Following our detailed report (here) of the UK IPO’s decision to refuse an SPC application for a single-ingredient product in light of earlier authorisations for combination products containing that ingredient (BL O/0705/25 of 31 July 2025), we now provide a brief update on the High Court’s dismissal of the applicant’s appeal ([2026] EWHC 663 (Ch) of 20 March 2026).

To recap, this judgment is likely to be relevant in scenarios where the regulatory path is, for example, A+B → A, A+B+C → A+B, or A+B → A+C (where each of A, B, and C are active ingredients) and a single-ingredient SPC is sought for A based on the later marketing authorisation (MA).

Recorder Douglas Campbell KC, sitting as a Judge of the Patents Court, endorsed the CJEU’s Medeva (C-322/10) line of case law, holding that it remains good law in the UK and is of general applicability. The result is that the first MA for a product containing the active ingredient, whether alone or in any combination, may constitute the first authorisation for that active ingredient for the purposes of Article 3(d) in the UK.

The Judge supplements the UK IPO’s reasoning with a couple of aspects that are new or receive greater emphasis:

1. Daiichi: the Judge considered paragraphs 57 and 58 of the UK Court of Appeal’s pre-Medeva judgment Generics v Daiichi ([2009] EWCA Civ 646). In Daiichi, the Court of Appeal held that an SPC to levofloxacin enantiomer alone was correctly granted despite an earlier MA to the racemic combination of levofloxacin and the corresponding R(+) enantiomer. In the present case, the Judge took the view that “the reasoning, particularly in the last sentence of paragraph [58], is indeed inconsistent with Medeva” and that “following Medeva the earlier MA discussed in Daiichi would now be treated as an MA for placing “A” alone, or indeed “B” alone, on the market” (paragraph 43). The Judge dealt in a similar way with the relevant part of the pre-Medeva High Court judgment in Astellas Pharma Inc v Comptroller General of Patents ([2009] EWHC 1916 (Pat)) and the decision of the Bundesgerichtshof in Lundbeck (Xa ZR 130/07), which the Judge noted was, in any event, a foreign decision (paragraph 45).

2. Innovation level: the Judge acknowledged at the outset that the single-ingredient nature of the product corresponds to the patented innovation (paragraph 3), yet made clear that this does not influence SPC eligibility under Article 3(d), stating that “even research considered worthy of a Nobel Prize would not for that reason alone satisfy the requirements of the SPC Regulation” (paragraph 55).

As set out in our previous report (here), we are seeing divergence across Europe in how patent offices and courts assess SPC eligibility in fact patterns such as those considered by the Judge in the present case. Indeed, the Judge noted that the Hungarian patent office granted the SPC after the applicant had presented arguments similar to those advanced in the UK (paragraph 70).

We illustrate below the impact of the Medeva line of case law on SPC eligibility under Article 3(d) in two exemplary regulatory scenarios (A → A+B, and A+B → A), from which it is clear that Medeva can be either restrictive or permissive. This table does not consider SPC eligibility under, e.g., Article 3(a), which is a fact-specific assessment having regard to the disclosure in the patent and the prior art.

It is possible that the SPC applicant will seek permission to appeal to the Court of Appeal, as the Judge noted that “Leon reserved its position to argue in a higher court that Medeva should not be followed or should be overruled” (paragraph 6).