Webinar: Orange Book listing sheets under the microscope
Key Considerations for Reshoring U.S. Drug Manufacturing
Drug Pricing Initiatives During the Trump Presidency
Podcast: IP Life Sciences Landscape: Aiding Orange and Purple Book Patent Owners in Developing PTAB Survival Skills
Patent law in Europe: What pharmaceutical companies need to know
EU excessive pricing laws
Polsinelli Podcast - Generic Drugs to Market - What's the Climate in 2014?
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
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
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
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
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
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
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
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
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
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
Last week, the Federal Circuit decided Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., 23-1169 (Fed. Cir. June 25, 2024), a case that spotlighted the issues of skinny labeling and induced infringement for generic...more
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
The Federal Circuit's recently issued decision in the Amarin/Hikma case continues the drama around skinny labeling for generic and biosimilar products, but the panel certainly went out of its way to couch its analysis as an...more
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
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
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
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
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
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
The Federal Trade Commission (“FTC”) has filed an amicus brief in Teva Branded Pharmaceuticals Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC to further the agency’s efforts to promote and protect generic drug...more
ANDA litigation is a high-stakes niche of pharmaceutical law that presents unique challenges not only for lawyers, but also for eDiscovery practitioners. Here’s why: under the Drug Price Competition and Patent Term...more
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
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
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
Hosted by American Conference Institute, the 20th Annual Paragraph IV Disputes & the 40th Anniversary of the Hatch-Waxman Act returns for another exciting year with curated programming that will take a retrospective look at...more