Most therapeutics are first developed and approved as monotherapies, with their use in combination with other actives generally introduced only at a later stage, if at all. The SPC implications of this regulatory sequence have been the subject of extensive case law, most recently addressed by the CJEU in joined cases C‑119/22 and C‑149/22 Teva v Merck as discussed in earlier articles.

The reverse trajectory, from combination therapy to monotherapy, is much less common. Although some therapeutics initially authorised as part of loose, co‑administered combination regimens (A for use in combination with B) may later obtain standalone approval (A for use alone), true fixed‑dose combinations (A+B) very rarely lead to later monotherapy authorisations (A), with contraceptives representing a notable exception for historical and regulatory reasons. However, step-down from an initial fixed‑dose combination (for example, from A+B+C to A+B) may occur, and later fixed-dose combination authorisations may also share one or more components with the original fixed‑dose combination (such as A+B followed by A+C).

In decision BL O/0705/25, the UK IPO considered SPC eligibility in the context of contraceptives, specifically addressing a scenario in which the active ingredient of a single‑ingredient contraceptive (drospirenone/Slynd®) had previously been approved as part of fixed-dose combinations with estrogen (Angeliq® and Yasmin®), and the applicant sought an SPC based on the later single‑ingredient authorisation and a corresponding basic patent. Following an oral hearing, the UK IPO rejected the SPC application on the basis that the Slynd marketing authorisation was found not to be the first authorisation under Article 3(d) of Regulation (EC) No 469/2009 (the SPC Regulation), in view of the earlier authorisations of drospirenone combinations.

The decision’s reasoning is likely to have broader relevance to fixed-dose combination-first scenarios, including those described above (A+B+C → A+B, and A+B → A+C). It suggests that, under current UK IPO practice, an SPC application for a particular active ingredient or combination must be supported by the first authorisation that contains that active ingredient or combination, even if the authorisation also includes additional active ingredients. For example:

• An authorisation for A+B+C is deemed the first authorisation for an SPC to any of the following “products”: A, B, C, A+C, B+C, or A+B, even if a later authorisation exists for A+B NOT C.
• An authorisation for A+B is deemed the first authorisation for an SPC to any of the following “products”: A, B, or A+B, and a later authorisation for A+C cannot support an SPC for A, but it can support an SPC for C or A+C.

The UK IPO is therefore, at least for now, continuing to follow the Medeva and Georgetown line of CJEU case law (retained in UK law following Brexit), as will be further discussed below. Our review of the public SPC registers indicates that most patent offices are still examining the corresponding SPC application, although some have granted it, such as France. Interestingly, similar facts have resulted in different results in other proceedings, as highlighted by a recent Swedish court decision: Pearl.

Background: SPCs may be granted for active ingredients based on combination authorisations that contain additional active ingredients

The CJEU’s judgments in Medeva (C-322/10) and Georgetown (C-422/10) held that an SPC may be granted for an active ingredient protected by a corresponding patent even where the supporting marketing authorisation relates to a medicinal product that contains additional active ingredients. Both cases arose in the context of multi-valent vaccines.

UK IPO: earlier combination counts as the first authorisation under Article 3(d)

While in Medeva and Georgetown this principle enabled SPC eligibility based on initial combination authorisations, in BL O/0705/25, the same reasoning led to the opposite outcome: an SPC based on a later mono authorisation was precluded by earlier combination authorisations.

In more detail, SPC applicant Laboratorias Leon Farma SA argued that, in light of Article 1(b) of the SPC Regulation, “drospirenone” is a different product from combinations containing drospirenone. This was said to be reinforced by the fact that, under European regulatory law, the earlier combination authorisations did not permit the marketing of the single-ingredient product, which required new clinical studies to obtain approval. Accordingly, the applicant submitted that, for the purposes of Article 3(d) of the SPC Regulation, the marketing authorisation for Slynd was the first authorisation to place the product “drospirenone” on the market.

The hearing officer rejected this argument, finding that the two earlier authorisations – Angeliq and Yasmin – both of which contain drospirenone together with an estrogen, meant that the Slynd authorisation was not the first authorisation for “drospirenone” under Article 3(d). The officer further noted (at paragraph 67) that the reasoning in Medeva and Georgetown is not confined to multi-valent vaccines and, in principle, allows a combination authorisation to support an SPC application for a single active ingredient contained within that combination. Paragraph 38 of C-443/12 Actavis was also cited in support, confirming that a first approval to a combination may, in principle, support an SPC for one of its components. Accordingly, in the present case, the first combination authorisation constituted the first authorisation for a drospirenone-only product for the purposes of SPC eligibility.

Our review of the public UK IPO register indicates that no SPC for the product “drospirenone” alone was ever filed on the basis of any combination authorisation. Instead, those combination authorisations supported SPC applications for drospirenone together with various forms of estrogen and patents relating to those combinations, in line with the approvals. In contrast, the basic patent in the present case claims advantages for drospirenone-only contraceptives over estrogen‑containing combination contraceptives, including reduced side effects. Indeed, claim 1 of the basic patent (EP3632448B1) expressly excludes estrogen (i.e. it was for A NOT B), stating:

“A pharmaceutical composition comprising drospirenone for use as a contraceptive for a female patient in need thereof, wherein:

(a) a daily active dosage unit of said composition comprises an amount of drospirenone of about 2 mg to about 6 mg of drospirenone, one or more pharmaceutically-acceptable excipients, and does not contain any estrogen […]” (emphasis added).

This stands in contrast to Medeva, where the claims of the basic patent “did not explicitly exclude the presence of additional active ingredients”, as acknowledged by the hearing officer (paragraph 66).

The UK IPO decision does not address the potential scope of an SPC based on the basic patent in question (A NOT B) and the marketing authorisation the UK IPO viewed as the first (A + B). In any event, our assessment indicates that no SPC term would have been available based on the basic patent in question and the authorisation viewed as the first by the UK IPO, as the combinations were authorised before the filing date of the basic patent. The applicant therefore appears to have been placed in an unfortunate position by the perhaps unintended consequences of earlier CJEU decisions.

Negative product definition rejected

As an auxiliary request, the applicant proposed amending the product definition in the SPC application to “drospirenone (not containing any estrogen)”, arguing that this would distinguish the product from Angeliq and Yasmin.

However, the hearing officer held that such a definition was not allowable because, Article 1(b) of the SPC Regulation requires a product is defined by “the active ingredient or combination of active ingredients of a medicinal product”, not by the exclusion of other active ingredients (paragraph 74).

Pearl: opposite outcome on similar facts, but could not be accounted for in the UK

The hearing officer was asked to consider Pearl (PMÄ 6595-24), a decision of the Swedish Patent and Market Court of Appeal that found an SPC application compliant with Article 3(d) under supposedly similar facts. Pearl Therapeutics, Inc. had applied for an SPC for a combination of glycopyrrolate and formoterol, based on a marketing authorisation for Bevespi®. During examination, the Swedish Patent and Registration Office (PRV) considered that the Bevespi authorisation was not the first in the sense of Article 3(d), due to a prior authorisation for Trimbow®, which contained glycopyrronium (synonymous with glycopyrrolate) and formoterol fumarate dihydrate, in addition to a third active ingredient, beclomethasone dipropionate. This represents a ‘step-down’ scenario (A+B+C → A+B).

The Swedish Court of Appeal disagreed with the PRV, limiting Medeva and Georgetown to situations where multiple active ingredients have multiple therapeutic uses, whereas in Pearl all active ingredients in both medicinal products related to the same therapeutic use (COPD). The Court held that, in such circumstances, a combination of two active ingredients constituted a different “product” from the combination of those same two active ingredients together with a third (paragraph 37). It also observed that this interpretation of “product” under Article 1(b) was consistent with the CJEU’s statements in the recent decision in Teva v Merck (paragraph 45).

However, the UK IPO hearing officer considered that they were not bound by Teva v Merck because it was delivered post-Brexit. They remained bound by Medeva via the Withdrawal Act 2018 (paragraph 27), and Medeva was not regarded as having been overturned by later decisions, including C-673/18 Santen, Newron [2024] EWCA Civ 128, and Merck Serono [2025] EWCA Civ 45 (paragraph 80). Accordingly, the hearing officer could not follow Pearl or the reasoning in Teva v Merck on which Pearl relied, because – to the extent that the approach taken in Teva v Merck differs from the approach taken in Medeva – the UK IPO was required to follow Medeva (paragraphs 62 and 76).

These contrasting approaches produced opposite outcomes under Article 3(d), even on supposedly similar facts:

• BL O/0705/25 (UK): Article 3(d) was not met because the earlier authorisations for Angeliq and Yasmin (A+B) were treated as authorisations for the same “product” as the authorisation for Slynd (A), applying Medeva.
• Pearl (Sweden): Article 3(d) was met because the earlier authorisation for Trimbow (A+B+C) was deemed to be for a different product compared to the authorisation for Bevespi (A+B), applying Teva v Merck.

This suggests that the conceptual division of active ingredients authorised as part of a combination therapy under the SPC Regulation, endorsed by Medeva and Georgetown, may not be settled, and may be applied differently depending on jurisdiction and/or factual context. SPC strategy should therefore be carefully considered when navigating a fixed-dose combination-first scenario.

At the time of writing, no record of an appeal against BL O/0705/25 has been identified. However, our review of the public SPC registers shows that the applicant is pursuing parallel SPC applications for the same product based on parent patent EP2588114B1, which also has claims to drospirenone in the absence of estrogen, and the same marketing authorisation as that relied on in BL O/0705/25.