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Generic Drugs Hatch-Waxman Novartis

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Novartis Pharms. Corp. v. MSN Pharms., Inc.

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Entresto® (valsartan/sacubitril) - Case Name: Novartis Pharms. Corp. v. MSN Pharms., Inc., Nos. 2024-2211, 2024-2212, 2024 WL 4969281 (Fed. Cir. Dec. 4, 2024) (Circuit Judges Lourie, Prost, and Reyna presiding; Opinion by...more

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Novartis Pharms. Corp. v. MSN Pharms. Inc. - Entresto® (sacubitril/valsartan)

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Case Name: Novartis Pharms. Corp. v. MSN Pharms. Inc., Civ. No. 20-MD-2930-RGA, 2024 WL 3756787 (D. Del. Aug. 12, 2024)....more

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Novartis Pharms. Corp. v. Hetero USA Inc. - Entresto® (sacubitril/valsartan)

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Case Name: Novartis Pharms. Corp. v. Hetero USA Inc., Civ. No. 20-md-2930-RGA, 2024 WL 3757086 (D. Del. Aug. 12, 2024)....more

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Novartis Pharms. Corp. v. Becerra - Entresto® (sacubitril/valsartan)

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Case Name: Novartis Pharms. Corp. v. Becerra, No. 24-CV-02234 (DLF), 2024 WL 3823270 (D.D.C. Aug. 13, 2024) (Friedrich, J.)....more

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Novartis Pharms. Corp. V. Accord Healthcare INC.

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Case Name: Novartis Pharms. Corp. v. Accord Healthcare Inc., No. 18-1043-KAJ (D. Del. August 10, 2020) (Jordan, J.)... Drug Product and Patent(s)-in-Suit: Gilenya® (fingolimod); U.S. Patent No. 9,187,405 (“the ’405...more

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Piramal Healthcare US Ltd. v. Novartis Pharms. Corp.

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Case Name: Piramal Healthcare US Ltd. v. Novartis Pharms. Corp., No. 19-12651 (SRC), 2020 U.S. Dist. LEXIS 38849 (D.N.J. Mar. 5, 2020) (Chesler, J.)....more

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Novartis Pharms. Corp. v. Accord Healthcare Inc.

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Case Name: Novartis Pharms. Corp. v. Accord Healthcare Inc., C.A. No. 18-1043-LPS, 2019 U.S. Dist. LEXIS 104969 (D. Del. June 24, 2019) (Stark, J.)....more

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Novartis Pharms. Corp. v. Accord Healthcare Inc.

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Case Name: Novartis Pharms. Corp. v. Accord Healthcare Inc., C.A. No. 18-1043-LPS, 2019 U.S. Dist. LEXIS 101106 (D. Del. June 17, 2019) (Stark, J.)....more

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Novartis Pharma Co. v. West-Ward Pharms. Int’l

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Case Name: Novartis Pharma Co. v. West-Ward Pharms. Int’l, No. 2018-1434, 2019 U.S. App. LEXIS 14122 (Fed. Cir. May 13, 2019) (Circuit Judges Stoll, Plager, and Clevenger presiding; Opinion by Stoll, J.) (Appeal from D. Del.,...more

Mintz - Intellectual Property Viewpoints

District of Delaware Dismisses ANDA Applicant for Lack of Venue under TC Heartland and In re Cray

On June 17, 2019, the United States District Court for the District of Delaware, in Novartis Pharmaceuticals Corp. v. Accord Healthcare Inc., et al., No. 18-cv-01043, held that venue was not proper in Delaware over Mylan...more

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Novartis AG v. Ezra Ventures LLC

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Case Name: Novartis AG v. Ezra Ventures LLC, Fed. Cir. No. 2017-2284, 2018 U.S App. LEXIS 34459 (Fed. Cir. Dec. 7, 2018) (Circuit Judges Moore, Chen, and Hughes presiding; Opinion by Chen, J.) (Appeal from D. Del., Stark,...more

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Novartis Pharms. Corp v. Breckenridge Pharm. Inc.

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Case Name: Novartis Pharms. Corp v. Breckenridge Pharm. Inc., No. 2017-2173, 2018 U.S. App. LEXIS 34462 (Fed. Cir. Dec. 7, 2018) (Circuit Judges Prost, Wallach, and Chen; Opinion by Chen, J.) (Appeal from D. Del., Andrews,...more

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Novartis Pharms. Corp. v. West-Ward Pharms. Int’l Ltd.

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Case Name: Novartis Pharms. Corp. v. West-Ward Pharms. Int’l Ltd., 15-cv-474-RGA, 2017 U.S. Dist. Lexis 205600 (D. Del. Dec. 14, 2017) (Andrews, J.)....more

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Novartis Pharms. Corp. v. Breckenridge Pharm., Inc.

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Case Name: Novartis Pharms. Corp. v. Breckenridge Pharm., Inc., Civ. Nos. 14-1043-RGA, 14-1196-RGA, 14-1289-RGA, 2017 U.S. Dist. LEXIS 46595 (D. Del. Mar. 28, 2017) (Andrews, J.)....more

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Novartis AG v. Ezra Ventures, LLC

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Case Name: Novartis AG v. Ezra Ventures, LLC, Civ. No. 15-0150-LPS, 2016 U.S. Dist. LEXIS 129502 (D. Del. Sept. 22, 2016) (Stark, J.) - Drug Product and Patent(s)-in-Suit: Gilenya® (fingolimod); U.S. Patent No. 5,604,229...more

WilmerHale

Stay Versus Stay: How Litigation Stays Pending IPRs Impact the 30-Month Regulatory Stay in Hatch-Waxman Litigation

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Upon initiation of a patent infringement action between branded and generic pharmaceutical companies, the Hatch-Waxman Act (21 U.S.C. § 355(j)) provides for an automatic 30-month stay of Food and Drug Administration approval...more

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Novartis Pharm. Corp. v. Zydus Noveltech Inc.

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Case Name: Novartis Pharm. Corp. v. Zydus Noveltech Inc., Civ. No. 14-cv-1104-RGA, 2015 U.S. Dist. LEXIS 103708 (D. Del. Aug. 7, 2015) (Andrews, J.) - Drug Product and Patent(s)-in-Suit: Exelon® (rivastigmine); U.S....more

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Novartis Pharm. Corp. v. Noven Pharm., Inc.

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Case Name: Novartis Pharm. Corp. v. Noven Pharm., Inc., Civ. No. 13-527-RGA, 2015 U.S. Dist. LEXIS 115246 (D. Del. Aug. 31, 2015) (Andrews, J.) - Drug Product and Patents-in-Suit: Exelon® (rivastigmine); U.S. Patent No....more

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Novartis Pharms. Corp. v. Watson Labs., Inc.

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Case Name: Novartis Pharms. Corp. v. Watson Labs., Inc., Fed. Cir. Nos. 2014-1799, -1800, 2015-1061, -1062, -1120, -1121, -1141, 2015 U.S. App. LEXIS 8374 (Fed. Cir. May 21, 2015) (Circuit Judges Lourie, Taranto, and Hughes...more

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