A complex question: defining the SPC product in Accord v Novartis [2026] EWHC 2127 (Pat)

Background

The case concerned European Patent (UK) No. 1 467 728 B1, owned by Novartis, and the associated SPC protecting Entresto. The patent covered combinations of valsartan and sacubitril and expired on 16 January 2023. The SPC took effect immediately afterwards and is due to expire on 15 January 2028.

Accord intended to launch a generic sacubitril/valsartan product and brought a clearing-the-way action challenging the validity of the patent on a number of grounds, including lack of plausibility, obviousness, collocation and lack of technical contribution. Novartis counterclaimed for threatened infringement. Meade J rejected all of Accord’s attacks on the patent. A more detailed analysis of the Court’s findings on the validity of the patent is available here.

Accord also challenged the validity of the SPC. That challenge turned on the relationship between the particular co-complex used in Entresto and the underlying combination of valsartan and sacubitril protected by the patent.

Identifying the “product”

The SPC described the product as “Sacubitril/valsartan, including pharmaceutically acceptable salts thereof” (paragraph [520]). Entresto itself, however, is not formulated as a simple admixture of those two active ingredients. Instead, it exists as a crystalline co-complex containing valsartan and sacubitril together with sodium ions and water.

That distinction mattered because Accord’s intended generic product took a different physical form. Rather than using the Entresto co-complex, it consisted of a conventional mixture of a valsartan salt and a sacubitril salt. Once Entresto is administered, however, the co-complex dissociates to release valsartan and sacubitril, while the sodium ions and water have no pharmacological effect of their own. Meade J summarised the structure of Entresto, in “crude terms”, as “a salt of valsartan and a salt of sacubitril physically stuck together by their inclusion in the co-complex” (paragraph [524]).

The central issue was therefore whether the relevant “product” under Articles 1(b), 3(a) and 3(b) was the particular Entresto co-complex, or the underlying combination of valsartan and sacubitril irrespective of the precise physical form in which those active ingredients were presented.

Accord argued that either answer resulted in invalidity. If the product was the co-complex, it was not protected by the basic patent as required by Article 3(a). If the product was instead the broader combination of valsartan and sacubitril, Accord argued that the marketing authorisations did not authorise that product for the purposes of Article 3(b), but only the specific co-complex formulation. Novartis’ position was that the relevant product was the combination of sacubitril and valsartan, which could be provided in different physical or chemical forms.

Meade J agreed with Novartis. He emphasised the distinction between a medicinal product under Article 1(a), which concerns the medicinal formulation, and a product under Article 1(b), which concerns the active ingredient or combination of active ingredients. He also noted that the same product must be identified consistently for all parts of Article 3, with the focus on the active ingredients “in the strict sense” (paragraph [542]).

Meade J also relied on what he described as a “consistent line of decisions in the European and domestic case law” (paragraph [544]). Those authorities establish that matters such as salts, excipients, adjuvants and formulation do not determine the identity of the SPC product. He referred in particular to Farmitalia (C-392/97), which established that a change in salt form doesn’t amount to a new product. The fact that Novartis would require an extension to its marketing authorisations to market a conventional admixture of valsartan and sacubitril therefore did not mean that the admixture was a different “product” for SPC purposes.

The regulatory materials led to the same conclusion. The SmPC explained that “[f]ollowing oral administration, Entresto dissociates into valsartan and the prodrug sacubitril” (paragraph [551]). Taken as a whole, the regulatory materials identified valsartan and sacubitril as the pharmacologically active substances rather than the co-complex itself. Meade J therefore concluded that “the active ingredients are valsartan and sacubitril and not the co-complex” (paragraph [561]).

Articles 3(a) and 3(b)

Having identified the product as the combination of valsartan and sacubitril, the Court found that both Article 3(a) and Article 3(b) were satisfied.

For Article 3(a), the Court applied the two-part test in Royalty Pharma (C-650/17). The combination of valsartan and sacubitril was repeatedly identified in the patent and its claims, so the fact that the later-developed co-complex itself could not have been identified from the patent was, as Meade J put it, “true but irrelevant given that the co-complex is not the product” (paragraph [569]). The Court also rejected Accord’s reliance on Novartis’ later patent and SPC applications for the co-complex. A later formulation may be sufficiently different to support novelty and inventive step without necessarily constituting a different SPC “product”.

The Court also held that the co-complex itself fell within claim 1, since the claim required valsartan and sacubitril salts to be present but did not require them to take the form of a conventional admixture.

For Article 3(b), the same product analysis was decisive. The fact that the Entresto marketing authorisations related to the co-complex did not mean that the authorised SPC product was limited to that physical form. Nor did the need for a regulatory extension to market a different formulation make a conventional admixture of valsartan and sacubitril a different SPC product. The Entresto marketing authorisations were therefore sufficient for the combination of the two active ingredients.

Comment

The decision provides a useful illustration of how SPC product identity is assessed separately from questions of patentability and regulatory treatment. The Entresto co-complex was structurally distinct from a conventional admixture of valsartan and sacubitril, had itself been the subject of later patent and SPC filings, and would require different regulatory treatment if marketed in another form. Meade J nevertheless treated those features as non-determinative once the relevant active ingredients had been identified as valsartan and sacubitril. The Article 1(b) inquiry was focused on the identity of the active ingredient or combination of active ingredients, rather than on the particular form in which they were presented.

A later-developed formulation of a combination of actives may therefore be (i) patentable over an earlier-developed combination of the same actives, and (ii) may need independent regulatory approval, but yet the later developed product could still be covered by an SPC on the earlier developed product.  The practical consequence is that disputes under Articles 3(a) and 3(b) may turn heavily on how the SPC “product” is identified at the outset. In Accord v Novartis, once the product was characterised as valsartan plus sacubitril rather than the co-complex, Accord’s formulation-based arguments fell away.