In brief
- In Accord Healthcare Ltd v Novartis AG, the Patents Court rejected validity challenges to Novartis' patent and supplementary protection certificate (SPC) for Entresto (sacubitril/valsartan), a blockbuster heart failure treatment.
- Rejecting attacks based on plausibility, obviousness, collocation, lack of technical contribution and SPC validity, Mr Justice Meade upheld both rights and confirmed that Accord's proposed generic product would infringe.
- On plausibility, whilst the judge described the outcome as a 'close call', the judgment confirms that a qualitative disclosure of successful experimental work may satisfy the plausibility threshold without numerical data, provided the skilled person would understand the application as communicating that such work had been carried out.
- The judgment also addresses combination pharmaceutical inventions and reliance on the regulatory dossier when identifying the relevant "product" for SPC purposes.
Background
Accord sought to clear the way for a generic version of Entresto by revoking Novartis' European patent (EP (UK) 1 467 728 B1) (Patent) and related SPC (SPC/GB16/025). Entresto treats heart failure, and in some territories, hypertension.
Accord challenged the Patent on several grounds and the SPC consequentially and independently. Novartis counterclaimed for threatened infringement. By trial, Accord accepted that its proposed generic would infringe a valid SPC.
Entresto combines the angiotensin receptor blocker (ARB) valsartan and neutral endopeptidase inhibitor (NEPi) sacubitril. In Novartis' product, the active ingredients form a co-crystal complex; Accord’s intended product contained separate salts mixed together.
The High Court's decision on validity
In what may be his final High Court judgment before he heads to the Court of Appeal, Mr Justice Meade comprehensively addressed each of Accord's validity attacks.
Lack of plausibility
Plausibility was a central issue in the case. The question was "whether the Patent makes plausible that the combination of valsartan and sacubitril specifically would provide a clinically useful result in hypertension".
The leading plausibility authority remains the Supreme Court's decision in Generics (UK) Ltd v Warner-Lambert Co LLC [2018] UKSC 56 (Warner-Lambert). This was affirmed by the Court of Appeal in Sandoz Ltd v Bristol-Myers Squibb [2023] EWCA Civ 472 (Apixaban CA) and Generics (UK) Ltd v AstraZeneca AB [2025] EWCA Civ 903 (Dapagliflozin CA). In broad terms, plausibility requires a patent application to provide a credible basis for believing that the claimed invention will achieve the technical effect asserted by the patentee. A mere assertion that an invention works will not be enough; the application must contain some disclosure that makes the claimed effect plausible to the skilled person.
The patent application in question did not disclose any numerical results, instead relying on qualitative statements that testing of the claimed combination had produced positive outcomes. This was ultimately sufficient for Mr Justice Meade, who held that, read as a whole, the application plausibly disclosed successful testing of the valsartan/sacubitril combination in animal hypertension models, with positive results compared with the individual components.
Mr Justice Meade described the issue as a "close call". He emphasised that the court's task was to assess what the application disclosed, rather than engage in "detective work" to infer unreported experiments. While noting that his view had "shifted back and forth during the trial", he concluded that any doubts arose when individual passages were considered in isolation rather than the application as a whole.
"Classical" obviousness
Accord's primary obviousness attacks relied on two prior art documents: Ksander and Trippodo. Mr Justice Meade rejected them, stressing the complexity of the underlying science and that neither the prior art nor common general knowledge directed the skilled person to the claimed valsartan/sacubitril combination. Neither citation therefore rendered the invention obvious.
Collocation
Mr Justice Meade rejected Accord's allegation that the invention was a mere collocation of two known compounds. It was sufficient that valsartan and sacubitril interacted positively rather than adversely; quantitative proof of synergy was unnecessary.
Lack of technical contribution
Accord argued that the Patent made no technical contribution over prior art documents Trippodo and Darrow, and merely selected arbitrarily from known ARBs and NEPis. Mr Justice Meade disagreed, finding that the Patent disclosed testing of the valsartan/sacubitril combination and was shown to produce a beneficial effect, not merely compounds from known classes. As he observed, demonstrating for the first time an advantage of a specific member of a broad class is itself a technical contribution.
Invalidity of SPC even if the Patent is valid
Mr Justice Meade's SPC analysis centred on the identification of the relevant "product" for the purposes of Article 3 of the SPC Regulation (Regulation (EC) No 469/2009). In addressing that issue, Mr Justice Meade undertook a detailed review of the regulatory materials, including the Summary of Product Characteristics (SmPC), EMA Assessment Report (EPAR) and marketing authorisation documents. He placed significant weight on those documents when determining that the relevant product was the combination of valsartan and sacubitril, rather than the marketed co-crystal complex.
That conclusion was decisive to the application of Articles 3(a) and 3(b). Under Article 3(a), the combination was expressly claimed and specifically identifiable from the Patent. Under Article 3(b), the marketing authorisation was held to authorise the same product namely the sacubitril/valsartan combination, the co-complex itself being treated as a matter of formulation rather than a distinct active product. The SPC was therefore valid and, as Accord accepted, its proposed generic product would infringe.
Key takeaways
The decision provides guidance on plausibility, combined inventions and SPC validity. In particular, on plausibility, it reinforces the post Warner-Lambert principle that plausibility must be found in the application itself: a bare assertion of efficacy is not enough. Unlike in Apixaban CA and Dapagliflozin CA, where the courts found only unsupported assertions of therapeutic efficacy and insufficient disclosure of experimental support for the claimed invention, Mr Justice Meade held that the application would be understood as disclosing positive experimental work with the claimed combination. This judgment therefore confirms that plausibility may be established through qualitative disclosure of experimental results, without the need for quantitative data, provided the skilled person would understand the application as communicating that such work had been carried out.
The judgment also highlights the Patents Court's reluctance to reconstruct inventions using simplified reasoning in scientifically complex fields. In addition, where a patent plausibly demonstrates a beneficial effect for a specific combination selected from broader known classes, that selection is unlikely to be viewed as an arbitrary one lacking technical contribution.
Finally, the SPC analysis highlights the importance of the regulatory dossier when identifying the relevant "product" for SPC purposes. Given Mr Justice Meade's approach, courts are likely to continue focusing on the active ingredients identified through the regulatory approval process rather than differences in formulation, salt form or co-crystal structure. The judgment reinforces the established SPC principle that changes in pharmaceutical form or presentation will not ordinarily create a different "product" where the underlying active ingredients remain the same.