News & Analysis as of

Section 337 Food and Drug Administration (FDA) International Trade Commission (ITC)

American Conference Institute (ACI)

[Event] 16th Annual Practitioners’ Think Tank on ITC Litigation & Enforcement - May 29th - 30th, Washington, DC

Returning to Washington in May, ACI’s 16th Annual Practitioners’ Think Tank on ITC Litigation & Enforcement is your opportunity to learn from and network with key members of the ITC Bench, senior ITC Attorneys and leading...more

Morrison & Foerster LLP - Federal Circuitry

Last Week In The Federal Circuit (March 27 – March 31): Consulting The Federal Circuit On Statutory Interpretation

While last week may have been spring break for many of our readers, the Federal Circuit didn’t take the week off. It still issued several interesting decisions, including our case of the week this week—which discusses the...more

Fish & Richardson

ITC Monthly Wrap-Up: February 2023

Fish & Richardson on

Over the past 10 years, the Commission’s 100-day program has evolved from a pilot program launched in 2013 to codification under Rule 210.10(b)(3). Rule 210.10(b)(3) authorizes the Commission to order the Administrative Law...more

Morrison & Foerster LLP

“Line-by-Line” vs. “As-a-Whole” Analysis: Clarifying the Mere Importer and Domestic Industry Analysis

The International Trade Commission’s (“Commission”) majority and dissenting opinions in Certain In Vitro Fertilization Products, Components Thereof, and Products Containing the Same (“In Vitro Fertilization”) illustrate two...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

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

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Section 337’s Potential for Defending Biologics Market Share Against Biosimilars

Enforcement of biologic patents at the United States International Trade Commission under Section 337 provides certainty and tactical advantages to patent holders that are unavailable in district court under the BPCIA. For...more

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