Marinus Pharmaceuticals Comments on Patent Challenge by Ovid Therapeutics Inc. and Provides Update on Marinus’ Post Grant Review

Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to developing and commercializing innovative therapeutics to treat seizure disorders, today affirmed its commitment to defending its patent portfolio amidst an Inter Partes Review (IPR) challenge of U.S. Patent 11,110,100 from Ovid Therapeutics, Inc. filed on March 26, 2024. This challenge relates to a Marinus patent for the use of ganaxolone in treating status epilepticus (SE) and refractory status epilepticus (RSE). Marinus has multiple patents relating to ganaxolone for the treatment of SE and RSE.

“Over the past two decades, Marinus has invested more than $100 million into our ganaxolone development programs in SE,” stated Dr. Scott Braunstein, Chairman and CEO of Marinus. “That investment has yielded a strong patent portfolio, fortified by robust clinical data on the pharmacology and effective dosing of ganaxolone, and underscores our commitment to improving the lives of patients and families affected by seizure disorders. We believe this Ovid challenge is without merit and is an unfortunate distraction to the important work we do at Marinus. As a company grounded in scientific research, we will vigorously defend our patents which support our mission of delivering innovative new treatment options to patients with significant unmet needs.”

Between 2021 and 2023, Marinus was granted two method of use patents (U.S. 11,110,100 B2 and U.S. 11,679,117 B2) by the USPTO for intravenous (IV) ganaxolone in the treatment of SE. These patents cover the clinical dosing regimen for SE patients, including those with RSE and super refractory status epilepticus. In Marinus’ Phase 2 trial in RSE, treatment with ganaxolone demonstrated rapid cessation of SE and led to the insight that a minimum plasma concentration of ganaxolone that was maintained over a duration of at least eight hours produced sustained resolution of SE even as the rate of infusion was decreased. This effect was not demonstrated with shorter durations at the target concentration or with lower plasma levels. These findings are described in the Marinus ‘100 Patent and are the basis of the dosing regimen being used in Marinus’ Phase 3 trial in RSE, the first randomized, controlled registration trial that has been conducted in this indication.