News & Analysis as of

Patent Infringement Novartis Abbreviated New Drug Application (ANDA)

Carlton Fields

Court Finds MSN Does Not Infringe Novartis’s Patent and Clears the Way for Generic Entresto

Carlton Fields on

In In re Entresto (Sacubitril/Valsartan) Patent Litigation, Judge Richard G. Andrews of the U.S. District Court for the District of Delaware granted MSN Pharmaceuticals Inc. a victory on noninfringement of U.S. Patent No....more

BakerHostetler

A Later-Discovered Improvement to an Invention Cannot Be Used To Reach Back and Invalidate an Earlier-Filed Patent

BakerHostetler on

Novartis markets and sells a combination therapy of valsartan and sacubitril under the brand name Entresto® for the treatment of various forms of heart failure. MSN submitted an Abbreviated New Drug Application seeking...more

Robins Kaplan LLP

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

Robins Kaplan LLP

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

Robins Kaplan LLP

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...

Fish & Richardson on

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

Robins Kaplan LLP

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

McDonnell Boehnen Hulbert & Berghoff LLP

Life Sciences Court Report - January 2020

About Life Sciences Court Report:  We will periodically report on recently filed biotech and pharma litigation. ...more

Robins Kaplan LLP

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

Robins Kaplan LLP

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

Knobbe Martens

Novartis AG v. Ezra Ventures LLC

Knobbe Martens on

Federal Circuit Summary - Before Moore, Chen, and Hughes. Appeal from the United States District Court for the District of Delaware. Summary: Obviousness-type double patenting does not invalidate an otherwise validly...more

Robins Kaplan LLP

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

Robins Kaplan LLP

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

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - September 2016

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Horizon Therapeutics, Inc. v. Lupin Ltd. et al. 1:16-cv-04438; filed July 21, 2016 in the District Court of New Jersey -...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - May 2016 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Ventana Medical Systems, Inc. v. Hologic, Inc. 3:16-cv-02703; filed May 18, 2016 in the Northern District of California. ...more

WilmerHale

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

WilmerHale on

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

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - March 2016 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Unimed Pharmaceuticals LLC et al. v. Lupin Atlantis Holdings SA et al. 1:15-cv-00904; filed October 9, 2015 in the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - February 2016 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Salix Pharmaceuticals, Inc. et al. v. Apotex, Inc. et al. 1:15-cv-00880; filed September 30, 2015 in the District Court...more

Robins Kaplan LLP

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

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - August 2015

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Millennium Pharmaceuticals Inc. v. Dr. Reddys Laboratories, Ltd. et al. 1:15-cv-00539; filed June 25, 2015 in the District...more

Robins Kaplan LLP

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

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - July 2015 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Alcon Research Ltd. v. Akorn Inc. 1:15-cv-00474; filed June 11, 2015 in the District Court of Delaware - ...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - June 2015 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Mayne Pharma International Pty Ltd. v. Merck & Co., Inc., et al. 1:15-cv-00438; filed May 29, 2015 in the District Court...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - September 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. UCB Inc. et al. v. Watson Laboratories Inc. (NV) et al. 1:14-cv-01083; filed August 21, 2014 in the District Court of...more

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