News & Analysis as of

Stays Prescription Drugs

Jones Day

Bill Seeks to Restrict 30-Month Stay in Hatch-Waxman Litigation to One Patent

Jones Day on

Senate Bill S. 4878 seeks to force innovator pharmaceutical companies to select a single Orange Book listed patent for the 30-month stay. ...more

Carlton Fields

Fourth Circuit Applies Supreme Court’s Coinbase Decision Outside Context of Arbitration

Carlton Fields on

The Fourth Circuit Court of Appeals recently concluded that the U.S. Supreme Court’s decision in Coinbase Inc. v. Bielski is not limited to interlocutory appeals involving arbitration....more

Robins Kaplan LLP

Novartis Pharms. Corp. v. Hetero USA Inc. - Entresto® (sacubitril/valsartan)

Robins Kaplan LLP on

Case Name: Novartis Pharms. Corp. v. Hetero USA Inc., Civ. No. 20-md-2930-RGA, 2024 WL 3757086 (D. Del. Aug. 12, 2024)....more

Proskauer - Employee Benefits & Executive...

Understanding Recent Litigation on Medication Abortion: A Guide for Health Plan Sponsors

Last Friday, the United States Supreme Court stayed a federal district court order that suspended the U.S. Food and Drug Administration’s approval of the drug mifepristone, which is used as part of a two-drug regimen to...more

BakerHostetler

Supreme Court Orders That Mifepristone Remain Widely Available Pending Appeal in Fifth Circuit

BakerHostetler on

On Friday, April 7, the Northern District of Texas issued a decision blocking the prescribing and dispensing of mifepristone nationwide. The court held that plaintiffs had a substantial likelihood of success on the merits...more

BakerHostetler

Challenge to the FDA's Approval of Abortion Medication

BakerHostetler on

On Friday, April 7, both the Northern District of Texas and the Eastern District of Washington issued decisions impacting the Food and Drug Administration’s (FDA) approval of the abortion drug mifepristone. The Texas decision...more

Goodwin

A Tale of Two Lawsuits: Federal Court in Texas Suspends FDA Approval of Medication Abortion Drug Mifepristone Nationwide, While...

Goodwin on

The US Supreme Court’s June 2022 decision in Dobbs v. Jackson Women’s Health Organization — which overturned Roe v. Wade and nearly 50 years of a federal constitutional right to abortion — has had a tectonic impact. Less than...more

Baker Donelson

Court Again Strikes Down 340B Payment Cuts; Remands Unlawful Payment Rules to HHS to Provide Relief

Baker Donelson on

A federal district court has ruled, for a second time, in favor of hospitals challenging the legality of Medicare payment cuts targeting certain hospitals in the 340B drug pricing program. In a May 6, 2019 decision, the U.S....more

Smart & Biggar

Rx IP Update - January 2018

Smart & Biggar on

Apotex granted damages from contract research organization for delayed FDA approval of two products - Appeal of summary dismissal under PMNOC Regulations: dismissal order stayed...more

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