News & Analysis as of

Food and Drug Administration (FDA) Pharmaceutical Patents Patent-in-Suit

Arnall Golden Gregory LLP

A Potential Poison Pill for Dosage Claims

On August 14, 2024, the US District Court for the District of Delaware entered final judgment in Wyeth—a patent infringement case relating to pharmaceuticals for treating non-small cell lung cancer (“NSCLC”)—vacating a jury...more

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Pharmacyclics LLC v. Alvogen Pine Brook LLC - Imbruvica® (Ibrutinib)

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Case Name: Pharmacyclics LLC v. Alvogen Pine Brook LLC, Civ. No. 19-434-CFC, 2024 WL 1885677 (D. Del. Apr. 30, 2024) (Connolly, J.) - Drug Product and Patent(s)-in-Suit: Imbruvica® (ibrutinib); U.S. Patents Nos. 8,008,309...more

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Teva Branded Pharm. Products R&D, Inc. v. Amneal Pharms. of NY, LLC - ProAir® HFA (Albuterol Sulfate)

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Case Name: Teva Branded Pharm. Products R&D, Inc. v. Amneal Pharms. of NY, LLC, Civ. No. 23-20964 (SRC), 2024 WL 2923018 (D.N.J. June 10, 2024) (Chesler, J.)....more

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Janssen Pharms., Inc. v. Tolmar, Inc. - Invega Sustenna® (Paliperidone Palmitate)

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Case Name: Janssen Pharms., Inc. v. Tolmar, Inc., Civ. No. 21-1784-WCB, 2024 WL 2972832 (D. Del. June 13, 2024) (Bryson, J.) - Drug Product and Patent(s)-in-Suit: Invega Sustenna® (paliperidone palmitate); U.S. Patent No....more

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Janssen Pharms., Inc. v. Teva Pharms. USA, Inc. - Invega Sustenna® (Paliperidone Palmitate)

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Case Name: Janssen Pharms., Inc. v. Teva Pharms. USA, Inc., No. 2022-1258, 2022-1307, 2024 WL 1355733 (Fed. Cir. Apr. 1, 2024) (Circuit Judges Dyk, Prost, and Hughes presiding; Opinion by Prost, J.) (Appeal from D.N.J.,...more

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Salix Pharms., Ltd. v. Norwich Pharms. Inc. - Xifaxan® (Rifaximin)

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Case Name: Salix Pharms., Ltd. v. Norwich Pharms. Inc., No. 2022-2153, 2023-1952, 2024 WL 1561195 (Fed. Cir. Apr. 11, 2024) (Circuit Judges Lourie, Chen, and Cunningham presiding; Opinion by Lourie, J.; Dissenting-in-part...more

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Amarin Pharma, Inc. v. Hikma Pharms. USA Inc. - Vascepa® (Icosapent Ethyl)

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Case Name: Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., No. 2023-1169, 2024 WL 3152087 (Fed. Cir. June 25, 2024) (Circuit Judges Moore, Lourie, and Albright presiding; Opinion by Lourie, J.) (Appeal from D. Del., Andrews,...more

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Mylan Pharms. Inc. v. Bayer Intellectual Property GmbH, C.A. - Xarelto® (Rivaroxaban)

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Case Name: Mylan Pharms. Inc. v. Bayer Intellectual Property GmbH, C.A. No. 23-556-RGA, 2024 WL 359468 (D. Del. Jan. 31, 2024) (Hatcher, M.J.) - Drug Product and Patent(s)-in-Suit: Xarelto® (rivaroxaban); U.S. Patents Nos....more

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Novartis Pharms. Corp. v. Mylan Pharms. Inc. - Entresto® (Sacubitril/Valsartan)

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Case Name: Novartis Pharms. Corp. v. Mylan Pharms. Inc., Civ. No. 19-cv-201, 2024 WL 384929 (N.D.W.V. Jan. 31, 2024) (Kleeh, J.) - Drug Product and Patent(s)-in-Suit: Entresto® (sacubitril/valsartan); U.S. Patents Nos....more

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Endo Par Innovation Co. v. BPI Labs, LLC - Adrenalin® (Epinephrine)

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Case Name: Endo Par Innovation Co. v. BPI Labs, LLC, C.A. No. 8:23-cv-1953-WFJ-TGW, 2024 WL 730478 (M.D. Fla. Feb. 22, 2024) (Jung, J.) - Drug Product and Patent(s)-in-Suit: Adrenalin® (epinephrine); U.S. Patents Nos....more

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Genentech, Inc. v. Sandoz, Inc. - Esbriet® (Pirfenidone)

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Case Name: Genentech, Inc. v. Sandoz, Inc., Civ No. 23-4085 (JXN)(LDW), 2024 WL 939692 (D.N.J. Mar. 5, 2024) (Wettre, M.J.) - Drug Product and Patent(s)-in-Suit: Esbriet® (pirfenidone); U.S. Patent No. 10,118,637 (“the ’637...more

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Bausch Health Ireland Ltd. v. Padagis Israel Pharms. Ltd. - Arazlo® (Tazarotene)

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Case Name: Bausch Health Ireland Ltd. v. Padagis Israel Pharms. Ltd., Civ. No. 22-4248 (SRC), 2023 WL 7131809 (D.N.J. Oct. 30, 2023) (Chesler, J.) - Drug Product and Patent(s)-in-Suit: Arazlo® (tazarotene); U.S. Patent Nos....more

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Norwich Pharms., Inc. v. Becerra - Xifaxan® (Rifaximin)

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Case Name: Norwich Pharms., Inc. v. Becerra, Civ. No. 23-1611 (RDM), 2023 WL 7174558 (D.D.C. Nov. 1, 2023) (Moss, J.) - Drug Product and Patent(s)-in-Suit: Xifaxan® (rifaximin); U.S. Patents Nos. 7,612,199 (“the ’199...more

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Eisai R&D Mgmt. Co., Ltd. v. Dr Reddy’s Labs., Inc. - Halaven® (Eribulin Mesylate)

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Case Name: Eisai R&D Mgmt. Co., Ltd. v. Dr Reddy’s Labs., Inc., No. 22-CV-5950, 2023 WL 7331272 (D.N.J. Nov. 7, 2023) (Chesler, J.) - Drug Product and Patent(s)-in-Suit: Halaven® (eribulin mesylate); U.S. Patents Nos....more

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Acadia Pharms. Inc. v. Aurobindo Pharma Ltd. - Nuplazid® (Pimavanserin Tartrate)

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Case Name: Acadia Pharms. Inc. v. Aurobindo Pharma Ltd., No. 20-985-GBW, 2023 WL 8622048 (D. Del. Dec. 13, 2023) (Williams, J.) - Drug Product and Patent(s)-in-Suit: Nuplazid® (pimavanserin tartrate); U.S. Patent No....more

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Corcept Therapeutics, Inc. v. Teva Pharms. USA, Inc. - Korlym® (Mifepristone)

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Case Name: Corcept Therapeutics, Inc. v. Teva Pharms. USA, Inc., No. 18-CV-03632 (RMB/LDW), 2023 WL 9017081 (D.N.J. Dec. 29, 2023) (Bumb, J.) - Drug Product and Patent(s)-in-Suit: Korlym® (mifepristone); U.S. Patents Nos....more

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Actelion Pharms. Ltd. v. Mylan Pharms. Inc. - Veletri® (Epoprostenol)

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Case Name: Actelion Pharms. Ltd. v. Mylan Pharms. Inc., No. 2022-1889, 2023 WL 7289417 (Fed. Cir. Nov. 6, 2023) (Circuit Judges Reyna, Stoll, and Stark presiding; Opinion by Stoll, J.) (Appeal from N.D.W.V., Bailey, J.) - ...more

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H. Lundbeck A/S v. Lupin Ltd. - Trintellix® (Vortioxetine)

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Case Name: H. Lundbeck A/S v. Lupin Ltd., 87 F.4th 1361, 2023 WL 8462010 (Fed. Cir. Dec. 7, 2023) (Circuit Judges Dyk, Prost, and Hughes presiding; Opinion by Dyk, J.) - Drug Product and Patent(s)-in-Suit: Trintellix®...more

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Novartis Pharms. Corp. v. Mylan Pharms. Inc. - Entresto® (Sacubitril / Valsartan)

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Case Name: Novartis Pharms. Corp. v. Mylan Pharms. Inc., Civ. No. 19-cv-201, 2023 WL 4375445 (N.D.W.V. July 6, 2023) (Kleeh, J.) - Drug Product and Patent(s)-in-Suit: Entresto® (sacubitril / valsartan); U.S. Patents Nos....more

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In re Entresto (Sacubitril/Valsartan) Patent Litigation - Entresto® (Sacubitril/Valsartan)

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Case Name: In re Entresto (Sacubitril/Valsartan) Patent Litigation, C.A. Nos. 19-1979, 19-2021, 19-2053, 2023 WL 4405464 (D. Del. July 7, 2023) (Andrews, J.) - Drug Product and Patent(s)-in-Suit: Entresto®...more

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Bristol-Myers Squibb Co. v. Xspray Pharma AB Sprycel®/Dasynoc® (Dasatinib)

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Case Name: Bristol-Myers Squibb Co. v. Xspray Pharma AB , No. CV 22-964 (RMB/MJS), 2023 WL 3354261 (D.N.J. Apr. 25, 2023) (Bumb, J.) Drug Product and Patent(s)-in-Suit: Sprycel®/Dasynoc® (dasatinib) U.S. Patents Nos....more

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Jazz Pharms., Inc. v. Avadel CNS Pharms. Xyrem® (Sodium Oxybate)

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Case Name: Jazz Pharms., Inc. v. Avadel CNS Pharms., No. 2023-1186, 2023 WL 2198640 (Fed. Cir. Feb. 24, 2023) (Circuit Judges Lourie, Reyna, and Taranto presiding; Opinion by Lourie, J.) (Appeal from D. Del., Williams, J.)  ...more

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Azurity Pharms., Inc. v. Alkem Labs. Ltd. - Epaned® (Enalapril Maleate)

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Case Name: Azurity Pharms., Inc. v. Alkem Labs. Ltd., No. 19-cv-2100, 2023 WL 1927613 (D. Del. Feb. 10, 2023) (Goldberg, J.) - Drug Product and Patents-in-Suit: Epaned® (enalapril maleate); U.S. Patents Nos. 10,786,482...more

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Sanofi-Aventis U.S. LLC v. Apotex Corp. Jevtana® (Cabazitaxel)

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Case Name: Sanofi-Aventis U.S. LLC v. Apotex Corp., C.A. No. 20-cv-804-RGA, 2022 WL 2643532 (D. Del. July 8, 2022) (Hall, J.)  Drug Product and Patent(s)-in-Suit: Jevtana® (cabazitaxel); U.S. Patents Nos. 8,927,592 (“the ’592...more

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Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc. Narcan® (Naloxone)

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Case Name: Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc., Case No. 2020-2106, 25 F.4th 1354 (Fed. Cir. Feb. 10, 2022) (Circuit Judges Newman, Prost, and Stoll presiding; Opinion by Stoll, J.; Dissenting Opinion by...more

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