RMMS Secures Non-Infringement Win on ORACEA® (doxycycline) Capsules

April 1, 2024 | Small Molecules

Recently, RMMS secured a favorable decision on behalf of its client, Lupin, in connection with litigation involving Galderma Laboratories’ rosacea drug, Oracea® (doxycycline) capsules.

On March 22, 2024, Judge Stephanos Bibas of the U.S. Court of Appeals for the Third Circuit, sitting by designation for the District of Delaware, held that the asserted claims of U.S. Patent Nos. 7,749,532 and 8,206,740 were not infringed, either literally or under the doctrine of equivalents.  Following a three-day bench trial held in January 2024, Judge Bibas concluded that Galderma’s “confused, conflicted” infringement theory “masquerades speculation as science,” finding it to be unsupported by hard evidence.

This win marks the first successful challenge by a generic manufacturer to overcome the Oracea® patents, which have provided Oracea® a generic-free market for nearly 18 years.

RMMS attorneys appearing for Lupin included William A. Rakoczy, Joseph T. Jaros, Natasha L. White, Katie A. Boda, and Adrianne C. Rose.

About RMMS 

Headquartered in Chicago, RMMS is a full-service litigation and intellectual property law firm with over 30 attorneys devoted to litigation and counseling in life sciences, engineering and other complex technologies, including specialty practice in the field of patent and regulatory counseling and litigation under the Hatch-Waxman Act, the Medicare Prescription Drug, Improvement, and Modernization Act (MMA), and the Biologics Price Competition and Innovation Act (BPCIA).