The UK High Court has handed down its decision on how the relevant “product” should be identified for SPC protection.

In Accord Healthcare Limited v Novartis AG [2026] EWHC 2127 (Pat), the court considered whether the relevant product was the particular crystalline co-complex present in the authorised medicinal product Entresto, or the underlying combination of the active ingredients valsartan and sacubitril.

The decision reinforces an important distinction: the medicinal product which receives regulatory approval and the “product” protected by an SPC are not necessarily the same thing.

What was the issue?

SPCs can provide an additional period of protection for patented medicinal products, compensating, in part, for patent term effectively lost while obtaining regulatory approval.

Entresto is used in the treatment of heart failure and contains valsartan and sacubitril in the form of a crystalline sodium co-complex. Following administration, the co-complex dissociates to release valsartan and sacubitril, which provide the relevant pharmacological effects.

Novartis’s SPC identifies the product as “sacubitril/valsartan, including pharmaceutically acceptable salts thereof”. The court therefore considered whether the “product” under the SPC regulation was the specific co-complex present in Entresto or the combination of valsartan and sacubitril.

This distinction matters because identifying the product determines how other requirements for SPC protection are assessed, including whether the product is protected by the basic patent under Article 3(a) and has a valid marketing authorisation under Article 3(b).

What did the High Court decide?

Mr Justice Meade concluded that the relevant product was the combination of valsartan and sacubitril, rather than the crystalline co-complex.

Central to the court’s reasoning was the distinction between the authorised “medicinal product” and the “product” for SPC purposes. The former concerns the actual formulation authorised for marketing, whereas the latter concerns the active ingredient or combination of active ingredients.

Moreover, the court considered the marketing authorisation and associated documents, including the summary of product characteristics and European public assessment report, and found that these “overwhelmingly” supported valsartan and sacubitril being the active ingredients.

The court also referred to a “consistent line of decisions” establishing that aspects such as the salt, excipients, adjuvants or formulation do not ordinarily determine the identity of the SPC product.

What about Articles 3(a) and 3(b)?

Having identified the product, the court applied the Court of Justice of the European Union (CJEU) Royalty Pharma (C-650/17) test to determine whether Article 3(a) was satisfied.

The combination of valsartan and sacubitril was repeatedly identified in the basic patent and its claims. Although the particular co-complex was developed later and could not have been identified from the patent, the judge considered this “true but irrelevant given that the co-complex is not the product”. The relevant question concerned the combination of valsartan and sacubitril, for which the court found the Article 3(a) requirements satisfied.

The court also rejected the Article 3(b) challenge. Although the marketing authorisation was for Entresto in its co-complex form, this did not mean that the authorised “product” for SPC purposes was limited to that particular form. Having identified the combination of valsartan and sacubitril generally as the “product” under the SPC regulation, the Court considered the marketing authorisation sufficient to satisfy Article 3(b) for that product.

Why is the decision important?

The decision demonstrates why patent, regulatory and SPC concepts should not be conflated. A particular physical or chemical form may be important from a patent or regulatory perspective without necessarily representing a different SPC “product”.

Notably, the court recognised that a simple admixture of valsartan and sacubitril could require different regulatory treatment to that of the Entresto co-complex. The co-complex was also a later development capable of supporting separate patent protection. Neither point meant that it represented a different product for SPC purposes.

For SPC applicants, the decision highlights the importance of identifying the relevant product at the outset.

Careful consideration should be given to how the active ingredient or combination of active ingredients is characterised in the basic patent, marketing authorisation and associated regulatory documentation, particularly for medicinal products involving salts, complexes, co-crystals or other specific physical forms.