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Patents Hatch-Waxman Novartis

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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

Fish & Richardson

District of Delaware Finds Non-Orange Book-Listed Patents Subject to the Same Pleading Standard as Listed Patents in ANDA...

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As part of the Hatch-Waxman Act, given the lack of information on the allegedly infringing product, courts have found that patentees can satisfy the pleading requirements of Twombly/Iqbal without having access to the accused...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

Jones Day

Lead Compound Analysis Not Always Applicable

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The Situation: In a Hatch-Waxman litigation, a district court determined that the claims covering a method of using the drug everolimus to treat kidney cancers were not obvious. The court found a motivation to "pursue"...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

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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

Proskauer - New England IP Blog

Biosimilars Update

Novartis came one step closer to becoming the first company to offer a biosimilar drug for sale in the United States. Last month, an independent panel voted 14-0 to recommend FDA approval of Sandoz’s (Novartis’ generics...more

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