January 2026 – Duane Morris Life Sciences Law

January 21, 2026January 21, 2026 by Jason Luo, Ph.D.

U.S. Supreme Court Grants Certiorari in Hikma v. Amarin, Placing “Skinny Label” Inducement in Focus

On January 16, 2026, the Supreme Court of the United States granted certiorari in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. (No. 24-889) to address when induced-infringement liability can attach to a generic drug launched under a “skinny label.” The grant centers on review of the Federal Circuit’s decision allowing Amarin’s inducement claims to proceed notwithstanding Hikma’s carveout, and it tees up the relationship between the Food and Drug Administration’s (FDA) carveout pathway and 35 U.S.C. § 271(b).

Read the full Alert on the Duane Morris LLP website.

January 7, 2026January 13, 2026 by Duane Morris

FDA Launches the TEMPO Pilot for Digital Health Devices to Improve Patient Access to Technologies

By Vicki G. Norton, Ph.d., Frederick R. Ball and Victoria (Tori) Hawekotte

The U.S. Food and Drug Administration has announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, through which FDA would exercise enforcement discretion over participant manufacturers’ digital health devices to improve patient access to digital health technologies. By exercising enforcement discretion, FDA would allow device manufacturers to forego certain marketing requirements, such as labeling and premarket authorization, while participating in the pilot program.

Read the full Alert on the Duane Morris LLP website.