The United States Patent and Trademark Office (USPTO) has denied a Petition for Reexamination concerning a patent covering the active ingredient in Harmony Bioscience’s narcolepsy drug Wakix (pitolisant). 

The petition was filed in July by Scorpion Capital, which made numerous claims, including that Harmony’s core patent was obtained via fraud and that the patentee misled the USPTO. Scorpion Capital asked the Patent Trial and Appeal Board to revoke the core patent for Wakix.

Following the USPTO’s decision, Harmony issued the following statement: 

“We are pleased that the [USPTO] rejected a challenge to the validity of claims within the patent covering the active ingredient in Wakix (pitolisant), in line with our expectations. This decision not only underscores our confidence in the strength of the Wakix patent portfolio but also reinforces our belief in the potential of the Wakix franchise. We continue to believe that Wakix represents a billion-dollar-plus opportunity in narcolepsy alone, with the potential to contribute up to an additional $1 billion dollars, if approved, in idiopathic hypersomnia and other current lifecycle management programs. We are proud of the work we do every day to address the unmet medical needs of patients living with rare neurological diseases.”

Scorpion Capital announced in a social media post today that it will be petitioning the USPTO’s ruling. 

Wakix, a first-in-class medication for the treatment of excessive daytime sleepiness or cataplexy in adult patients with narcolepsy, has been commercially available in the US since Q4 2019. Wakix was designed and developed by France-based Bioprojet. Harmony has an exclusive license from Bioprojet to develop, manufacture, and commercialize pitolisant in the US.

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