Patent Trial and Appeal Board Denies Institution of Inter Partes Review of Novartis’s Entresto® Patent on Combination of Valsartan and Sacubitril

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On February 16, 2021, the Patent Trial and Appeal Board ruled in favor of Venable Fitzpatrick’s client Novartis Pharmaceuticals Corporation and against petitioner Biocon Pharma Limited in IPR2020-01263. The Board denied Biocon’s petition to institute inter partes review of U.S. Patent No. 8,101,659 (“the ’659 patent”). The ’659 patent claims pharmaceutical compositions comprising the active agents valsartan and sacubitril (or salts thereof), which covers Novartis’s Entresto® Product.

Agreeing with Novartis, the Board found that Biocon’s petition advanced the same or substantially the same prior art that was presented to the examiner during prosecution. The Board also agreed that Biocon failed to show material error in the examiner’s consideration of Novartis’s unexpected results evidence presented during prosecution. The Board exercised its discretion to deny institution under 35 U.S.C. § 325(d).

Novartis was represented by Venable Fitzpatrick attorneys Christina SchwarzNicholas KallasSusanne FlandersShannon ClarkLaura FishwickErin Belfield, and Ju Yun Son.