Bristows and Three New Square defend Novartis’ SPC on Entresto in the UK

The parties are fighting over EP 1 467 728. The patent protects the combination of the angiotensin receptor blocker valsartan and the neutral endopeptidase inhibitor sacubitril. The two compounds form the basis of Novartis’ drug Entresto, used globally to treat heart failure and, in some countries, hypertension.

Although the patent expired in January 2023, Novartis holds SPC/GB16/025, which extends protection until 2028 in the UK.

In 2025, Accord brought the action to clear the way for launching a competing product following the expiry of Novartis’ data exclusivity on 23 November 2026. Accord Healthcare sought a declaration of invalidity from the UK High Court. Novartis counterclaimed for threatened infringement of the SPC.

Plausibilty and obviousness

In his judgment, UK High Court judge Richard Meade rejected Accord’s attacks on multiple fronts, including classical obviousness over two prior art references, lack of plausibility, collocation, and lack of technical contribution (case ID: HP-2025-000010).

Richard Meade

Accord had also challenged the SPC on two alternative bases. But Meade also dismissed the separate challenges to the SPC’s validity.

Given Meade’s finding that the SPC is valid on Novartis’ definition of the product, Accord’s earlier concession that its generic product would infringe in that scenario meant infringement was established.

Accord can appeal but JUVE Patent does not know whether the generics manufacturer will take this step. For now, Accord may not launch a generic version of Entresto on the UK market.

Similar outcome in Dutch proceedings

The UK ruling follows a decision earlier this year from the Dutch Court of Appeal. The court similarly upheld the validity of EP 728 and the related Dutch SPC in proceedings brought by Synthon.

The Dutch court found that combining valsartan with sacubitril was not obvious to the skilled person at the priority date. That decision upheld a 2023 ruling from the District Court The Hague. EP 728 had previously survived opposition proceedings at the EPO, filed by Mundipharma and withdrawn in 2010.

Win and loss for Three New Square

All barristers involved in the proceedings come from well-regarded barrister set Three New Square. Pharma expert Thomas Mitcheson led the team on Novartis’ side, alongside Stuart Baran, who dealt with the SPC issues, and Bethany Halbard.

The three winning barristers were instructed by Bristows. The leading UK patent litigation firm has a long-standing relationship with Novartis. The Swiss pharma giant instructs Bristows for UK and UPC cases. The Bristows team is led by partner Brian Cordery. Katie Cambrook and Kate O’Sullivan complete the team.

At Novartis, Principal IP Counsel Carmen Frigola-Deulofeu led the case together with Principal IP Counsel Denis Barbier, and Christiane Marti, head of commercial IP for Novartis’s cardio, renal and metabolism division.

Accord relied an Three New Square barristers Thomas Hinchliffe and Thomas Lunt, with Lunt handling the SPC issues in oral closings. They were instructed by Accord’s go-to law firm Pinsent Masons. London-based partner Christopher Sharp led the team, comprising Josie Miller and Venus Lam. Accord’s IP counsel Camille Sullivan led the case from the in-house side. (Co-author: Konstanze Richter)