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Food and Drug Administration (FDA) International Trade Commission (ITC) Pharmaceutical Industry

Ropes & Gray LLP

[Podcast] Non-binding Guidance | Talkin’ Trade: Trends in False Advertising and Related Competitor Disputes Involving...

Ropes & Gray LLP on

On this special collaborative episode of Ropes & Gray's Non-binding Guidance and Talkin’ Trade podcast series, life sciences regulatory and compliance partner Josh Oyster is joined by intellectual property litigation partner...more

Foley & Lardner LLP

GLP-1 Receptor Agonists: Drug Litigation Overview and Trends

Foley & Lardner LLP on

The recent uptick and rise in popularity of GLP-1 drugs for addressing weight loss and obesity has led to an increase in U.S. litigation involving this class of drugs. Over the past few years, litigation has focused on a wide...more

ArentFox Schiff

As the (Customs and Trade) World Turns: November 2024

ArentFox Schiff on

Welcome to the November 2024 issue of “As the (Customs and Trade) World Turns,” our monthly newsletter where we compile essential updates from the customs and trade world over the past month. We bring you the most recent and...more

American Conference Institute (ACI)

[Event] 13th Summit on Biosimilars & Innovator Biologics - June 28th - 29th, Boston, MA

This June, join the “who’s who” of the biosimilars and innovator biologics industries as they gather in Boston for ACI’s 13th Annual Summit on Biosimilars & Innovator Biologics....more

Pillsbury Winthrop Shaw Pittman LLP

Despite Amarin, ITC May Be Right Prescription For Pharma

Foreign-made drugs, nutritional supplements and medical devices imported into the United States with false or misleading labeling or designed to look like an established competing product in violation of the Lanham Act could...more

Mintz - Intellectual Property Viewpoints

Federal Circuit Affirms that the ITC Cannot Investigate an FDCA Violation without the FDA’s Say-So

In Amarin Pharma, Inc. v. Int’l Trade Comm’n (18-1247), the Federal Circuit affirmed the International Trade Commission’s (“ITC”) finding that Amarin’s false advertising claim under § 43(a) of the Lanham Act was precluded by...more

McDonnell Boehnen Hulbert & Berghoff LLP

Amarin Pharma, Inc. v. ITC (Fed. Cir. 2019)

The International Trade Commission, although having limited jurisdiction, can be a very powerful ally to U.S. industries facing foreign competition. The Commission's power to interdict importation of infringing articles can...more

Akin Gump Strauss Hauer & Feld LLP

The Federal Circuit Finds Jurisdiction over the ITC’s Decision Not to Institute an Investigation Under Section 337 and Explains...

• The International Trade Commission (ITC) can decline to institute an investigation when a complaint fails to state a cognizable claim under Section 337 of the Tariff Act, 19 U.S.C. § 1337 (“Section 337”). • A decision...more

American Conference Institute (ACI)

[Event] Biosimilars Summit – Legal, Regulatory, and Commercial Strategies – June 24th-25th, New York City, NY

2019 marks the 9th anniversary of the Biologics Price Competition and Innovation Act (BPCIA). ACI has been with you from the introduction of the first House and Senate bills through to the actual signing of the law. As we...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin | December 2017

Sen. Hatch Introduces New Bill Regulating Cosmetic Safety - Sen. Orrin Hatch (R-Utah) has introduced legislation aiming to modernize cosmetics regulation, proposing amendments to the Federal Food, Drug and Cosmetic Act...more

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