UK High Court Upholds Novartis’s Sacubitril Valsartan SPC: What Is The Relevant “product”?

In Accord Healthcare Ltd v Novartis AG [2026] EWHC 2127 (Pat) (Accord) the UK High Court rejected a challenge by Accord Healthcare to Novartis’s supplementary protection certificate (SPC) for the combination of sacubitril and valsartan.

The decision addresses a fundamental question under the SPC Regulation: how should the “product” protected by an SPC be defined? The Court held that the relevant product was the combination of sacubitril and valsartan, rather than the specific co-crystal formulation authorised in Novartis’s Entresto®.

The judgment also provides useful context for the High Court’s subsequent decision in [2026] EWHC 2414 (Pat), Takeda, discussed in our separate article, concerning whether lisdexamfetamine qualifies as an “active ingredient” for SPC purposes.

Why did the definition of the “product” matter?

Entresto® is authorised for the treatment of heart failure and contains sacubitril and valsartan as a co-crystal complex. Accord planned to launch a competing product containing a simple admixture of separate sacubitril and valsartan salts.

Accord challenged Novartis’s SPC under Articles 3(a) and 3(b) of the SPC Regulation. These require the product to be protected by a basic patent in force and covered by a valid marketing authorisation (MA).

The key question was therefore how that “product” should be defined. Accord argued that it was the specific sacubitril valsartan co-crystal authorised in Entresto®. Novartis argued that it was the combination of sacubitril and valsartan more generally, irrespective of its physical form.

What was the relevant “product”?

The Court agreed with Novartis. The relevant product was the combination of sacubitril and valsartan, not the specific co-crystal.

Article 1(b) defines a “product” as the “active ingredient or combination of active ingredients of a medicinal product”. The Court distinguished the “product” from the medicinal product itself, which is the particular formulation authorised for sale.

The pharmacology supported that distinction. Once administered, the sacubitril and valsartan salts dissociate and exert their therapeutic effects independently. Those effects do not depend on whether the active ingredients are administered as a co-crystal or a simple admixture.

The regulatory documents underlying the MA were also consistent with that analysis. Although a different formulation would require a variation to the MA, that did not make it a different “product” for SPC purposes.

Accord’s Article 3(b) challenge therefore failed: the authorised product was the combination of sacubitril and valsartan covered by the SPC.

Was the product protected by the basic patent?

The Court then considered Article 3(a), applying the two-part Royalty Pharma test. The product must:

• necessarily come under the invention covered by the basic patent, as understood by the skilled person in light of the patent’s description and drawings; and
• be specifically identifiable by the skilled person from the information disclosed in the patent, taking account of the prior art at the filing or priority date.

The Court found both requirements satisfied.

For the first requirement, the patent repeatedly identified the combination of sacubitril and valsartan, including in claim 1. Accord argued that the claims were narrower because they covered only a conventional admixture and required a pharmaceutically acceptable carrier. The Court rejected both arguments. The claims were not limited to a particular type of mixture, and Article 3(a) is not an infringement test.

For the second requirement, Accord argued that the patent did not disclose the specific co-crystal. But that argument depended on defining the product too narrowly. Once the relevant product was identified as the combination of sacubitril and valsartan, both active ingredients were specifically identified in the patent.

Accord’s Article 3(a) challenge therefore also failed.

How does the decision relate to Takeda?

The approach in Accord is also relevant to the High Court’s subsequent consideration of Article 1(b) in Takeda.

The cases concern different aspects of the definition of “product”. In Accord, the question was whether the particular physical form of two active ingredients — a co-crystal rather than a simple admixture — affected the identity of the product. The Court held that it did not, having regard to both the pharmacology and the regulatory treatment of the active ingredients.

In Takeda, the issue was instead whether lisdexamfetamine (LDX) could be regarded as a new “active ingredient” given that it is effectively a pro-drug of dextroamphetamine (DEX). As discussed in our separate review, the High Court upheld Takeda’s SPC, concluding that LDX could be regarded as an active ingredient having regard to its different pharmacokinetic profile and EMA guidance.

The judge in Takeda also expressly referred to Accord, noting that it had proceeded on the basis that the active ingredients were those identified as such by the regulators when granting the relevant marketing authorisations.

Read together, the decisions indicate the importance of the regulatory identification of the active ingredient or combination of active ingredients when determining the “product” for SPC purposes.

What does the decision mean for SPCs?

Accord illustrates how the definition of the “product” can determine the analysis under Article 3. A particular formulation of active ingredients is not necessarily a distinct product for SPC purposes, even where that formulation may itself require additional regulatory approval or be the subject of later patent protection.

The judgment also reinforces the distinction between the Article 3(a) test and an infringement analysis. Additional features in a patent claim do not necessarily prevent the authorised product from satisfying Article 3(a), although the scope of the resulting SPC remains limited by the claims of the basic patent.

For Article 3(b), regulatory materials such as the SmPC are likely to be important in identifying the authorised active ingredient or combination of active ingredients. In Accord, those materials supported the Court’s conclusion that the relevant product was sacubitril and valsartan generally, rather than the particular co-crystal formulation.

Related Material

UK High Court upholds Takeda’s lisdexamfetamine SPC: will the CJEU agree? – our review of the subsequent High Court decision concerning the meaning of “active ingredient” under Article 1(b) of the SPC Regulation.