Key Facts
- •Appeal concerning the meaning of 'product' in Article 3(b) of Regulation (EC) No. 469/2009 (SPC Regulation).
- •Case involves a supplementary protection certificate (SPC) for safinamide (Xadago), a Parkinson's disease treatment.
- •Patent EP (UK) 1 613 296 claims the use of safinamide in combination with levodopa and a peripheral decarboxylase inhibitor (PDI).
- •Marketing authorisation is for safinamide alone (Xadago), although the Summary of Product Characteristics (SmPC) mentions its use as add-on therapy with levodopa and/or other Parkinson's disease medications.
- •The question is whether the marketing authorisation authorises the combination claimed in the patent, or only safinamide alone.
Legal Principles
The meaning of 'product' in Article 3(b) of the SPC Regulation must be interpreted strictly to mean the active ingredient or combination of active ingredients.
CJEU case law, particularly Santen C-673/18.
The intended use of a medicinal product does not constitute a decisive factor for the grant of an SPC. The 'product' is not dependent on how it is used.
Santen C-673/18
The SPC scheme is intended to be simple and transparent, not requiring minute analysis of marketing authorisations.
Explanatory Memorandum COM (90) 101 final, and the judgment's interpretation thereof.
To grant an SPC, the product authorised by the marketing authorisation must be the same as the product protected by the patent.
SPC Regulation Article 3
Outcomes
Appeal dismissed.
The marketing authorisation was for safinamide alone, not the combination claimed in the patent. The mention of levodopa and PDI in the SmPC relates to the use of safinamide, not the composition of the authorised product.