date:
20 December 2024
Osborne Clarke summary
- Alexion marketed a range of pharmaceuticals for the treatment of rare diseases. One such pharmaceutical was Soliris, the active ingredient of which was eculizumab. Eculizumab was covered by a patent family held by Alexion, including the divisional patent in this case. Alexion lodged an application for provisional measures, including a preliminary injunction, with the Hamburg LD, claiming that Amgen was infringing its divisional patent by the sale of its biosimilar product BEKEMV.
- The Hamburg LD dismissed Alexion's application, finding that although there was a sufficient degree of certainty that the patent was infringed, it could not be established to the necessary degree of certainty that the patent was valid. It held that not only did it need to consider the likelihood of invalidity based on its own assessment, but that it also needed to take into account the likelihood of an invalidity decision by the EPO. Although in general there should be no difference between the two because both legal bodies apply the same standard, there may be a difference in claim interpretation. The Hamburg LD held that it was reasonably likely that the EPO would revoke the patent due to lack of sufficient disclosure.
- Alexion appealed the Hamburg LD's decision, arguing that the Hamburg LD erred in predicting that the EPO might differ in its approach to claim construction and that it might consider the patent insufficiently disclosed in future proceedings.
- The Court of Appeal dismissed Alexion's appeal and its preliminary injunction application, but for different reasons to the Hamburg LD. The Court of Appeal came to a different, narrower claim construction on the basis that an error in a patent claim can only be corrected via claim interpretation if the existence of an error and the precise way to correct it are sufficiently certain to the average skilled person on the basis of the patent claim, taking into account the description and the drawings and using common general knowledge at the filing date of the patent. In this case, the existence of an error and the way to correct it were not sufficiently certain to the average skilled person.
Issue
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