Entitlement to an SPC under Article 3(d) of an uncombined medicinal product (drospirenone): Laboratorios Leon Farma SA v Comptroller-General of Patents [2026] EWHC 663 (Ch) – 20 March 2026

By Daniel Byrne, Partner, VENNER SHIPLEY, London 

Summary

The historic CJEU decision in Medeva (C-322/10) states that a product “A” having an SPC precludes a later SPC for product “A + B” (except in some special cases). However, does the Medeva decision prevent a product “A” from being granted an SPC where that product has previously been authorised as part of a combination “A + B”?

The court held that it does. It confirmed that the IPO had been right to refuse an SPC for drospirenone on that basis: an earlier marketing authorisation (“MA”) for drospirenone in combination with estrogen meant that the later MA for drospirenone alone was not the first MA for drospirenone.

Although combination therapies often develop from monotherapies, this case underlines the risk of obtaining regulatory approval for a combination therapy first, before later seeking an SPC based on approval of one ingredient of that combination alone.

Background

Leon Farma applied for an SPC for drospirenone (a contraceptive), relying on a monotherapy MA. Earlier MAs, however, had already authorised drospirenone in combination with estrogen. The UKIPO refused the application under Article 3(d), finding that the earlier combination MAs meant that the monotherapy MA was not the first authorisation for drospirenone, under Medeva.

Leon Farma appealed to the High Court arguing that this was wrong and the monotherapy MA should be treated as the first authorisation.

Leon Farma’s main points were that: i) the term ‘product’ should be construed strictly, so that an MA for product ‘A+B’ is not an MA for product ‘A’ alone, ii) that Medeva is actually a narrow exception to the rule and should only apply to Article 3(b), and not Article 3(d), iii) that other UK and EU legal authorities demonstrate that Medeva is limited or wrong, and iv) there are teleological arguments in favour of granting the SPC. It we further and stated that it would be willing to amend the description of the product to “drospirenone (not containing any estrogen)”.

The Decision

The appeal was dismissed. The court was very clear that one of the earlier combination MAs was the first MA for drospirenone for the purposes of Article 3(d), which meant that Leon Farma’s monotherapy product for drospirenone alone was not eligible for an SPC.

Essentially, an MA for a combination product counts as an authorisation for each active ingredient in that combination. The court did not agree that it could be argued that Medeva was wrongly decided or should be treated as an exception. There was mention of the Court of Appeal’s decision in Generics v Daiichi ([2009] EWCA Civ 646), which pre-dated Medeva, and which the court doubted would be decided in the same way today. It refused to carry out an ad hoc balancing or teleological exercise, and held that a proposed disclaimer in the SPC product definition, such as ‘drospirenone (not containing any estrogen)’, would not overcome the objection at hand.

The court also gave some commentary that, although the drospirenone-only product may have been innovative and protected by its own patent, that was not enough to justify the grant of an SPC. This mirrors comments made in other cases.

The decision confirms that it remains difficult for patentees to argue that a patented medicinal product containing an active ingredient that has already been the subject of an MA, even as part of a combination product, should qualify for an SPC.

The case confirms the interpretation of Article 3(d) of the SPC Regulation such that a “reverse” Medeva produces the same result.

Entitlement to an SPC under Article 3(d) of an uncombined medicinal product (drospirenone): Laboratorios Leon Farma SA v Comptroller-General of Patents [2026] EWHC 663 (Ch) – 20 March 2026

By Daniel Byrne, Partner, VENNER SHIPLEY, London