United States Court of Appeals for the Federal Circuit ______________________

IN RE: ENTRESTO (SACUBITRIL/VALSARTAN)

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NOVARTIS PHARMACEUTICALS CORPORATION, Plaintiff-Appellant

v.

TORRENT PHARMA INC., TORRENT PHARMACEUTICALS LTD. Defendants

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NOVARTIS PHARMACEUTICALS CORPORATION, Plaintiff-Appellant

v.

ALEMBIC PHARMACEUTICALS LIMITED, ALEMBIC PHARMACEUTICALS INC., Defendants

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NOVARTIS PHARMACEUTICALS CORPORATION, Plaintiff-Appellant

v.

MSN PHARMACEUTICALS, INC., MSN Case: 23-2218 Document: 106 Page: 2 Filed: 01/10/2025

2 NOVARTIS PHARMACEUTICALS CORPORATION v. TORRENT PHARMA INC.

LABORATORIES PRIVATE LTD., MSN LIFE SCIENCES PRIVATE LTD., Defendants-Appellees

HETERO USA, INC., HETERO LABS LIMITED, HETERO LABS LIMITED UNIT-III, Defendants ______________________

2023-2218, 2023-2220, 2023-2221 ______________________

Appeals from the United States District Court for the District of Delaware in Nos. 1:19-cv-01979-RGA, 1:19-cv- 02021-RGA, 1:19-cv-02053-RGA, 1:19-cv-02053-RGA, 1:20- md-02930-RGA, Judge Richard G. Andrews. ______________________

Decided: January 10, 2025 ______________________

DEANNE MAYNARD, Morrison & Foerster LLP, Washington, DC, argued for plaintiff-appellant. Also represented by SETH W. LLOYD; NICHOLAS NICK KALLAS, CHRISTINA A. L. SCHWARZ, Venable LLP, New York, NY.

WILLIAM A. RAKOCZY, Rakoczy Molino Mazzochi Siwik LLP, Chicago, IL, argued for defendants-appellees. Also represented by KEVIN E. WARNER; RONALD M. DAIGNAULT, RICHARD JUANG, Daignault Iyer LLP, Vienna, VA.

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Before LOURIE, PROST, and REYNA, Circuit Judges. LOURIE, Circuit Judge. Following a three-day bench trial, the United States District Court for the District of Delaware determined that Case: 23-2218 Document: 106 Page: 3 Filed: 01/10/2025

NOVARTIS PHARMACEUTICALS CORPORATION v. 3 TORRENT PHARMA INC.

claims 1–4 of U.S. Patent 8,101,659 (“the ’659 patent”) were not shown to be invalid for obviousness, lack of enablement, or indefiniteness, but were shown to be invalid for lack of written description. In re Entresto (Sacubitril/Valsartan) Pat. Litig., No. 20-md-2930, 2023 WL 4405464, at *13, *21, *22 (D. Del. July 7, 2023) (“Decision”). Judgment was entered on those grounds. Appellant Novartis Pharmaceuticals Corporation (“Novartis”) challenges the district court’s written description determination. Appellees MSN Pharmaceuticals, Inc., MSN Laboratories Private Ltd., and MSN Life Sciences Private Ltd. (collectively, “MSN”)1 argue that the judgment of invalidity should be affirmed, either by affirming the district court’s written description determination or, alternatively, by reversing the district court’s obviousness or enablement determinations. For the following reasons, we reverse the district court’s determination that the claims lack an adequate written description, and we affirm its determinations that the claims were not shown to be invalid as either non- enabled or obvious.

1 Of the presently named defendants, only MSN participates in this appeal. Each of Hetero USA Inc., Hetero Labs Limited, Hetero Labs Limited Unit-III (collectively, “Hetero”), Torrent Pharma Inc., Torrent Pharmaceut