English High Court Rules No SPC Based On Authorisation Of Monotherapy A Where A+B Was Authorised First

In Laboratorios Leon Farma SA v The Comptroller General of Patents ([2026] EWHC 663 (Ch)), the High Court of England and Wales has reached an important conclusion relating to Article 3(d) of the SPC Regulation. Specifically, the Court has ruled that in cases where a medicinal product is first authorised as a combination therapy (“A+B”), but a later monotherapy product (“A”) is developed and authorised, the later marketing authorisation to the monotherapy “A” cannot be used as the basis for an SPC application.

Background to the case

The present case concerns an appeal from the UKIPO, which refused an SPC application from Laboratorios Leon Farma (Leon) directed to the product drospirenone based on a marketing authorisation (MA) to the monotherapy “drospirenone”, where a previous MA directed to the combination therapy “drospirenone + estrogen” had previously been granted.

The UKIPO had considered that such an SPC application did not meet the requirements of Article 3(d) of the SPC Regulation, which requires that

“the [authorisation to place the product on the market as a medicinal product] is the first authorisation to place the product on the market as a medicinal product.”

The leading decision on the interpretation of Article 3(d) is the CJEU decision in Santen (C-673/18), which is retained EU law following the UK’s departure from the EU. This decision holds that Article 3(d) is to be applied strictly – the “first” MA is the first MA issued for a particular “product” (i.e. active ingredient), regardless of e.g. use of the product, or product formulation.

Furthermore, the CJEU in the Medeva (C-322/10) and Georgetown (C-422-10) decisions previously held that if a marketing authorisation (MA) was granted to a multi-component product A+B+C+… then such an MA could be considered as the first MA to any one of the active ingredients within the product. Thus, for example, such an MA could serve as basis for an SPC application to A alone (product A was being authorised, albeit in combination with other actives). This ruling was made in the context of multivalent vaccine products, where the authorised product necessarily had to be a combination of active ingredients.

Following these precedents from the CJEU, the UKIPO refused Leon’s application for an SPC to “drospirenone” on that basis that, following Medeva, the “first” MA on which an SPC to the monotherapy drospirenone could have been based was the MA to the combination product “dropsirenone + estrogen”. Thus, following Santen, the MA to the monotherapy A was not the “first” MA for the product A within the meaning of the SPC regulation. The requirements of Article 3(d) of the regulation were not met.

The UKIPO further rejected Leon’s auxiliary request to define the SPC in negative terms – i.e. a product definition of “drospirenone (not containing any estrogen)”.

The High Court finds Medeva to be generally applicable and good law

The High Court ruled against Leon on appeal, agreeing with the approach of the UKIPO hearing officer. The decision itself focuses primarily on the questions of (i) what exactly did Medeva decide, and (ii) was the decision in Medeva flawed (as Leon had argued)?

On question (i), Leon sought to argue that the findings of Medeva were based on exceptional facts, and limited to scenarios where the multiple active ingredients in an MA to A+B+C+… were each directed to different therapeutic applications, e.g. multivalent vaccines. Leon’s submissions in this regard relied on the argument that the CJEU in Medeva expressly took a teleological approach to deciding that case, in order to avoid the undesirable situation in practice where individual components of (e.g.) multivalent vaccines could not be protected by an SPC because regulators would only ever grant an MA to a combination product.

The Court however disagreed that the findings of Medeva were limited as Leon suggested. In particular, it was noted that the Advocate-General in the Medeva case considered that it would be undesirable to prevent SPC protection in “all spheres” in which manufacturers found themselves obliged, for legal or practical reasons, to place a medicinal product on the market in combination with other ingredients. The Court noted that the CJEU, agreeing with the Advocate-General, used similarly non-limiting language in its final judgement:

“[Article 3 of the SPC regulation] does not preclude the competent industrial property office of a Member State from granting a SPC for a combination of two active ingredients, corresponding to that specified in the wording of the claims of the basic patent relied on, where the medicinal product for which the MA is submitted in support of the SPC application contains not only that combination of the two active ingredients but also other active ingredients…” (Medeva C-322/10, paragraph 42; emphasis added)

Critically, the Court notes that whilst a monotherapy product A is clearly “not the same product” as the combination product A+B, Medeva finds that an MA to combination A+B+… nonetheless “does not preclude” the granting of an SPC to monotherapy A based on the MA to the combination A+B. Therefore, the marketing authorisation for the combination A+B is the “first” MA on which an SPC to monotherapy A could, and should, be based. It is accordingly consistent with all the existing case law, notably Medeva and Santen, to conclude that:

(a) on the one hand, the monotherapy A is a distinct “product” from the combination A+B for the purposes of (e.g.) evaluating the requirements of Articles 3(a) and 3(c) of the regulation; but

(b) nonetheless, the MA to the combination product A+B is the “first” relevant MA on which an SPC to the monotherapy could be based, which is relevant to Article 3(d).

Hence, where there is an earlier MA to a combination A+B, a later MA to the monotherapy A is not the “first” MA on which an SPC to product A can be based, and an SPC based on the later MA to the monotherapy does not meet the requirements of Art. 3(d).

Later case law from the CJEU does not overturn Medeva

On question (ii), Leon argued that notwithstanding the interpretation of Medeva discussed above, Medeva had been wrongly decided. Leon’s submission was that this conclusion could be inferred from a body of other case law (although acknowledged that none of the cases they referred to explicitly overturned Medeva). The Court did not agree.

The single most relevant case that was considered in this regard is the CJEU’s 2024 judgment in Teva II (C-119/22 and C-149/22). Leon’s contention was that this decision was unequivocal in stating that (i) when considering Article 3(c) of the SPC regulation, a combination product A+B was a different “product” to a monotherapy product A, and (ii) that the term “product” must be interpreted the same way for all arms of Article 3 of the SPC regulation. Thus, Leon argued that the findings of Teva II were incompatible with the findings of Medeva, insofar as if the “product” at issue in its SPC application had to be the monotherapy drospirenone (and not the combination dropirenone + estrogen), the relevant marketing authorisation to be considered under Article 3(d) also had to be a marketing authroisation directed to the monotherapy drospirenone. Accordingly, Leon argued, it must be inferred that in Teva II the CJEU has overruled its judgment in Medeva.

The UKIPO hearing officer had avoided addressing the substance of this argument by pointing out that because Teva II had been decided by the CJEU after the UK’s withdrawal from the EU, the UKIPO was not bound by Teva II but it was bound by the earlier decision in Medeva. Thus, to the extent that Teva II might overturn Medeva, such a finding could not be followed by the UKIPO and lower courts in the UK.

The Court has however addressed the substance of Leon’s argument and is clear in its conclusion that Teva II is not incompatible with Medeva. In particular, the Court concluded that:

• Teva II states that monotherapy A and combination therapy A+B are different “products” within the meaning of the SPC regulation – which is not contested.
• However, Medeva does not provide direction as to what a “product” is, but rather what a marketing authorisation is directed to. Specifically it tells us that an MA to a combination therapy A+B can be considered an MA to place product A on the market. There is accordingly no conflict between Medeva and Teva II.
• Further, Teva II considered only the opposite situation to Medeva, where the combination product A+B was developed later than the monotherapy products A and B, both of which had previously been authorised individually, so is distinguishable on its facts.

Leon had also argued that the Swedish Court of Appeal had been asked to rule on a very similar fact pattern to the present case in Pearl Therapeutics. The Swedish court had come to a contrary view to the UKIPO, arguing that – following Teva II – an SPC could be granted to monotherapy A based on an MA to that monotherapy A, where an earlier MA to a combination therapy A+B exists.

On this point, the English Court however considered that the Swedish court’s judgment is brief and is difficult to draw conclusions from: in particular, it does not explain why Medeva did not apply to the facts of the case before it, and was unclear as to whether it considers Teva II to overturn Medeva. Accordingly, the English Court was not persuaded by the decision of the Swedish court and was content to arrive at the opposite conclusion.

The Auxiliary Request

Finally, the Court briefly considered Leon’s auxiliary request to define its SPC in negative terms to exclude the combination therapy – “drospirenone (not containing any estrogen)”. However, the Court considered that the words “not containing any estrogen” are a superficial amendment that do not refer to a relevant active ingredient given the facts at issue, and thus cannot change what the “product” being protected is.

Conclusions

The main takeaway from the present case is that – in the UK at least – it is now clear that an SPC cannot be based on an MA to a monotherapy product A, where a combination product A+B has previously been authorised. Whilst this will be disappointing news to some innovator companies, particularly those working in the small molecule field (where development of a monotherapy to replace a combination therapy on the market is likely to be of significant benefit to patients, e.g. by reducing the potential for side effects from taking multiple drugs), it will be welcome news to vaccine developers in particular that Medeva is still held by the English Court to be good law, since Medeva provides the legal foundation for allowing SPC applications to individual components of medicines that must necessarily be marketed as multi-component products.

There is, however, now clear case law divergence on this point between the High Court in England and Wales and the Swedish Court of Appeal in Pearl Therapeutics. It will therefore be interesting to see how other courts in the EU consider this point as and when it arises in national court proceedings, and whether any EU national court considers that a question on this issue should be referred to the CJEU. It will also be interesting to see whether Leon apply for permission to appeal the present decision to the Court of Appeal and whether such permission is granted. We will await further developments in this area with interest.