Catalyst Pharmaceuticals Inc, a biopharmaceutical company, announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for US Patent Application Serial Number 14/340,749. The patent claims a method of treating Tourette's Disorder using the entire class of GABA-aminotransferase inactivators, including CPP-115 and vigabatrin (marketed in the US by Lundbeck as Sabril).

A Notice of Allowance is issued after the US Patent and Trademark Office (USPTO) determines that the prosecution of the merits of a patent has been completed. The patent can then be granted from an application upon payment of the issue fee. Catalyst expects the patent to issue in the next few months. Once issued, the patent would be expected to expire no earlier than its twenty-year term in January 2033. The expiration of this patent could also be extended by up to 5 years under the patent term restoration act, depending on the review and approval of a new drug application for a drug claimed in this patent and upon the indication approved for that drug.

Catalyst is the exclusive licensee from Northwestern University for US patent number 6,794,413 covering the composition of matter for CPP-115. Catalyst is also developing a generic version of vigabatrin tablets that could be used in a 505(b)(2) application for a new indication of Tourette's Disorder for vigabatrin by Catalyst or a development partner.

Patrick J. McEnany, chairman and chief executive officer of Catalyst, commented, "A strong intellectual property estate has always been a fundamental objective of the company and we are pleased by the Notice of Allowance for this patent application, which further enhances Catalyst's intellectual property around our CPP-115 drug candidate."

Tourette's Disorder (TD) occurs in all ethnic groups; males are affected three to four times more often than females. The Centers for Disease Control and Prevention (CDC) reported in 2009 TD prevalence estimates from a national, telephone-based survey in which they asked parents if their children had received a diagnosis of the disorder. The trial found that three of every 1,000 children have TD, but it is thought that this underestimates the true occurrence of the disorder. The prevalence of TD in adults is expected to be significantly less than in children as tic symptoms generally abate in later adolescence or early adulthood.

Tourette's Disorder (TD) is a neurodevelopmental disorder characterized by multiple tics, which are repetitive, non-rhythmic involuntary movements and vocalizations that persist for more than one year. Onset occurs in most children by about age five to six years. Some of the more common simple motor tics include eye blinking, facial grimacing, shoulder shrugging, and head or neck jerking. Common simple vocal tics, include grunting, throat clearing, coughing and squeaking. Among the most dramatic and disabling complex tics are those that result in self-harm, such as punching or poking oneself, or complex vocal tics such as coprolalia (uttering swear words) or echolalia (repeating the words or phrases of others). Many patients with TD experience additional neurobehavioral problems including inattention, hyperactivity and impulsivity, and obsessive-compulsive symptoms such as intrusive thoughts/worries and repetitive rituals.