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
4/17/2025
/ Corporate Taxes ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Income Taxes ,
Internal Revenue Code (IRC) ,
IRS ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Industry ,
Tax Appeals ,
Tax Deductions
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
2/12/2025
/ Appeals ,
Enforcement Actions ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
International Trade Commission (ITC) ,
Investment ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Section 337 ,
Technology Sector ,
Trade Remedies
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
1/20/2025
/ Antitrust Provisions ,
Biden Administration ,
Cease and Desist Orders ,
Enforcement Actions ,
Imports ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
International Trade Commission (ITC) ,
Regulatory Agenda ,
Regulatory Reform ,
Trade Policy ,
Trade Relations
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
7/10/2024
/ Administrative Procedure Act ,
Chevron Deference ,
Chevron v NRDC ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Judicial Authority ,
Loper Bright Enterprises v Raimondo ,
Regulatory Authority ,
Relentless Inc v US Department of Commerce ,
SCOTUS ,
Statutory Interpretation
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
6/14/2024
/ Abbreviated New Drug Application (ANDA) ,
Drug Pricing ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Hatch-Waxman ,
Life Sciences ,
Medicare Modernization Act ,
Orange Book ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
USPTO
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
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
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
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
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
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
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
3/7/2024
/ Abbreviated New Drug Application (ANDA) ,
Chevron Deference ,
Chevron v NRDC ,
Drug Design ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
International Trade Commission (ITC) ,
Medicare Modernization Act ,
Nutritional Supplements ,
Prescription Drugs ,
SCOTUS