News & Analysis as of

Federal Food Drug and Cosmetic Act (FFDCA) International Trade Commission (ITC)

Wolf, Greenfield & Sacks, P.C.

Top Five Recent Developments in Section 337 Litigation

2023 was an exciting year for Section 337 litigation at the ITC and 2024 is off to an equally interesting start. In this article, Libbie DiMarco reviews five of the most interesting recent developments in Section 337...more

Axinn, Veltrop & Harkrider LLP

FDA After Chevron

Under the Supreme Court's Chevron doctrine, courts will defer to a federal agency's interpretation of an ambiguous statute unless that interpretation is unreasonable. Chevron U.S.A. Inc. v. Natural Resources Defense Council,...more

McDermott Will & Emery

Nothing Fishy Here: No Private Right of Action Precludes § 337 Unfair Competition Claim

McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit affirmed an International Trade Commission (ITC) decision not to institute an investigation where the underlying statutory scheme precluded a private right of action. Amarin...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

Jones Day

Federal Circuit Asserts Jurisdiction to Review ITC’s Non-Institution Decision

Jones Day on

In a long-awaited decision, a split panel of the Federal Circuit confirmed on May 1, 2019, that the Court has jurisdiction to review the ITC’s decision not to institute an investigation. Amarin Pharma, Inc. v. Int’l Trade...more

Jones Day

ITC Institutes Investigation Based on Allegation of Drug Sales Without FDA Approval

Jones Day on

Normally, it is the FDA that monitors the improper distribution of drugs. But, as it turns out, the International Trade Commission (“ITC”) might be able to enter the fray too. On April 18, 2018, the ITC issued a notice...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

Hogan Lovells

Hogan Lovells ITC Section 337 Monthly Highlights

Hogan Lovells on

The latest news round-up from our Hogan Lovells ITC Section 337 practice, including a new section featuring "tips from the bench" by former ITC Judge Theodore (Ted) R. Essex. ...more

Foley & Lardner LLP

Advancing New Claims Under the Lanham Act

Foley & Lardner LLP on

Implementing unique litigation tactics, on June 15, 2016, Foley & Larder LLP filed a complaint under Section 337 of the Tariff Act at the International Trade Commission (“ITC”) on behalf of Par Pharmaceutical and related...more

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