Marinus Pharmaceuticals Comments on Patent Challenge by Ovid Therapeutics Inc. and Provides Update on Marinus’ Post Grant Review - Seite 2

Marinus’ first provisional patent application for ganaxolone in SE was filed in February 2015. In August 2016, Ovid filed a provisional patent application on the use of ganaxolone in epileptic disorders, despite having no ganaxolone development programs.

In March 2023, Marinus initiated a Patent Trial and Appeal Board (PTAB) post-grant review (PGR) challenging Ovid’s SE patent for ganaxolone (U.S. 11,395,817 B2) to invalidate the patent prior to Marinus’ potential commercial launch of ganaxolone in SE. Marinus’ petition for PGR argues that the claims of the Ovid ‘817 Patent are invalid and should not have been issued by the USPTO on multiple grounds, including that the claims were anticipated by Marinus’ existing patent application filed in February 2015, and that the claims were obvious over the prior art.

In response to Marinus’ request for PGR, Ovid abandoned 23 of the 31 claims in its patent. The Patent Office subsequently instituted the PGR on the remaining claims. Marinus believes Ovid’s swift action in relinquishing the majority of their claims underscores the merits of the PGR challenge. In instituting the PGR, the PTAB stated that it was more likely than not that Marinus would be able to invalidate the remaining eight claims of the Ovid ‘817 Patent. The PGR process is ongoing, and a final decision is expected by the middle of 2024. Marinus most recent filing in the PGR can be found here.

Marinus emphasizes its long-standing commitment to developing innovative therapies for patients with rare genetic epilepsies and refractory seizure disorders and remains focused on its mission to bring ganaxolone to patients in need.

About Marinus Pharmaceuticals
Marinus is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders. The Company first introduced FDA-approved prescription medication ZTALMY (ganaxolone) oral suspension CV in the U.S. in 2022 and continues to invest in the potential of ganaxolone in IV and oral formulations to maximize therapeutic reach for adult and pediatric patients in acute and chronic care settings. For more information about Marinus visit www.marinuspharma.com.

Forward-Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding Marinus, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "may", "will", "expect", "anticipate", "estimate", "intend", "believe", and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Examples of forward-looking statements contained in this press release include, among others, statements regarding the Marinus’ patent portfolio and the related IPR filed by Ovid and the PGR filed by Marinus; and other statements regarding the company's future operations, financial performance, financial position, prospects, objectives and other future events.