Entresto® (sacubitril / valsartan)
Case Name: In re Entresto (sacubitril/valsartan) Patent Litigation (Novartis Pharms. Corp. v. MSN Pharms. Inc.), Civ. Nos. 20-md-2930-RGA, 22-cv-1395-RGA, 2025 WL 1911823 (D. Del. July 11, 2025) (Andrews, J.)
Drug Product and Patent(s)-in-Suit: Entresto® (sacubitril / valsartan); U.S. Patent No. 11,096,918 (“the ’918 patent”)
Nature of the Case and Issue(s) Presented: Novartis holds the NDA for Entresto, a drug used to treat heart failure, having the active ingredients sacubitril and valsartan. The ’918 patent is not an Orange Book-listed patent and claims the chemical compound that comprised Entresto, which is an amorphous solid form of sacubitril, valsartan, and sodium cations (“Amorphous TVS”). The priority date of the ’918 patent is April 4, 2006. MSN submitted to FDA an ANDA seeking approval to make and sell generic Entresto. Novartis filed suit, alleging infringement of the ’918 patent. After a four-day bench trial, where MSN withdrew its invalidity arguments, and post-trial briefing, the court found that Novartis had not proven that MSN infringed the ’918 patent.
Why MSN Prevailed: A certain molecule, compound, or complex will produce a unique Raman spectrum. A Raman spectrum for a sample of a compound should be the same as a Raman spectrum for a different sample of the same compound. The parties disputed whether MSN’s ANDA is predominately Amorphous TVS. Novartis’s expert created a reference sample to compare with MSN’s ANDA. The parties disputed whether that reference sample and the corresponding Raman spectrum of the sample were sufficiently reliable. Based on shifted peaks in the compared spectra, expert testimony, and relying on Novartis’ own references, the court found that the expert’s Raman spectrum was not reliable.
Before trial, one of MSN’s co-defendants, Noratech, asserted that Novartis failed to produce its expert’s Raman spectrum sample in violation of Rule 26. The court indicated it would take an adverse inference against Novartis for failing to produce the sample. Novartis argued the applicability of an adverse inference in favor of MSN because MSN was not the defendant that requested the sample. Given the discretionary nature of an adverse inference, the court rejected Novartis’ arguments. First, there was prejudice: MSN wanted to test the sample Novartis used to show MSN’s ANDA infringed but could not. Second, the sample was not misplaced and fell under the scope of the requested production, which is sufficient to show that Novartis “intended” to withhold the sample. Third, while true that MSN was not the party that sought production of the sample, this was discovery common to both defendants.
