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Regulatory Requirements › Patent Litigation › Enforcement Actions

Axinn, Veltrop & Harkrider LLP

Compounding Problems: Recent Decisions on Tirzepatide Highlight Interplay Between FDA Anti-Compounding Enforcement and Private...

Axinn, Veltrop & Harkrider LLP on

Earlier this month, a federal district court denied the Outsourcing Facilities Association’s preliminary injunction motion, which sought to preclude FDA from taking enforcement action against compounded tirzepatide...more

Sheppard Mullin Richter & Hampton LLP

FDA’s Semaglutide Shortage Resolution: Legal Implications and Risks for Compounding Pharmacies

Sheppard Mullin Richter & Hampton LLP on

Last month, the U.S. Food and Drug Administration (the “FDA”) announced in a Declaratory Order the resolution of the shortage of semaglutide injection products Wegovy and Ozempic (the “February Declaratory Order”). On March...more

Knobbe Martens

Federal Circuit’s Lashify Decision Expands “Domestic Industry” at the International Trade Commission

Knobbe Martens on

Lashify, Inc. v. International Trade Commission Before: Prost, Taranto, and Chen. Appeal from ITC Investigation. The Federal Circuit expands the economic prong of the domestic-industry analysis to include domestic spending on...more

Troutman Pepper Locke

New Federal Circuit Ruling Opens the ITC to Many More IP Owners

Troutman Pepper Locke on

In a recent ruling, the U.S. Court of Appeals for the Federal Circuit upended years of settled law and ruled that sales and marketing expenses, by themselves, can be the basis for a finding of domestic industry in an...more

Morrison & Foerster LLP

Federal Circuit Significantly Broadens Qualifying Expenses for Economic Domestic Industry at the ITC

Morrison & Foerster LLP on

On March 5, the Federal Circuit held that sales, marketing, warehousing, quality control, or distribution expenditures may count as “employment of labor or capital” for purposes of satisfying the economic domestic industry...more

Jones Day

The Federal Circuit Expands Scope of Domestic Industry Requirement in Lashify

Jones Day on

In Lashify v. ITC, the Federal Circuit held that the economic prong of the domestic industry requirement, which is a precondition for obtaining International Trade Commission Section 337 relief, can be satisfied with...more

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