RADNOR, PA — Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a leader in developing treatments for rare genetic epilepsies and refractory seizure disorders, is currently embroiled in a legal battle to protect its intellectual property rights. The dispute centers around U.S. Patent 11,110,100, which covers the use of ganaxolone in treating status epilepticus (SE) and refractory status epilepticus (RSE), conditions characterized by prolonged or repeated seizures.
The challenge to Marinus’s patent comes from Ovid Therapeutics, Inc., which filed an Inter Partes Review (IPR) on March 26, 2024. This process allows parties to contest the validity of a patent through the Patent Trial and Appeal Board (PTAB), a legal avenue that has become increasingly common in the fiercely competitive pharmaceutical industry.
“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.”
Marinus has been granted two method-of-use patents by the U.S. Patent and Trademark Office (USPTO) for intravenous (IV) ganaxolone in the treatment of SE between 2021 and 2023. These patents are pivotal, as they cover the clinical dosing regimen for patients suffering from SE, including those with RSE and super refractory status epilepticus. Marinus’s Phase 2 trial in RSE demonstrated ganaxolone’s effectiveness in rapidly ceasing SE, with findings indicating that maintaining a minimum plasma concentration of ganaxolone for at least eight hours led to sustained resolution of SE. These results form the foundation of the dosing regimen used in Marinus’s ongoing Phase 3 trial, the first randomized, controlled registration trial for this indication.
The genesis of this patent dispute can be traced back to Marinus’s first provisional patent application for ganaxolone in SE, filed in February 2015. Despite having no development programs for ganaxolone, Ovid filed a provisional patent application for its use in epileptic disorders in August 2016. In March 2023, Marinus initiated a post-grant review (PGR) to challenge Ovid’s SE patent for ganaxolone, seeking to invalidate it before the potential commercial launch of ganaxolone in SE. Ovid’s subsequent abandonment of most of their claims in response to the PGR underscores the contentious nature of this dispute.
This legal tussle highlights the critical role of patents in the pharmaceutical industry, where companies invest heavily in research and development to bring new therapies to market. Patents provide a period of exclusivity that helps recoup these investments and fund future innovations. However, the intricacies of patent law, especially in fields as complex as pharmaceuticals, often lead to disputes that can delay the availability of new treatments.
For patients suffering from SE and RSE, the outcome of this dispute could have significant implications. If Marinus successfully defends its patent, it may expedite the availability of ganaxolone as a treatment option. Conversely, prolonged legal battles can stall the drug’s market entry, affecting those in dire need of innovative therapies.
As the PTAB continues its review, industry watchers keenly await the final decision, expected by mid-2024. This case not only underscores the high stakes involved in pharmaceutical patent disputes but also reflects the broader challenges facing drug innovation and commercialization in today’s healthcare landscape.
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