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EWHC confirms Medeva: earlier combination MA precludes SPC for drospirenone monotherapy under Article 3(d); disclaimers and separate patent insufficient (Laboratorios Leon Farma v Comptroller)

Published on: 15 April 2026

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Laboratorios Leon Farma SA v The Comptroller-General of Patents [2026] EWHC 663 (Ch)

What are the practical implications of the case?

The outcome confirms that patentees still struggle to argue that a patented medicinal product merits an SPC where its active ingredient has already been the subject of an MA, even when that earlier authorisation related to a combination product. The judgment reaffirms the construction of Article 3(d) of Regulation (EC) 469/2009 (the SPC Regulation). Notably, the court held that the converse of Medeva produces the same position: an earlier MA for a product containing ingredients A+B prevents a subsequent MA for ingredient A alone (and likewise B alone) from fulfilling the criteria for an SPC. In short, a prior combination MA blocks reliance on a later mono‑ingredient MA for SPC purposes, so the statutory requirements under Article 3(d) are not met in these circumstances...

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