UK High Court upholds Novartis’ Entresto patent and SPC in Accord challenge

Novartis has successfully defended its Entresto patent protection in the UK, after the High Court rejected Accord Healthcare’s challenge to the validity of the relevant patent rights and found that Accord’s intended generic product would infringe.

Mr. Justice Meade handed down judgment in Accord Healthcare Ltd v. Novartis AG [2026] EWHC 2127 (Pat) on August 13, finding that the relevant Novartis patent was valid while in force, that its supplementary protection certificate (SPC) was valid and that Accord’s proposed generic product would infringe.

The dispute concerns European Patent No. EP 1 467 728, covering the combination of sacubitril and valsartan used in Entresto. The underlying European patent expired in 2023, while the associated UK SPC provides additional protection until 2028.

The decision provides a fresh UK consideration of plausibility in relation to a product claim and also addresses classical obviousness, technical contribution, collocation and SPC issues. 

Entresto is marketed by Novartis for the treatment of heart failure and is one of the company’s most commercially important products.

Accord’s validity challenge

Accord Healthcare, part of Intas Pharmaceuticals, challenged Novartis’ patent protection as it prepared to enter the UK market with a generic version of Entresto.

Accord sought revocation of the relevant patent rights on validity grounds, while Novartis pursued infringement relief in response to Accord’s intended product. Reuters reported that Accord was intending to launch a competing product later this year. 

Meade J rejected Accord’s attacks on the patent. The court found the patent valid while it was in force, upheld the SPC, and found that Accord’s intended product would infringe. 

The ruling is therefore a significant setback for Accord’s planned UK generic launch.

Plausibility takes center stage

For patent practitioners, one of the most significant aspects of the judgment is its treatment of plausibility.

The case represents a further UK consideration of plausibility in relation to a product claim. The judgment also addresses classical obviousness and technical contribution, according to Three New Square, whose members acted for Novartis.

The issue is particularly important in pharmaceutical patent litigation because questions of plausibility can affect whether the specification provides an adequate basis for the technical effect relied upon by a patentee.

The judgment is therefore likely to attract attention from pharmaceutical patent practitioners because of its treatment of plausibility and the evidential foundation for a claimed technical effect.

A detailed examination of Meade J’s reasoning may also provide useful guidance for applicants drafting combination-product patents and seeking protection for therapeutic effects across the scope of a claim.

Combination claims and collocation

The judgment also addresses collocation, an issue with particular significance for combination-product patents.

Entresto combines two active pharmaceutical ingredients — sacubitril and valsartan. Whether a claimed combination represents a patentable technical contribution, rather than simply an aggregation of known components, can be central to the validity analysis of combination-product patents.

Three New Square confirmed that the judgment addresses collocation alongside plausibility, classical obviousness and technical contribution.

For pharmaceutical companies, the decision therefore provides a potentially useful example of how UK courts approach inventive-step arguments where protection is sought for a combination of active ingredients rather than a novel molecule alone.

SPC protection survives

The case also involved the validity of Novartis’ SPC. The underlying European patent expired in 2023, but the associated SPC extends protection in the UK until 2028. Reuters reported that the SPC is due to expire in 2028, preserving additional protection for Entresto beyond the expiry of the underlying patent. 

The High Court’s finding that the SPC is valid is therefore commercially significant for Novartis and represents a setback for Accord’s planned generic entry. The judgment also illustrates why patent and SPC positions need to be assessed together when evaluating generic-entry strategies.

A European picture of divergent litigation

The UK decision is particularly interesting when viewed alongside litigation concerning Entresto elsewhere in Europe.

Reuters reported that Novartis’ patent protection had separately been upheld following proceedings in the Netherlands. 

The Dutch litigation has itself generated significant interest among European patent practitioners, creating an opportunity to compare how national courts have approached related Entresto patent disputes.

At the same time, the US position has been less favorable to Novartis. Reuters reported that Novartis previously lost a US case seeking to prevent a generic version of Entresto from entering the market. 

The contrasting litigation trajectories underline an important feature of pharmaceutical patent strategy: even where related patent rights are being litigated in multiple jurisdictions, differences in national law, procedure, claim construction, validity standards and evidential approaches can produce different outcomes.

The proceedings should therefore not be treated as applications of one identical legal test. The precise claims, procedural history and legal issues in each jurisdiction need to be considered separately.

Commercial significance for Novartis

The stakes for Novartis are substantial.

Reuters reported that Entresto accounts for approximately 10% of Novartis’ sales, making the preservation of its remaining market exclusivity commercially significant. 

The company’s success in the UK comes as it faces a broader period of patent-expiry pressure affecting major products.

For Accord, meanwhile, the judgment represents a setback to its plans to enter the UK market with a generic version of Entresto later this year, as reported by Reuters. 

Drafting lessons for pharmaceutical patentees

The decision is likely to attract particular attention from practitioners working on combination therapies.

Three New Square’s summary identifies four substantive patent issues — plausibility, classical obviousness, technical contribution and collocation — in addition to the SPC questions. 

Taken together, those issues highlight the importance, at the drafting stage, of considering not only whether a combination appears inventive but also how the specification establishes the technical contribution associated with that combination.

The case may also provide useful guidance on the evidential foundation for therapeutic effects relied upon in pharmaceutical claims.

That makes Accord v. Novartis relevant beyond Entresto itself. As pharmaceutical companies increasingly seek patent protection for combinations, formulations and therapeutic applications, the boundary between a genuine technical contribution and an aggregation of known features remains an important battleground.

A significant UK victory, but not the end of the Entresto story

The High Court’s decision gives Novartis a significant victory in the UK: the relevant patent was found valid while in force, the SPC was upheld and Accord’s intended generic product was found to infringe.

But the wider Entresto litigation demonstrates why pharmaceutical patent protection cannot be assessed solely at the European level. The different litigation outcomes in the UK, Netherlands, and the US show how related patent disputes can develop differently across jurisdictions.

For patent practitioners, the UK judgment’s treatment of plausibility, technical contribution and collocation may ultimately prove as important as its immediate commercial effect.

The case therefore offers a timely reminder that, for combination drugs, the strength of the eventual patent position can depend heavily on how the technical contribution is articulated and supported from the outset — and how that disclosure withstands validity challenges years later.

The case is Accord Healthcare Ltd v. Novartis AG, [2026] EWHC 2127 (Pat).

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