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Subject Matter Jurisdiction Prescription Drugs

McDermott Will & Emery

This Week in 340B: August 6 – 12, 2024

McDermott Will & Emery on

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

Holland & Knight LLP

Religious Institutions Update: January 2024

Holland & Knight LLP on

Failure to Extend Extracurricular Opportunities to Parochial School Students Violates Free Exercise In Religious Rights Foundation of Pa. v. State College Area Sch. Dist., No. 23-CV-01144, 2023 WL 8359957 (M.D. Pa. Dec. 1,...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

Kramer Levin Naftalis & Frankel LLP

Northern District of Illinois Holds That a Biosimilar Applicant Is Not a Necessary Party to a BPCIA Lawsuit

On Aug. 23, 2021, the U.S. District Court for the Northern District of Illinois denied Alvotech hf.’s motion to dismiss AbbVie’s biosimilar lawsuit involving its blockbuster arthritis drug, Humira. AbbVie Inc. et al. v....more

Faegre Drinker Biddle & Reath LLP

New FDA Policy on Homeopathic Drugs Survives Preliminary Injunction Appeal

The FDA’s recent policy shift regarding homeopathic drugs was recently supported by the D.C. Circuit Court of Appeals in MediNatura v. FDA, No. 20-5341 (D.C. Cir. 2021), when it upheld the denial of a preliminary injunction...more

ArentFox Schiff

Drug Importation Lawsuit Stays Alive, For Now

ArentFox Schiff on

In July 2020, the Trump Administration issued an Executive Order (the EO) directing the Secretary of the Department of Health and Human Services (HHS) to take certain actions and finalize rulemakings designed to “support the...more

Stinson - Government Contracting Matters

D.C. District Court Declines to Follow Narrow, Strict Guidance on Permanent Injunctions Sought by the FTC

The FTC has accused Surescripts, LLC (“Surescripts”) of using improper tactics to sustain its monopoly over services related to electronic prescriptions in violation of the Sherman Act. Surescripts has challenged the D.C....more

Nutter McClennen & Fish LLP

Product Liability 2018 Year in Review

Massachusetts state and federal courts issued a number of important product liability decisions in 2018. The Product Liability practice group at Nutter recently reviewed these cases. Highlighted below are some of the key...more

Sheppard Mullin Richter & Hampton LLP

340B Drug Pricing Program Litigation Update: American Hospital Association, Et Al. v. Azar

On July 17, 2018, the Court of Appeals for the D.C. Circuit upheld the D.C. District Court’s decision to dismiss the lawsuit led by the American Hospital Association, the Association of American Medical Colleges, and...more

Foley & Lardner LLP

Federal Circuit Finds ANDA Jurisdiction Before PIV Certification

Foley & Lardner LLP on

Our first article on Vanda Pharmaceuticals, Inc. v. Aventisub, LLC focused on the subject matter eligibility of the personalized method of treatment claims under 35 USC § 101. Next, we considered how the Fanapt® label was...more

Patterson Belknap Webb & Tyler LLP

Sovereign Immunity for State Plaintiffs in Antitrust Class Actions?

The Third Circuit recently denied a petition for rehearing en banc a panel’s earlier decision in the In re Flonase Antitrust Litigation. In that case, the panel decision addressed the degree to which class settlements can...more

Searcy Denney Scarola Barnhart & Shipley

Judge Kicks Benicar Claims

Benicar is used to treat high blood pressure. In June 2015, numerous plaintiffs sued the manufacturer of Benicar, Daiichi Sankyo, Inc. and Forest Laboratories LLC in the St. Louis Circuit Court. Plaintiffs alleged injuries...more

McDonnell Boehnen Hulbert & Berghoff LLP

Sandoz Inc. v. Amgen Inc. (Fed. Cir. 2014)

Last year, Sandoz filed a declaratory judgment action against Amgen and Roche related to its etanercept biosimilar drug product, which it developed to compete with Amgen's Enbrel® TNF inhibitor. Specifically, Enbrel® is a...more

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