Background
Accord Healthcare sought to clear the way to launch a competing heart-failure medicine after Novartis’s data exclusivity expired in November 2026. It challenged European Patent (UK) No. 1 467 728 B1, which claimed a pharmaceutical combination of the angiotensin receptor blocker valsartan and the neutral endopeptidase inhibitor sacubitril. Although the patent expired in January 2023, it served as the basic patent for SPC/GB16/025, which protects Novartis’s Entresto product until 2028.
Accord alleged that the patent was invalid for lack of plausibility, several forms of obviousness, collocation, and lack of technical contribution, relying principally on the prior-art publications Ksander and Trippodo and on the Darrow patent application. It separately challenged the SPC under Articles 3(a) and 3(b) of the assimilated SPC Regulation. Novartis counterclaimed that Accord’s intended product—which would contain separate salts of valsartan and sacubitril rather than Entresto’s co-crystal complex—threatened infringement.
The Court’s Holding
Mr Justice Meade rejected every attack on the patent. The patent made the claimed combination’s therapeutic utility sufficiently plausible, and Accord did not establish that combining valsartan and sacubitril was obvious to either the hypertension or heart-failure skilled person over Ksander or Trippodo. The court also rejected the collocation and lack-of-technical-contribution challenges, concluding that the patent had been valid while in force.
The court also upheld the SPC. For SPC purposes, the relevant “product” was the combination of the active ingredients valsartan and sacubitril, not Entresto’s co-complex form. That combination satisfied both limbs of the Royalty Pharma test under Article 3(a), was covered by the relevant marketing authorisation under Article 3(b), and fell within claim 1 even when presented as the co-complex. Because Accord had accepted that its proposed product would infringe if Novartis’s product definition prevailed and the SPC was valid, infringement followed without a separate determination.
Key Takeaways
- Accord failed to invalidate the valsartan-and-sacubitril patent on plausibility, obviousness, collocation, or lack-of-technical-contribution grounds.
- The SPC “product” was the combination of the two pharmacologically active ingredients, not their particular co-crystal, salt, or formulation.
- Accord’s planned product using separately mixed salts of valsartan and sacubitril would infringe Novartis’s valid SPC.
Why It Matters
The judgment preserves Novartis’s UK SPC protection for Entresto until 2028 and prevents Accord’s proposed launch on the case as decided. It also illustrates that SPC product identification focuses on active ingredients in the strict sense rather than the medicinal product’s particular physical or chemical presentation.
For pharmaceutical patent litigation, the decision further shows that disclosure of individual components and possible research routes does not by itself establish that their specific combination was obvious. The court assessed the asserted routes through the prior art against the knowledge and motivations of the relevant skilled teams and found that Accord had not proved its case.