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

Rhea-AI Summary

Marinus Pharmaceuticals reaffirms its commitment to defending its patent portfolio amidst an IPR challenge by Ovid Therapeutics related to the use of ganaxolone in treating seizure disorders. Marinus has invested over $100 million in ganaxolone development programs, yielding a strong patent portfolio supported by robust clinical data. The company believes the challenge is without merit and vows to vigorously defend its patents.

Insights

Intellectual Property Legal Expert

An ongoing Inter Partes Review (IPR) presents significant implications for the pharmaceutical industry, particularly concerning patent rights and commercial exclusivity. In the case of Marinus Pharmaceuticals, the defense of its patent for ganaxolone, a treatment for status epilepticus (SE), is paramount as it underpins the company's future revenue streams. The fact that Marinus has invested heavily in the development of this therapeutic underscores the potential financial impact of this IPR. The validity of patents can affect market dynamics, competition and investor confidence.

Marinus' strategic move to initiate a Patent Trial and Appeal Board (PTAB) post-grant review (PGR) against Ovid Therapeutics' competing patent suggests a proactive approach to protect its intellectual property. The relinquishment of claims by Ovid in response to the PGR indicates a potential weakness in their patent position, which could be favorable for Marinus. Investors should monitor the outcome of these legal proceedings as they will likely influence Marinus' market position and the commercial potential of ganaxolone. The final decision expected by mid-2024 will be a critical juncture for both companies involved.

Pharmaceutical Market Analyst

The patent dispute between Marinus Pharmaceuticals and Ovid Therapeutics over ganaxolone's use in treating SE is a key event that may impact the drug's market potential. With Marinus' emphasis on their robust clinical data and the strategic importance of their Phase 3 trial, the outcome of the patent challenges will have direct consequences on their ability to market ganaxolone exclusively. Exclusivity is critical in recouping R&D investments, which for Marinus exceeds $100 million.

Furthermore, the patent covers specific clinical dosing regimens, which are integral to the drug's therapeutic efficacy. If Marinus retains its patent rights, it solidifies its competitive edge in the SE treatment market. However, should the challenge by Ovid prove successful, it could lead to increased competition and potential generic entrants, diluting Marinus' market share and revenue potential. Stakeholders should consider the implications of the patent dispute's outcome on the company's valuation and future earnings.

Biotech Industry Analyst

The biotech sector is highly sensitive to developments in clinical trials and intellectual property rights. Marinus Pharmaceuticals' Phase 2 trial results for ganaxolone in refractory status epilepticus (RSE) and the ongoing Phase 3 trial are pivotal in demonstrating the drug's efficacy and safety. Clinical trials in the biotech industry are the cornerstone for FDA approval and market acceptance. Positive trial outcomes can lead to significant stock price movements and increased investor interest.

It is also important to recognize the strategic implications of patent protection in the biotech industry. Patents not only provide a competitive moat but also serve as valuable assets that can be leveraged for partnerships or licensing deals. The strength and breadth of Marinus' patent portfolio will be a determinant in their ability to secure such deals. The PTAB's preliminary view favoring Marinus could bolster investor confidence in the company's ability to defend its intellectual property, which is a critical component of its overall valuation.

RADNOR, Pa.--(BUSINESS WIRE)-- 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.

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.

Forward-looking statements in this press release involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, our ability to prevail in the IPR and PGR, the company’s ability to continue as a going concern; unexpected market acceptance, payor coverage or future prescriptions and revenue generated by ZTALMY; unexpected actions by the FDA or other regulatory agencies with respect to our products; competitive conditions and unexpected adverse events or patient outcomes from being treated with ZTALMY, uncertainties and delays relating to the design, enrollment, completion, and results of clinical trials; unanticipated costs and expenses; the company’s cash and cash equivalents may not be sufficient to support our operating plan for as long as anticipated; our ability to comply with the FDA’s requirement for additional post-marketing studies in the required time frames; the timing of regulatory filings for our other product candidates; clinical trial results may not support regulatory approval or further development in a specified indication or at all; actions or advice of the FDA or EMA may affect the design, initiation, timing, continuation and/or progress of clinical trials or result in the need for additional clinical trials; the size and growth potential of the markets for the company’s product candidates, and the company’s ability to service those markets; our ability to develop new formulations of ganaxolone or prodrugs; our ability to obtain, maintain, protect and defend intellectual property for our product candidates; the potential negative impact of third party patents on our or our collaborators’ ability to commercialize ganaxolone; delays, interruptions or failures in the manufacture and supply of our product candidate; the company’s expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; the company’s ability to obtain additional funding to support its clinical development and commercial programs; the potential for our ex-US partners to breach their obligations under their respective agreements with us or terminate such agreements in accordance with their respective terms; the risk that drug product quality requirements may not support continued clinical investigation of our product candidates and result in delays or termination of such clinical studies and product approvals; and the availability or potential availability of alternative products or treatments for conditions targeted by us that could affect the availability or commercial potential of our product candidate. This list is not exhaustive and these and other risks are described in our periodic reports, including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240327247358/en/

Investors

Jim DeNike

Senior Director, Investor Relations

Marinus Pharmaceuticals, Inc.

jdenike@marinuspharma.com

Media

Molly Cameron

Director, Corporate Communications & Investor Relations

Marinus Pharmaceuticals, Inc.

mcameron@marinuspharma.com

Source: Marinus Pharmaceuticals

FAQ

What is the purpose of Marinus Pharmaceuticals' commitment amidst the IPR challenge by Ovid Therapeutics?

Marinus is defending its patent portfolio related to the use of ganaxolone in treating seizure disorders.

How much has Marinus invested in ganaxolone development programs?

Marinus has invested over $100 million in ganaxolone development programs.

What does Marinus believe about the challenge from Ovid Therapeutics?

Marinus believes the challenge is without merit and vows to vigorously defend its patents.

What patents has Marinus been granted by the USPTO for intravenous ganaxolone in the treatment of SE?

Marinus was granted two method of use patents (U.S. 11,110,100 B2 and U.S. 11,679,117 B2) for intravenous ganaxolone in the treatment of SE.

What did Marinus' Phase 2 trial in RSE demonstrate about ganaxolone treatment?

Treatment with ganaxolone demonstrated rapid cessation of SE and led to sustained resolution of SE with a minimum plasma concentration maintained over at least eight hours.