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Federal Circuit Holds Generic’s Hatch-Waxman Litigation Expenses Deductible

A March 21 Federal Circuit decision in Actavis Laboratories FL, Inc. v. United States, No. 23-1320 (Fed. Cir. Mar. 21, 2025) marked a victory for generic drug developers, affirming that legal expenses incurred defending...more

Federal Circuit Clarifies That “Quantitatively Small” Investments Can Establish Significant and Substantial Investment in Domestic...

On Friday, Feb. 7, 2025, the Federal Circuit issued a precedential opinion in Wuhan Healthgen Biotech. Corp. v. U.S. Int’l Trade Comm’n, No. 23-1389, 2025 WL 420819 (Fed. Cir. 2025). The three-judge panel, consisting of Chief...more

USITC Commissioner Series: Commissioner Schmidtlein is Stepping Down, Which Could Lead to More Tailored Exclusion Orders

On Thursday, January 16, 2025, the U.S. International Trade Commission (ITC) announced that Commissioner Rhonda K. Schmidtlein will step down on February 1, 2025. Commissioner Schmidtlein was sworn in on April 28, 2014 and...more

The Floodgates Have Opened: Supreme Court Scuttles Chevron, Brings New Uncertainty to Regulated Industries

For forty years, Chevron has put a thumb on the scales in favor of the executive agencies whenever their decisions were challenged in court. Now, the Supreme Court has overturned that longstanding precedent, issuing its...more

Hatch-Waxman Overview

The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, forms the current framework for the United States’ regulation of drug approvals. The law amended the Food, Drug, and...more

Federal Circuit Revamps Obviousness Test for Design Patents

In its recent en banc decision issued in LQK v. GM Global, the Federal Circuit overruled the Rosen-Durling test for design patent obviousness, jettisoning decades-old precedent and loosely outlining a design patent...more

Rethinking Interchangeability, Top Cases, and Battling Misinformation at FDLI’s Annual Conference

1 Last week, the Food and Drug Law Institute held its Annual Conference while also celebrating its 75th anniversary. There, members of FDA and industry players gathered to discuss the latest legal, policy, and regulatory...more

USITC Commissioner Series: The Court's FRAND Dance May Soon Reach its Finale

In prior posts for this series, we have discussed areas of law where Commissioners have voiced their dissent and demonstrated a clear divide among the decision-makers. But when it comes to Standard Essential Patents (SEPs),...more

USITC Commissioner Series: Top Dissenting Issues

Following my colleagues’ efforts in this series, this post examines the dissent/concurrence practice of the Commissioners at the U.S. International Trade Commission (USITC) – specifically the “hot” issues that drew the most...more

USITC Commission Series: Meet the (Vocal) Commissioners

As my colleagues Brian Johnson and Ian Swan reported in March, dissenting and concurring opinions in Section 337 Investigations, either as footnotes or separate opinions, at the International Trade Commission (ITC) have...more

USITC Commission Series: the Era of the Mini-Opinion Has Begun

At the International Trade Commission (ITC), every decision made by an Administrative Law Judge (ALJ) is subject to review by a panel of up to six Commissioners. In general, the Commission speaks as a unified voice through...more

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

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