Laboratorios Leon Farma v Comptroller: SPC application for drospirenone-only contraceptive fails Article 3(d) test

The High Court has dismissed an appeal by Laboratorios Leon Farma SA ("Leon") against the refusal of its supplementary protection certificate application for drospirenone, the sole active ingredient in the oral contraceptive Slynd. The decision, handed down on 20 March 2026 by Recorder Douglas Campbell KC sitting as a judge of the Patents Court, confirms that prior marketing authorisations for combination products containing drospirenone — namely Angeliq and Yasmin — constituted earlier authorisations to place the product on the market for the purposes of Article 3(d) of the SPC Regulation (Regulation EC 469/2009, now assimilated EU law).

Leon's basic patent, EP (UK) 3 632 448, specifically claimed a pharmaceutical composition comprising drospirenone without any estrogen, reflecting the novel character of Slynd as a progestogen-only contraceptive. Although the UKIPO accepted that Articles 3(a) to 3(c) were satisfied, it refused the application on the ground that the Slynd marketing authorisation was not the first authorisation to place drospirenone on the market. Both Angeliq (drospirenone plus estradiol) and Yasmin (drospirenone plus ethinyl estradiol) had received authorisations years earlier.

The Medeva question

The central issue was the proper application of the CJEU's decision in Medeva (C-322/10). Leon advanced several arguments for limiting or distinguishing Medeva: that it applied only to multi-disease vaccines or products directed at different therapeutic targets; that it governed Article 3(b) but not Article 3(d); and that subsequent authority had impliedly undermined it.

The court rejected each in turn. Recorder Campbell held that Medeva established a generally applicable principle — that a marketing authorisation for A+B constitutes an authorisation to place A (and B) on the market — without restriction to any particular category of medicinal product. The Advocate General's opinion in Medeva had expressly addressed "all spheres" in which patented active ingredients are marketed in combination with others, with multi-disease vaccines serving merely as the illustrative example.

On the question of whether Medeva applied equally to Article 3(d) as to Article 3(b), the court found no logical basis for differentiation. The concept of "product" must bear the same meaning throughout Article 3, as confirmed by Birss LJ in Newron Pharmaceuticals v Comptroller [2024] EWCA Civ 128. It would be incoherent, the court reasoned, for "marketing authorisation" to carry different meanings across limbs of the same article.

Subsequent authority considered

Leon relied on an extensive body of case law — including Generics v Daiichi, Santen, Newron, Merck Serono v Comptroller [2025] EWCA Civ 45, Teva II (C-119/22 and C-149/22), and a Swedish appellate decision in Pearl Therapeutics — in support of the proposition that Medeva was either limited or wrong. The court acknowledged that none of these decisions expressly overruled Medeva, and found that none did so by implication either.

The reasoning in Daiichi — that a racemate A+B was not an authorisation for the enantiomer A alone — was noted to be inconsistent with Medeva, which post-dates it, though the court was not required to resolve whether the result in Daiichi remained correct on other grounds. Teva II, which confirmed that A+B is a different product from A or B alone for purposes of Articles 3(a) and 3(c), was found to address the converse situation and to say nothing inconsistent with Medeva's rule on marketing authorisations.

The court also declined Leon's invitation to undertake its own teleological analysis in favour of granting the SPC, citing Birss LJ's observation in Newron that the balance of interests is struck by the terms of the Regulation itself — not by case-by-case judicial weighing.

Leon's auxiliary request — proposing to redescribe its product as "drospirenone (not containing any estrogen)" — was also dismissed. The qualification refers to the absence of another active ingredient, not to a distinct active ingredient, and does not alter the identity of the product for the purposes of Articles 1 and 3.

The appeal was dismissed in its entirety. The case is a firm restatement that, under the assimilated SPC Regulation, a prior combination product marketing authorisation prevents a later standalone SPC application from satisfying Article 3(d), regardless of the novelty or therapeutic significance of the patented formulation.

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