Cases

PRECEDENTIAL UNITED STATES COURT OF APPEALS FOR THE THIRD CIRCUIT ____________ No. 24-1819 ____________ ASTRAZENECA PHARMACEUTICALS LP; ASTRAZENECA AB, Appellants v. SECRETARY UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES; ADMINISTRATOR CENTERS FOR MEDICARE & MEDICAID SERVICES _______

598 F.Supp.2d 1271 (2009) David HALLER, Plaintiff, v. ASTRAZENECA PHARMACEUTICALS LP, et al., Defendants. Case No. 6:07-cv-15733-Orl-22DAB. United States District Court, M.D. Florida, Orlando Division. February 6, 2009. *1272 F. Kenneth Bailey, Jr., Fletcher Vines Trammell, K. Camp Bailey, Michael W. Perrin, Robert W. Cowan, Bail

United States Court of Appeals FOR THE DISTRICT OF COLUMBIA CIRCUIT Argued October 24, 2022 Decided May 21, 2024 No. 21-5299 NOVARTIS PHARMACEUTICALS CORPORATION, APPELLEE v. CAROLE JOHNSON, IN HER OFFICIAL CAPACITY AS ADMINISTRATOR, HEALTH RESOURCES AND SERVICE ADMINISTRATION AND XAVIER BECERRA, IN HIS OFFICIAL CAPACITY AS SECRETARY, UNITED STATES DEPARTMENT OF

United States Court of Appeals FOR THE DISTRICT OF COLUMBIA CIRCUIT Argued April 17, 2025 Decided September 26, 2025 No. 24-5235 NOVARTIS PHARMACEUTICALS CORPORATION, APPELLANT v. ROBERT F. KENNEDY, JR., IN HIS OFFICIAL CAPACITY AS SECRETARY OF HEALTH AND HUMAN SERVICES, ET AL., APPELLEES Appeal from the United States District Court

*1249MEMORANDUM OPINION AND ORDER VIRGINIA EMERSON HOPKINS, United States District Judge I. INTRODUCTION This case comes before the court on Defendant Novartis Pharmaceutical Corporation (“Novartis” or “NPC”)’s Motions To Strike Expert Testimony. Novartis has moved to exclude the testimony of the following experts:

USCA4 Appeal: 25-1056 Doc: 126 Filed: 03/31/2026 Pg: 1 of 70 PUBLISHED UNITED STATES COURT OF APPEALS FOR THE FOURTH CIRCUIT No. 25-1054 PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA, Plaintiff – Appellee, v. JOHN B. MCCUSKEY, in his offic

GRIFFITH, Circuit Judge: In this case, Spectrum Pharmaceuticals claimed that the Food and Drug Administration’s approval of a cancer drug violated *1064 Spectrum’s exclusive marketing rights. The district court granted summary judgment against Spectrum, and we affirm. I

MEMORANDUM OPINION STARK, District Judge: I. INTRODUCTION Plaintiffs AstraZeneca UK Limited, IPR Pharmaceuticals, Inc., AstraZeneca AB, Shionogi Seiyaku Kabushiki Kaisha, and the Brigham and Women’s Hospital, Inc. (collectively, “AstraZeneca”) filed a complaint against Defendant Watson Laboratories, Inc. (“Watson”) on October 26, 2010. (D.I. 1) AstraZeneca alleges that Watson’

United States Court of Appeals FOR THE DISTRICT OF COLUMBIA CIRCUIT Argued May 5, 2026 Decided August 18, 2026 No. 25-5425 TEVA PHARMACEUTICALS USA, INC., ET AL., APPELLANTS v. ROBERT F. KENNEDY, JR., IN HIS OFFICIAL CAPACITY AS SECRETARY OF HEALTH AND HUMAN SERVICES AND MEHMET OZ, IN HIS OFFICIAL CAPACITY AS ADMINISTRATOR OF THE CENTERS FOR MEDICARE & MEDICAID SERVICES,

Cite as 2014 Ark. 124 SUPREME COURT OF ARKANSAS No. CV-12-1058 ORTHO-MCNEIL-JANSSEN Opinion Delivered March 20, 2014 PHARMACEUTICALS, INC. f/k/a JANSSEN PHARMACEUTICA, INC., APPEAL FROM THE PULASKI AND/OR JANSSEN, LP; AND COUNTY CIRCUIT COURT JOHNSON & JOHNSON, INC. [NO. CV2007-15345]

UNDER SEAL MEMORANDUM OPINION KETANJI BROWN JACKSON, United States District Judge Table Of Contents I.BACKGROUND ... 69 A. Colchicine: A Drug For The Treatment Of Gout ... 69 B. FDA’s Drug Approval Framework: The Hatch-Waxman Amendments ... 71 1. NDAs, ANDAs, and 505(b)(2) NDAs ...71

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA TEVA PHARMACEUTICALS USA, INC., Plaintiff, Civil Action No. 25 - 113 (SLS) v. Judge Sparkle L. Sooknanan ROBERT F. KENNEDY, et al.,1 Defendants. MEMORANDUM OPINION This ca

726 F.Supp.2d 778 (2010) FLEXSYS AMERICA LP, Plaintiff, v. KUMHO TIRE U.S.A., INC., et al., Defendants. Case No. 5:05CV156. United States District Court, N.D. Ohio, Eastern Division. July 15, 2010. *781 John C. Fairweather, Amanda M. Leffler, Lisa S. Delgrosso, Brouse McDowell, David C. Mine, Akron, OH, Robert M. Masters, Bhaskar

663 F.Supp.2d 856 (2009) Andrew GILMORE and Deidre Booth, Plaintiffs, v. DJO INCORPORATED, a Delaware corporation; DJO LLC, a Delaware corporation; McKinley Medical, LLC, a Colorado corporation; Moog, Inc., a New York corporation; Curlin Medical Inc., a Delaware corporation; and AstraZeneca Pharmaceuticals LP, AstraZeneca LP, Zeneca Holdings, Inc., Delaware corporations, Defendants. No. 2:08-CV-1252-HRH.

341 F.Supp.2d 1057 (2004) State of WISCONSIN, Plaintiff, v. ABBOTT LABORATORIES, AMGEN, INC., Astrazeneca Pharmaceuticals, LP, Astrazeneca, LP, Aventis Pharmaceuticals, Inc., Aventis Behring, LLC., Baxter International, Inc., Bayer Corporation, Boehringer Ingelheim Corporation, Bristol-Myers Squibb Co., Dey, Inc., Fujisawa Healthcare, Inc., Gensia Sicor Pharmaceuticals, Inc., Glaxosmithkline, Inc., Johnson & Johnson, Inc., Pfizer, Inc., Pharm

MEMORANDUM OF DECISION ZOBEL, SENIOR UNITED STATES DISTRICT JUDGE In 2015, Sinotau Pharmaceutical Group (“Sinotau”) and Navidea Biopharmaceuti-cals, Inc. (“Navidea”), executed a Binding Term Sheet involving an exclusive license to NAV4694, a pharmaceutical imaging agent. In this lawsuit, Sinotau alleges that Navidea breached its contractual obligations to Sinotau by refusing to abide by the parties’ agreemen

MEMORANDUM AND ORDER SARIS, District Judge. I. INTRODUCTION Defendants have moved to dismiss the Amended Complaint filed by the County of Suffolk in New York in this multi-district litigation involving allegations of fraud against various pharmaceutical companies.1 Suffolk alleges that Defendant pharmaceutical manufacturers have fraudulently inflated th

MEMORANDUM AND ORDER SARIS, District Judge. I. INTRODUCTION The question raised in these related remand motions is whether a new Supreme Court decision can be an “order or other paper from which it may first be ascertained” that a case is removable under 28 U.S.C. § 1446(b). Plaintiffs Illinois, Kentucky and New York brought these seven actions in various state courts alleging t

*194MEMORANDUM AND ORDER SARIS, District Judge. I. INTRODUCTION The States of Montana and Nevada allege that pharmaceutical manufacturers fraudulently overstate the published “average wholesale prices” (“AWP’s”) of many of their prescription drugs to the detriment of the States, which reimburse providers based on AWP’s, and their ci

RANDOLPH D. MOSS, United States District Judge To encourage pharmaceutical companies to study the safety and effectiveness of pediatric uses of drugs approved for adults, the Federal Food, Drug, and Cosmetic Act ("FFDCA") grants six months of "pediatric exclusivity" to the sponsor of a brand-name drug if the sponsor conducts studies that "fairly respond" to a "written request" from the Food and Drug Administration ("FDA"). 21 U.S.C