News & Analysis as of

Patent Infringement Intellectual Property Protection Generic Drugs

Robins Kaplan LLP

Astellas Pharma, Inc. v. Sandoz Inc. - Myrbetriq® (mirabegron)

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Case Name: Astellas Pharma, Inc. v. Sandoz Inc., Nos. 2023-2032, 2023-2063, 2023-2089, 2024 WL 4219374 (Fed. Cir. Sept. 18, 2024) (Circuit Judges Lourie, Prost, and Reyna presiding; Opinion by Lourie, J.) (Appeal from D....more

Alston & Bird

Patent Case Summaries | Week Ending September 20, 2024

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Vascular Solutions LLC, et al. v. Medtronic, Inc., et al., No. 2024-1398 (Fed. Cir. (D. Minn.) Sept. 16, 2024). Opinion by Mazzant (sitting by designation), joined by Moore and Prost....more

DLA Piper

Amarin v. Hikma: Defining the Limits of Protection That Skinny Labels Afford

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On August 22, 2024, Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals, PLC (collectively Hikma), filed a petition for rehearing en banc, asking the US Court of Appeals for the Federal Circuit to reconsider its recent...more

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Generically Speaking: A Hatch-Waxman Litigation Bulletin Second Quarter - New ANDA Cases

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This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to the Hatch-Waxman Act. It also includes the same information for proceedings...more

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Generically Speaking: A Hatch-Waxman Litigation Bulletin Second Quarter - Generic Launches

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This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....more

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Generically Speaking: A Hatch-Waxman Litigation Bulletin Second Quarter - ANDA Litigation Settlements

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This chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant to the Hatch-Waxman Act....more

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Generically Speaking: A Hatch-Waxman Litigation Bulletin Second Quarter - ANDA Approvals

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This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA....more

Troutman Pepper

Federal Circuit Decision Clarifies Obviousness-Type Double Patenting and Patent Term Adjustments in Allergan v. MSN Laboratories

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On August 13, the Federal Circuit issued a precedential ruling in Allergan v. MSN Laboratories (Case No. 24-1061). This decision reversed the District of Delaware's application of the Federal Circuit precedent in In re:...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

McDonnell Boehnen Hulbert & Berghoff LLP

Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc. (Fed. Cir. 2024)

The Federal Circuit once again had an opportunity to opine on the extent of behavior by a generic drugmaker who opts to accept a "section viii carve-out" in its FDA approval (resulting in a so-called "skinny label) on...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

Jones Day

Federal Circuit Revives Induced Infringement Claims Despite "Skinny Label" Carve-Out

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The Situation: The Hatch-Waxman Act allows generic drug manufacturers to "carve out" a brand's patented indications from their proposed labeling. Generic manufacturers often rely on these so-called "skinny labels" to try to...more

Alston & Bird

Patent Case Summaries | Week Ending June 28, 2024

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Amarin Pharma, Inc., et al. v. Hikma Pharmaceuticals USA Inc., et al., No. 2023-1169 (Fed. Cir. (D. Del.) June 25, 2024). Opinion by Lourie, joined by Moore and Albright (sitting by designation). Amarin markets and sells...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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Janssen Pharms., Inc. v. Tolmar, Inc. - Invega Sustenna® (Paliperidone Extended-Release Suspension)

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Case Name: Janssen Pharms., Inc. v. Tolmar, Inc., Civ. No. 21-1784-WCB, 2024 WL 834762 (D. Del. Feb. 26, 2024) (Bryson, J.)  - Drug Product and Patent(s)-in-Suit: Invega Sustenna® (paliperidone extended-release suspension);...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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UCB, Inc. v. Mylan Techs. Inc. - Neupro® (Rotigotine)

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Case Name: UCB, Inc. v. Mylan Techs. Inc., Civ. No. 22-cv-216 (D. Vt. Mar. 8, 2024) (Reiss, J.) - Drug Product and Patent(s)-in-Suit: Neupro® (rotigotine); U.S. Patents Nos. 8,246,979 (“the ’979 patent”) and 8,246,980 (“the...more

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Mallinckrodt plc v. Airgas Therapeutics LLC - INOmax® (Nitric Oxide)

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Case Name: Mallinckrodt plc v. Airgas Therapeutics LLC, Civ No. 22-1648-RGA, 2024 WL 1251260 (D. Del. Mar. 22, 2024) (Andrews, J.) - Drug Product and Patent(s)-in-Suit: INOmax® (nitric oxide); U.S. Patents Nos. 9,770,570...more

Alston & Bird

Patent Case Summaries | Week Ending April 5, 2024

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Janssen Pharmaceuticals, Inc., et al. v. Teva Pharmaceuticals USA, Inc., et al., Nos. 2022-1258, -1307 (Fed. Cir. (D.N.J.) Apr. 1, 2024). Opinion by Prost, joined by Dyk and Hughes....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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