News & Analysis as of

Appeals Prescription Drugs

Wilson Sonsini Goodrich & Rosati

The PTAB Review - August 2024

This issue of The PTAB Review begins by providing an analysis of how institution decisions consider declaration testimony submitted by a patent owner. Next, it summarizes proposed rulemaking from the United States Patent and...more

Akin Gump Strauss Hauer & Feld LLP

Federal Circuit: Reverses Motion to Dismiss—Generic Manufacturer’s Label Combined with its Expansive Public Statements Plausibly...

The Federal Circuit reversed a decision from the District of Delaware dismissing a case for failing to plead induced infringement because the totality of the evidence raised fact questions that could not be resolved on a...more

Foley Hoag LLP

D.C. Circuit Holds 340B Program Does Not Prohibit Drug Manufacturers from Imposing Contract Pharmacy Restrictions

Foley Hoag LLP on

On May 21, 2024, the United States Court of Appeals for the District of Columbia Circuit (“D.C. Circuit”) issued its decision in United Therapeutics Corporation v. Carole Johnson, et al./Novartis Pharmaceuticals v. Carole...more

Bass, Berry & Sims PLC

D.C. Circuit Becomes Second Federal Appeals Court to Allow Restrictions on 340B Contract Pharmacies

Bass, Berry & Sims PLC on

On May 21, the U.S. Court of Appeals for the D.C. Circuit issued a unanimous decision in favor of drug manufacturers, finding that certain manufacturer restrictions on the use of contract pharmacies under the 340B drug...more

McDermott Will & Emery

This Week in 340B: April 30 – May 6, 2024

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

McDermott Will & Emery

Same Product in Different Packaging May Constitute Separate Market for Antitrust Purposes

McDermott Will & Emery on

Addressing an issue of first impression, the US Court of Appeals for the Second Circuit concluded that two medications that contain the same ingredients but are packaged in different forms constitute separate markets for...more

A&O Shearman

Federal Circuit affirms district court finding of no induced or contributory infringement of generic depression drug

A&O Shearman on

In H. Lundbeck A-S v. Lupin Ltd., Case No. 2022-1194 (Fed. Circ. December 7, 2023), Plaintiffs, H. Lundbeck A/S (“Lundbeck”) and Takeda Pharmaceutical Company Ltd., Takeda Pharmaceuticals U.S.A., Inc., Takeda Pharmaceuticals...more

Cozen O'Connor

Notice of Appeal - A quarterly newsletter reviewing Third Circuit opinions impacting white collar defense lawyers - Fall 2023

Cozen O'Connor on

BACKGROUND- A sugar distributor sought to acquire a sugar producer. The district court determined that the relevant product market included distributors as sources of refined sugar, in addition to sugar producers. The...more

ArentFox Schiff

Investigations Newsletter: Supreme Court Again Tightens FCA Intent, But Tricky Questions Linger

ArentFox Schiff on

The US Supreme Court brushed aside novel assertions from two pharmacy retailers on June 1 and ruled unanimously that False Claims Act liability hinges on whether defendants subjectively believed their claims were “false.” In...more

Epstein Becker & Green

Podcast: The Legal Battle Over Mifepristone - Diagnosing Health Care

On April 21, 2023, the U.S. Supreme Court ruled to preserve access to the prescription abortion drug mifepristone. However, while the case continues in the U.S. Court of Appeals for the Fifth Circuit, the future of...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

Kohn, Kohn & Colapinto LLP

The Government’s Ability to Combat Fraud is on the Line in False Claims Act Supreme Court Case

Oral arguments are scheduled for April 18, 2023, in the Supreme Court case combining two Seventh Circuit Court of Appeals cases U.S. ex rel. Schutte v. SuperValu, Inc. (“SuperValu”) and U.S. ex rel. Thomas Proctor v. Safeway,...more

Dechert LLP

Dechert Re:Torts Newsletter - Key Developments in Product Liability and Mass Torts - Issue 2

Dechert LLP on

Federal Appeals Court Dismisses Challenge to Interim PFAS Guidance, Leaving Important Questions Unresolved - A federal appeals court dismissed a challenge to EPA's interim guidance for PFAS levels in drinking water,...more

Foley Hoag LLP

Product Liability Update - January 2023

Foley Hoag LLP on

MASSACHUSETTS - Massachusetts Federal Court Holds State Law Claims Alleging Misleading “Rapid Release” Labeling Of OTC Acetaminophen Tablets Preempted By Federal Food, Drug, And Cosmetic Act, As Tablets’ Dissolution Rate...more

McDermott Will & Emery

This Week in 340B: January 2023 #5

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets on more than 40 340B cases to provide you with a quick...more

Bass, Berry & Sims PLC

Third Circuit Ruling Allows Restrictions on 340B Contract Pharmacies

On January 30, the U.S. Court of Appeals for the Third Circuit issued a unanimous decision in favor of drug manufacturers, finding that manufacturer restrictions on the use of contract pharmacies under the 340B drug pricing...more

Foley Hoag LLP

United States Court of Appeals for the Third Circuit Holds That Drug Manufacturers Are Not Required to Contract with Unlimited...

Foley Hoag LLP on

On January 30, 2023, the United States Court of Appeals for the Third Circuit issued its decision in Sanofi Aventis U.S. LLC v. United States Department of Health and Human Services, enjoining the United States Department of...more

McDermott Will & Emery

Court Rules in Favor of Manufacturers in 340B Contract Pharmacy Case

Earlier today, the US Court of Appeals for the Third Circuit issued a much-anticipated decision in one of the 340B contract pharmacy cases. The decision is a win for drug manufacturers who have sought to restrict access to...more

Bass, Berry & Sims PLC

Ninth Circuit Affirms Broad Scope of False Claims Act’s Public Disclosure Bar

Bass, Berry & Sims PLC on

On August 25, the U.S. Court of Appeals for the Ninth Circuit issued an opinion in which it held that ex parte patent prosecutions by the Patent and Trademark Office (PTO) qualify as “other Federal . . . hearing[s]” under...more

Bass, Berry & Sims PLC

Second Circuit Agrees that the Anti-Kickback Statute Does Not Contain a “Corruption” Element

Bass, Berry & Sims PLC on

On July 25, the U.S. Court of Appeals for the Second Circuit affirmed the U.S. District Court for the Southern District of New York (SDNY) decision granting summary judgment in favor of the Department of Health Human Services...more

Foley Hoag LLP

American Hospital Association et al. v. Becerra et al.: Supreme Court Rejects CMS Policy to Adjust Medicare Part B Payments for...

Foley Hoag LLP on

Earlier this week, the Supreme Court released its opinion in American Hospital Association et al. v. Becerra et al., a case that involves the proper method for the Medicare program to reimburse hospitals for outpatient drugs...more

Robinson+Cole Health Law Diagnosis

Supreme Court Decides in Favor of 340B Hospitals Regarding Medicare Reimbursement Methodology

On June 15, 2022, the U.S. Supreme Court unanimously ruled in favor of “340B” hospitals in a notable statutory interpretation case concerning how the federal Medicare program reimburses hospitals for prescription drugs. The...more

McDermott Will & Emery

HRSA Filings in Genesis Shed Light on Definition of “Patient” for 340B Covered Entities

McDermott Will & Emery on

A recent case before the US Court of Appeals for the Fourth Circuit addressed the issue of which persons qualify as “patients” of a 340B program participating entity (covered entity). Court-ordered filings in ongoing...more

Foley & Lardner LLP

Seventh Circuit Court of Appeals Reiterates Validity of Objective Reasonableness Defense to FCA Claims

Foley & Lardner LLP on

In a 2-1 opinion issued on April 5, the Seventh Circuit Court of Appeals again held that an objectively reasonable interpretation of a relevant statute or regulation precludes the required finding of intent under the False...more

123 Results
 / 
View per page
Page: of 5

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide